chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Confirmed with customer no other AE occurred; a dose of ROTATEQ was administered to a patient after a temperature excursion; This spontaneous report was received from a medical assistant referring to a 10-week-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 04-OCT-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) oral, lot number 1707486, expiration date 20-MAR-2022 (dose not reported) for prophylaxis. No adverse event was reported.  The vaccine underwent a temperature excursion of 32.9 degrees Farhrenheit for 24 hour. No previous temperature excursions were detected.
Significant redness, swelling, and tenderness at injections site, then hives. Treated with Keflex for possible super infection and Benadryl for hives.
At approximately 2:00 AM I woke up with body aches, a very bad headache, and chills.  These symptoms continued for the next twelve (12) hours and disrupted my ability to function normally.
Could not move their legs; Legs were shaky shaky shaky/Hands were trembling and shaking; Tender arm; A spontaneous report was received from a consumer concerning a 96-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced not being able to move her legs, legs were shaky, hands were trembling and arm was tender.  The patient's medical history included dementia. Concomitant medications were not mentioned.   On 04 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 031120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06 Mar 2021, approximately a day prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Mar 2021, prior to receiving mRNA-1273, the patient could not move her legs and  noticed her legs were shaky. Patients daughter had to help her to get up. Hands were trembling and shaking (could not drink from a glass of water and had to use a straw).  it affected her muscles; her legs were like jelly. She is in mild mid-stage of dementia but it had no impact on that level. She only had a tender arm after the first dose. Treatment for the events was not mentioned.   Action taken with mRNA-1273 in response to the events is not applicable as both doses of the vaccine have been taken.   The events, legs were shaky,hands were trembling, were considered resolved on 08 Mar 2021 and outcome of arm tenderness was unknown.; Reporter'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.
FLUZONE QIV NP PFS, reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no reported adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA057733 and 2023SA057309.  This case involves adult patient of an unknown age and gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.  It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  Action taken: not applicable.  Outcome:  Unknown for both the reported events   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 guidelines. 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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
swelling of both ankles,  both knees and right elbow; rash; read blotches on ankles and blister; read blotches on ankles and blister; product=COVID 19, brand=Pfizer; prev dose brand=moderna; Moderna: 02Oct2022; Pfizer Bivalent: 02Oct2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 at 15:00 as dose 5 (booster), single (Lot number: GJ6739) at the age of 77 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Oct2022 as dose 4 (booster), single (Lot number: 056M21A), in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 30Sep2022 as unk, single. Vaccination history included: moderna (DOSE 1, SINGLE; Lot No: 025J20-2a; anatomical location: Arm Right, Administration Time: 04:00 PM), administration date: 28Jan2021, when the patient was 76-year-old, for Covid-19 Immunization; moderna (DOSE 2, SINGLE;  Lot No: 013a2121A; anatomical location: Arm left, Administration Time: 04:00 PM), administration date: 25Feb2021, when the patient was 76-year-old, for Covid-19 Immunization; moderna (DOSE 3, SINGLE;  Lot No: 066d21a; anatomical location: Arm left, Administration Time: 12:00 PM), administration date: 23Aug2021, when the patient was 76-year-old, for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 02Oct2022, outcome "unknown", described as "Moderna: 02Oct2022; Pfizer Bivalent: 02Oct2022"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 02Oct2022 at 15:00, outcome "unknown", described as "product=COVID 19, brand=Pfizer; prev dose brand=moderna"; RASH (non-serious) with onset 03Oct2022 at 08:00, outcome "recovered"; RASH MACULAR (non-serious), BLISTER (non-serious) all with onset 03Oct2022 at 08:00, outcome "not recovered" and all described as "read blotches on ankles and blister"; SWELLING (non-serious) with onset 08Oct2022, outcome "not recovered", described as "swelling of both ankles,  both knees and right elbow". The events "read blotches on ankles and blister", "swelling of both ankles,  both knees and right elbow" and "rash" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash macular, blister, swelling, rash.  Additional information: There were no known allergies. Patient received antibiotics followed by prednisone.
Pulmonary Emboli, unprovoked, diagnosed on the 19th. Vaccine administered on the 15th
This case was reported by a consumer via call center representative and described the occurrence of cellulitis of arm in a 10-year-old male patient who received FLUARIX QUADRIVALENT (batch number TP225, expiry date 30th June 2014). On an unknown date, the patient received FLUARIX QUADRIVALENT .5 ml. On 9th October 2013, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced cellulitis of arm (serious criteria GSK medically significant) and swelling arm. The patient was treated with antibiotics unknown. On an unknown date, the outcome of the cellulitis of arm and swelling arm were unknown. The reporter considered the cellulitis of arm and swelling arm to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follow: Vaccine Service Rep reported that HCP received the vaccine FLUARIX QIV. Pt. reports swelling of the arm. Pt. went to the ER and doctors diagnosed as cellulitis. Pt. received antibiotics. Correction following the clarification received on 13 August 2015: This case was reported by a nurse via call center representative and not by a consumer as previously reported.
This spontaneous report was received from a female nurse of unknown age, reporting on herself.  No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the nurse was attempting to withdraw the vaccine from the single dose vial of PNEUMOVAX 23 lot # R022879, expiring on 02-AUG-2020 , when it "exploded" and the liquid forcefully expelled from the vial and hit the nurse in the hands and face (accidental exposure while preparing drug for administration). At the time of the report, the nurse was completely fine, and suffered no adverse effects from the incident.
all I had was a little sore arm; Initial information was received on 17-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (age and gender unspecified) who had a little sore arm (pain in extremity), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious little sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Flu like symptoms, low grade fever, body aches, hives in both arms and few hives on torso. Symptoms lasted for 4 days.
Approximately 10-15 minutes after receiving my booster Moderna vaccine in my left arm, my left ring finger began to throb, swelling-up and turning purplish. The pharmacist suggested I take some Benadryl and go to urgent care, which I did. I was not assessed in urgent care, however the Benadryl appeared to help resolve the symptoms. I am quite concerned I may have the same or a worse reaction if I receive another booster shot. I would appreciate any information or guidance you may offer.
Three days after second shot I ran a fever of 99 to 100 and had body aches like the flu for two days.  On November 1st I started having really bad cramps and menstrual bleeding but I am in menopause and have not had a menstrual cycle in several years.  I will be goin to a local physician if bleeding does not stop.
I first started to have after the first and second vaccine, I had menstrual bleeding that was abnormal.  I had more fatigue than normal.  I did have a site reaction where the injection was given.  It was a big circle, warm, itchy, and lasted 3-4 days.  It came back on day 9 and went away again.  I had vertigo and dizziness the first 48 hours.  I had flu like symptoms.  I have a long-term lymph node issue.  They have been swollen and inflamed.  I have them in my arm, clavicle area, both breast, neck, and the groin area.  They have going on since June 25th.   It has also been accompanied with fatigue and feeling unwell.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 24-JUL-2015, the patient was vaccinated with an improperly stored dose of MMR II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
lumps on leg; weird pimple; pains like an athlete preparing for the Olympics; I was basically bedridden for two months; unable to complete tasks and work which is a relatively small amount; I have a scar; had bleeding; extreme fatigue; debilitating muscle aches; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Apr-2021. The most recent information was received on 23-Jul-2021 and was forwarded to Moderna on 23-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MASS (lumps on leg), ACNE (weird pimple), PAIN (pains like an athlete preparing for the Olympics), BEDRIDDEN (I was basically bedridden for two months) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to complete tasks and work which is a relatively small amount) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Speech disorder (speech problem) and Cancer. Concomitant products included INSULIN.    On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MASS (lumps on leg), ACNE (weird pimple), PAIN (pains like an athlete preparing for the Olympics), BEDRIDDEN (I was basically bedridden for two months), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to complete tasks and work which is a relatively small amount), SCAR (I have a scar), HAEMORRHAGE (had bleeding), FATIGUE (extreme fatigue) and MYALGIA (debilitating muscle aches). At the time of the report, MASS (lumps on leg), ACNE (weird pimple), PAIN (pains like an athlete preparing for the Olympics), BEDRIDDEN (I was basically bedridden for two months), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to complete tasks and work which is a relatively small amount), SCAR (I have a scar), HAEMORRHAGE (had bleeding), FATIGUE (extreme fatigue) and MYALGIA (debilitating muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Follow up information provided updates on patient. On an unknown date, post vaccination, the patient reported that she experienced symptoms of fatigue, lump on leg, pain, hemorrhage, scarring, myalgia and loss of independence.  No treatment information was provided.   This case was linked to MOD21-071383 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Significant follow up received. New events added. On 23-Jul-2021: NNI follow up received.
per pt she received both the flu shot and pneumonia shot on 9/21/20, then on 9/26/20 she lost vision in 1 eye for about 10 seconds, eye sight recovered, and this happened again about 10 min later, but her eye sight has returned to normal since then
It's been 9 days since the injection, and my shoulder is still a bit sore. It hurts to raise my arm very high or to sleep on my right side.
Patient received Pfizer COVID-19 Bivalent as the 1st  shot in the primary series instead of  the monovalent vaccine.  No adverse reaction to vaccine reported.  Patient is scheduled to receive the Pfizer COVID monovalent vaccine for 2nd dose in series as recommended.
3 hours post vax, the pt started crying and moaning and then vomited repeatedly for 4 hours. She than began running a fever and the next evening her temp reached 105 and remained so until the next day after the ER visit.
Patient developed slight rash on the arm, instructed to contact provider regarding next best steps. This was patients second dose so no concern about further vaccination.
I experienced soreness at the injection site, a slight headache and fatigue just 5 hours after the shot.  Everything except for the sore arm which I couldn't sleep on for 3 days was gone and I felt fine. The strange thing that happened almost exactly 72 hours after my shot was the light rash I developed.  Not on my arm at the injection site, but down my side along my rib cage ( on the same side as my arm that received the shot)  It resembled a very light colored hives looking rash, quite itchy, but was gone completely by morning when I awoke.
Shot was given extremely high in the arm, almost at shoulder joint. Pain in upper left arm for two days, becoming worse over the next four weeks. Now pain is severe and I can barely move my arm.  Everyday task, like getting dressed and washing hair have become almost impossible without extreme pain.
Chest pain. Elevated troponins in ER. Myocarditis or pericarditis.
Headache, nausea with vomiting, emesis; Medications: Diphenhydramine at 4:26 AM; Ketorolac at 4:30 AM, metoclopramide at 4:28 AM, Sodium Chloride 0.9%.
expired dose given to a 3 year old female, no AE; Initial information received on 18-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years old female patient who received an expired vaccine 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5254AA and expiry date: 18-Sep-2019) via intramuscular route in the left thigh, on 04-Dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient recieved HEPATITIS B VACCINE and INFLUENZA VACCINE as concomitant medication.  It was a case of actual medication error due to expired vaccine used. It was reported that expired dose given to a 3 year old female.  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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a medical assisstant refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 15-MAR-2017, 16-MAR-2017, 20-MAR-2017, 20-MAR-2017, 23-MAR-2017, 23-MAR-2017, and on 30-MAR-2017, the patients were vaccinated with improperly stored doses of ROTATEQ (orally; lot # M040269, expiration date: 28-APR-2018; dose was not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion from 32 degrees Fahrenheit to 35 degrees Fahrenheit for 52 hours. Digital data logger was not involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA000955:
Pt had local reaction to DTaP left deltoid - swollen, red and hot to touch.
A day or two after receiving this shot, I developed a twitch in my right eyelid.  A day or two after that, the same in my left.  It has been two weeks since the shot, and the twitching seems to have stopped.  If this is a coincidence, it seems peculiar to me.
C/o stiffness in joints, achy back muscles, tired, has been going on for 2 weeks. Advised to see provider.
FEVER 102F, VOMITING X1 DAY.  RUNNY NOSE, COUGHING, FATIGUE X5 DAYS.
Patient sat down and reported feeling unwell - felt nauseous, faint, slow breathing like he was going to pass out. He looked pale
Several Hundred Patients dosed / multiple vials that were had been opened and were being stored in the fridge, freezer and one at room temperature without any  labeling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Several Hundred Patients dosed / multiple vials that were had been opened and were being stored in the fridge, freezer and one at room temperature without any  labeling) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Several Hundred Patients dosed / multiple vials that were had been opened and were being stored in the fridge, freezer and one at room temperature without any  labeling). At the time of the report, PRODUCT STORAGE ERROR (Several Hundred Patients dosed / multiple vials that were had been opened and were being stored in the fridge, freezer and one at room temperature without any  labeling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.  Reporter stated that the provider had no temperature monitoring equipment, data loggers and was not labeling vials appropriately. She noted that there were multiple vials that were had been opened and were being stored in the fridge, freezer and one at room temperature without any  labeling. During the inspection, she observed the provider remove a vial from the freezer and started shaking the vaccine very hard to get them to thaw more quickly instead waiting the appropriate time. She indicated that a few hundred patients have received vaccines from this provider. No information was available on the patient involved, dates of administration, storage or any relevant information The reporter could not get temperature information as the vaccine provider was not keeping temperatures or logs.  According to reporter, number of patients affected was 68  Lot numbers for the Moderna vaccine include 939905, 038C21A, 021C21A, and 023C21A.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow up received on 18-Nov-2021 has lot no and patient effected details updated in I narrative. On 19-Nov-2021: Follow-up attached contains no new information.
One hour after the injection, my brain began to feel hazy. My short-term memory was terrible. Remembering simple tasks was very difficult. The best way I can describe it is that it felt like I had consumed marijuana. I do not use marijuana or any other drugs. I had not consumed alcohol. The effects were similar to that of marijuana in that there was a ?peak? and a ?come-down.?  The peak lasted a little more than one hour, and began about one hour after the injection. The effects slowly faded until I didn?t feel completely normal until I woke up this morning. Today, I have no symptoms other than a sore arm.