chrisvoncsefalvay/vaers-outcomes huggingface dataset:
one of their vaccines was used to give two booster doses accidently from vials that were expired past their beyond use date of 12FEB2022.; one of their vaccines was used to give two booster doses accidently from vials that were expired past their beyond use date of 12FEB2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (one of their vaccines was used to give two booster doses accidently from vials that were expired past their beyond use date of 12FEB2022.) and PRODUCT STORAGE ERROR (one of their vaccines was used to give two booster doses accidently from vials that were expired past their beyond use date of 12FEB2022.) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (one of their vaccines was used to give two booster doses accidently from vials that were expired past their beyond use date of 12FEB2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (one of their vaccines was used to give two booster doses accidently from vials that were expired past their beyond use date of 12FEB2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (one of their vaccines was used to give two booster doses accidently from vials that were expired past their beyond use date of 12FEB2022.) and PRODUCT STORAGE ERROR (one of their vaccines was used to give two booster doses accidently from vials that were expired past their beyond use date of 12FEB2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that vials were initially stored in refrigerator on 13Jan2022 6:00 AM and last date to use was 12Feb2022. 2 booster doses were given from one vial.  No concomitant medications were reported.   This case was linked to MOD-2022-483927 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Follow-up received contains no new information.
Patient experienced/reported nausea post administration, approximately two hours after. Patient had emesis x1, to where Zofran given by mouth, w/ patient reported relief.
Developed severe mid back pain and thought was a kidney infection. Went to PCP on 11/1/2021 to be evaluated for kidney infection, but was negative. Provider told her that it was either reaction to Covid booster vaccine or pleurisy. Having difficulty initially with standing straight d/t pain and difficult to breath.
While patient was waiting in the office room after receiving GARDASIL and Hep A, patient loss consciousness for a few seconds. Patient woke up saying that it felt like a dream. Per mom's report. Pt was given juice and peanut butter with pretzels. Pt feeling back to normal.
several brief episodes of twitching of rt shoulder or leg;initially every 10min x 2hr & dec to much less often (1 every few days lasting few seconds);no assoc lethargy or feeding disturbance
The patient received the COVID-19/Janssen vaccine at 12:33pm.  Approximately, 5 minutes after receiving it, the stated that he was feeling dizzy and had ringing in his ears.  I had him lie down with his knees elevated.  He stated that he felt better in the supine position.  I attempted to take his blood pressure, but was unable to get a reading after two tries.  After a few minutes, he stated that he no longer had any ringing in his ears, but felt some numbness in his arms.  His fingers were cold and I had a difficult time finding his pulse.  While he was resting, he stated that he had anxiety to needles and "white coat" syndrome.  He felt that he was okay to sit up, so he did without any adverse reactions.  He drank some water and stated that feeling was returning to his arm.  I asked if he had eaten anything this morning and was told, just a cup of coffee.  We speculated that low blood sugar could have possibly compounded the situation.  At approximately 12:55pm, he felt well enough to leave.  I had him contact his mother who was in the store to accompany him out at around 1:00pm.
NONE (We gave DTap instead of TdaP).  There was no adverse event.  Therefore no date or time available.
This case was reported by a physician and described the occurrence of limping in a 5 year old male subject who was vaccinated with Diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix) for prophylaxis. The subject had no pre existing medical conditions. There were no concurrent medications. On 5/6/2006 at 5:00pm, the subject received 5th dose of Infanrix in the left thigh (lot AC14B035AA). On 5/6/2006, the subject also received the 2nd dose of measles, mumps and rubella virus vaccine MMR II lot 0151R, at an unspecified site of administration. On 5/7/2006, 1 day after vaccination with Infanrix, the subject experienced limping, and was noticed to have significant erythema and induration at the injection site of Infanrix. The subject was seen at a physicians office and was treated with Cetirizine hydrochloride Zyrtec, prednisolone Prelone and cephalexin. The physician considered the events were disabling because the child missed school and clinically significant or requiring intervention (OMIC). The events resolved on or after 5/7/2006 and on or before 5/12/2006. The physician considered the events to probably be related to vaccination with Infanrix.
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and unknown gender. On an unspecified date, the unspecified number of patients were vaccinated with doses of improperly stored VAQTA (lot# L013380 with an expiry date of 04-NOV-2017 and lot K005958 with an expiry date of 09-FEB-2017). No adverse effects were reported. Additional information has been requested.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:38 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:38 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 59.85 for dose administered on 03-APR-2021.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion 03-APR-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge 30-MAR-2021 and beyond use date for the vial was reported as 29-APR-2021. Product moved to clinic on 03-APR-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Resident inadvertently received a 4th dose of the Pfizer vaccine. 3rd dose was administered on 9/30/21. No adverse reactions were noted. Resident remains in the skilled nursing facility and family and MD were notified.
pt recv vax 31OCT on 5NOV woke w/flu like sx, dizziness, h/a, nausea & fever of 100.6;states this was first time recv flu vax-pt had terrible flu last winter;
It was reported that a 59 year old female received Fluzone SV 98-99 USP on Sep 29, 1998. Reportedly sometime after the vaccination the pt experienced an aching, swollen, red arm. From additional information received on Nov 16, 1998 it was reported the pt recovered from this experience.
ACUTE NON ST ELEVATION MI HYPOTENSION 10/23/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Case reference number 1999028872 is a spontaneous report from a RPH regarding a 29 year old man who received a dose of Havrix in the Gluteal region. No adverse even resulted from this maladministration of the vaccine.
Malaise, generalized body aches, chills, temp 102, erythema, induration, tenderness left upper arm from shoulder to elbow. Transient left axillary lymphadenopathy.
Severe axillary, supraclavicular, and ant cervical lymph node swelling on left.  Left hand and facial numbness. Stroke w/u in ER with CT angio and perfusion and brain MRI with w/o gad all normal, labs normal. Sensory deficit resolved in 24hrs.  Lymphadenopathy still severe at present.
Child broke out with pox-like rash a few hours (about 4 hrs) after MENACTRA, Tdap and chickenpox vaccine. Pox-like spots covered back of thigh, mostly right thigh and a few other spots noted on torso, shins rash is itchy. Child has headache. Referred child to MD for diagnosis.
Initial information received on 13-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 81-years old female patient who developed so painful and pain even went down to my hand and up to my head and neck and couldn't move hand, had to have arm close to body while she received vaccine FLUZONE HIGH DOSE. The patient's past vaccination(s) included FLUZONE HIGH DOSE. (It was reported that the patient was received the dose for years and years but not last year because he was sick). The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Rheumatoid arthritis with (It was reported that the patient have had Rheumatoid for fifty some years, and right hand is all crippled from it). On 08-Dec-2018, the patient received a 0.5 ml single dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine (frequency once) lot number not reported via unknown route in the left arm. On an unknown date, the patient developed a non-serious couldn't move hand, had to have my arm close to my body (injected limb mobility decreased), so painful and pain even went down to my hand and up to my head (pain localized) (Unknown latency) following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. It was reported that patient have more pain due to Rheumatoid, One finger still doesn't feel right. Patient was always so tired. (Other relevant tests included no lab data.) Final diagnosis was pain even went down to my hand and up to my head and neck, so painful and couldn't move it/ had to have my arm close to my body. The patient was treated with DEPO-MEDROL for pain. The patient was recovered from all the events. List of documents held by sender: none.
APROX. 12-36 HR AFTER INJECTION, SORE INJECTION SITE, SEVER HEADACHE, ELEVATED TEMP/MILD FEVER, SEVERE CHILLS, MODERATE BODY ACHE, EXTREME FATIGUE, EXTREME MUSCLE WEAKNESS. MAINTAINED APPETITE 36-48 HOURS AFTER INJECTION , MUSCULAR WEAKNESS 48-72 NO EVENTS
About 3 weeks after my first dose, I woke up with blurry vision in my left eye. I went to have it checked. I was diagnosed with Epi Retinal Bulge/Wrinkle. This caused my vision to be rippled and blurred and distorted. I have declined surgery for this so far.
Started bad at school, When she came home she had gotten in bed.  Temp was 101.  Later that night 103.  Given Tylenol.  2 AM temp was 102.  This morning she was soaked, but fever has not returned.
Pt develop heavy vaginal bleeding with clots 5 days after receiving the shot. Bleeding was heavy enough to drop her hemoglobin and require an emergency D&C.
Received 2nd COVID-19 vaccine booster in error. Not recommended at this time. No moderate or severe immunocompromised medical condition documented or verbalized.
12/27/21 Symptoms started that evening with sniffles and a weird headache I normally don't get. After that day on Tuesday, I was tired and by Thursday/Friday it continued. Saturday and Sunday the congestion started. That following Monday 01/03/22 my whole sinus was congested. 01/05/22 my ears were plugged up and my throat started to get irritated later in the day. 01/06/22 I started to lose voice, I had sinus pressure and pain, and my teeth and cheeks above my eyes hurt. 01/07/22 I was tired and coughing with a sinus headache and the pain was constant. 01/08/22 I had zero energy and lethargic and kept falling asleep and I was the same since Wednesday. Today 01/12/22 I started to feel fine other than a random cough so often but it's only when I talk for long, otherwise I don't cough. I'm not congested and have no sinus pressure pain. I tested positive on 01/07/22 from a rapid test at a pop-up clinic and my doctor also wanted me to get a PCR on Saturday so I did get that and confirmed it was positive. Saturday night after results my doctor called me and prescribed me medicine because I'm certain I ended up with a sinus infection based on symptoms and I do have a history of it turning into URI or walking pneumonia, so I wanted to stop it.
Aches, pains, chills, modest temperature, significant headaches, joint pain, insomnia, exhaustion
From initial information received on 10/18/04 from the patient regarding an adverse event occurring in the USA, it was reported that the 28 year old male received a dose of YF-VAX, lot number 0960560, expiration date 6/4/99; a dose of oral TYPHOID VACCINE, lot number 015089.1A; and a dose of HEPATITIS A VACCINE, lot number 0764H, administered on 1/23/99. The routes and sites of administration were not reported. The patient was seen by a physician on 1/23/99 after developing a local reaction at the injection site. He had no shortness of breath and did not have an increased heart rate. His initial blood pressure reading was 230/120. Subsequent blood pressure readings were 230/120, 170/103, 166/109, 164/86, and 164/80. He was treated with Clonidine 0.2mg. The patient reported that the developed heart failure and kidney failure as well as severe hypertensin. Per the patient , his physicians were unable to determine the cause of these conditions. Reportedly he did not recover from these events.  (OMIC). From additional information received on 8NOV2004 from the patient, it was reported that he will be seeing his cardiologist in two weeks. His recovery status was not reported. The adverse event coding has been updated from kidney disorder to kidney failure.
48 hrs after vaccine, extreme lethargy, fatigue, nausea, hyperalgesia, fever of 100 degrees, diahreah, muscle aches. All side effects persist despite alternating advil and tylenol now on day 6. Took PCR covid test in case on 4/4/21 and was negative.
COVID-19; Metallic taste; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DYSGEUSIA (Metallic taste) and DIARRHOEA (Diarrhea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Avastin. Past adverse reactions to the above products included Allergy with Avastin. Concurrent medical conditions included Thoracic outlet syndrome, Diabetes, Gout and Hypertension. Concomitant products included METFORMIN from 01-Jun-2017 to an unknown date, LOSARTAN from 01-Jan-2006 to an unknown date, ALLOPURINOL from 01-Jan-2006 to an unknown date, ACETYLSALICYLIC ACID (ASPIRINE) from 01-Jun-2013 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2022, the patient experienced DYSGEUSIA (Metallic taste) and DIARRHOEA (Diarrhea). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown and DYSGEUSIA (Metallic taste) and DIARRHOEA (Diarrhea) was resolving.            Patient took other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine.  From 28-May-2022 to 29-May-2022, the patient treated with unspecified medication(batch lot number FY6826) for COVID-19.  CC: This spontaneous case concerns a patient of unknown age and gender, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred unknown days after a dose of mRNA-1273 vaccine administration, given as the third dose. Patient also reported the non-serious events metallic taste and diarrhea which occurred 207 days after the mRNA-1273 vaccine administration. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred unknown days after a dose of mRNA-1273 vaccine administration, given as the third dose. Patient also reported the non-serious events metallic taste and diarrhea which occurred 207 days after the mRNA-1273 vaccine administration. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
no adverse effect; an expired PNEUMOVAX 23 vaccine was administered; This spontaneous report was received from a nurse manager, and refers to a patient of an unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.   On 25-AUG-2020, the patient was vaccinated with expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0,5 ml, once (indication, route of administration were not provided)  (lot # R033342, expiration date reported as 03-AUG-2020, which was verified to be valid). The vaccine did not have any previous temperature excursions. No additional adverse event was reported.   This report is not-valid due to lack of patient's identifiers. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R033342; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Shingle like pain from ankle through calf and thigh Severe.  Began suddenly and unrelentingly.   Leg cramp.   No rash.
Swollen lymph node in R armpit 3-4 days after vaccine was administered. Bruising with redness surrounding the lymph node visible in the armpit and very tender to the touch. The pain radiates through the shoulder and down through the arm into the thumb. Swollen lymph node came back 3-4 weeks later feeling the same pain with the same visible bruising and redness around the lymph node. The lymph node is visibly protruding into the armpit and very tender.
pt recv vax & devel an inj site rxn, numbness, pain & an inability to lift either the arm or hand;addtl info recv 31JUL96;pt recovered;
uncomfortable; fussy; patient under the age of 4 was inadvertently given a dose of QUADRACEL; Initial information received on 14-Feb-2022 regarding an unsolicited valid  non-serious case from a physician.  This case involves a 4 months old female patient whom under the age of 4 was inadvertently given a dose of quadracel, experienced uncomfortable and fussy while receiving Diphtheria-15/Tetanus/5 hybrid AC Pertussis/IPV (MRC5) vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 23-Sep-2021, the patient received a dose of suspect Diphtheria-15/Tetanus/5 hybrid AC Pertussis/IPV (MRC5) vaccine once (strength, lot and batch number: unknown) via intramuscular route in an unknown administration site for immunization. Information on batch number has been requested.  Concomitant medications included Rotavirus vaccine; Hepatitis B vaccine; Pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination.  On 23-SEP-2021 the patient under the age of 4 was inadvertently given a dose of Quadracel (product use issue), had been uncomfortable (discomfort), fussy (irritability) (latency: same day) following the administration of Diphtheria-15/Tetanus/5 hybrid AC Pertussis/IPV (MRC5) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (product se issue, uncomfortable, fussy).  At time of reporting, the outcome was Unknown for the events product use issue and fussy, was Recovered / Resolved on an unknown date for the event uncomfortable.  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.
Pt recvd vax 10MAR93 & exp rash on trunk, neck, face, arms (punctate rash); no koplik spots; OM, sore throat, t105, sz;
1hr post vax was pale & skin on extremities was mottled; pt shivering; No cyanosis & no difficulty breathing, no hives noted; ?pale limp episode; child was swaddled in blankets;
Patient received both doses of vaccine.  Last dose received 02/18/2021.  Patient tests positive for COVID on 02/25/2021 and hospitalized on 02/27/2021 with COVID.  As of 03/02/2021 patient remains hospitalized.