chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the Moderna second dose 15 minutes after 6 hour throw away time; A spontaneous report was received from a nurse concerning a 24-year-old male patient, who was administered Moderna's second dose fifteen minutes after six hours throw away time.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their second planned doses of mRNA-1273 (Batch number: 09L20A) on 09 Feb 2021 for the prophylaxis of COVID-19 infection.  On 09 Feb 2021 the patient received the second dose of vaccine,however the dose suffered an excursion and remained out of the refrigeration 15 minutes after the 6 hour throw away time after being punctured. The nurse states it was only 15 min after the 6 hour time frame.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, administered Moderna's second dose fifteen minutes after six hours throw away time, was considered resolved.; Reporter's Comments: This report refers to a 24-year-old male who had an NS unexpected event of Expired product administered for mRNA-1273, lot # 09L20A with no associated adverse events. The event occurred the same day as the second dose of mRNA-1273. Reporter stated dose was affected by an excursion out of refrigeration more than 6 hours after being punctured, given 15 minutes after the 6 hours. Very limited information regarding this event has been provided at this time.  Further information has been requested.
This spontaneous report was received from a nurse regarding a patient of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. On 05-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, route not reported, product lot# J011212) that expired on 29-AUG-2014. No adverse effects was reported. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
Started my period following vaccine off cycle following both the first and second dose.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Aug2021 16:00 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single and administered in arm right, administration date 25Aug2021 10:15 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Thimerosal" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Aug2021, outcome "recovering", described as "Started my period following vaccine off cycle following both the first and second dose.". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. Patient did not take any other medications in two weeks. If covid prior vaccination was reported as Yes and if covid tested post vaccination reported as No. Covid test post vaccination reported as no. Adverse event start date reported as 26Aug2021 06:00 AM.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11 hours after injection started having low back pain. then 99 temp. all day had back pain and fatigue. Slept on and off with my eyes feeling heavy for first 28-30 hours. Slept through the night but still had constant low back pain today at 36 hours.
pt recvd vax MAY93 & 1 day following vax pt devel Bell's Palsy & was treated w/Steroids; pt recovered w/in 72 hrs; No further details were provided
Dry mouth, tingling, light-headedness, followed by swelling of tongue, difficulty in breathing w/chest pain radiating to lt shoulder;
Patient noticed pain radiating down her arm, back, and upper leg after administration of vaccine.  Later that evening the injection site became red, inflammed, and very painful.  The patient went to her primary care physician three days after vaccine administration because the injection site was still inflammed and very painful.  The primary care physician prescribed an antibiotic.
Mild itching and throat itching/scratching Vital Signs 0829 - BP 142/92, HR 101, RR 20, Temp 98.8, SPO2 99% Vital Signs 0832 - HR 83, SPO2 98% Vital Signs 0850 - BP 120/80, HR 70, RR 18, Temp 97.6, SPO2 99% Benadryl administered at 0829 by  RN
This spontaneous report as received from a nurse refers to 6 unspecified patients received doses of RECOMBIVAX HB (lot H010380, exp 18-NOV-2014) on unspecified dates, that were exposed to an unsupported temperature excursion (28.8F for 8 minutes) on an unspecified date in May 2013. No adverse effect reported. This is one of several reports received from the same source(related case # 1308USA05499). Additional information has been requested.
Information has been received from a certified medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition were not reported. Concomitant therapies included GARDASIL 9, HAVRIX (manufactured by GlaxoSmithKline (GSK)), ENGERIX (manufactured by GSK), FLUZONE (manufactured by Sanofi), IPV (manufacturer unknown), MENACTRA (manufactured by Sanofi) and TDaP vaccine (manufacturer unknown). The patient also received an Mantoux test. On an unknown date, the patient inadvertently received a dose of PROQUAD (lot # M015700, expiration date 26-SEP-2017, rHA (recombinant human albumin); dose and route were unknown) instead of VARIVAX (wrong vaccine administered). The patient also received M-M-R II (lot #, expiration date, dose and route were unknown) (overdose). All suspect therapies and concomitant therapies were give during the same visit. No adverse effect had been reported in the patient. Additional information is not expected as there is no consent for follow up.
Approx 4 1/2 hours after vaccination, chills, headache, muscle aches, drowsiness began along with soreness, warmth and a light pink rash at injection site.
Hard, hot swollen upper arm, hot, itchy, rash cascading down arm, currently 6+ days but appears to be resolving slowly. Episodic chills, muscle ache, joint pain, GI distress and anorexia intermittently,  causing me to stay in bed for several hours at a time, unable to conduct normal routines, currently 6+ days but appears to be resolving slowly.  I tested for COVID x2 just in case. I severely limit my exposure and have not been ill since pre pandemic. I am reporting due to the length of these symptoms. I have never had such a strong reaction to a vaccine. I previously was given the Pneumovax 5 years ago without anything remarkable.
Left arms swollen lymph nodes; runny nose; sore throat; headache; fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 06Jan2021 12:00 at a single dose in the left arm for COVID-19. Medical history included asthma, seasonal allergies and allergic to many different animals, all from an unknown date and unknown if ongoing. Concomitant medication included sertraline hydrochloride (ZOLOFT) and gabapentin. The patient previously took KEFLEX and experienced allergies. On 06Jan2021 12:00 PM, the patient experienced left arms swollen lymph nodes, runny nose, sore throat, headache and fatigue. Treatment received included Zpak. The patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in a nursing home/senior living facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Covid nasal swab: negative and rapid Covid test: negative, both on 07Jan2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous prospective pregnancy report as received from a currently 25-year-old female patient referring to herself. The patient was allergic to SULFA. She had no pertinent medical history. On 17-NOV-2017, the patient was vaccinated with the first dose and on 17-JAN-2018, with the second dose of GARDASIL 9 0.5 ml suspension for injection, in upper arm with a dosing schedule as 0, 2 and 6 months, for human papillomavirus (HPV) protection (exact dose, lot # and expiration date were not reported). Concomitant therapies included unspecified prenatal vitamins and venlafaxine hydrochloride ER. The patient became pregnant with last menstrual period (LMP) of 11-APR-2018 and estimated delivery date (EDD) of 16-JAN-2019. The LMP and EDD were calculated based on the number of weeks of pregnancy at the time of reporting. The pregnancy outcome was pending. The patient sought medical attention and visited an obstetrician-gynecologist (OB/GYN). There were no lab diagnostic tests performed. There was no treatment given. The patient was scheduled to receive her last injection of GARDASIL 9 on 17-JUL-2018.
Patient received three vaccines on date of visit Tdap (ADACEL), Hep A and Yellow Fever (YF-Vac). Pre-vaccination, patient mentions has fainted with shots - asked patient to lay down on exam table but she declined preferring to sit in chair - after 3rd injection patient slumped, then had seizure. Medics called and also checked by ARNP - discharged with mother who later called to report pt vomited x 3 on way home - will go to ED if worsens and FU with PCP.
Cough; Runny nose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) and RHINORRHOEA (Runny nose) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough) and RHINORRHOEA (Runny nose). At the time of the report, COUGH (Cough) and RHINORRHOEA (Runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Extreme chills, shaking, high fever, 102.7 for 24 hours
Covid dose #2 (Lot EN6201) given at 1:19pm.  Pt began feeling flushed, hot, and weak at approximately 1:30pm.  She was able to walk into Triage under her own power.  BP was 190s/90s upon arrival to traige.  Pt pale and complained of feeling lightheaded and that she felt like she was going to pass out.  400ml of orange juice given since patient stated that she had not eaten since 8am.  Blood sugar taken 15 minutes after resulted at 116.  Multiple blood pressures taken resulted in consistent 190s/90s.  911 called by provider at 2:07pm.  Fire Department arrived on scene at 2:13pm.  EMS arrived on scene at 2:16pm.  Vitals taken by EMS and it was determined that since her blood pressure continued to be elevated similar as prior and she felt unable to stand under her own power to take her to Emergency Department.  EMS left the clinic at 2:30pm.  Pt had all belonging with her and her family had been notified.  She remained conscious and able to answer questions throughout the event.
Throat swelling; tongue swelling; raw inside of mouth cheeks; fever blister above lip; soreness; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 17:45 (Lot number: Pf2590) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Coconut allergy" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE HYDROCHLORIDE. Past drug history included: Compazine, reaction(s): "known allergies: compazine"; Dilaudid, reaction(s): "known allergies: dilaudid". The following information was reported: PHARYNGEAL SWELLING (non-serious) with onset 09Nov2021 01:00, outcome "recovering", described as "Throat swelling"; SWOLLEN TONGUE (non-serious) with onset 09Nov2021 01:00, outcome "recovering", described as "tongue swelling"; STOMATITIS (non-serious) with onset 09Nov2021 01:00, outcome "recovering", described as "raw inside of mouth cheeks"; ORAL HERPES (non-serious) with onset 09Nov2021 01:00, outcome "recovering", described as "fever blister above lip"; PAIN (non-serious) with onset 09Nov2021 01:00, outcome "recovering", described as "soreness"; FATIGUE (non-serious) with onset 09Nov2021 01:00, outcome "recovering", described as "tiredness". The events "throat swelling", "tongue swelling", "raw inside of mouth cheeks", "fever blister above lip", "soreness" and "tiredness" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pharyngeal swelling, swollen tongue, stomatitis, oral herpes, pain, fatigue.  Additional information included: The patient did not receive any other vaccine in four weeks. The patient had no covid prior vaccine. The patient had no covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
The day of Vaccine everything was fine. The next day my daughter was dizzy and felt very weak. She nearly fainted twice. The weakness subsided after two days but she continued to feel dizzy for a total of five/six days. The last few days she described that if she looked up of down and then went to focus on something she still felt dizzy. She has not complained of this for the last three days. It was very worrisome. And, it felt like there was no one to turn too.
1- Arm pain which lasted two days including site redness and bruising. 2- brain fog  which lasted 6 days. 3- vertigo which lasted 6 days ended today for the most part. 4-very tired and lethargic which is ongoing.
p/vax pt inhaled, eyes rolled back, went limp, stopped breathing, became pale, lips turned blue;p/1min inhaled;went limp again;30sec inhaled then cried;
Sensorineural hearing loss right ear, 4 times. Hearing loss occured again after contracting actual virus.
Red, inflamed arm & pain to touch on left deltoid. (Right arm was and still is in sling from another cause).
On 7/27/00, the pt developed redness and swelling of the right thigh. On 7/28/00, the pt developed hives, erythema multiform. Further information has been requested. Follow up received 09/26/2000 states the patient developed the erythema multiforme on 7/30/2000. The patient was given Benadryl and Prevone as treatment. These symptoms resolved on 08/04/2000.
Currently pregnant, healthy singular pregnancy, 12 weeks at time of vaccination, due date 8/5/2021. Two previous pregnancies with healthy, live births (5/2015 and 2/2018). Received vaccination Tuesday 1/26 at 4 pm. Feeling tired by 9 pm. Had difficulty sleeping over night and bizarre dreams when I did fall asleep. Wednesday had moderate symptoms all day - fatigue, dizziness, body aches, joint pain, chills and hot flashes (no fever), nausea, and headache. Thursday morning (1/28), symptoms were more mild, but noticed urine was dark. By early afternoon, urine had gotten much more dark and looked to be blood in urine. Went to OB provider who confirmed blood in urine and urine sent out for culture, no infection found. Unknown cause of blood in urine. Headache has continued since 1/27, worse in the morning.
Headache, Myalgia, CoughWheeze, Diarrhea, NauseaVomiting, Fatigue, Chills, Dyspnea Narrative:
Bad itching, bad rash, hard time breathing, coughing, can hardly talk, fever, headaches, still not well!
Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.). Within a month of getting my vaccine, I started to have problems with my joints locking up. I was diagnosed with rheumatoid arthritis. It effected different joints at different times. It started with my feet and then it was in my shoulders. I experienced stabbing pain. My joints would lock up on me as well. I visited my regular doctor three times. My blood work was high for inflammation and rheumatoid factors. I was referred to a rheumatologist and I was prescribed some medications that did not work. It has been over six months and I am still in severe pain. I am scheduling to see another rheumatologist soon because I am still in severe pain. I have recently experienced some seizures.
This is an instance of breakthrough COVID-19 disease, after which death occurred.  The individual was a resident of a long-term care facility.  The individual was vaccinated with the Pfizer product on 01/21/2021 and 02/27/2021 at two different facilities.  The individual tested positive for COVID-19 via a PCR test on 04/22/2021.   The individual was seen in a clinic on 04/23/2021 and was released from isolation on 05/03/2021.   There was no hospitalization associated with this illness reported, but the individual died on 05/14/2021.   Death certificate details are as follows:  Part I Cause of Death   A: Acute Pulmonary Failure   B: COVID 19 Part II Other Significant Conditions:    COPD, CHF, Chronic Kidney Disease, Obstructive Sleep Apnea
9 month old patient receiving menquadfi with no reported adverse event; Initial information received on 07-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 9 months old male patient who reported a medication error due to a 9 month old patient receiving menquadfi with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] 0.5 ml 1 DF (dosage form) lot U7299AC in  (strength, formulation, frequency, administration site unknown) (expiry date: 04-AUG-2024) for prophylactic vaccination.  On 07-Nov-2022 the patient developed a non-serious event "9 month old patient receiving menquadfi with no reported adverse event" (product use issue) (unknown latency) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event product use issue.     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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Employee administered Fluzone "high dose" Quadrivalent flu vaccine on 10/5/21 by 11-7 Supervisor. Employee under 65years of age. Currently, employee doesn't report any adverse reactions.
Vertigo symptoms developed about 2 weeks after 1st dose. Has symptoms intermittently for last 2 weeks.
100 fever lasting more than 24 hours.  Pain at injection site.  Body aches.  Fatigue.
The day following vaccination, mom reports patient manifesting redness, swelling, warmth around left arm. Taken to clinic. Mom called health department on 3/3/03 to report this reaction and said patient was doing much better.
First dose was only pain at the injection site.  During the 2nd dose injection, the needle became disattached from the syringe during the injection process. The needle stayed in my arm and had to be pulled out manually. There was no way to note how much of the vaccine was actually delivered. I am, however confident that I received enough of the dosage to cause me some uncomfortable side effects starting within 12 hours. I had a low grade fever, chills and a pretty significant headache that lasted about 18 hours. After that point, I took an alleve and the symptoms resolved within an hour.   These are all typical side effects so I wasn't going to fill this form out, but I have noticed something unusual that I haven't seen much about. My taste is way off. I am now 5 days out from my 2nd vaccine and still nothing tastes right. Not bad or like anything specifically, it's just that nothing has any flavor. I can still smell just fine and can minimally taste my food but it just doesn't taste normal.
Erythema of 4.5 cm by 3.8 cm in left arm. Mild tenderness and mild induration.
BIGEMINY, TACHYCARDIA, PULSE 90-110 RESTING, SLIGHT CHEST PAIN.  1/25/07 Received medical records from hospital which reveal patient seen in ER 10/15/06 for chest pain which felt like constant burning.  Also had nasal congestion.  Tx w/antacid & d/c to f/u by PCP next day. FINAL DX: GERD & chest pain, non cardiac.
I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 10/27/2021 WEAKNESS I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 10/27/2021 AFTERCARE FOR PODIATRY SURGERY I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 10/27/2021 ATHEROSCLEROSIS OF BILAT LEGS W PAIN AT REST
rash on left arm above his wrist on forearm; itching all over the body after rash formed; This is a spontaneous report from a contactable consumer (Patient). A 60-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on 19Mar2021(at the age of 60-years-old) administered in Arm Left as a single dose for COVID-19 immunisation. Medical history included blood pressure increased from an unknown date and unknown if ongoing. Concomitant medication(s) included lisinopril taken for blood pressure increased, start and stop date were not reported; cyanocobalamin (B12 1000 SR) taken for supplementation therapy, start and stop date were not reported. On an unspecified date, the patient experienced itching all over the body after rash formed was reported as worsened, rash on left arm above his wrist on forearm. He had both doses of his Pfizer COVID vaccine, states he is trying to report a delayed side effect, that 17-18 days after his first dose was administered on 19Mar2021, he developed a rash on his arm, states it was above his wrist on his forearm o his left arm. States he did get the second dose on 09Apr2021, states the rash came before, about 4-5 days before, maybe the weekend of 03Apr2021, exact dates unknown. States he was gardening and doing yard work so he was unsure if it had to do with that. No additional Vaccines were administered on Same Date of the Pfizer Suspect. The adverse event did not result Emergency Room and Physician Office visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering for rash on left arm above his wrist on forearm and not recovered for another event.  No follow-up attempts are needed. No further information is expected.