chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 02-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 24-MAR-2016), "TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had four temperature excursions: 48 hours (Lowest recorded temperature was 0 F (0 Celsius); 24 hours (Lowest recorded temperature was -1 F (-1 Celsius); 48 hours (Lowest recorded temperature was 1 F (1 Celsius) and 72 hours (Highest recorded temperature was 9 F (9 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved. Additional information has been requested.
Chills; Low Fever; Sore arm; tired; This is a spontaneous report received from a contactable consumer or other non hcp.A 73-years-old female patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EL9266),via an unspecified route of administration, administered in Arm Left on 15Feb2021 09:30,at the age of 73 years old,as Dose 1,single for covid-19 immunization. Medical history included cervicogenic headache from an unknown date and unknown if ongoing. Concomitant medication(s) included amlodipine, atenolol and iron taken for an unspecified indication, start and stop date were not reported. The patient previously took Lexapro, celebrex, hydrocodone, hydrochlorothiazide and experienced drug hypersensitivity. The patient experienced chills, low fever, sore arm and tired on 15Feb2021 16:00.The patient underwent lab tests and procedures which included body temperature: 99.5 on 15Feb2021.The patient was not diagnosed with Covid prior vaccination and not tested post vaccination.The patient had not received any other vaccine within 4 weeks.The patient had not received any treatment for the event. The outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a colleague who on an unspecified date was vaccinated with a dose of Gardasil. The next day, the colleague experienced liver failure. The reporting physician implied that liver failure was related to therapy with Gardasil. Upon internal review, hepatic failure was considered to be an other important medical event. Additional information has been requested.
Information has been received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-OCT-2015, the patient was vaccinated with improperly stored RECOMVBIVAX HB (lot # K010216, expiration date 17-SEP-2016, (strength, dose and route were unknown). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
10/31/2023@1452- flu vaccination. 17 hours post vaccination, pain, erythema, pruritus observed on injection site. Also tingling on left hand/fingers. On 11/2/2023, employee had headache, chest muscle tightness on the upper left location with continued localized erythema, warm to touch and pruritus. Left arm continued to be sore, with some still some tingling. 11/3/2023- Pruritus worsening.
This spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc underwent first temperature excursion with Tmax 8.2 degree centigrade for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree centigrade for 23 minutes (explicitly coded as incorrect product storage). On an unspecified date, two temperature excursions were identified after an audit. On 06-Nov-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch  number: 252672 and expiry date: 30-Jun-2019) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse events after administration. This case is linked to (201805262) due to same reporter.
Between 8-14 days later my shortness in breath got worse to the point i got chest pains and dizziness.  Went to the hospital and had low oxygen and blood pressure of 170/109. Result was a blood clot in my leg and 2 large clots in my lung.  Treatment now is heparin and eliquis .
This spontaneous report as received from a pharmacist refers to a 76 year old female patient with no medical history or drug allergy. On 27-OCT-2013 the patient was vaccinated with PNEUMOVAX23 (lot# reported as J004196; expiry date: 06-DEC-2014), 0.5 ml, intramuscular. There was no concomitant medication. The next day (28-OCT-2013), patient complained of soreness in arm, that she could not lift her arm, it was red and hot to touch. Pharmacist stated patient went to an unspecified physician at an unspecified time in the last 3 days and patient was diagnosed with an "infection"; pharmacist stated "I'm assuming it's cellulitis." Pharmacist stated there was no redness at the injection site, most notable underneath the arm. Pharmacist stated unspecified physician prescribed BACTRIM and patient "felt good, able to move arm more yet arm still red and hot." Pharmacist stated patient "had a pneumonia shot before" at an unspecified time in the past. The outcome of infection and cellulitis is unknown. No lab tests were performed. Additional information has been requested.
Within thirty min of shot mouth went dry and couldn?t swallow. Pain at injection 3 hours after shot and next day. Fever of 102 next day for three days and swollen right lymph node above collar bone. Swollen lymph node continued for a week and is still sensitive and slightly swollen a week later.
pt recv vax & had episode of weakness, fainting x2;stated had seemed ok & had to rest;pt was reportedly fine the next day;
Minor muscle soreness in arm and neck. Left facial paralysis and minor pins and needle sensation in neck area. Starting 4:30pm 05/26/21.
pt recv vax 06may96,on 08aug96 pt devel a breakthrough varicella rash of 30 lesions.It was also reported that pt may have been exposed to varicella @ daycare;
patient was administered quadracel subcutaneously instead of intramuscularly due to patient moving around during administration with no reported adverse event; Initial information received on 19-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 years old female patient to whom DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] was administered  subcutaneously instead of intramuscularly due to patient moving around during administration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination.  On an unknown date, the patient received 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE, suspension for injection (strength not reported) (lot number: C5970AA; Expiration Date: 02-Feb-2024) via subcutaneous route in the thigh nos for prophylactic vaccination instead of intramuscularly due to patient moving around during administration with no reported adverse event (incorrect route of product administration) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event incorrect route of product administration.   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.   Additional information was received on 19-Aug-2022: concomitant vaccine MMR added, dosing details with batch no. and expiration date was added for Quadracel. Text amended accordingly.
Death on 4/16/2021?.  Hemorrhaged (mouth), and choked on blood.   Family was present at the time of occurrence but nothing could be done to help her.  This was 16 days after receiving the J and J shot and would not perform autopsy due to age even when her primary wouldn?t sign off on the death cert.
Double vision, numbness, tingling, shooting pains, started with double vision 5 days after flu shot then numbness ran in back, hands, feet, lips, then shooting pains. Then slowly began to correct it's self one day at a time.
My daughter had the vaccine and two days later she started to have teeth shattering and progressively got worse after time, no fever, no chills, uncontrollable day and night, it lasted for about a week. I got her to a neurologist and he gave her Botox on her jaw and after 4 to 5 days it finally stopped. Before the Botox she took an anti anxiety medication and that made it worse then she took a muscle relaxer and that did not help. They did a ton of blood work, EKG. She saw a pediatrician, immunologist, rheumatologist, neurologist. There was an indicator  that she has allergies because something showed blood is elevated when your allergies are bad.
Itching all over body started night of vaccination 01/21/2021 and then 10 day post vaccination hive/itching at left arm injection site.  Per patient she took over the counter Benadryl , no difficulty breathing, shortness of breath.  She contacted her  doctors office for follow up regarding her reaction vaccination.   Patient did not receive vaccination via a health department clinic reported that she received the first vaccination at a  Hospital clinic, advised her to contact them and let them know of her reaction as well. Per patient she was advised by her doctor to post pone the second vaccination at this time.
ACUTE NON ST ELEVATION MI 4/6/2023 DYSPNEA ACUTE NON ST ELEVATION MI 4/6/2023 BACTEREMIA ACUTE NON ST ELEVATION MI 4/6/2023 MELENA ACUTE NON ST ELEVATION MI 4/6/2023 DYSPHAGIA
A 17 year 10 month 3 weeks 4 day old patient incorrectly received the Moderna vaccine on 08/21/2021.  The patient waited the appropriate 15 minutes and had parental approval. This was not discovered until the end of business day.
Had both vaccines in left deltoid, about 1 hour after had left upper arm pain, 3 hours later had body aches in lower back, legs, hips, by same evening had severe left arm pain and decreased ROM, chills started 11 PM - did not sleep well, this AM woke up 10:00 AM significant better - has left arm pain, but body aches and chills resolved no redness, no swelling to left arm ROM returned.
received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccine) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccine). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow up document received included Follow up-E-mail ID confirmed and the document contains Non-significant information
Took to urgent care on 2/6. Was vomiting. Falling asleep and had fever of 103.
High fever and chills lasting 3 days.  Extreme body pain (level 8) lasting 2 days.  Level 10 pain in both legs.  Extreme swelling in both feet and ankles with small white blisters on top of both feet.  Level 10 headache still have it. Diarrhea beginning 07/24/2012.  Loss of appetite.  I have not eaten for 3 days,  Very tired,  I slept for 2 days.  Extreme pain, level 10 now in lower back.  Constant urination, 12-15 times in 24 hours lasting 3 days.
For the past 2-3 days, have been using the bathroom more than regularly and my hands feel like they are asleep.
Patient got Covid-19 pneumonia two weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (Patient got Covid-19 pneumonia two weeks ago) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 7006 3200 03 and 7006 3200 03) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Sep-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 PNEUMONIA (Patient got Covid-19 pneumonia two weeks ago) (seriousness criterion medically significant). At the time of the report, COVID-19 PNEUMONIA (Patient got Covid-19 pneumonia two weeks ago) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported. The caller was a clinical trial participant from the Phase 3 of the Moderna Clinical trials. The patient received his first Moderna Covid-19 vaccine. No adverse events reported. The patient received his second Moderna Covid-19 vaccine. No adverse events reported. The patient got Covid-19  Pneumonia two weeks ago (as reported). The patient received his second Moderna Covid-19 vaccine on  30SEP2020  lot number 7006 3200 03  No Adverse Events reported  Patient provides   permission for Safety to contact him. Patient prefers to be contacted via telephone. The patient got Covid-19  Pneumonia 2 weeks ago.  Company comment: This case concerns a 64-year-old male patient with no reported relevant medical history, who experienced the unexpected serious AESI event of COVID-19 pneumonia. The event occurred on unknown date in 2021 after the second dose of Moderna COVID-19 Vaccine administered on 30-SEP-2020. The rechallenge was not applicable since no events were reported after the first dose and no additional dosing was expected. The benefit-risk relationship is not affected by this report. Additional information has been requested.; Sender's Comments: This case concerns a 64-year-old male patient with no reported relevant medical history, who experienced the unexpected serious AESI event of COVID-19 pneumonia. The event occurred on unknown date in 2021 after the second dose of Moderna COVID-19 Vaccine administered on 30-SEP-2020. The rechallenge was not applicable since no events were reported after the first dose and no additional dosing was expected. The benefit-risk relationship is not affected by this report. Additional information has been requested.
Rash on face, legs, and arms. Burning sensation with rash, blotchiness on skin and scalp, tightness in chest.
On 12/29, child had a fever induced seizure while sleeping (fever of 105).  6 weeks later, child had another seizure while awake and playing.  When paramedics arrived, fever was 102, blood sugar was 140.  Took child 1.25 hours to become responsive after seizure.
Since this date (reported as since the vaccine administration), the patient had been dizzy and the injections site had been significantly swollen; Since this date (reported as since the vaccine administration), the patient had been dizzy and the injections site had been significantly swollen; This spontaneous report has been received from a nurse regarding a 10-years-old female patient. the patient's concurrent conditions included anxiety and mild asthma. Historical conditions were not reported. The patient had no drug reactions or allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonidine and lamotrigine (LAMICTAL).   On 22-FEB-2021, the patient was vaccinated the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 injection intramuscular (IM) as human papillomavirus (HPV) prophylaxis (lot # 1691180, expiration date 15-NOV-2022). On the same date, she was also vaccinated with diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) 1 injection as prophylaxis (dose, frequency, route of administration were not reported).   Since this date (reported as since the vaccine administration), the patient had been dizzy and the injections site had been significantly swollen. She sought for medical attention. No laboratory diagnostics and studies were performed. No treatment was given for the events. On 24-FEB-2021, the patient's mother called the clinic to report the events. On 09-MAR-2021, the events were recovering (also reported as recovery date, conflicting information). The patient did not experience any additional adverse symptoms.   The causality between the events and the suspect therapies was unknown. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1691180; expirationdate: 12-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
information has been received from a female medical assistant with seasonal and environmental allergies which included mold and dander, cardiac disorder, a history of pulmonary valve replacement and tricuspid valve repair who on Jan 07, 2003 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (lot#643251/0445M). It was noted that there were no concomitant therapies. On Jan 7, 2003 the patient developed a red, slight bump, with injection site swelling. She also developed fatigue. On Jan 8, 2003 the patient developed a fever of 101 and shortness of breath. It was noted that the patient was under the care of a physician. On Jan 9, 2003 the patient was treated with diphenhydramine (Benadryl) and all of her symptoms resolved.  Additional information is requested.
1 day p/vax pt devel a 2-3cm nodule @ the site of vax;pt recovered;this is 1 of 2 pt from this site to devel an inj site nodule p/vax lot# 431966 (tetramune);
very minor, diminishing fatigue; has had minor nasal congestion; headache first day only; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (has had minor nasal congestion), HEADACHE (headache first day only) and FATIGUE (very minor, diminishing fatigue) in a 54-year-old male 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (has had minor nasal congestion), HEADACHE (headache first day only) and FATIGUE (very minor, diminishing fatigue). At the time of the report, NASAL CONGESTION (has had minor nasal congestion), HEADACHE (headache first day only) and FATIGUE (very minor, diminishing fatigue) had resolved.            No relevant concomitant and treatment medications were reported. The patient was average build and in good health. It was reported patient had minor nasal congestion, headache first day only, very minor, diminishing fatigue, for 3-4 days total. Patient gave credit Moderna for his better condition because his family who took Pfizer got COVID-19.
about 30 hours after receiving the shot I got a rash on my stomach and feet.  mild rash which I took Benadryl for.  I have in the past gotten rashes when I have had an infection (UTI, etc.)
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 32-year-old, adult male patient. The patient had no relevant medical history and had not received any concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235 and expiry date: 30-Jun-2019). On an unspecified date in Oct-2018, after vaccination, the patient experienced soreness. On 17-Oct-2018, the patient still had a bit soreness but was fine (recovering). This case 201804680 was cross-linked with the original case 201804657 due to the same reporter. Significant case amendment (19-Oct-2018): The description to be coded for the verbatim 'Received 1.5 ml dose instead of 0.5 ml' in the event tab was changed from extra dose administered to overdose. The narrative and case comment amended accordingly.
Injection site pain for a week with swelling and redness. The site (now 8 days later) is sill raised and red but not swollen.
Patient experienced nausea,  faint, and slightly vision loss after 10 mins of administering the second dose of COVID shot. Heart rate was reported as 101/68 and pulse was reported as 79. Emergency service was declined by patient's mom ( claim herself as a MD).
Pt's rt thigh is very red & swollen; extends to approx 1-2 inches above knee to 1-2 inches below hips.Child is also fussy; but active, walking & jumping.
Period came 10 days early. Excessive vaginal bleeding, lasting several months causing need for hysterectomy  at 26 years old
Redness, itching, and swelling at injection site.  It is also hot.  Slight chills yesterday.
HEADACHES, VERTIGO, VOMITING LIQUIDS, HIGH FEVER AND DEHYDRATION. It last 30hrs. Still dealing with nausea.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
pt recv vax & reported to clinic next day w/fever 103-104, generalized total body skin discomfort & chest tightness;tx w/pred & DPH;
edema - axillary (R) on chest side (not arm) not lumpy, nothing to palpate, not tender/red/hot just edema (2nd booster)
urticara started w/in 8hrs of vax & worst in 1st 48hrs p/vax;