chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of administered expired FLUMIST was received from a health professional concerning a 25-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 04-Mar-2012. On 08-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 16-Apr-2012: No late occurring adverse events were reported.
This is a spontaneous report based on information received by Pfizer and Merck National Service Specialist (Service Request Number #1-12577085789) by a contactable nurse. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration at single dose on unknown. The patient medical history and concomitant medications were not reported. The patient experienced injection site reaction on an unspecified date with outcome of unknown. Follow-up attempts completed. No further information expected.
Patient stated that about 30 minutes after receiving the vaccine she had severe nausea and vomitting she was also experiencing chills.  She reported to me tht she still felt  like that 1 hour later.  She will follow up with the pharmacy.
PT HOSPITALIZED WITH BLOOD CLOTS IN LUNGS. DISCHARGED FROM HOSPITAL A FEW DAYS LATER.
Left deltoid is red, swollen, skin is warm to touch and tight.  Pt denies any nausea/vomiting/diarrhea.  Pt states he started feeling a "low headache in the background" starting today (4/16/2015).
Gave Hep a then HPV. After second shot patient reported feeling hot and light headed. Patient remained seated and did not lose consciousness. Open window and door, as room was hot. Patient reported he had not eaten anything. Patient had brief dry heaves. Observed patient about 15 minutes until he reported feeling ok. Patient able to leave on his own.
10/29/03: Pt called health dept in the AM to report right arm a little swollen and red at injection site, reported increased pain. Advised pt to hold ice to arm and take antiinflammatory, e.g. ASA, Ikotrin as tolerated and to call back or see MD PM. 10/30/03: Pt to health dept, reports increased pain, increased redness, increased swelling. This nurse noted increased redness, increased swelling and hot to touch from site of injection at right deltoid to elbow. Referred to MD. 10/31/03: Nurse phoned pt, she reports she did see doctor and was Dx'd with infection. Is taking antibiotic (Keflex) and Benadryl per doctor's order. It states she ran a fever last night of 102 degrees. She states she is feeling better today, swelling is decreased and pain decreased.
Sleeplessness with no energy loss ,itching without rash.  Strange taste. Self monitoring no treatment.
Swelling, red skin, white bumps at injection site. White bumps turned to red bumps after about 4 hours. My daughter was extremely  cranky and not her self the remainder of the day. She had a mild temperature (99.2 degrees, at the appointment prior to vaccines it was 98.3).
dizziness; headache; Initial information received on 29-Jul-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 16 years old patient (gender not reported) who experienced dizziness and headache, while he/she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications not reported.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6522AB via unknown route in unknown administration site.  On an unknown date, the patient developed dizziness and headache following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Details of lab data not reported.  Final diagnosis was headache and dizziness.  It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was not reported.  List of documents held by sender: none.
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 28 months old patient (also reported as 6 month old) who received 0.5 ml inadvertently instead of 0.25 ml of FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication received. On 24-Oct-2018, the patient received a single 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6263CA via intramuscular route in the right thigh. It was a case of actual medication error due to accidental overdose and expired vaccine used. It was unknown whether adverse event occurred or not. 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 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.
This spontaneous report as received from a pharmacist via field representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route, lot # and indication were not provided). On an unknown date the patient experienced severe abdominal pain. The patient sought medical attention by calling the pharmacist to ask her for guidance, and the pharmacist told the patient to call her back if the abdominal pain did not resolved "in a few days." The representative did not know whether or not the patient has recovered, and she did not know if the patient notified her primary healthcare provider. The pharmacist did not hear back from the patient. The representative did not know the date of the ZOSTAVAX administrator any identifying information of the patient. She did not known if the patient received any treatment. The outcome of severe abdominal pain was unknown. Additional information has been requested.
Tinnitus for the last couple of hours is the most annoying and painful for me daughter.   Also she has a headache, sore arm, and sore muscles all over.
Another balding spot; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Another balding spot) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ALOPECIA (Another balding spot). At the time of the report, ALOPECIA (Another balding spot) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to MOD-2021-155071 (Patient Link).
My sister was vaccinated with the COVID-19 Janssen vaccine (J&J) the last week of March, 2021. She received a COVID-19 Moderna "booster" shot on October 27, 2021. Several days after receiving the vaccine, she started to feel a sharp pain under her left breast and then experienced shortness of breath. On November 1, 2021 (5-days after her second vaccine/ a mix-and-match JJ/Moderna), she was admitted to the ICU and was found to have blood clots in her lungs. She was treated with Ribaroxaban (Xarelto) and released on November 3, 2021. From her account, she did NOT have thrombocytopenia (low platelets) as is associated with TTS (Thrombosis with Thrombocytopenia Syndrome) as was feared since she originally received the J&J vaccine and is 50 years old.
Heart fluttering and shortness of breath with slight dizziness. Started the day after the shot.  Every few hours for the 1st month, then once a day for about 3 months, then about 3 times a week since then.
This spontaneous report was received from a certified medical assistant, refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, patients were vaccinated with improperly stored GARDASIL 9, lot # L014415, expiry date 25-JUL-2017 and lot # L023230, expiry date 28-JUL-2017, (dose, frequency and route of administration not reported). It was reported that the vaccines were exposed to temperature of 12.6 degree Celsius for 2 hours and 9 minutes because of data logger. No previous temperature excursion reported. No adverse effect reported. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Patient presented to her regular office appt on 2/17/2021 with afib with RVR. Patient transported to the hospital for further work up.
High fever (102+), nausea, vomiting, muscle ache, rapid heartbeat, eye pain, headache.
Shingles; Ill-defined disorder; Death; This spontaneous report was received from a lawyer and a patient (pt) of unknown age and gender regarding a case in litigation on 05-DEC-2022. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On or about 20-NOV-2022, the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for long-term prevention of shingles and zoster-related conditions in the local pharmacy. Subsequently the pt was treated for shingles and other zoster-related conditions.  On 02-MAY-2018, the pt passed away, the cause of death as well as if an autopsy was performed were not reported. At the reporting time, the outcome of herpes zoster reactivation and other related conditions was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).
Could not lift head or get out of bed without passing out.  Necessitated transport to emergency room via ambulance.  ECG, brain MRI, head catscans all "normal."  Medication for vertigo helped some.  11/30/09 Medical records and discharge summary received for DOS 10/21-10/23 Final DX: Orthostatic hypotension, BPV C/O feeling of almost passing out when trying to get up or ambulating, dizziness, feeling of oncoming LOC. SOB, diaphoresis.  PE revealed BP 160/90. Bruised thigh.  Thigh numbness. Sciatica sx. Dehydration. Depression w/mild anxiety.  Presyncope w/orthostatic dizziness and postional hypotension.
flushing; light headed; felt really spacy for like 2 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 14Feb2021 09:00 (Lot number: EN6201) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Factor 5 Leiden" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FLUSHING (non-serious) with onset 14Feb2021, outcome "recovered" (14Feb2021), described as "flushing"; DIZZINESS (non-serious) with onset 14Feb2021, outcome "recovered" (14Feb2021), described as "light headed"; FEELING ABNORMAL (non-serious) with onset 14Feb2021, outcome "recovered" (14Feb2021), described as "felt really spacy for like 2 hours".  Additional information: After the first dose, in 5 minutes, she had flushing, was light headed, and felt really spacy for like 2 hours. It went away. No additional vaccines administered on same date of the Pfizer suspect. The patient had no prior Vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
We were going to visit some relatives, so we decided to take some COVID-19 test and they were negative. My throat was sore with white spots on it, and I decided to call and have some antibiotics called in. On 9/26/22, we went hiking and were at high elevation. It was hard to hike because we were at altitude. I didn't have Tachycardia that day. Then, 9/28/22, we were riding bikes, and I went into the ranger station to look at shirts and my heart rate went up to 138. Because it didn't go down, the gift called EMS to check me out. After about 35 or 40 minutes my heart rate started to come back down. I think I may not have hydrated well that day, maybe that is why my arrhythmia kicked in. We started heading back to our car and the Tachycardia kicked back in. After about 25minutes the EMS was called again, they did an EKG and it showed that I had a fast rhythm and then acutely dropped back to normal. My symptoms were chest tightness, and arms tingling. I didn't have any more fast rhythms, but I did have another episode of 2 beats and then a drop beat. It has been doing that for a while now. Since coming back, my doctor has instructed me to go to the emergency room if I continue to have problems. On 10/3/22, I got back to Ohio and called the Cardiologist because my arrythmia is still happening. I was trying to go see him and they told me to go to the emergency room. I went there and spent the day in the emergency room. They did several tests to rule out a heart attack. They also checked for clots and did an echocardiogram. After passing all the tests, they let me go home on that night. Then on 10/5/22 they did and echocardiogram and everything was ok. The last thing they are going to do is a 30-day monitor to decide which mediation I will need.
client began feeling like tongue was thick, blurry vision, general itching all over body 3 minutes after receiving immunization.  10:05 am:  Client was given 0.5 ml of Benadryl IM in the Right deltoid.  Vital signs were bp 121/85, respirations @ 20, heart rate 90 bpm.  Oxygen sats were 98%.  Client was assessed by paramedics. 10:18 am: bp 114/82, Oxygen sats at 100%, heart rate 82. Client reported she felt less urticaria, less tongue thickness, and vision improved. Watched client for the next hour.  Last assessment: 11:07 am: blood pressure 110/74, heart rate 80, no tongue thickness, no itching, no blurred vision. Client left on own accord and drove self home from vaccine pod. Recommended client follow up with primary care physician to discuss options for second dose of moderna vaccine.
Massive migraine headache for 12 days starting Aug 16.  Never had them before.  Acetaminophen helped but then got migraine relief OTC and it knocked it back.   Slight fever 1-2 degrees.  Had full panel of blood work done on Aug 23, 2021.  Liver enzymes (AST and ALT were 500 to 1000% over the normal range.  Six other blood tests were out of normal range, HDL cholesterol, triglycerides, white blood count, red blood count, Hematocrit, and platelet count.
Temperature excursion with lowest temperature of 0.17 degree Celsius for 9 days with no reported adverse event; Menquadfi has been administered post excursion (lowest temperature reached 0.17 C and the total excursion lasted 9 days) with no reported adverse event; Initial information received on 12-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 years old female patient who was administered meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] post excursion (lowest temperature reached 0.17 degree Celsius and the total excursion lasted 9 days) 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 HPV vaccine VLP RL1 4V (yeast) (Gardasil); and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix).  On an unknown date the suspect meningococcal A-C-Y-W135 (T conj) vaccine was exposed to a temperature excursion with lowest temperature of 0.17 degree Celsius for 9 days with no reported adverse event (product storage error).  On 08-Jul-2022, the patient received a dose of suspect meningococcal A-C-Y-W135 (T conj) vaccine (lot U7249AA, expiry date: 11-Mar-2024; formulation, strength and dose not reported) via intramuscular route in the right deltoid for immunization.  On 08-Jul-2022, the patient was administered meningococcal A-C-Y-W135 (T conj) vaccine post excursion (lowest temperature reached 0.17 degree Celsius and the total excursion lasted 9 days) with no reported adverse event (poor quality product administered) (latency: same day).  Action taken was not applicable.  Outcome: Unknown for both the events   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. ; Sender's Comments:  01187328:
pain and stiffness in neck; Swelling of wrist and hand; pain and stiffness in neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain and stiffness in neck), MUSCULOSKELETAL STIFFNESS (pain and stiffness in neck) and SWELLING (Swelling of wrist and hand) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Drug allergy. Concomitant products included BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced NECK PAIN (pain and stiffness in neck). On 23-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (pain and stiffness in neck) and SWELLING (Swelling of wrist and hand). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NECK PAIN (pain and stiffness in neck), MUSCULOSKELETAL STIFFNESS (pain and stiffness in neck) and SWELLING (Swelling of wrist and hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included ibuprofen. She had her first dose of vaccine on March 13th 2021. It was given on left arm. Caller mentioned that on 22nd March she had stiffness and pain in neck. On 23rd Night she noticed swelling in wrists and hands. She has taken Ibuprofen for this. Caller asked about the ingredients of the vaccine, she wanted to know if vaccine contains Acyclovir as she is allergic to that medication.
June 10, 2014 pt had his school physical and received his PENTACEL in his Left arm and PROQUAD in his right L arm was warm that evening and swollen. By June 11, swelling was worse. By June 12, he was vomiting, feeling ill, with an arm significantly swollen, 1 inch larger in circ. from R arm.
My daughter received two vaccinations. She started to show signs of weakness on her lower right leg before the third shot. The day of the third shot a friend saw her noticeably falling, tripping that evening. She continued to show weakness in her right leg to the point of not being able to walk more than a step or two without needing to grab onto something. We took her to the ER. She had lesions on her spinal cord and brain stem. "A lot of lesions" said the pediatric intensive care doctor. The current diagnosis is ADEM but there are tests we are still waiting on and she has several follow up appointments.
A rash on her forehead that spread over her face.  Neck is stiff, joints hurt, No reaction at the site of the shot.  Emergency Room visit on 11/29/2009 with 5 days of Prednisone 50 mg/day.  Rash proceeded to cover all her face including hair as well as arms and top of upper body. On 12/01/09 Doctor's visit. Many symptoms involving multi-systems. Blood Culture drawn.  Another Emergency Department Visit on 12/4/2009.
At Hepatitis A outreach, box of Hepatitis A vaccine in cooler, was pediatric instead of adult. Used vial of pediatric instead of adult. Revaccination with Adult Hepatitis A Vaqta R018775 in Left Deltoid. Exp 2019Aug09
This is spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 12-JAN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two separate temperature excursion (dates unspecified): lasting for 48 hours, with the lowest recorded temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 1 degree Fahrenheit (also reported as 1 degree Celsius) and another lasting for 72 hours, with the highest recorded temperature of 9 degrees Fahrenheit (also reported as 9 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacy student referring to an unspecific number of patients, of unknown age and gender. Medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M033096 (expiration date 31-MAY-2018), (route, dose and frequency were not reported). The vaccine was exposed to temperature of -2.1 C, during 4 hours 6 cycles. The call was because of data logger. No previous temperature excursions and no adverse effects were reported. There was no Product Quality Complain (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Left arm with 6 cm area with erythema and very warm to to touch. No fever. Site is painful.
CLIENT REPORTS 13 DAYS FROM VACCINE DATE, HE BROKE OUT WITH CLEAR FILLED BLISTERS ON HIS LEGS. HE REOPRTS THEY TRAVELED FORM HIS CALVES, TO HIS THIGHS, AND THEN TO HIS ARMS. BLISTERS IMPROVED AND WENT AWAY AFTER 3-4 DAYS. BLISTERS WERE EXTREMLY ITCHY AND PAINFUL. CLIENT STILL HAS HEALING AREAS BUT OTHERWISE NO OTHER CONCERNS. CLIENT REPORTS NO CHANGE IN ACTIVITIES, DOES NOT WEAR SHORTS, NO CHANGE IN HIS HEALTH OR DIET AND NO HISTORY OF A REACTION OF THIS NATURE IN THE PAST.  CLIENTS WIFE SAID IT LOOKE DLIKE CHICKEN POX.  CLIENT NOTES HIS FAMILY WAS ILL IN JANUARY OF 2020 AND THEY FELT IT MAY HAVE BEEN COVID.
KINRIX (Dtap and Polio) given instead of separate Dtap and Polio (IPV) vaccines.
The same day of vaccination in evening swollen throat/hoarse voice, "achy" eyes. That night she woke up with numb fingers on both hands - next morning sx resolved.
fever 103 28JUN & 29JUn-MD 1JUL97;rash-face & chest for 5 days;fussiness 3-7 days;loss of appetite;
Cough, fever, malaise, headache  COVID POSITIVE 01/16/21