chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Neurologic symptoms; exposure via transplant; Initial information was received on 11-May-2022 regarding an unsolicited valid serious case received from a health professional.  This case involves an Adult and unknown gender patient who experienced neurologic symptoms and had exposure via transplant after organ transplant was received from an individual who had received a blood transfusion from a third individual who recently (within 1 week) was vaccinated with YF VAX  (yellow fever vaccine).  Cluster case- 2022SA176292, 2022SA177055, 2022SA177145 and 2022SA177095  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 yellow fever vaccine - solution for injection (lot number, expiration date, dose, frequency, strength not reported) via unknown route in unknown administration site.  On an unknown date the patient developed neurologic symptoms (neurological symptom) and exposure via transplant (unknown latency).   seriousness- medically significant for neurological symptom  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event neurologic symptoms.  At time of reporting, the outcome was Unknown for the events.; Sender's Comments: Sanofi company comment dated 18-May-2022: This case concerns an unknown age adult patient who had Neurologic symptoms and exposure via transplant after the organ transplant was received from an individual who had received a blood transfusion from a third individual who recently (within 1 week) was vaccinated with YF VAX. Available information is limited. A significant temporal relationship cannot be established due to lack of information on event onset date and vaccine start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Furthermore, information regarding condition at the time of vaccination, medical history, concomitants, lab data excluding other predisposing etiologies, intervention (if any), corrective treatment/medical management, family history, would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Pharmacist administered a 1ml dose of the Moderna Covid 19 Vaccine to a patient.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Pharmacist administered a 1ml dose of the Moderna Covid 19 Vaccine to a patient.) 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 17-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 milliliter. On 17-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Pharmacist administered a 1ml dose of the Moderna Covid 19 Vaccine to a patient.). At the time of the report, INCORRECT DOSE ADMINISTERED (Pharmacist administered a 1ml dose of the Moderna Covid 19 Vaccine to a patient.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's Demographics were lost due to a glitch   No concomitant medications were given.  No treatment information was provided.
Sore arm, pronounced body aches, extreme fatigue, severe headache, upper respiratory stuffiness, lungs ache with deep breaths, chills, slight fever. Literally feels like I have a bad case of the flu.
Fever fever, sore throat, fatigue, malaise Narrative: Per pt. report:  ". I received the COVID vaccine yesterday, 1/20. This morning I have the following symptoms: temp 100.2; slight sore throat, fatgue, and malaise."
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (soreness in arm after 1st dose) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 003B21A) for COVID-19 immunization. No medical history reported. On Mar 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (soreness in arm after 1st dose). At the time of the report, pain in extremity (soreness in arm after 1st dose) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-098114 (patient link).
Patient received COVID vaccine at 1036 am.  She was observed for 15 minutes with no symptoms.  She went to appointment at the Clinic, checked in at 1055 am.    Patient and clinic RN  were talking  and patient was acting her normal self for 15-20 minutes. When RN started to ask patient findings questions about her clinic,  patient stopped responding and had a blank stare on her face. Patient did not have LOC. Patient also moving her lips/mouth making smacking noises. Medical emergency assist was called.  Patient verbally unresponsive, Pulse ox as low as 68%, oxygen applied via oxymask at 15 liters, turned down to 5 liters when sats improved.  Blood sugar 104, EKG done.  Patient was transported via ambulance to hospital. Patient was unable to remember who brought her to the clinic today as patient doesn't drive. Called and spoke with patient's daughter who states that she drove mom and that she was currently with her in the ambulance. Daughter asked what happened, writer relayed events as they happened. Daughter thankful for the call and care. No INR test performed today.
Large local (6 cm of wheal and flare) that occurred 2 days after vaccination. Associated pain & pruritus.
Sunday 12/1/07-Started with myalgia, chills, fever 101-left eye swelling. Then 12/5/07 left eye pain and sinus congestion Tx-Zithromax x 5 days, Tobranex eye ointment 12/6/07
PATIENT GOT MODERNA 1ST DOSE ON 3/25 AND HER SECOND DOSE SHOULD BE NON 4/19 BUT PATIENT CAME AND GOT THE SHOT ON 4/12.  The early day for  her 2nd dose  should be 4/15 (24-42 days from the first one).
Was driving a vehicle and started having vision problems and pulled off road and started loosing consciousness.  911 dispatched and taken to hospital.
DAY 1:FEVER, NAUSEA , WEAKNESS, CHILLS, NASAL CONGESTION, CHEST CONGESTION, RUNNY NOSE,  BODY ACHES  DAY 10-- SHAKY, TIRED, WEAK, GENERAL FEELING OF NOT FEELING WELL.
Symptoms started at 3:22 am 12/31/2020  fever 102.7. Severe pain all over my finger nails even hurt , swelling at injection site , worst headache ever, very thirsty, sore all over. I had Covid 9/17/2020  It wasn?t as bad as the side effects from the vaccine.
A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a three-year-old male.  The patient's medical history included no history of asthma.  Concomitant medications were not available.  On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunization and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications).  There were no adverse events associated with theses medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is being submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error.  Additional information was received on 05-Feb-2009 and incorporated into the narrative: gender and age; confirmation that there were no adverse events. Additional information was received on 31-Mar-2009 and incorporated into the narrative product complaint investigation results.
Information has been received from a doctor of pharmacy concerning a 26 year old female hospital employee who in 2001 was vaccinated with a dose of MMR virus vaccine live (lot number not available). It was reported that the patient received the vaccination 2 years ago, and subsequently had a negative measles titer (date not reported). Unspecified medical attention was sought. Additional information has been requested.
Pt received the vaccine and stated approximately 7 minutes after got an excruciating pain in his lower middle back.  Stated he was walking in the skywalk and had to have a security guard help him to sit down.  Was not able to walk on his own.  Said he sat down for approximately 10 minutes and was completely resolved.  No pain and was able to walk.  Never got any pain in arm or anywhere else.
The patient was 6 year old female who was given Pfizer Pediatric Dose 1 and right after that patient started vomiting. Had no other symptoms. Assessed no anaphylaxis (tingly lips, or difficulty breathing/swallowing), No medications needed. Offered patient water.  Followed up after 1 hour, patient was fine.
On 1/20/2022, I was talking with my boss by phone, and he noticed that my voice sounded different. It sounded like I had a head cold or an allergy. He instructed me to get tested for COVID-19. I contacted our company's safety department, and they made arrangements for me to be tested on 1/21/2022. I underwent a rapid test on 1/21/2022, and the result was positive. I contacted my PCP, and he prescribed me a Flovent HFA inhaler and Tessalon capsules. My symptoms were similar to those of a head cold. I also had a sore throat and a little bit of a cough. I may have also had night sweats one night. All in all, my symptoms lasted about 4 or 5 days and then they were gone. If I hadn't been tested, I would have just thought that I had a mild cold. I was in isolation for 14 days, and during this time, I just worked from home.
symptomatic of Covid; symptomatic of Covid; inoculated on 15Dec2020; patient was scheduled on 04Jan2021 for 2nd dose; inoculated on 15Dec2020; patient was scheduled on 04Jan2021 for 2nd dose; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via an unspecified route of administration on 15Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was inoculated on 15Dec2020 and currently on 28Dec2020 the patient was symptomatic of Covid. The patient was scheduled on 04Jan2021 for 2nd dose. The outcome of the events symptomatic of Covid was unknown.  Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.
Patient received a flu immunization intramuscularly in Left arm at public flu clinic on 10/22/08.  Reports severe increased swelling, redness and pain at site, requiring cold compresses and Acetaminophen
This spontaneous report as received from a pharmacist refers to a 25 year old female patient with drug reaction/allergies to penicillin (unspecified) and no other pertinent medical history. On 04-NOV-2013, the patient was vaccinated with VARIVAX (merck), 0.5 ml, subcutaneous in the left arm. Lot number were not reported. There was no concomitant medication. On the evening of 04-NOV-2013 the patient's left arm was warm, red and itchy and a little sore to the touch at the injection site. All events resolved totally after two weeks on an unspecified date (approximately in November 2013). The patient did not seek medical attention. No lab diagnostic studies were performed. Additional information has been requested.
treated by a healthcare provider for shingles; Information has been received from a lawyer and the patient regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) by a health care provider for the long term prevention of shingles and zoster related conditions. Subsequent to the patient's vaccination, he was treated by a healthcare provider for shingles. As a direct and proximate result of patient's vaccination, he would continue suffer ongoing injuries including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.    The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). The outcome of shingles was unknown.
Pt reports having a headache X 2 days, then nausea and vomiting X 1 day. Pt reports she was afebrile. Pt also reports an outbreak of fever blisters. Pt feel weak now. Pt encouraged to see MD for continued weakness.
Clinician was reviewing patient questionnaire and discussing J&J and Moderna vaccine.  Moderna vaccine was covered on the table and a dose of J&J was brought to the clinician on a separate tray and both vaccines were labeled.  Following his discussion, he accidently picked up the Moderna vaccine and administered that instead of the J&J which the patient requested.  Patient will return for her second Moderna in 28+ days.
N/A Pt has not experienced any adverse effects. Pt who is few months younger than 12 years, received the Adult dose of Pfizer Vaccine! but she was fine according to her Mother!
burning upper abdomen; chills, fever, nausea, body aches; no fever; difficulty reading sx began 7NOV92 & lasted aprpox 36-48hrs;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX. Concomitant products included lisinopril and metoprolol. On 23rd February 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, joint pain, injection site rash, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site rash, injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the joint pain was recovering/resolving. It was unknown if the reporter considered the injection site pain, joint pain, injection site rash, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient was receiving Multivitamins as concomitant drug. The patient was administered SHINGRIX in the left deltoid. The patient planned to follow-up with her physician on an unknown date.
All signs of allergic response visible around mouth area.  Rash, slightly swollen tongue, blisters.
Patient was given 0.2 ml of undiluted Pfizer Covid (5-11y) vaccine. No side effects were reported.
Fevers, pruritis, redness/swelling around injection site x 24 24 hrs post administration (injection site L upper arm).
Syncope with questionable brief (seconds) seizure that resolved in 10-15 seconds total. Patient rested in office for 15-20 min and drank some water. Had normal vital signs after event. She passed out 15 min after injection.
Headache and fever up to approx 102F for over 10 hours. Treated with ibuprofen and cold compresses.
This person is a volunteer and recieved an Afluria Influenza vaccine at a mass flu vaccination clinic.  After the vaccine was administered, she reports pain in the vaccinated arm. She saw her PCP and an urgent care. She is doing physical therapy and has follow up appts with her PCP.
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and influenza-like symptoms. On an unknown date, the outcome of the injection site pain and influenza-like symptoms were unknown. It was unknown if the reporter considered the injection site pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination were not reported. The reporter (daughter of the patient) stated that the patient experienced pain at injection site and flu like symptoms after receiving the SHINGRIX. This case has been linked with case US2018GSK077003 and US2018GSK168550 reported by the same reporter.
arm tenderness; very sore by the injection site; fatigue; Chills; tested positive for COVID; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID), TENDERNESS (arm tenderness), INJECTION SITE PAIN (very sore by the injection site), FATIGUE (fatigue) and CHILLS (Chills) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) for an unknown indication, LEVOTHYROXINE.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). On an unknown date, the patient experienced TENDERNESS (arm tenderness), INJECTION SITE PAIN (very sore by the injection site), FATIGUE (fatigue) and CHILLS (Chills). On 15-Jan-2021, TENDERNESS (arm tenderness), INJECTION SITE PAIN (very sore by the injection site), FATIGUE (fatigue) and CHILLS (Chills) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, COVID-19: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Treatment for the symptoms included Tylenol.
fever 99.7; Body ache; Headache; This is a spontaneous report from a contactable nurse reported for self. This 52-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Jan2021 at single dose (LOT# EL1284) for covid-19 immunisation. The patient got vaccine yesterday (01Jan2021) and had a side effect. The patient had a fever 99.7, body ache, headache on 02Jan2021 and wanted to know if can take anything. Outcome of the events was unknown.
Approximately one hour after receiving the influenza vaccination, the patient complained of itching and a red, acne-like rash at the injection site.
Body aches - resolved after 36 hours Fever (100.5) - resolved after 24 hours Chills - resolved after 24 hours Loss of appetite - resolved after 36 hours Headache - resolved after 36 hours
Inappropriate schedule of vaccine administered; Sinus infection; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), SINUSITIS (Sinus infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In March 2021, the patient experienced ILLNESS (Sickness). On 18-Nov-2021, the patient experienced SINUSITIS (Sinus infection). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, ILLNESS (Sickness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown and SINUSITIS (Sinus infection) had not resolved.       No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This adverse event occurred because of a faulty needle attachment.  I inspected the screw on needle as I have hundreds of times before attaching it to the prefilled fluzone hd.  It must have a a hairline crack in it and then the pressure of the vaccine caused it to break because when I stuck the patient and began administering the vaccine most of it squirted out of the connection between the vaccine itself and the screw on needle.  I examined the needle once the safety was on it and the plastic had a large crack down it and at the connector.  I made sure to discard any other needles from that box.  The patient was not harmed and did not require any treatment at this time.  The only concern was lack of efficacy of the vaccine since she did not get the full dose.
High feaver, swelling is the left arm sore and hot lymph nodes and throat swelled shut rash and feaver chicken pox scares became red and inflamed lasting over 72 hours
On 08/15/2021 I did not make an immediate correlation. Symptoms --mild headache, vaginal discharge, and thrush on my tongue.  They continue to get worse until the end of September. In September I went to see my physician. She prescribed an absorbic acid flush, or vitamin C flush. I have been doing different baths to try get rid of the systemic candida. At the end of September, Dr.  diagnosed it as systemic candida.   My symptoms have not completely recovered. I am still experiencing some of the symptoms.
8 hours after injection got cold, then shakes and fever, 12 hours post vaccine I had severe!!! pain in any area that I had any type of chronic pain - lower back, right hip, and recently fractured 2nd metatarsal on left foot, this was not myalgia this was severe uncontrollable pain unrelieved with NSAIDS, Tylenol or Tramadol.  it lasted for 16 plus hours where it hurt to move,  I broke a fever 3 times, severe thirst, after the pain subsided I had a severe left sided headache.  The whole time I was fatigued but unable to sleep due to pain.  Now three days later I have developed, to the site of my injection , a 1 cm by 1 cm oval shaped, extremely tender red raised nodule.  I am still very tired and having low grade temps with sweats and chills.