chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; temperature excursion for VAQTA; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender. No information regarding patient's medical history, concurrent conditions or concomitant therapies was provided.  On 03-JAN-2022, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) lot # U024505, expiration date 15-OCT-2022 (dose, dose number and site of administration were not provided) for prophylaxis (Product storage error) . No details regarding time and conditions were provided for the temperature excursion. No adverse events were reported (No adverse event).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA006297: US-009507513-2201USA005595: US-009507513-2201USA005673: US-009507513-2201USA005751: US-009507513-2201USA005901: US-009507513-2201USA006305: US-009507513-2201USA006322: US-009507513-2201USA006342: US-009507513-2201USA006419: US-009507513-2201USA006445: US-009507513-2201USA006536:
Patient described scratchy throat and uneasy feeling, within 10 minutes of vaccination. Patient said he felt like an allergic reaction, Ambulance was called and patient taken to Emergency Room. At no time was there any trouble breathing.
TOOK SECOND DOSE ON DAY 4; TOOK VIVOTIF WITH FOOD; A spontaneous case report was received from a caregiver on 17-Jan-2019 for three consumers.  Based on the information obtained from the caregiver, three individual case safety reports PVX201901-000046 (PVX2019-172; mother), PVX201901-000047 (PVX2019-173; son) and PVX201901-000048 (PVX2019-174; husband) were created and cross-linked in the database.  This case report describes a male child who "took second dose on day 4" and "took Vivotif with food". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took the first dose of Vivotif on 14-Jan-2019 after dinner. He took the second dose on 17-Jan-2019 with breakfast.  The action taken with Vivotif with respect to events "took second dose on day 4" and "took Vivotif with food" was not applicable.  The clinical outcome of the events "took second dose on day 4" and "took Vivotif with food" was unknown.  Company's Comment: The causality of the events "took second dose on day 4" and "took Vivotif with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the events "took second dose on day 4" and "took Vivotif with food" was considered as not applicable. US-PaxVax Berna GmbH-PVX201901-000046: US-PaxVax Berna GmbH-PVX201901-000048:
Pt seen by PMD 10/9/07.  Dx with sinusitis & pharyngitis, flu like symptoms.  Then present to ER x3 on consecutive days 10/15/07, 10/16/07 & 10/17/07.  Pt was told she had Guillain Barre syndrome, never hospitalized.  Pt reported unable to walk, talk.  Then resolved by 11/17/07 but L sided weakness recurred.  11/16/07 Hospital ER records reviewed which reveal patient experienced intermittently a line showing up on left side of face from left eye to left corner of mouth.  Neuro & psych consults done at outlying hospital & was d/c.  Neuro consult repeated & was found to be WNL.  Recommended observation admit & formal psych evaluation but refused.  D/C to home & outpatient psychiatric f/u. FINAL ER Diagnosis: Bipolar disordr; & conversion reaction. 1/15/08 Reviewed ER medical records which reveal patient experienced 4 days of progressive weakness, body aches, tingling, numbness, difficulty moving extremities, sudden loss of speech when seen 10/15/07 after transfer from outlying ER.  Neuro consult done & found reflexes intact, speech intact & able to move all extremities.  Observed & d/c to home. FINAL DX: weakness. Returned to ER 10/16/07 w/confusion, left arm numbness, unable to walk.  Exam revealed DTRs intact & would speak only to husband.  Attempted to obtain psych consult but patient angry & left. FINAL DX: psychogenic dx.
felt a throbbing pain on her elbow; Joint pain.; She had sore arm; Feels as if her muscles were damaged; she cannot stretch her arm all the way to the back; that she cannot carry or hold anything on her left side; This is a spontaneous report from a non-contactable other healthcare professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported),via an unspecified route of administration on 29JAN2021;second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported),via an unspecified route of administration on 19Feb2021 as a single for COVID-19 immunisation. Medical history included covid-19 from Dec2020 to Dec2020 it was not severe just headache and body aches. The patient's concomitant medications were not reported. It was reported that, therapist counsellor said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 29JAN2021, and the 2nd dose on 19FEB2021. However, ever since she received the vaccine, she noticed that her muscles got affected to the point that she cannot carry or hold anything on her left side. She said that she cannot stretch her arm all the way to the back. She also said that she felt a throbbing pain on her elbow and feels as if her muscles were damaged. HCP also mentioned that she had sore arm and joint pain. She was concerned since she feels that the symptoms are not getting any better. HCP wants to know if there have been any reports similar to her reaction. HCP also mentioned that she previously had Covid back in Dec2020 but said that it was not severe just headache and body aches. No product quality complain was reported. The outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
joint pain got worse; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (141003).  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 60 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "joint pain got worse".  Additional information: patient reported xeljanz was placed on hold on 29Oct21 for 6 weeks per md due to getting the covid vaccine and wanted her to be off xeljanz for that period. joint pain got worse due to missed doses, stated "she will never do that again". no infections or illnesses reported. patient told she would have md at appointment that day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4x4 raised red and hardened, itchy and soar, hot patch at injection site. Lasted about 4 days before symptoms subside. About 1 wk before all symptoms are gone.
This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID rebound after Paxlovid) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19. No Medical History information was reported. On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 20-May-2022, the patient experienced COVID-19 (COVID rebound after Paxlovid). At the time of the report, COVID-19 (COVID rebound after Paxlovid) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. No treatment information was reported. Company Comment: This spontaneous case concerns a 31 year old female patient wit no medical history reported, who experienced Non-serious, unexpected, AESI of Covid-19 (COVID rebound after Paxlovid) which occurred 6 months 17 days post vaccination with the third dose of mRNA-1273 vaccine. The information regarding the Dose 1, Dose 2 Covid 19 vaccine of this patient was  not reported. This patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID, a Co-suspect non-company product) which started 3-May-2022 given at unspecified dose and frequency. The details surrounding the event like clinical course, treatment medication, results of laboratories/diagnostic procedures and if any medical consults was done  were not reported. Outcome of the event was reported as resolving. The benefit -risk relationship of mRNA -1273 (Moderna Covid 19 Vaccine) is not affected by this report. Sender's Comments: This spontaneous case concerns a 31 year old female patient wit no medical history reported, who experienced Non-serious, unexpected, AESI of Covid-19 (COVID rebound after Paxlovid) which occurred 6 months 17 days post vaccination with the third dose of mRNA-1273 vaccine. The information regarding the Dose 1, Dose 2 Covid 19 vaccine of this patient was not reported. This patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID, a Co-suspect non-company product) which started 3-May-2022 given at unspecified dose and frequency. The details surrounding the event like  clinical course,  treatment medication, results of laboratories/diagnostic procedures and if any medical consults was done were not reported. Outcome of the event was reported as resolving. The benefit -risk relationship of mRNA -1273 (Moderna Covid-19 Vaccine) is not affected by this report.
Headache, Throat swelling, eyes itchy and swelling, nausea, vomiting, chills, cough, fever.
PMH of CAD, HTN, DM2, atrial fibrillation on Eliquis who was last seen normal at 2330. Family heard a thud in pt's bedroom and found him on the ground with left gaze. EMS called, placed pt on a C-collar and brought to ED as a stroke code activation. On presentation, pt with left gaze and right hemiparesis and LLE weakness. He was non-verbal and not following commands. Head CT showed no acute hemorrhage. CTA with perfusion did not show a large vessel occlusion or significant hypoperfusion. Clinical picture suspicious for ictal event so he admitted to the NSICU for further workup.
Body aches, chills, cold sweats, eyes burn.; Body aches, chills, cold sweats, eyes burn.; Body aches, chills, cold sweats, eyes burn.; Body aches, chills, cold sweats, eyes burn.; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 13May2021 12:00 (Lot number was not reported) as single dose (at age of 34-year-old) for covid-19 immunisation. Medical history was reported as none. First dose of bnt162b2 (BNT162B2) was administered on 22Apr2021 12:00 PM in right arm (at age of 34-year-old) for covid-19 immunisation. Concomitant medication received within 2 weeks of vaccination included ibuprofen (IBUPROFEN). Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. On 13May2021 16:30 patient experienced body aches, chills, cold sweats, eyes burn. Patient had not recovered from the events at the time of the report. No follow-up attempts are possible. Information about batch/lot number cannot be obtained.
So, I became congested in the back of throat. I took allergy medication, and nothing worked. It won't go away. Around May got extremely sore throat can't drink water. I went to express care and there was no viral bacterial infection. I took about three days to subside. Randomly 4 months later it came back did not go to express care; very painful.
Moderna Booster 0.25mL was administered to this patient at the age of 17yo during a walk-in vaccine appointment at our office. This vaccine is authorized for 18 yo and older only. This VARES submission is to document a vaccine administration error. There were no known adverse events or health outcomes for this patient.
Case previously recorded as MA2009-3675. Consumer reported the following information via MedCom on 4 NOV 2009: A 33-year-old female patient, who was in the sixth month of her pregnancy was vaccinated i.m. with S-OIV-FLUVIRIN (batch no. unknown) on 3 NOV 2009. No adverse event was reported.
No more space for data above, but pt also received MMRV (Proquad) Lot MO44575) in her Right thigh given subcutaneously at the same time as the other above vaccinations, dose 1 of series. Pt was noted to have hives of face and chest almost immediately after the vaccines were given. No signs of anaphylaxis, wheezing, lip or tongue swelling, emesis, rhinorrhea, diarrhea, no hypotension. SBP 120 after the incident. I evalauted the patient and gave 4 mL (1 mg/kg/dose) benadryl liquid, which the patient took, and hives were resolving after 30 minutes so pt was sent home with strict precautions.
dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.  No adverse event was reported. The vial had not undergone any temperature excursion issue. The vial was initially placed in the refrigerator on 21-Sep-2021.
On January 13, 2007, fever of 101.7 gave Tylenol 1 1/2 teaspoons every 6 hours. Fever continued until 1/16/2007. On 1/16/2007, no fever. On 1/17/2007, tool pt to Dr because she now has a rash on her chest up. Dr said it was a virus and that the rash was not chicken pox or shot.
Left leg swollen, red 2cm x 1, induration 4cm x 4cm x 48 hrs after injection. Pt started on Augmentin BID x 10 days. No fever noted at visit. Pt stable no lymphadenopathy. Cellulitis.
pt recv vax 22MAY97 by 12noon & 23MAY97 pt c/o aching joints & flu-like sx;25MAY97 had a T102;did not see MD 27MAY97 still has a low grade fever;allergic to neomycin & on steroid for asthma;
This spontaneous report as received from a physician refers to a 27 years old female patient. The patient was vaccinated with GARDASIL (lot number, expired date, dose, route and injection site were not reported) on 12-APR-2012. No other co-suspects were reported. No concomitant medications were reported. On 12-APR-2012 the patient experienced GARDASIL injection at the age of 27. It was unspecified whether the patient sought medical attention. Additional information has been requested.
Within one hour post vax, this pt experienced a puffy lip and loss of feeling in her lip. She was treated with 50 mg Benadryl and recovered.
This spontaneous report was received from a nurse practitioner, referring to multiple unspecified patients of unknown age and gender. Information about current condition, concomitant medication and medical history were not provided. On unspecified dates, unspecified patients were vaccinated with unspecified number of doses of improperly stored M-M-R II (M044351 with expiration date 04-NOV-2018; M034387 with expiration date 19-JUL-2018 and M008588 with expiration date 26-FEB-2018; concentration, dose, route and frequency were unknown) for prophylaxis. No adverse effects were reported. The vaccines were stored at 47 degrees Fahrenheit(F) to 77F (51F) for 1 hour 20 minutes, and 32F to 35F (34F) for 3 hours and 46 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA009616: US-009507513-1707USA009615:
Complaining of left arm swollen from deltoid area down to elbow, 2 days, post vax. Pt seen in office on 5/5/01.
Immediate tingling sensations in fingertips of left hand on three fingers (pointer, middle and ring fingers).  Thought it would go away but it got worse over the course of a week and plateaued to a constant "pins and needles" numbness in those fingers, the same fingers in the right hand, and a couple toes in the right foot.  Left hand is worst, then Right hand, then Right foot.  No symptoms in Left Foot.  Sought medical attention and the earliest I could see a doctor was 7 JAN 21.
This spontaneous report was received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On an unknown date, the patients was vaccinated with improperly stored doses of M-M-R II lot # N023150 with expiration date 24-AUG-2019 (strength, anatomical location or route of administration were not provided) for prophylaxis; which was previously reconstituted with a properly stored sterile diluent (MERCK). The storage temperature of the vaccine was reported as 47.3 degrees Fahrenheit (°F) for a time frame of 45 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. The call was due to a data logger. This case is a non valid case due to no patient identifier.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in an 82-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Caller was an Office Manager. There were no power outages that would have impacted the Moderna vaccine. She stated that because their facility had not been able to download the digital data logger for the months of Dec2021, Jan2022, and Feb2022. Thus, they considered need to treat this issue as a temperature excursion. No adverse event was reported. No treatment medications were reported.
This spontaneous report was received from a pharmacist refers to a 66 year old female patient. No medical history or concurrent conditions were reported. On 22-SEP-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous route (1 time shot; Lot number reported as: K007984). Co-suspect or concomitant therapies were reported. On approximately 2014, reported as after receiving ZOSTAVAX, the patient experienced rash 2 inches in diameter at the injection site. Patient sought medical attention. At the time of the report, the outcome of the event was unknown. The causal relationship between the event and ZOSTAVAX was unknown. Additional information has been requested.
pt recv vax 12FEB96 & 2NOV96 pt devel a rash w/watery blisters in hair line & lesions on face, trunk & vaginal areas;4NOV96 was examined by nurse practitioner & dx w/chickenpox;
Per mother rec'd imm 3-26-08 3:30 pm.  Around 6pm taken to ER with continued N, HA, low grade fever, stomach pain, chest pain.  Dr said side effect from Tdap.  On 3-28-08 2pm back to ER with fever, severe HA (headache).  Tx with migraine pain medicine.  Dr said could be Tdap or HPV.  3-31-08 still with some HA, fever.
with arm soreness and a bit more tired; with arm soreness and a bit more tired; This is a spontaneous report from a contactable Other-HCP. A 64-year-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Batch/Lot number was not reported) via an unspecified route of administration on Apr2021 (at the age of 64-year-old) as dose 1, single for COVID-19 immunization and received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Batch/Lot number was not reported) via an unspecified route of administration on Apr2021(at the age of 64-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Covid vaccine twice on Apr2021 with arm soreness and a bit more tired afterwards but doing ok now. The outcome of the events was resolved on unspecified date in 2021.  Information on the lot/batch number has been requested.
Patient's daughter reported that her dad spiked a high fever the following day, which caused them to take him into the hospital. Once arriving at the hospital he developed seizures and eventually passed away. This was the limited information I was given.
I started getting symptoms of sore and scratchy throat. I had a slight headache with sinus drainage, body aches, and fever. I did an at home COVID-19 test on 6/2/2022 that was positive. I did a telehealth visit with my doctor and was not prescribed anything. Today my symptoms have got worse and stronger.
patient received under the age of 65 years Fluzone High-Dose vaccine, no AE; patient received under the age of 65 years Fluzone High-Dose vaccine, no AE; Initial information was received on 03-Mar-2020 regarding an unsolicited valid non-serious case from a consumer.   This case involves a patient who was under 65 year of age received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination on unknown date.  Medical history, medical treatment, vaccination and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number was requested.