chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration; No adverse event; Vaccine was expired on 13-Aug-2022 and was administered on 30-Aug-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration), EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Aug-2022 and was administered on 30-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (unspecified COVID-19 vaccine Dose 2) and COVID-19 Vaccine (unspecified COVID-19 vaccine Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine and COVID-19 Vaccine.    On 30-Aug-2022 at 4:14 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Aug-2022 at 4:14 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Aug-2022 and was administered on 30-Aug-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration), EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Aug-2022 and was administered on 30-Aug-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 PRODUCT STORAGE ERROR (Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Aug-2022 and was administered on 30-Aug-2022).    No concomitant medications were reported.   The vaccine was delivered and placed into the freezer on 18-Apr-2022. The vial size was reported as 5.5 ml. Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration on 30-Aug-2022 vial was placed into refrigerator on 29-Aug-2022. The vial did not undergo any temperature excursion.   No treatment details were reported.
Patient phoned EHS on 2/22 and inquired about her side effects and how long they should be lasting?  Patient experiencing ha, and pain at injection site.  Patient  states it is getting better, but still voiced her concerns.  Education provided of side effects vs illness and side effects lasting 7 days, follow up with PCP Dr. for further advice, and if patient continues to have symptoms after 7 days, phone EHS back for further evaluation.  Patient agrees to above plan of care. EHS filled out RL6 for pt.
I broke out in a blistering rash on both buttocks, both hands, and both arms.
administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:asthma and hypertension.  Concurrent medical conditions included Asthma and Hypertension.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date).    No concomitant medicine were reported. Patient identifiers for patient number 7 are documented in this case. No treatment medicine were reported.
Pt reported for 2nd dose of vaccine and stated that when she received her first dose, she felt that it was given "at a downward angle"  in her left upper deltoid, closer to her shoulder. she had difficulty moving her arm for at least a week - and at 4 weeks out still has some "twinges" of pain when she moves her arm a certain way.
Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) outcome was unknown. Not Provided     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown  This case is crosslinked with MOD21-078568
Patient stayed 15 minutes at the pharmacy and we noticed a small quarter sized red spot at the injection site. The patient was counseled to keep an eye on the swelling and if it got worse to contact her doctor or go to the emergency room if it was serious enough. The patient stated that she took benadryl before bedtime and it seemed to help but when she woke up the next morning the site was really red all the way around her arm and hurt. There was also swelling, redness, and heat. The patient did go to her doctors who told her that it looked like an allergic reaction but to let the pharmacy know so we could fill out a report in case it was not and there was something wrong with the vaccine.
Feeling faint Loose body. fallen to the ground. After this event he experienced dizziness with weakness for the rest of the day.
Chills, shaking, fever of 101F, joints aching. Pushing fluids and resting. Will call doctor if fever stays high until noon.
This spontaneous report was received from a physician via company representative and refers to a male patient of an unknown age. The patient's medical history included splenectomy. Information about the patient's allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, anatomical location, lot# and expiration date were not reported). On an unknown date, the patient experienced injection site reaction. The patient did not receive any treatment for reported event. The outcome of the event was unknown. The relatedness between the event and PNEUMOVAX 23 was not provided.
She took the vaccine and 4-5 hours later she went into Afib/ she still has Afib right now; sweating; pulse went up; This is a spontaneous report from a contactable consumer (patient) reported that. A female patient of an unspecified age received bnt162b2 (COMIRNATY, Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing and her heart has been regular for at least 4 weeks, she went to the doctor on Thursday and everything was okay, no irregularities, no missed beats. The patient concomitant medications were not reported. The patient historical vaccine includes bnt162b2 (COMIRNATY, Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single and dose 2, single for covid-19 immunisation. On an unspecified date of 2021, patient experienced AFIB after 4-5 hours later vaccination, was sweating and her pulse went up. She went to see the doctor on Friday, and he sent her to the ER to get her checked out, she still has Afib right now. The patient underwent lab tests and procedures which included heart rate went up on an unspecified date of 2021. Outcome of the events AFIB was not recovered, and other events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I had a wet cough and a runny nose on Monday afternoon. I also felt more fatigued. I called the doctor as I had had a cold that had lasted a few weeks. On Tuesday morning I took an at home COVID-19 test and it was positive. I then had a tele visit. The doctor prescribed PAXLOVID and a Z-PAK to treat my symptoms. I began to feel better after about 2 days. It was a slow subsiding but getting better every day. I still have a runny nose and a bit of a wet cough. I am not 100% recovered.
Large, red, rash (2 inches by 2 inches) around injection sight.  Sight is warm to touch and slightly painful.
This spontaneous prospective pregnancy report was received from a nurse and refers to a 22 year old female patient. The patient did not have pertinent medical history and drug reaction or allergies. The patient did not take any concomitant medication. On 01-AUG-2016, the patient was inadvertently vaccinated with a dose of VARIVAX subcutaneous, lot # L010146, expiration date 24-MAR-2017 (anatomical location and dose were not provided). At the time of vaccination the patient was 16 weeks pregnant. The patient's last menstrual period (LMP) was estimated as 11-APR-2016, date of conception as 25-APR-2016 and estimated date of delivery as 16-JAN-2017. The pregnancy outcome at the time of the report was pending. The fetal outcome was unknown. The patient did not receive any treatment, did not have any lab diagnostic studies performed and did not seek medical attention. Additional information has been requested.
Information has been received from a physician, concerning a 51-year-old female patient with sinusitis, hyperlipidemia and no known drug allergies, who on 29-OCT-2008 received a dose of 0.5 ml PNEUMOVAX (lot # 661529/0868X, injection site unknown) via intramuscular route.  Concomitant therapies included multi-vitamins (unspecified) and FLONASE.  One hour after the administration, the patient experienced pain, redness, and swelling at the injection site.  On 30-OCT-2008 when the patient was seen for follow-up, the reaction had gotten worse.  Most of the deltoid are was affected.  There was swelling and induration.  The patient was treated with ROCEPHIN.  Blood cultures and CBC were performed without results reported.  At the time of reporting, the patient was not recovered from the events.  Follow-up information has been received from the physician concerning the 51-year-old female patient with no illness at the time of vaccination, who on 29-OCT-2008 received the first dose of PNEUMOVAX (lot # 661529/0868X) via intramuscular route in her right deltoid at 9:00 AM.  She developed swelling within 1 hour after vaccination.  Within 24 hours, there were pain, erythema, swelling over most of deltoid area and upper arm.  ER/DR visit was required.  She was treated for cellulilits with IV ROCEPHIN and CLINDAMYCIN.  On 03-NOV-2008, she recovered from the events.  This is one of two reports received from the same source.  No further information is available.
Heart started racing within a couple of minutes of the vaccine.  Felt flushed and tingly/prickly all over.  Breathing was kind of quick, almost like a panic attack.  Symptoms went away after a few minutes.  *Have had something similar happen when administered the drug they give to do a CT scan.  NOT a comfortable sensation!
pt recvd vax;2 wks later, devel rash consisting of approx fourteen lesions;
Patient up to date on vaccinations with last vaccination on 10/01/21 who admitted to hospital with altered mental status.  Patient with no respiratory distress or hypoxia during stay but did test detected for COVID upon admission.  "Pt presented to hospital with AMS. In the ED: T max of 100.5 HR 128 R 20. Labs: WBC 25.3. UA showed UTI. Pt started initially on Zosyn in the ED and transitioned to Rocephin. Urine Cx later revealed e.coli, blood cx negative. On antibiotics pt turned around very quickly with a rapid return to baseline for cognition, as per her grand-daughter who was with her throughout her stay. WBC improved, and VSS with pt afebrile. It is is felt that she had a toxic metabolic encephalopathy with sepsis 2/2 UTI with incidental co-infection of COVID. Not hypoxic during her stay. PT cleared her for discharge to home with continued home tehrapy. Pt medically stable for discharge, will prescribe her oral antibiotics for continued treatment of her UTI, and she would benefit from Home Care for rehab services. DME provided for wheelchair for home"
Information has been received from a register nurse referring to a patient of unknown age and gender. There was no concurrent condition or medical history reported. The nurse stated that another unspecified nurse might have inadvertently used the 0.4% sodium chloride diluent for ACTHIB instead of sterile water diluent to reconstitute a dose of MMR II (dosage, lot# and route not reported) on an unknown date. The nurse could not confirm whether this improper reconstitution of MMR II had actually occurred, or if it had, whether this improperly reconstituted dose of MMR II was administered to a patient. The nurse stated the other unspecified nurse might have confused sterile water diluent with the ACTHIB 0.4% sodium chloride because the vials looked similar, as they were both clear vials with white labels. No adverse effect reported. Additional information has been requested.
Initial unsolicited report received from a pharmacist on 20 June 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (Pertussis Containing Vaccine) (Batch number, expiration date, route and site of administration: not reported) on an unspecified date (reported as many years ago). Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On an unspecified date, post vaccination the patient experienced anaphylactic reaction to the pertussis containing vaccine. Relevant diagnostic tests/laboratory data and corrective treatment were not reported. On an unspecified date, patient recovered from the event. Upon internal review, the company decided to consider the event serious because of important medical: anaphylactic reaction. List of documents held by sender: none. Sender's Comments: A Male patient reported to have an anaphylactic reaction following DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED). No further information available in this case. Exact time to onset with the event is unknown. Anaphylaxis can be caused by various factors such as medications, antigen, insect bite, any exposure to chemical, vaccine or its preservative. Dates of vaccination and occurrence of the reported event, patient's past medical history, any concomitant medication, past vaccination history and allergic history are needed to further assess this case. Due to limited available information causality cannot be assessed for now.
ACUTE PULMONARY EMBOLISM 3/23/2023 L5 VERTEBRAL OTHER TYPE FX, INIT HYPOTENSION 3/23/2023 L5 VERTEBRAL OTHER TYPE FX, INIT ACUTE RESPIRATORY FAILURE 4/10/2023 L5 VERTEBRAL OTHER TYPE FX, INIT ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/13/2023 L5 VERTEBRAL OTHER TYPE FX, INIT ACUTE PULMONARY EMBOLISM 3/23/2023 LYMPHOMA UNSPECIFIED TYPE, UNSPECIFIED SITE HYPOTENSION 3/23/2023 LYMPHOMA UNSPECIFIED TYPE, UNSPECIFIED SITE ACUTE RESPIRATORY FAILURE 4/10/2023 LYMPHOMA UNSPECIFIED TYPE, UNSPECIFIED SITE ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/13/2023 LYMPHOMA UNSPECIFIED TYPE, UNSPECIFIED SITE ACUTE PULMONARY EMBOLISM 3/23/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOTENSION 3/23/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE  ACUTE RESPIRATORY FAILURE 4/10/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/13/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Patient was given Trumemba vaccine instead of the needed Gardasil. Patient's parents have been notified and will bring patient in to have the needed Gardasil vaccine administered.
Chills, fever (101.4), vomiting, headache, body ache, fatigue, weakness
Improperly stored vaccine administered; No other AE details available; This spontaneous report was received from a registered nurse referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug allergies and reactions were not reported.     On 04-DEC-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status recombinant human albumin (rHA) (strength and route of administration were not reported; lot# was T021638 and expiration date was reported as 21-FEB-2021, but upon internal validation established as 21-DEC-2021) 0.5 milliliter for prophylaxis, which experienced temperature excursion (product storage error).   No other adverse event (AE) details available at this time. The vaccine underwent temperature excursion of -13.3 degree Celsius for 4 hours 15 minutes. There were no previous temperature excursions. The digital data logger was involved.
4/26/05 Mother in with c/o redness, warm to touch, size of 50 cent piece. Per mother pt c/o fuzziness, c/o sore throat.
Pregnant; This spontaneous pregnancy case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PREGNANCY (Pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Oct-2021. On 29-Jan-2021, the patient experienced PREGNANCY (Pregnant). At the time of the report, PREGNANCY (Pregnant) outcome was unknown.        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 relevant concomitant medications were reported. No treatment information was provided.
Myalgia, Arthralgia, Fever, NauseaVomiting, loss of appetite, chills, sweating Narrative:
To Whom it may concern  Hello CDC, This is regarding our daughter. She had heart inflammation and heart block after taking Pfizer Vaccine on 14th May and this case was already reviewed by another department so we are not including all the technical details again here. Pfizer is the only foreign object went into her body and we were staying inside our home during the vaccine period.   We are very concerned at the moment as we are not sure whether to take additional vaccine or keep ourselves isolated as our daughter has not yet taken the 2nd vaccine. We need some guidance on the next steps please. Could you please help ?  Our daughter got into syncope episode just before bed time so we were able to  rush her to nearby emergency otherwise should would have died,    This news has been spreading on social media and we are trying our very best to avoid press requests as we keep getting calls from media about this incident. We are just worried about our daughter and trying to take the next best steps with CDC help.   Concerned Parents
This case involves an unknown age and unknown gender patient who experienced flu (influenza) after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease, or risk factor. The patient medical history, medical treatment(s), vaccination(s)concomitant medication 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 and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if there were laboratory data/results available. It was not reported if the patient received any corrective treatment for the event (flu). At time of reporting, the outcome was unknown for the event flu. There will be no information available on the batch number for this case.
Woke up day 12 could not get out of bed, extreme joint pain in arms, wrists, shoulders, fingers, neck, legs, ankles, toes... joints "locked" ongoing joint pain, swelling and locking to the point of not being able to walk or use arm and fingers on days. Pain is significant adn affects every day activities.
NECK PAIN VERY TENDER TO TOUCH; SHOULDER PAIN VERY TENDER TO TOUCH; LOW GRADE FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 23 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-MAY-2021 18:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAY-2021, the subject experienced low grade fever. On 07-MAY-2021, the subject experienced injection site pain. On 08-MAY-2021, the subject experienced neck pain very tender to touch. On 08-MAY-2021, the subject experienced shoulder pain very tender to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, and injection site pain on 08-MAY-2021, and had not recovered from shoulder pain very tender to touch, and neck pain very tender to touch. This report was non-serious.
Patient felt dizzy, blurred vision and went black for 2 seconds. Pt was sitting on exam table, we put her supine immediately, was pale and sweaty. B/P 90/60 -*pt had not had breakfast also* was given cranberry juice, after 5 mins colour was pink, B/P 100/60-felt better -observed for a further 20 mins. Released home with step-father.