chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Healthcare worker refers to an unspecified patients of unknown demographics. It was reported that on an unknown date since December 2014 the patients were vaccinated with improperly stored MMR II (dose, route, lot # and frequency unspecified). No concomitant medications were reported. Healthcare worker stated that on an unknown date, some complaints may have been made with regards to sore arms but that's nothing out of the ordinary. Healthcare worker could not provide information regarding any specific patient (s) who may have experienced the symptom. She stated that they "always" received complaints regarding sore arms after administration of vaccines. No further information was provided. The outcome of sore arm and incorrect product storage was unknown. Causality assessment for the event sore arm not reported. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Headache, Body aches, Chills  Subsided 24hrs post vaccine.
Recurrent diarrhea at 9:40 AM, 10 AM, 10:15 AM, 10:20 AM, 10:55 AM, 2 PM, 6 PM, 6:45 PM, 6:55 PM, 7:10 PM, 7:20 PM, 8:25 PM, 8:45 PM, 11 PM.  Low-grade fever, headache, chills.  On liquid diet throughout.
was administered the medication at -2 degrees Celsius; No additional AE; This spontaneous report was received from a consumer referring to (herself) a 23-year-old female patient. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On unknown day(reported as 'about one month ago'), the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (1 dosage form, exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis(Prodct storage error).  On unknown dates, the suspect vaccine experienced a temperature excursion of -2 degrees Celsius for 72 hours. No additional adverse events (AEs) or product quality complaints (PQC) were reported (No adverse event).
My adverse event started on 11/17/2022 in the morning. I had headache, fatigue, pain, swelling, and nausea. I went to the doctor on 12/19/2022.  She was an ENT. She said I had Sinus Infection. She prescribed me with Benzonatate for cough and also antibiotic. It's for 10 days.   I have another appointment tonight  and I haven't recovered yet.
Severe pain started within 1 hour of injection. No swelling or redness, but marked immobility of left shoulder. Ortho consult 10 days later when still incapacitated -- dx subacromial bursitis from vaccine.  Pt reported vaccine given very high on shoulder. Medrol dose pack and NSAIDs and PT given. Dx of SIRVA.
no adverse event; products experienced supported temperature excursion; This spontaneous report was received from medical assistant and referred to a patient with unknown gender and age. The patient's medical history, current condition, concomitant therapy, drug allergy or reaction was not provided.  On 21-MAR-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) VIAL 2, administered 2mL/once, oral (strength not provided) (lot # 1742464 with expiry date 20-SEP-2022) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5mL/once (strength and route not provided) (lot # u014992 with expiry date 29-OCT-2023) after products experienced supported temperature excursion (Incorrect product storage). Both vaccines for prophylaxis. There was no additional adverse event.
Pfizer-BioNTech COVID-19 Vaccine swollen lymph nodes around collar bone and neck. First started noticing them that night. There were two swollen. 2 days later, 3 new lymph nodes swollen. It has been about 2 weeks and lymph nodes still swollen
Covid arm, severe swelling arm, under arm, breast. had in leg for second shot. Covid rash again and dubsrquent bruising . both approximately 6 inches in diameter
Intense, life threatening inflammatory neuropathy commencing on 10/10/2021 and continuing to this day.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. The nurse reported that there had been an unspecified number of patients either late for their second or third dose of GARDASIL (lot # unspecified). The nurse could not provide any patient specific details at the time of the call. No adverse event reported. The therapy start dates were not reported. Additional information is not expected.
The patient received Daptacel and not Adacel with no adverse event; four week old patient received Daptacel, Ipol, and ActHIB with no adverse event; Initial information received on 30-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Media Information (under reference 00878770).  This case involves a 34 days old male patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of Adacel (wrong product administered), also received HIB (PRP/T) VACCINE [ACT-HIB] and IPV (VERO) [IPOL] (Product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Merck ROTAVIRUS VACCINE and Pfizer PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) [lot and expiration date were not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On 08-Nov-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (ORAL SOLUTION IN SINGLE-DOSE CONTAINER, Total, lot C5774CA and expiration date: 18-Sep-2022) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received dose of suspect HIB (PRP/T) VACCINE and dose of suspect IPV (VERO) [lot number and expiration date were not reported] via unknown route in an unknown administration site for prophylactic vaccination  It was a case of an actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration (same day latency).  It was reported "A four week old patient received Daptacel and not Adacel, Ipol, and ActHIB and she would like to know how to proceed with the patient."  At time of reporting, no adverse event 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.  There will be no information available on the batch number for IPOL and ACT-HIB.
On 1/5/2021, I woke up with severe abdominal pain that I went to the urgent care first 2:00 pm 1/6/2021 the doctor there sent me to the er . In the Er They did am MRI and blood work and said there was nothing wrong with me and they couldn?t explain my 9/10 pain. I followed up with my regular doctor about 4 days later she could also not explain my pain. I explained to the urgent care, the er and my regular doctor that I revived the covid moderna shot on 1/4/2021 and that fact was disregarded by each doctor.
he had a stroke late week and is 99% percent sure it was due to the COVID vaccine.; This is a spontaneous report from a contactable male consumer reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single, for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced stroke on an unspecified date patient stated, he had a stroke late week and was 99% percent sure it was due to the covid vaccine. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Moderna COVID 19 Vaccine EUA  Patient admitted for planned total knee arthroplasty.  No complication and discharged as planned
Was very tired the next day and took a 2 hour nap around 2 pm, feeling better after waking. Vertigo started the following afternoon and by the 24 hour mark was totally incapacitating.  I couldn't stand any noise or light and became overwhelmingly  nauseous with vomiting occurring around 8 pm.  After sleeping for an hour the nausea was gone but the vertigo remained to the point where I needed assistance to safely get to the bathroom.  By about 11 pm the vertigo subsided significantly and I was able to walk unaided again. I slept for 11 hours and today (Feb 13, 2022) I'm only feeling somewhat tired.
first shot in DEC-2021, missed the second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in december 2021).   On an unknown date, the patient receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 6-JUL-2022 Reporter's Comments: The patient just realized that he/she missed the time schedule for second shot. It's been over 7 months since his/her first dose. The patient wanted to know if there any risk of it and recommendation.  Additional supportive information: As patient did not receive 2nd dose of Shingles vaccine as per recommended interval, which led to incomplete course of vaccination.
body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) 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 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced MYALGIA (body aches). At the time of the report, MYALGIA (body aches) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
I did not sense any vaccine being injected on my 2nd shot. Was it just a saline shot?
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE and BLOOD PRESSURE INCREASED in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 011J20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included METOPROLOL TARTRATE, LISINOPRIL, SIMVASTATIN, CLOPIDOGREL, CALCIUM CARBONATE, VITAMIN D, ZINC, and DOXYCYCLINE MONOHYDRATE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced MALAISE and BLOOD PRESSURE INCREASED. At the time of the report, MALAISE and BLOOD PRESSURE INCREASED outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement: 161/102 (High) (his normal range was 160/72). On 11-Mar-2021, Heart rate: 67 (Inconclusive) bpm.         Concomitant medications included clear lungs extra strength two a day. No treatment information was provided.
left breast swollen; Numbness in both hands; Both hands swollen; Coughing; Super weak; Really tired; Severe headache; Left Armpit  swollen and shooting pain; The shot site(upper left arm) started hurting within 12 hours and could not touch or sleep on left side; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150) via an unspecified route of administration in the left arm on 04Apr2021 at 12:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient reported of no known allergies to medications, food, or other products. Concomitant medications included paracetamol (TYLENOL EXTRA-STRENGTH) and clonazepam (MANUFACTURER UNKNOWN) 1mg three times a day and more pharma (unspecified) for an unknown indication and from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 within 12 hours after vaccination, the patient experienced shot site hurting (upper left arm) and reported that she could not touch or sleep on the left side. The patient reported that it did hurt when she tried to use her left arm. On 05Apr2021 at 20:00, the patient experienced left armpit and breast swollen and shooting pain, numbness in both hands, both hands swollen, coughing, super weak, really tired and severe headache. It was unknown if any therapeutic measures were taken as a result of the reported events. The event resulted in doctor or other healthcare professional office/clinic visit on 06Apr2021 at 14:45. The clinical outcome of the event left armpit and breast swollen and shooting pain, numbness in both hands, both hands swollen, coughing, super weak, really tired, severe headache and shot site hurting were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
The adverse event, not including some slight pain and fatigue right after, is mild in nature. However, I felt it was appropriate to report anyhow. From the research I have read, I believe it's called "Covid Arm." I have had no symptoms since two days after and now, suddenly this morning, my arm was tender to the touch again and there was some redness around the injection site.
Chest pain down right arm into right hand, radiating down into abdomen.  Symptoms started 0800 hours 06/17/2021.  Symptoms returned 06/18/2021 at 0600 hours.   Emergency Department visit Dx: STEMI Treated with IV heparin and metoprolol
urticarial rash 2 days p/vax; only seen by mom spontaneous recovery w/o need for office visit;
I also had a steroid shot in my hip 2 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (I also had a steroid shot in my hip 2 weeks ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pneumonia (hospitalized with pneumonia in past.). Concurrent medical conditions included Brain cancer metastatic, Autoimmune disorder NOS and Asthma.   In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 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 MUSCULOSKELETAL DISCOMFORT (I also had a steroid shot in my hip 2 weeks ago). At the time of the report, MUSCULOSKELETAL DISCOMFORT (I also had a steroid shot in my hip 2 weeks ago) outcome was unknown. Not Provided          No concomitant medications was reported. Patient received unspecified steroid as treatment medication. It was reported that, The patient did not feel protected and had hospitalized with pneumonia in the past and patient don't want to repeat visit with COVID-19.
7.5 x 9.5 erythema and warmth on upper left thigh.
Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Kinrix and Boostrix. On an unknown date, an unknown time after receiving Kinrix and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21 Mar 2023 A medical assistant reported that Boostrix and Kinrix vaccines were exposed to 47.4 degree F and 30.2 degree F.The health care professional mentioned that the temperature probe was placed too close to the cooler. The some of these vaccines were administered, and asked if patients had to be re-vaccinated. The reporter did not share information about patients who received these doses nor information about Boostrix and Kinrix vaccines (lot number, date of administration, expiry date). Permission for follow up was not requested.
About 5-7 mins after immunization, patient started to complain of not being able to hear and see. I gave him and ice pack and made him lay down to see if that would help for about 30-45 secs. Then complained of nausea. I listened to his lungs and was wheezing throughout, B/P: 60/ 40, HR was 74. He was diaphoretic and pale. After about 3-5 mins after giving epi, b/p was 90/60, clear lungs, hearing and vision changes resolved.
This spontaneous report as received from a health care professional refers to an unspecified number of patients of unknown age and gender who since 08-SEP-2014 had been vaccinated with COMVAX (dose, route, lot # and expiration date were not provided) which were exposed to temperatures outside of the recommended range and assessed for stability. No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Swollen elbow and lower biceps. Very painful to light touch and hot.  Had high fever all day since.
Received flu shot on 10/10/14 and fever started on 10/12/2014 and SPIKED at 103.5 degrees Mon 6 AM 10/13/2014 again fever rose to 103.5 degrees early MON AM. AFLURIA Syringe by CSL lab via Pharmacy.
Covid Arm - Red Raised Lesion 2 in. By 2 in. At Injection Site, Erythema, Itching, Warm To Touch, Hives.
Muscle pain, muscle cramps, muscle spasms; headache; alternating shivering and fever; swelling at injection site, redness at injection site.
Client had pressed her call pendant this morning (2/18/2021) at 0750, LPN found client in her bed unable to stand. Client reported she had to use the restroom, upon standing client, LPN noticed blood on client's pillow. After assisting with ambulation to her bathroom, LPN noticed blood covering the floor near her shower. After further assessment, blood appeared to me coming from the back of client's head. Vital signs assessed while she sits on the toilet.  BP: 128/92 O2: 89% on RA RR: 18 HR: 69 T: 99.1 Client reported significant dizziness, lightheadedness, and nausea. She reported unsteadiness when standing. Quarter sized lump with dried blood noted on the back of client's head. She does report left arm soreness, likely from where vaccine was administered. Ambulance was contacted while LPN assisted dressing client. Client was unable to recall the incident that occurred overnight, she did not utilize her call pendant during initial fall. Time of fall/incident unknown.
Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Apr2021 10:00 (Batch/Lot number: unknown) at the age of 51 years as dose 2, single and administered in arm left, administration date 02Apr2021 10:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin when i was young. Concomitant medication(s) included: IBUPROFEN. The following information was reported: TINNITUS (non-serious) with onset 04Apr2021, outcome "not recovered", described as "Tinnitus". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus.  Additional information: The facility where the most recent COVID-19 vaccine was administered pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnosed with COVID-19, Since the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts completed. No further information is expected.
Next day after receiving zoster vaccination, patient experienced welts/swelling under L eye, redness, no blurred vision, no pain, no itching.  Called Triage line.
Patient received expired second dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired second dose of the Moderna vaccine) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired second dose of the Moderna vaccine). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired second dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-338604 (Patient Link).
Two - inch diameter bruise, with small amount of swelling. Patient says entire left arm is sore. Shot appeared to be given 2 inches below actual deltoid muscle. Shot was given on 9/6/11 & I spoke with patient 9/11/11.
L upper arm swollen, red x 6x6 1/2 cm, very tender, WBC 12.8, T 98.8F,  placed on Keflex
Diarrhea and flu-like symptoms. Though may be developing dairy allergy. Changed diet. Symptom got worse. No bowel control. Diagnosed with ulcerative colitis. Attempted to control with medication. Still resulted in surgery to remove colon and appendix. Had ileostomy and pouch for several months before j pouch and closure surgeries.
Patient came into pharmacy the day after her PNEUMOVAX injection complaining of severe pain and inflammation on arm of injection for PNEUMOVAX.
Patient received Pfizer dose #1 on  5/28/21, dose #2 on 6/18/21 and booster dose on 8/23/21.  Patient received their booster dose to early.   At this time there has been no adverse events reported to us by the patient.