chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shivering; is real hot; stuffy nose; nausea; arm has lump on it; can't even lift arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (shivering), HOT FLUSH (is real hot), NASAL CONGESTION (stuffy nose), NAUSEA (nausea) and SKIN MASS (arm has lump on it) in a 75-year-old female patient 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 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (shivering), HOT FLUSH (is real hot), NASAL CONGESTION (stuffy nose), NAUSEA (nausea), SKIN MASS (arm has lump on it) and MUSCULAR WEAKNESS (can't even lift arm). At the time of the report, CHILLS (shivering), HOT FLUSH (is real hot), NASAL CONGESTION (stuffy nose), NAUSEA (nausea), SKIN MASS (arm has lump on it) and MUSCULAR WEAKNESS (can't even lift arm) outcome was unknown.      No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-037683 (E2B Linked Report).; Sender's Comments:  MOD21-037683:cross link
Patient became hypotensive, bradycardic and diaphoretic. AOX4, GCS 15. Airway uncompromised.
101.1 Fever; chills; body aches; headache; Eye twitching; Fatigue; This is a spontaneous report from a contactable nurse (patient). An adult non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in left arm on 06Jan2021 10:45 at single dose for covid-19 immunization in hospital. Medical history included were none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There was no allergies to medications, food, or other products. The patient's concomitant medications were not reported. There was no other vaccine in four weeks. The patient previously took first dose of bnt162b2 on 16Dec2020 05:00 PM via intramuscular in left arm for covid-19 immunization. The patient experienced 101.1 fever, chills, body aches, headache, eye twitching, fatigue on 06Jan2021 16:00. The events were non-serious. The events did not result in emergency room or physician visit. There was no treatment for the events. The outcome of the events was resolving.     Information on the Lot/Batch number has been requested.
breathing difficulties (SOB, lips turned blue, stopped breathing for 20sec);fever 103 APAP given;high pitched crying for 4hr;call to MD;
Once I stopped taking ibuprofen/acetaminophen, at noon on Friday, I developed an intermittent low-grade fever (around 100.5), intense body aches, fatigue and nausea, and the injection site was swollen, red and hot to the touch. These symptoms continued through four days after the day of injection. Most symptoms are gone now, but my arm is still swollen, tender, warm to the touch and bruised. It sometimes aches enough that I need to take ibuprofen.
Nausea and vomiting, intractability of vomiting not specified, unspecified vomiting type  Diarrhea, unspecified type  Right lower quadrant abdominal pain  Elevated liver enzymes IMPRESSION:  1. There is inflammation and small amount of free fluid in the right upper quadrant adjacent to the gallbladder neck, right lobe of the liver and hepatic flexure of the colon. The gallbladder appears to be distended with associated mucosal hyperenhancement and question of gallbladder folds versus stones in the region of the gallbladder neck. This could represent findings of early acute cholecystitis. Recommend right upper quadrant ultrasound to better assess. Other causes of inflammation in the right upper quadrant such as diverticulitis, colitis or duodenitis are considered less likely.  2. Moderate urinary bladder wall thickening, which seems slightly greater than expected for incomplete distention with relatively normal size of the prostate gland. Recommend correlation with urinalysis to assess for possible cystitis.  3. Normal appendix.  4. Diffuse fatty infiltration of the liver.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021 at 8:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 8:54 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.72  No concomitant medications were reported. Batch number 019B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit at 8 AM. This vial was moved to fridge on 23-03-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 31-Mar-2021. 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 medications were reported.  This case was linked to MOD-2022-566976 (Patient Link).
Fever 100F, Abdominal pain, Myalgias, Headaches, Chills: within 6 hours of vaccine.
Large area of swelling, pink-red with central red streaks left thigh about 5 cm medially and inferiorly to injection site. Rx given for Augmentin for possible cellulitis.
Adverse event: tenderness and swelling at site of dermal filler (both cheeks of the face).   Treatment: none.  Time course: symptoms started approximately 48 hours after vaccination and lasted for approximately 36 hours.
Scratchy throat, dizziness, faint feeling. Progressing to lip swelling and difficulty breathing.
right arm has been red, swollen, itchy, and slightly painful at the site of my YF vaccine, approximately 5-6cm in size
Two hours after receiving vaccine started having tingling and numbness in feet. On 7/18/19 started affecting calves, knees, and hands sporadically.
Seizure like activity, shaking and brief loss of consciousness. Called 911, transferred to local hospital.
Patient states that on evening of vaccination she noticed decreased range of motion in her arm. She visited MD and they were not concerned, told her it would improve w/time. Symptoms are continuing to improve.
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (BUD: Nov 1, 2021 but administered vaccine on Jan 16, 2022) and product storage error (stored all of the Moderna vaccines in refrigerator and administered past the BUD date) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011F21A) for COVID-19 immunization. No medical history reported. On Jan 16, 2022, patient received the fourth dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 16, 2022, patient administered expired product (BUD: Nov 1, 2021 but administered vaccine on Jan 16, 2022). On an unknown date, patient experienced product storage error (stored all of the Moderna vaccines in refrigerator and administered past the BUD date). At the time of the report, administered expired product (BUD: Nov 1, 2021 but administered vaccine on Jan 16, 2022) and product storage error (stored all of the Moderna vaccines in refrigerator and administered past the BUD date) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, one of the providers stored all of the Moderna vaccines in their refrigerator and administered past the BUD date. BUD date: Nov 1, 2021. Expiration date: Mar 19, 2022.
coma; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 manufacturer unknown), for COVID-19 immunization. The following information was reported: COMA (medically significant), outcome "unknown".  Clinical information: Caller seemed upset regarding the Pfizer COVID 19 vaccine saying this is not truly a vaccine. That is just kicked you guys out and said that you're going to pay for his daughter who is in a coma since she took her second Pfizer shot. It doesn't even work, it doesn't prevent COVID. You don't even know what's in the vaccine.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 06-NOV-2017, the patient received an expired improperly stored dose of VARIVAX lot # L042266 and expiration date 27-OCT-2017 for prophylaxis (strength, dose, anatomical location, route of administration were not reported) with sterile diluent (lot number and expiration date were not reported). It was reported that on an unspecified date, the vaccine and the sterile diluent were exposed to a temperature of 35 degrees Fahrenheit for 23 hours. The reporter stated that there was no previous temperature excursion. It was unknown by the reporter if the call was placed because of a Digital Data logger report.
pt received 2 2nd doses of the moderna covid19 vaccine in the same right deltoid
Sickness; vaccination site pain; tiredness; cough; muscle pain; chills; joint pain; shaking last night; feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp.   A 66-year-old male patient received bnt162b2 (BNT162B2(Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 29Apr2021 as 2nd dose, single for covid-19 immunisation. Medical history included influenza. There were no concomitant medications.  Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered (Batch/Lot Number was unknown) as single dose for covid-19 immunisation. It was reported that, Caller would state that he received the second dose of the Pfizer Covid-19 vaccine yesterday morning (9 o clock) On unknown date of 2021 and he has been experiencing injection site pain, tiredness, cough, muscle pain, chills, joint pain, feeling unwell, he was shaking last night and took some Aspirin. Stated that he does not have a fever today and he did not experience this symptom after receiving the first dose. The first dose he had almost no symptoms other than tiredness which was manageable. He says yesterday and all night he had them. Vaccine clarified to have been the second dose of the Pfizer COVID-19 vaccine. He says he has almost every single one of the side effects listed on the brochure in the last 24 hours, and he would like to know if he should panic now or wait. He says that the last time he was this sick was when he got a case of the flu. Therapeutic measures were taken as a result of, shaking last night (tremor). The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Menveo was given instead of Bexsero; patient had received the Menveo booster already; This case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXH7108, expiry date unknown) for prophylaxis.   Previously administered products included menveo (booster already when patient  was 16 year of age).   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 9-Aug-2022 Reporter's Comments: The reporter stated that an additional dose of Menveo was administered to a 18 year old a patient that was scheduled for a dose of Bexsero and Menveo was given instead. The patient had received the Menveo booster already when she was 16 year old and no adverse events were reported by prescriber or patient, the reporter thinks it was a nurse mistake as she prepared and administered the wrong vaccine. The reporter did not give consent to follow up. Additional Supportive Information: The patient had received the Menveo booster already which leads to extra dose administered. Menveo was given instead of Bexsero which leads to wrong vaccine Administered
Patient presented with a potential reaction to the COVID19 vaccine. I was called to his vehicle in the vaccination tent. The patient had a witness vasovagal with true syncope. The patient was roused within 2 seconds and was responsive. He was moved to the monitoring area, placed in the supine position, and closely observed. He was given aggressive oral hydration.
have diarrhea since Monday; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (have diarrhea since Monday) in a female patient of an unknown age 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 29-Mar-2021, the patient experienced DIARRHOEA (have diarrhea since Monday). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Diarrhoea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (have diarrhea since Monday) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.
Pt devel unconsolable crying over 5 hrs so far; 16APR continues to be fussy; On APAP q 3-4hrs while awake; Phoned MD who advised witholding future Pertussis;
RECURRENT NOSE BLEEDS; WEIRD SENSATION IN HEAD; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced recurrent nose bleeds. On 2021, the subject experienced weird sensation in head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from recurrent nose bleeds, and weird sensation in head. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.
Soreness at injection site- immediate lasting 1 day; Headache- 24 hours after lasting 8 hours; Pain under arm/ lymph nodes- began 12 hours after injection, lasting 2 days  Patient used warm compresses where pain was- did not provide much relief.
8 x 9 cm of erythema on the right thigh and 12 x 9 cm on the left -> Cellulitis of lower extremity. Cephalexin 500mg 3 times daily for 10 days was prescribed for treatment.
Patient states had 3 days of fever, at times as high as 104, finally better after 3 days. Patient took OTC acetaminophen.
Patient received DT on 6/1/09. Started feeling ill 6/2/09; i.e. HA, fatigue, red sore arm. On 6/3/09 had significant episode of dyspnea with headache and sore neck. Temp 99 degree on 6/5/09 and large local patch at injection sire. Started PREDNISONE on 685/09. Recovered by 6/8/09.
patient inadvertently received both ActHib and Pentacel same day during visit/ no AE; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 months old male patient who received vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB (PRP/T) VACCINE [ACT-HIB].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 29-May-2019, the patient received a 0.5ml dose of suspect HIB (PRP/T) VACCINE lot UI900AA, expiry date 08-Oct-2019 via intramuscular route in the right thigh. On 29-May-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ100AA, expiry date 13-Jun-2020 via intramuscular route in the left thigh.  It was an actual medication error due to extra dose administered.  It was reported that p patient inadvertently received both ActHib and Pentacel same day during visit.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
couldn't sleep for days; increased sweating; had headache; increased blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep for days), HYPERHIDROSIS (increased sweating), HYPERTENSION (increased blood pressure) and HEADACHE (had headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (couldn't sleep for days), HYPERHIDROSIS (increased sweating), HYPERTENSION (increased blood pressure) and HEADACHE (had headache). At the time of the report, INSOMNIA (couldn't sleep for days), HYPERHIDROSIS (increased sweating) and HEADACHE (had headache) outcome was unknown and HYPERTENSION (increased blood pressure) had resolved.            Concomitant medications included medication for increased blood pressure. It was reported that patient had to double her blood pressure medication after her booster shot. No treatment information provided.   This case was linked to MOD-2022-648645.   Reporter did not allow further contact
Injection site swollen, painful,  very warm to the touch, itchy, a few small bumps, large red circle around injection site
had chills, sweat, body aches, joint pain, headache. by Sunday I was fine and then Tuesday I developed the worst headache of my life and my face swelled up and my eyes got puffy and I was really sick. I had joint pain and sweats and chills again.
This spontaneous report as received from a Licensed Practical Nurse refers to 4 year old male patient. The patient previously received one dose of measles virus vaccine live (Enders-Edmonston) mumps virus vaccine live (Jeryl Lynn) rubella virus vaccine live (Wistar RA 27/3) (M-M-R), one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 12-JUL-2018 the patient was vaccinated with improperly stored PROQUAD from lot R003292 dose 1, subcutaneous in the left arm for prophylaxis (Product storage error). On the same day, the patient was also vaccinated with KINRIX from lot 53NB2 dose 1, intramuscular in the right arm for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The reporter was not sure which sterile diluent (manufacturer unknown) lot numbers were used.  The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1807USA007589.