chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients).    Case contains the information regarding patient 67 of 100 reported.  Concomitant products were not reported.  Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, lot numbers unknown to the HCP.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Pt received  both doses of Moderna Jan and Feb 2021 at off-site location. Pt insisted on receiving Janssen in addition for extra coverage compared to Moderna. Explained to patient that there is no current recommendation on getting both vaccines as there is no study on safety/efficacy on getting both vaccines. Pt still wanted to receive the vaccine. Because there is no contraindication of getting both vaccines and there was not clear instructions in this situation at the time (5/19), Pt received Janssen. Report is now made as soon as  instructions was sent out by corporate regarding similar situations. Pt was counseled to monitor on potential side effects of both vaccines.
needle separated from hub and part of the dose trickled down recipient's arm.  It was at this time discovered that she was under age, so another dose was not administered.
>24 hrs after administration parent reported a rash to right thigh.  Photo provided appears to be circular, approx 1/2 dollar size with raised edges and red in color. No weeping noted.  Patent reports no SOB or pain to site.  Administering staff reports using 25G 1" needle with a 90degree angle.   Pt status monitored daily by Nurse Manager, no further progression of rash noted.
pt recv vax & pt presented w/approx 50 lesions on trunk, legs & scalp;reporter noted that his was a vaccine failure;
developed a circular rash the size of a grapefruit around the injection site and that it was sensitive and inflamed.; developed a circular rash the size of a grapefruit around the injection site and that it was sensitive and inflamed.; Initial information received on 07-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 54 years old female patient who had developed a circular rash the size of a grapefruit around the injection site and that it was sensitive and inflamed. After receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 02-Nov-2022, the patient received 0.5ml, 1X(once)total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On 02-Nov-2022 the patient developed a non-serious event of developed a circular rash the size of a grapefruit around the injection site and that it was sensitive and inflamed. (vaccination site rash, inflammation) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. She states most of it has cleared up but there is some residual redness left.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome: recovering
Patient administered moderna covid vaccine while temperature excursion was ongoing(possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 33-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. No Treatment information was reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients. Reporter does not have details on how many patients were impacted or any information on patients.
Severe nausea and vomiting. Chills/fever/fatigue. This is the second dose and family realized that the first time he recieved the dose had a similar incident and had to go to ER.
Sx onset 7/4/21 with cough, sore throat & runny nose. Household contact of a positive case.
Achy; Fatigued; Had muscle aches the next day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), FATIGUE (Fatigued) and MYALGIA (Had muscle aches the next day) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (Achy), FATIGUE (Fatigued) and MYALGIA (Had muscle aches the next day). At the time of the report, PAIN (Achy), FATIGUE (Fatigued) and MYALGIA (Had muscle aches the next day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were reported.
Patient felt dizzy and nauseous and was taken to the sick bay with ice pack supplies. Crackers and juice were given. Initial Vitals: 134/82-86 Vitals: 120/77-71 Patient felt better and went home with husband.
Next day he got fever; started feeling itchy all over his body; This is a spontaneous report received from a contactable consumer or other non hcp. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 20Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced started feeling itchy all over his body on 20Apr2021, next day he got fever on 21Apr2021. Clinical course was reported as he got on Tuesday 20Apr2021 the first dose of the Pfizer covid vaccine and that night at approximately 8-9 pm he started feeling itchy all over his body. Next day he got fever, but the itchiness has not got away. The clinical outcome of the event fever was unknown and another event feeling itchy all over his body was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
c/o pain lt arm pit; 13AGU93 red, swollen, fever, no appetite 4x5cm swelling lt pectural region; heat & Ceclor;
After receiving the injection my arm was very sore for about 3 weeks. It was sore with movement. Just the muscle was sore. I was on cruise and 12 days after on February 22nd, 2023, I got COVID-19. I thought it was my allergies. It was like it was a sinus infection. I had runny nose, pressure in my ears face and forehead and headache. I had seen the doctor on the cruise, He gave me a three-day Z-PAK. Which the first dose was taken and made me nauseated and learned to eat before taking. Now I'm still under doctor's care and was out of the window to get the antiviral. I am still having right ear pain, and I was given a prescription for amoxicillin.
Initial unsolicited report received from a pharmacist on 07 Oct 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of flu shot (manufacture: unknown, batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, two weeks after vaccination, the patient had experienced Bell's palsy. Patient's laboratory data and corrective treatment was not reported. Outcome of the event was not reported. Upon internal review, this case was considered as serious due to important medical event: Bell's palsy. List of documents held by sender: none. Sender's Comments: Bell's palsy was suspected in this case after vaccination with INFLUENZA VACCINE of unknown manufacturer however diagnosis was not conformed. Time to onset two weeks is compatible with the role of vaccine. Additional information on investigation results ruling out a concurrent infection and exploration of alternate etiologies and patient's history of reaction after previous vaccinations are needed to further assess this case. Based on information role of vaccine cannot be assessed.
Information has been received from a physician concerning a 17 year old male patient who on an unspecified date was vaccinated with an unspecified 0.5mL dose of GARDASIL. It was reported that the patient experienced a diffuse rash in the morning after receiving GARDASIL. The patient sought medical attention by calling the physician. It was reported BENADRYL was given as treatment for the adverse event. On an unspecified date, the patient recovered from diffuse rash. Follow-up information received from the physician revealed that the patient was a 17 year old male with no pre-existing allergies, birth defects or medical conditions and no history of adverse events following prior vaccination and no illness noted at the time of vaccination who on 23-MAY-2012 was vaccinated IM with the second 0.5 mL dose of GARDASIL in his left arm (lot # 672721/0101AE, expiration date 10-OCT-2014). No illness at time of vaccination was noted. On 04-MAY-2012 the patient experienced abdominal pain and bloating, generalized rash and diarrhea. No laboratory tests/diagnostics studies were performed. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
About 15 minutes later - body felt like it was on fire; shortness of breath; heart rate was pounding very fast. I stayed in an observation room for about 3 hours. Next day, I couldn't feel my right arm. I started getting fever, chills. I had all symptoms of the coronavirus. Saturday at 03:00 am - I woke up and I couldn't feel my arm or my fingers on my right side. I called the Emergency number. I stayed home and took Tylenol. Couldn't feel my arm at all that Saturday - dead. Sunday - same thing. Monday morning, I woke up, I could feel a little bit of my fingers but I noticed that I had blisters full of blood between your index finger and your thumb. I didn't go to work that day. The doctor wrote me out of work for the rest of the week. I didn't have any sensation on my pinkie or ring finger. I had a little bit of sensation on the rest of my fingers. I stayed at home and I didn't do anything with my arm and it slowly started getting better. That whole week I was having symptoms that were just like coronavirus. They came and went. the following Saturday, I started being able to move my arm around and doing more stuff and slowly it came back but I'm not 100%. I can't lay on the right hand side too long - it starts feeling like my arm is asleep. I got the second dose February 12th.  I spoke to an allergy doctor and an anesthesiology doctor (video and telephone visits) - they told me I was having common side affects that people were having from the vaccine but they didn't know why.
The pt experienced flu-like symptoms, dizziness with an onset of 3 minutes. Pt states neck sore and swollen.
Patient believed that her previous COVID vaccine was Moderna administrated on 04.30.21, but upon documenting today's Moderna dose, it was noted that patient's 1st COVID vaccine was actually Pfizer administered on 03.15.2021.  This RN advised patient and reported this event.  No distress was noted immediately following visit, but this event is being reported as a precaution in the event that additional considerations need to be made.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 58-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site reaction (For tolerance to the 1st dose received in March 2018, refer case US2018106401). On 12th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 13th June 2018, 1 days after receiving SHINGRIX, the patient experienced headache, eye swelling, leg pain, labored breathing, fatigue, ear feels clogged, shivering, temperature regulation disorder, walking difficulty and feeling abnormal. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the headache, eye swelling, leg pain, labored breathing, ear feels clogged, shivering, temperature regulation disorder, walking difficulty and feeling abnormal were not recovered/not resolved and the outcome of the fatigue was unknown. The reporter considered the headache, eye swelling, leg pain, labored breathing, fatigue, ear feels clogged, shivering, temperature regulation disorder, walking difficulty and feeling abnormal to be probably related to SHINGRIX. Additional details were provided as follows: The patient received her 2nd dose of SHINGRIX in left arm. The patient felt walking was an effort for her. The patient experienced overheated, shivering, ears plugged, body shutting down, labored breathing, arms aching, legs aching, eyes swollen and headache.
This study case was received from an investigator on 27 August 2012. A 35-year-old female subject (date of birth not reported) with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 10 February 2011 elevated rapid Troponin levels [not within normal limits (positive).] Treatment (other than medication) was provided to the subject. The date of recovery was reported as 10 February 2011. On 10 February 2011, the subject also had a central laboratory Troponin I level of <0.10 ng/ml. On 10 February 2011, the subject had a normal ECG reading. There was no other reported visit. The subject had no concomitant medications. No further information was available at the time of the report. The subject's outcome was recovered. According to the Investigator, the event of elevated central lab troponin was considered an important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. List of docs held by sender: medical records.
Unable to communicate verbally, drooling when given water to drink,  Transient Ischemic Attack
Vaccines May 30. Rash occurred June 9-N approx Spread over face, down to legs. Papular, light pink blanching rash. no excavation. no fever. Feeling well. Rash most likely improving.
Swelling, redness, bruising, 1 day after vaccination at injection site, also noticed lower back pain. Patient starting feeling tired and dizzy starting 1 day after vaccination.
Employee received H1N1 injection on 10/27/09. Reports arm (L deltoid) was sore. Thought it would resolve. Decided to notify employee health on 11/10/09 as symptoms continued to worsen. Reports pain in arm and "sharp" pain/tingling from shoulder to fingers. Not resolved with TYLENOL, MOTRIN. Employee has made appointment with PCP for 11/10/09.
3 days after vaccine I developed edema in left hand and wrist, unable to make a tight fist+ swollen left neck supraclavicular lymph nodes+ left side/flank/chest (muscular) tightness. Visited PCP. Clear chest Xray, scheduled arm ultrasound to rule out blood clot
I became dizzy to the point where I got confused and felt intoxicated,  then I  fainted. I recovered quickly afterwards
No adverse events reported, second dose of Moderna vaccine was administered only 18 days after first dose in error.
Information has been received from a registered nurse concerning a patient who on 24-JUL-2008 was vaccinated with a dose of ZOSTAVAX instead of VARIVAX. The nurse did not state this was a product confusion. Follow up information was received from R.N. indicated that this was a human error. Additional information has been requested.
Relates started with watering eyes for 2 weeks then into shortness of breath and ended up with heart issues, weakness, dizziness and hospitalization.
Site around injection about the size of a quarter dollar red swollen. Chickenpox spots on arms, legs, back, groin area. Ran fever 102 degrees, chills, fatigue. Ibuprofen, TYL.
Patient received a dose of IPOL vaccine twice in one day with no ae; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00511293) and transmitted to Sanofi on 09-Mar-2021.  This case involves a six months old male patient who received a dose 0.5 mL dose of suspect IPV (VERO) [IPOL] (lot R1B252M and expiration date: 13-Mar-2021) via intramuscular route in left thigh for prophylactic vaccination twice in one day (extra dose administered) on 09-Mar-2021.  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX), HIB VACCINE CONJ (TET TOX) (ACTHIB) (dose: other), PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE), ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for Immunisation.  It was actual medication error due to extra dose administered (on same day).  The reporter would like to know the potential side effect.  At the time of report, the patients experienced no adverse event.  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 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.
the eye is more swollen; the vaccine- once the needle was retracted- a "Mist" of the residual RECOMBIVAX from the syringe went into the patient's mother's eye; the vaccine- once the needle was retracted- a "Mist" of the residual RECOMBIVAX from the syringe went into the patient's mother's eye; complained of stinging and pain in eye (unknown which eye is effected); blurred vision; This spontaneous report has been received from a registered nurse concerning a female patient of unknown age. The patient's drug reactions or allergies, concomitant therapies, medical history, and concurrent conditions were not provided.   On 19-MAY-2022, the patient's daughter was vaccinated with a dose of Hepatitis B Vaccine (Recombinant) thimerosal-free (RECOMBIVAX HB) pre-filled syringe (dosage regimen, route of administration, and anatomical site were not reported) lot #T018888, expiration date 03-NOV-2022, administered as prophylaxis.  On that day, after the administration of the vaccine -once the needle was retracted- a "Mist" of the residual from the syringe went into the patient's eye (Accidental exposure to product) (Exposure via eye contact). The patient immediately complained of stinging and pain in eye (unknown which eye was affected) (eye pain); also, the caller reported that she was taken to eye wash station and did rinse her eyes for approximately one minute. The patient also complained of blurred vision. On the same date, she sought medical attention and was seen by ophthalmologist and prescribed a lubricating eye drop. On 20-MAY-2022 (also reported as, "the day after incident happened"), she stated that the eye was more swollen (Eye swelling). At the reporting time, the patient had not recovered from the events.     The causal relationship between Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) and the events of eye pain, blurred vision, and eye swelling was not provided.