chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product storage error; Covid-19 vaccine that were given beyond the 30 day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date.) and PRODUCT STORAGE ERROR (Product storage error) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022 at 9:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date.) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient Not contacted HCP about any reactions.  No concomitant medication information provided. No treatment medication information provided.
Product Storage Error; administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and PRODUCT STORAGE ERROR (Product Storage Error) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A and 939906) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product Storage Error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and PRODUCT STORAGE ERROR (Product Storage Error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Dose administered after 30-day Use By Date or after manufacturer date of expiry Number of doses/vials: -18; Date the vial was initially stored in the refrigerator: - HCP will call back to provide the information Date(s) of administration of vaccine: 09May2022 - 9 doses; 11May2022 - 9 doses It was unknown whether this was the patients' 1st or 2nd or booster doses. I was informed that the team had accidentally administered expired Moderna COVID-19 vaccine to 18 patients: 9 patients on 5/9/22 and 9 patients on 5/11/22 (vaccine expired 5/5/22). When investigated the above issue further, I identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 1/11/22, which means that all doses administered more than 30 days after 1/11/22 are not in accordance with the EUA. This included 84 doses administered to 82 patients (as 2 patients received 2 doses from this lot more than 30 days after it was in the fridge) administered between 2/16/22 and 5/11/22. Note: these 82 patients include the original 18 from the above case. The vaccine in question did NOT experience any temperature excursions. No treatment medications were reported.
Received 0.25 ml First Monovalent primary dose/one patient received half of the dose that she was supposed to have received for her first dose in primary series; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Received 0.25 ml First Monovalent primary dose/one patient received half of the dose that she was supposed to have received for her first dose in primary series) and NO ADVERSE EVENT (No adverse event) in an 8-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Received 0.25 ml First Monovalent primary dose/one patient received half of the dose that she was supposed to have received for her first dose in primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25 ml First Monovalent primary dose/one patient received half of the dose that she was supposed to have received for her first dose in primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Received 0.25 ml First Monovalent primary dose/one patient received half of the dose that she was supposed to have received for her first dose in primary series).    Concomitant medications were not reported. On 17-nov-2022 patient received 2nd Monovalent Primary dose was from the same expired vial.                               No treatment information was provided by the reporter.    This case was linked to MOD-2022-680257 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2022: Live Follow up received contains non -significant information- event verbatim updated.
Floaters in left eye; Edgy and Agitated; edgy; Discomfort in Arm; Brain Fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 (Lot number: EN6207) at the age of 65 years as 2nd dose,single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood Pressure, diagnosed about 10 years ago. Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement; HCTZ taken for blood pressure measurement. Vaccination history included: Bnt162b2 (First Dose of the Covid Vaccine: Given on 16 Feb 2021; Lot Number: EN6200.), administration date: 16Feb2021, when the patient was 65 years old, for COVID-19 IMMUNIZATION, reaction(s): "sore arm". The following information was reported: LIMB DISCOMFORT (non-serious) with onset May2021, outcome "not recovered", described as "Discomfort in Arm"; FEELING ABNORMAL (non-serious) with onset May2021, outcome "not recovered", described as "Brain Fog"; VITREOUS FLOATERS (non-serious) with onset 13May2021, outcome "not recovered", described as "Floaters in left eye"; AGITATION (non-serious) with onset May2021, outcome "not recovered", described as "Edgy and Agitated"; FEELING ABNORMAL (non-serious) with onset May2021, outcome "not recovered", described as "edgy". Additional information: States right after the vaccine he had slight soreness in the left arm. Says it lasted maybe a day if that after the first dose of the vaccine. after the second dose of the vaccine he felt edgy and agitated that evening. States he felt that way for a couple hours and then he was fine. The patient was stated lately he has been having unusual symptoms and wonders if they are connected to the vaccine. He was stated that about a week ago he noticed discomfort in his left arm where the vaccine was given, no redness or anything like that. He was said that he had been doing yard work the day he noticed it so he did not think much of it. Thursday morning he woke up and had floaters in his left eye. He went online to see the danger possibly associated with floaters in the eye and it said to call the eye doctor. He went to the eye doctor and they told him they could see the floaters but no other issues; the floaters may possibly go away on their own. Stated he has also been somewhat edgy and agitated; like he felt the night after his second dose of the vaccine. Patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
From time of injection mild pain that grew every day. Aprox. 30+days later increased pain, dull ache in left shoulder. 10 days after pain in left shoulder joint, weakness and burning in area. This same pain I was feeling in left shoulder, I have in right shoulder. And now has traveled into both forearms. 3/18/2014 Had Xrays R&L shoulders, no sign of injuries, etc. This day I had injection of Cortisone in left shoulder, as pain was more, and constant. 3/22/2014 I still have no relief.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 30-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 30-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 30-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 30-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 30-Jul-2022).    No concomitant product use was reported. Patient received half dose. The number of doses/vials administered were 35 vials On 04-Jun-2022 the vials were initially stored in the refrigerator.The vaccines were administered from the 04-Jun-2022 until the 26-Jul-2022 Vial did not undergone any temperature excursions. No treatment information was provided.
Not pregnant never pregnant. Fever in low 100s the day after, arm pain, hard swelling measuring around 7 inches by 5 inches in arm lasting 4 days, arm hot to touch, itchy bumps on firearms, aching joints, nausea and diarrhea for 5 days, tightness and heaviness in chest, labored breathing and shortness of breath, severe headache, chills, sinus pressure, high blood pressure. Went to urgent care after 6 days of nausea, shortness of breath that was worsening. Given covid test and flu test both negative. Provider prescribed steroid pack, steroid cream, and Kennalog IM injection. Slowly improving symptoms, at date of writing, 2 weeks post vaccine, continued shortness of breath as evidenced by needing to pause for breath midway through a sentence, taking time to catch breath after bending over or physical activity, fatigue.
When he got up to use restroom his symptoms were very mild, though when he woke up the symptoms persisted for ~ 1 week.  Does not recall any illnesses, but mother felt that patient seemed a little more fatigued ~ 1 week prior.  Went to ER 6/4/21 with tightness in his chest worse with deep breathing, cough, laughing, worse laying down and better sitting upright.  Got Pfizer COVID19 vaccine 4/10/21, which is ~ 8 weeks prior to symptoms starting.  ECG showing diffuse ST elevation concerning for pericarditis.  Troponin was negative, chest x-ray was negative.  He was given the instructions to take ibuprofen for 1-2 weeks and just stopped the ibuprofen yesterday.  His symptoms resolved after 4 days of using ibuprofen.
Pt. states he experienced mild itching last evening on upper part of body and leg.  Also states that right side of face appears swollen
c/o left side (injection side) lymphadema during the 1st week; f/u w/PCP, US done; told it would resolve in a couple of months. Narrative:
4/20/21: rash noted at mid low back 4/21/21: rash spreading to neck, upper back, and chest, referred to Derm. Dx urticaria, Rx zyrtec 10 mg daily, hydroxyzine 25 mg Q HS, Triamcinolone cream BID 4/23/21: worsening urticaria in same locations. Consulted dermatology lab ordered and were unremarkable for systemic symptoms of DRESS. Added pepcid AC 20 mg BID and increased hydroxyzine 50-75 mg Q HS
Headache, Myalgia, Arthralgia, ErythemaMultiform, Diarrhea, NauseaVomiting, HYPERglycemia, Fatigue, Pain Narrative:
Pain around my heart, high blood pressure and tingling, pins and needles primarily in my face starting with the left side of my face and then (after 10 hours) also including the right side of my face as well as some of my head, my ears and neck. I went to the hospital emergency room to rule out heart attack and the hospital ruled out heart attack.
Information has been received from a registered medical assistant concerning a 5 year old male who on 21-MAY-2003 was vaccinated subcutaneously with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 643591/0867M). The patient, who has a history of eczema, was experiencing an eczema exacerbation at the time of vaccination. Concomitant therapy, that same day, included a third dose, intramuscularly of Prevnar (lot # 49392). On 07-Aug-2007, the patient developed itchy, red, pustuled lesions that erupted in crops. The onset of new ones occurred hours later with minimal crusting. The patient had about 12-15 spots total at the time of examination. Additional information is not expected.
A report has been received from a health professional concerning a patient born on 25-JAN-2006, male subject, who had been receiving FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The patient experienced part of the FLUMIST Quadrivalent leaked into the eye of the patient. The outcome of the event of part of the FLUMIST Quadrivalent leaked into the eye of the patient is unknown. The report was considered to be non-serious.
No additional adverse events reported.; Office manager reporting that an expired dose of MMRII was given to a 6 year old patient.; This spontaneous report has been received from an office manager (also reported as a health care professional) via email concerning a 6-year-old male patient.  There was no information about the patient's medical history, concurrent conditions, or concomitant medications.  On 27-APR-2022 (also reported on 26-APR-2022 by the same reporter,conflicting information), the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (injectable) rHA,  lot #: T001214, expiration date:17-JAN-2022 for as prophylaxis (dose and route of administration were not reported) (Expired product administered).   No adverse reaction to receiving an expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccine has been reported by the patient or his family. The practice manager would like a call back regarding follow up including what to expect due to the child having received an expired vaccine.
numbness on left side of face later same day, woke in middle of night the next day with upset stomach and feeling of extreme weakness. Feeling of blacking out. Called emergency services. By the time they arrived, the feeling passed as I broke out in a sweat and returned to normal. Declined to go with them to hospital as assumed it was just a reaction to the shot. The following weeks I would get a rapid heartrate (even detected on smart Watch) and lightheadedness. The feelings started to get better around the time of the second shot so I declined to get that. Still had rapid heart rate off and on for months.
Was given Tdap vaccine, right arm. Age 60. Within hours was experiencing high fever 103.4. Muscle, joint pain, despair. Couldn't work for the next two days. Continued high fever. Reached out to my doctors and was told to take Tylenol which I had been and that this is not a common side effects for adults. I've suffered horribly these past few days. My right arm is useless. And I've lost over 2 thousand dollars in wages. I'm qoories that I don't know what else could be in store for me on the future. This vaccine is the newly released latex free version of the TdAP by Sanofi.
About 6 minutes after administering HPV vaccine, patient fainted. No history of fainting in the past.
Patient was supposed to get a Moderna primary series 2nd dose and instead he was administered the Pfizer-BioNTech COVID-19 Vaccine, Omicron Bivalent maroon cap formula 6 month to 4 years for his 2nd primary dose; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; No adverse reaction; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was supposed to get a Moderna primary series 2nd dose and instead he was administered the Pfizer-BioNTech COVID-19 Vaccine, Omicron Bivalent maroon cap formula 6 month to 4 years for his 2nd primary dose), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No adverse reaction) in a 9-month-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was supposed to get a Moderna primary series 2nd dose and instead he was administered the Pfizer-BioNTech COVID-19 Vaccine, Omicron Bivalent maroon cap formula 6 month to 4 years for his 2nd primary dose), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was supposed to get a Moderna primary series 2nd dose and instead he was administered the Pfizer-BioNTech COVID-19 Vaccine, Omicron Bivalent maroon cap formula 6 month to 4 years for his 2nd primary dose), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Patient was supposed to get a Moderna primary series 2nd dose and instead he was administered the Pfizer-BioNTech COVID-19 Vaccine, Omicron Bivalent maroon cap formula 6 month to 4 years for his 2nd primary dose), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products).    No concomitant medication was reported.  Treatment information was not provided by the reporter.   Reporter did not allow further contact
Pt got 4th DTAP on 1/14/03 in right upper thigh. Pt came in with a reaction on 1/16/03.
ACUTE RESPIRATORY FAILURE 12/18/2022 INFECTIOUS COLITIS  ACUTE ON CHRONIC RESPIRATORY FAILURE 9/9/2022 INFECTIOUS COLITIS  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/4/2022 INFECTIOUS COLITIS  ACUTE RESPIRATORY FAILURE 12/18/2022 UPPER GI HEMORRHAGE  ACUTE ON CHRONIC RESPIRATORY FAILURE 9/9/2022 UPPER GI HEMORRHAGE  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/4/2022 UPPER GI HEMORRHAGE  ACUTE RESPIRATORY FAILURE 12/18/2022 ANEMIA  ACUTE ON CHRONIC RESPIRATORY FAILURE 9/9/2022 ANEMIA  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/4/2022 ANEMIA  ACUTE RESPIRATORY FAILURE 12/18/2022 UTI DUE TO INDWELLING URINARY CATHETER, INIT  ACUTE ON CHRONIC RESPIRATORY FAILURE 9/9/2022 UTI DUE TO INDWELLING URINARY CATHETER, INIT  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/4/2022 UTI DUE TO INDWELLING URINARY CATHETER, INIT  ACUTE RESPIRATORY FAILURE 12/18/2022 COPD STAGE 2 MODERATE (FEV1 50-79%)  ACUTE ON CHRONIC RESPIRATORY FAILURE 9/9/2022 COPD STAGE 2 MODERATE (FEV1 50-79%)  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/4/2022 COPD STAGE 2 MODERATE (FEV1 50-79%)
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-OCT-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # L033707 with expiry date of 18-MAY-2015. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt was given a TD & Hep-A immunization on 6/22/2000 in the morning and was alright until 6/25/2000 at 15:55, she was watching TV when she starting having a seizure. Her arms and legs went outward and got stiff, her eyes went back into her eye sockets and her lips turned blue. This lasted about 7 minutes. She was incoherent and was taken to ICU and released on 6/26/2000. Put on RX for seizures. She is to be evaluated by a neurologist.
pt recvd Hep B vax on 18FEB92 & recvd 2nd vax on 20MAR92 & on 22MAR92 pt exp a sore arm; pt recovered;
Rapidonsetfeverof102.3andsevereheadacheextremelysorearmputmeinbedforeighteenhoursandmyarmwassoreforfourdays
arm was numb; This is a spontaneous report received from a contactable consumer (patient). A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in the left Arm on 15Apr2021 at 12: 50 PM (Lot Number: EW0158) as single dose (at the age of 40-year-old) for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  Reported her arm was numb on the side where she received the injection on 15Apr2021. It went numb pretty quickly after the first dose - then it was numb for about 24 hours. It went away completely in two days. The outcome of the event was recovered on 17Apr2021.  No follow-up attempts are needed. No further information is expected.