chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Max/low temperature reached: 1.3C Duration out of labelled range: 38 minutes with no reported adverse event; FLUZONE QUAD MDV had been administered to a patient post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old female patient who has been administered vaccine Influenza quadrival A-B multidose vaccine preserved [Fluzone quadrivalent multidose] post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Temperature excursion occurred on 01-Sep-2022 for Fluzone Quad MDV (punctured and unopened) and cause is unknown. Max/low temperature reached 1.3C Duration out of labelled range: 38 minutes with no reported adverse Event (product storage error).  Other vaccines involve in temperature excursion were Daptacel, Acthib, Menquadfi, Fluzone Quad PFS (all unopened).   On 02-Sep-2022, the patient received a dose of suspect Influenza quadrival A-B multidose vaccine preserved (formulation, dose: unknown) (lot UJ879AB, Exp date: 30-Jun-2023) via unknown route in unknown administration site as Prophylactic vaccination post excursion with no reported adverse event (poor quality product administered).  Action taken: not applicable.   At time of reporting, the outcome was Unknown for 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.
R Leg - Varicella red + swollen + itching 18mm x 40mm.
Information has been received from a physician concerning a pt who on an unk date was vaccinated with varicella virus vaccine live. On 04May05 the pt experienced a mild case of breakthrough with very few lesions. No other information was available regarding the adverse experience or the pt's outcome. There was no product quality complaint reported. Unspecified medical attention was sought by the pt. Additional information has been requested.
COVID-19 Pfizer Vaccine dose #1 12/21/20 (Lot EJ1685); Tubersol TB test placed on the same day COVID-19 Pfizer Vaccine dose #2 1/11/21 (Lot EL1284) 1/12/2021: Patient presents to ED via EMS for chief complaint -- He stated that he was diagnosed with COVID-19 in November 2020.  The patient has not had any recent Covid 19 exposures.  He has not congregated with family members and others for Christmas.  He comes in for shortness of breath to the ED that is accompanied by fever.  Prior to getting his Covid vaccine 19 he was seen good health.  The patient finds that he short of breath, dyspneic on exertion, and feels overall weak and fatigued.  He has shaking chills according to him. Patient is diagnosed with PE likely due to untreated DVT (Patient reports "taking girlfriend's coumadin") from 1/7.
bad chest pain; left arm was numb; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (bad chest pain) and HYPOAESTHESIA (left arm was numb) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced CHEST PAIN (bad chest pain) and HYPOAESTHESIA (left arm was numb). At the time of the report, CHEST PAIN (bad chest pain) and HYPOAESTHESIA (left arm was numb) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, Heart rate: high (High) Fast heartbeat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information reported. No treatment medications were reported.  Patient experienced fast heartbeats and almost felt like she had a heart attack but 36 hours later, it was manageable.
I did not have risk associated with the possibility of a stroke. However, I experienced and was treated for a stroke on 07/27/2021. I was taken by ambulance when I could not speak and remember words that normally came naturally to me. According to the Emergency room doctors, I experienced a blockage in the language area, 3 blockages, according to the neurologist in the emergency room. I was given medication to dissolve the clots in the brain and admitted for 2 days afterward. I was given medications to take going home and have continued to do so. I have also been wearing a cardiac monitor for 30 days per cardiologist orders. Slowly, I have been regaining the ability to speak and recall words.
This spontaneous report as received from a physician refers to a patient of unknown age and gender who on 01-DEC-2014 was vaccinated with third dose of ROTATEQ, 2 ml, oral (lot # and expiration date were not reported) and on 15-JAN-2015, the patient received fourth dose of ROTATEQ, 2 ml, oral (lot # and expiration were not reported). The physician did not know the date when the therapy started. No adverse effect was reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Vaccine given 10 days early, given 2/2/21 instead of 2/12/21
Pt recvd Hep B vax on 29SEP87,29OCT87 &29MAR88.Titers drawn p/ 3rd dose showed no immunity;4th dose given & satisfactory titer achieved.
On 8/16/2017 8 days after receiving the MMRV shot he had a febrile seizure. There were not any signs or symptoms that day leading up to the seizure. He ate and drank normally all day and around 6:30 he had a febrile seizure and went limp. 911 was called and he was taken to the hospital his fever spiked to 103.4. He was given Tylenol and Motrin until the fever broke. We had a follow up appointment on 8/17/2017 and the Nurse Practitioner believed that this was a result from receiving the MMRV shot and suggested a report to be filed.
Tongue feeling itchy. Seen by EMS, observed for 30 minutes. Discharged home at 11:30 AM. Recorded by R.N.
This spontaneous report as received from a pharmacist refers to a 22 year old female patient. The patient has no pertinent medical history or drug reactions/allergies. On 30-SEP-2013 the patient was vaccinated with GARDASIL 120 Y (dose 1; route, dosage and lot number unknown). No concomitant medication was reported. The pharmacist reported that on 03-OCT-2013 patient developed a headache. The pharmacist said the patient felt like his spine was shooting out of his head. The patient was bedridden with pain. The patient sought medical attention by contacting the pharmacist and received treatment with ibuprofen and naproxen. The patient was reported as not recovered from the events. Upon internal review the events were considered as disabling as the patient was bedridden. Additional information has been requested.
Patient received Hep A (Havrix), PedvaxHib, and PCV 13 vaccine on 11/6/2014 and mother states patient started getting fever the next day of 101-102 on average, lasting 4-5 days; at one point peaking to 103. Patient also got a rash on abdomen and back that lasted about 4-5 days as well. Mom admits patient does have sensitive skin and has a history of eczema. Mom says this rash looked different then her eczema. Patient went ot the ER and was monitored.
(L) thigh with erythema, slight swelling & warm to touch after MMRV. Icing & PRN  Motrin given x 2 days. Some improvement in symptoms. (R) thigh with slight erythema after DTAP-IPV. Icing & PRN Motrin x 2 days. Some improvement in symptoms.
Colitis; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS (Colitis) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. SA113102) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COLITIS (Colitis). The patient was treated with PREDNISONE for Colitis, at a dose of UNK, qd. At the time of the report, COLITIS (Colitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Second dose was scheduled on 18 May 2021.
Rash - hive-like to bilateral arms and legs. Described as pink streaks, rash itches.
This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced little headache after the second dose. The outcome of the event was reported as unknown.   The report is cross referenced to report ID: 9FHZJM4R.  Follow-up attempts are needed. Further information is expected.
Patient received a completed series of Pfizer and then received a dose of Janssen. 1st dose of Pfizer on 12/21/20, 2nd dose of Pfizer on 1/11/21, 3rd dose of Janssen on 3/30/21.
PATIENT CALLED 7/11@8:45AM AND REPORTED ABOUT A QUARTER SIZE EDEMA (NOT SO MUCH REDNESS). SHE WAS CONSULTED TO APPLY HC AND MAY USE NSAID TX. SHE WAS ALSO ADVISED TO CALL BACK NEXT DAY IF NOT IMPROVING OR GETS WORSE. PATIENT ALSO REPORTS DIARRHEA.
Within 20 minutes of injection, patient was itching, swollen and had 10cm.
3 weeks post vaccine on March 15 at 10 am, I began to have severe abdominal epigastric pain for 3-4 weeks, severe knee joint pain never experienced before and seems to be progressing, heart palpitations and arrythmias, nausea, fatigue, still occuring and have never experienced any of this prior to vaccine. I have had to miss work due to illness and I NEVER do that.  I am a retired Veterinarian and cannot explain any of this except for the vaccine
One week after receiving the vaccine shot, my left upper arm from should down began to itch.  Slight red, under the skin 'rash' could barely be seen.  The individual spots did not seem to be the specific irritant.  The arm around the shoulder was somewhat achy and tight feeling.  I was able to sleep through the night after rubbing on Sarno-anti itch lotion.  Could not get comfortable on my left side, with the shoulder area hurting.
Severe inflammatory response with burning, blistering hives, general swelling, lymph node pain and soreness.
1 day later, experienced soreness in left arm, 2 days later, experienced headache and stiffness of neck and shoulders, and 3 days later awoke at 9am and soon after felt severe chest tightness and pain accompanied by shortess of breath, dizziness and nausea (feeling of vasovagal). After about 10 minutes, I chest tightness went away and I took myself to the ER, where they did blood tests, EKG, xray of lungs. Everything was normal.
Cellulitis, induration and lymphangitis left upper extremity. Ultrasound negative for abscess. Treated with IV ANCEF while inpatient, transitioned to outpatient ceftriaxone IV and then transitioned to oral KEFLEX.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 10-APR-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot# reported as K0045078, expiration date: 01-APR-2016, dose and route were not provided). No adverse effects reported. Additional information has been requested.
mild local reaction redness 2? circle and slight raised at injection site, tenderness the next morning after  the vaccination
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 14-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
2/14/06 Pt felt nausea, vomiting, difficult swallowing and wheezingin the evening at 2000 hrs approx 10 hrs after vaccine (2/14/06 1035). Pt had expressed no allergy to eggs or problems with previous vaccination. 2/15/06 Pt reported ernesis/nausea that cleared up by mid-day.
I am reporting COVID arm.  Itching, a rash and some tissue inflammation appeared on day 8 post-vaccination.  On day 9, a red patch (where the rash was) is present around the vaccination site.    All previous day reactions were reported though vsafe.
Case number PHEH2012US015848 is an initial spontaneous report received from a medical assistant on 30 Jul 2012: This report refers to multiple patients. They were given only the 135-CYW liquid component of MENVEO vaccine (batch number: A11071) on undetermined dates. It was reported that there were two patients that received a partial dose of MENVEO. No other adverse reaction was reported following this administration error.
encephalopathy/encephalitis.  12/12/2006: Hospital MR received for admission from 11/05-28/2006 for c/o of nausea and dizziness which rapidly progressed to an organic encephalopathy. HPI: 75 yr old presented to the ER with nausea, vomiting, and dizziness.   PE revealed no localized finding however daughter stated he is not making sense (speaks Korean).   Admitted due to worsening mental status and agitation.  Seen by multiple consultants.  Pt. had occasional seizures during hospitalization. PEG tube inserted on 11/17/06 for feedings. Transfered to another hospital on 11/28/2006 for 2nd opinion. Impression is generally of an encephalitis (infectious vs other-vasculitis) vs CVA vs. meningitis. One consult mentions the possibility of an influenza related reaction. Awaiting Discharge summary for final DX. 02/05/2007 D/C Summary received.  As above with the following discharge DXs: 1) encephalitis  2) acute renal failure 3) dehydration  4) seizure disorder  5) pneumonia  6) diabetes mellitus  7) hypertension  8)  hypercholesterolemia. 02/26/2007 MR received for an additional 44 day hospital stay for condition as above.  Multiple consults included. Little improvement overall, however some improvement noted after 10 doses of IV Solumedrol.  Mental status continued to wax and wane.  Pt was discharged to a skilled nursing facility. Final DX:  Possible Hashimoto Encephalitis.
Severe pain, cellulitis resulting in 2 visits to the E.R. at hospital.  Arm infection (swelling, hot to touch)Dizziness, headache.
High heart rate I believe 2 days after vaccine. My heart rate was steadily high for at least 30 minutes I couldnt get it to slow.; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 25Mar2021 as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021, the patient experienced high heart rate 2 days after vaccine, the patient's heart rate was steadily high for at least 30 minutes and couldn't get it to slow. The patient did not receive any treatment for the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event high heart rate was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
INJECTION WAS GIVEN AT 2:06 AND CLIENT FELT LIGHT HEADED AT 2: 10P.M.  SPO2 WAS 99% AND PULSE WAS 63. AT 2:16, BP WAS 97/67 AND PULSE WAS 72.  CLIENT WAS MONITORED FOR 30 MINUTES AND DID NOT LOSE CONCIOUSNESS AND LEFT INDEPENDENTLY.
The day of there was soreness, that night arm pain got worse. The following more the arm was heavy and super sore.  There was a long red spot  the night of 4/28/21  the vaccination. There was a bruise previously until it turned into the red spot.
Patient developed GBS- lumbar puncture proven- 4 days following 2nd dose of Moderna vaccination.   Progressive lower extremity weakness requiring hospitalization.   Hospitalized from 4/20/21-5/8/21.  Treated with 5 days of IVIG.
Vaccine admin Wed 3 pm. Thurs no problem. Friday am, patient woke up almost fully blind right eye.
Immediate reaction to Hep A within seconds site of inj. became red, warm and some spotting red dots.
I start to have a rash in my thorax the late afternoon after vaccination (3/9/21).  I though it was a mosquito bits and didn't pay attention.  The next day appear more in my thorax and legs.  The third day I have more and start having an enantema in all of my body.  the itch was incredible.  I started to take cortisone 10 mgr. once a day, Claritin and Benadryl al night.   the itch start to demised but not the rash.  I took cortisone for 5 days and continue with Claritin  in the day and Benadryl at night.  Yesterday,  started with itch in my thorax and today I found more rash.  I don't know what to do?
not feeling well, weak; not feeling well, weak; freezing/chills; aches and pains; Nauseated; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer reported that she started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), Pfizer Covid vaccine manufacturer; unspecified, NDC number, expiry date; unknown, intramuscularly from 26Jan2021 at 12:45 pm to 26Jan2021 at 12:45 pm at single dose on left arm, towards the shoulder up high for prevent Covid. Vaccination facility type; hospital, Vaccine was not administered at military facility. Patient was 79 years old, weight; 77.11 kg, height; 155 cm at the time of vaccination. Patient medical history, relevant tests and concomitant medications were reported as none. Past drug event included soreness with flu shot (drug name unspecified). Patient did not have name, lot, ndc, or expiration date for the flu shot. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available, additional Vaccines Administered on Same Date of the Pfizer Suspect and prior Vaccinations (within 4 weeks) were reported as none. Patient experienced not feeling well, weak, freezing/chills, aches and pains and nauseated from 26Jan2021 at 12: 45 pm to ongoing. Patient got her Pfizer Covid vaccine on on 26Jan2021 at 12:45 pm, Tuesday afternoon. She has not been feeling well since then. She was freezing, she had the chills, aches and pains, she is really kind of nauseated. Nausea is the most irritating thing right now and it seems like chills have gone away. She asked how long does this last and is there anything she should be done. Advised to contact hcp, HCP: no email. All her symptoms started Tuesday night. She has had to stay covered up all the time. She feels kind of weak, and she has been laying around covered up, states that could make her sore since she is not up and doing anything. She is not throwing up, she is queasy, she does not want to eat anything like she is afraid. Patient declined any treatment given. The reported adverse event did not require a visit to emergency room or physician office. The outcome of events was recovering for chills and not recovered (From 26Jan2021 to ongoing) for other events . Investigation assessment; no.
patient did not receive 0.25 ml of the booster dose; The syringe malfunctioned and more than 3/4 of the dose leaked out from the side of the syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient did not receive 0.25 ml of the booster dose) and DEVICE CONNECTION ISSUE (The syringe malfunctioned and more than 3/4 of the dose leaked out from the side of the syringe) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, the patient experienced UNDERDOSE (patient did not receive 0.25 ml of the booster dose) and DEVICE CONNECTION ISSUE (The syringe malfunctioned and more than 3/4 of the dose leaked out from the side of the syringe). On 14-Jan-2022, UNDERDOSE (patient did not receive 0.25 ml of the booster dose) and DEVICE CONNECTION ISSUE (The syringe malfunctioned and more than 3/4 of the dose leaked out from the side of the syringe) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.
Approximately 5 months after vaccination, I developed weakness in my legs, similar to, but not as severe as previously when diagnosed with Guillan-Barre.
Pt reported having "warm skin" and developed hives on upper and lower extremities. Pt denied other symptoms but was taken to a higher level of care within the facility for observation.
Weakness. Sweating. Dizziness. Diarrhea. Shortness of breath.
Pt c/o dizziness, leg & arm weakness, and lightheadedness. S/S lasted about an hour. Pt was placed in a supine position., two set of vitals were taken, pt was given water. S/S resolved with no need for EMS involvement. Vitals 1st set: BP 138/75, HR 69 , Pain 1/10. O2 97. Vitals 2nd set:  BP 149/77, HR 75 , Pain 1/10. O2 97.  Random BG level: 208. Pt declined further intervention, stated he had not taken his meds in the morning and after s/s resolved left facility w/ out further incident.
Patient received the shot on 5/7/21 and by 5/9/21 he had swelling in lymph lode, under arm on the side he had received the vaccine.
About 20-25 minutes after receiving the shot, my left cheek began to tingle. In the days that followed, the left side of my face, especially my cheek felt like I had razor burn. My left eye became dry, but that went away, as did scalp itching. I began to produce more saliva on the left side of mouth. My face felt heavy, my upper jaw at times aching, but mostly my lower jaw. The inside of my left ear hurt occasionally along with upper jaw pain. My left lymph node became swollen, as did the left side of my face.  My doctor on Zoom said these were symptoms of Bell's Palsy, though I did not have the characteristic drooping eye or mouth of Bell's Palsy. My symptoms have abated, but persist five weeks after administration of the shot.