chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 11/07/03, concerning a 37 year old female vaccinee who experienced flu like symptoms consisting of general achiness, lethargy, headache, low grade fevers, congestion and coughing approximately two weeks after receiving Fluvirin vaccine on an unknown day in October 2003. The vaccinee was seen in a physicians office on 11/07/03 and she appeared to be doing well. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/24/2004: Follow up information received from a health care professional indicated that an influenza test revealed a positive result. The patient was treated with Amantadine and recovered with conservative treatment. No follow up pending.
Arm starting throbbing.  Pain shoots up right side of neck and down right arm to the finger tips.  The event happened in elsewhere but went to the doctor and his nursing assistant were we lived and said sometimes the pain lasts for weeks.  It is now over 2 months and the pain gets worse.  I take Tylenol daily.  My doctor referred me to an orthopedic doctor.  He said it was not a medical issue.
However her life ended on 19Oct2022 after getting your vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: suffered complications. The patient's concomitant medications were not reported. The following information was reported: DEATH (death, medically significant) with onset 19Oct2022, outcome "fatal", described as "However her life ended on 19Oct2022 after getting your vaccines". Patient had COVID 19 in it before the vaccines and suffered complications however her life ended on 19Oct2022 after getting vaccines, her way of living was not at 100% due to complications was very thankful for your research and the ability that your vaccines her family was in better hands then her COVID. After so much health problems shes in peace withheld. She passed away on Monday unexpectedly from one day to another you could be gone. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. The patient date of death was 19Oct2022. The reported cause of death was unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: However her life ended on 19Oct2022 after getting your vaccines
Patient reports pain in left deltoid as well as at injection site that has lasted over 3 weeks
Muscular type problems - sore muscles; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Muscular type problems - sore muscles) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscular type problems - sore muscles) and FATIGUE (Fatigue). At the time of the report, MYALGIA (Muscular type problems - sore muscles) and FATIGUE (Fatigue) outcome was unknown.        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.   No relevant concomitant medications were reported. No treatment information was reported.
I was fine for the first twelve hours and then I had extreme arm pain, all the way down my entire arm, and expanded through my whole body. I had extreme body aches, and headaches. Joint pain was very bad. Took Tylenol, but that didn't help, and I iced my arm but that also did not help. I was not able to to sleep all night. Fevers, chills, and fatigued. Right arm is still pretty red and hot to the touch.
patient received an Adacel which had been frozen and thawed- multiple excursions over the course of a few months, vaccines dropped to 1.4 C and 1.5 Celsius and same vaccines have gotten down to -4 Celsius/No AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health professional (office staff).  This case is linked to cases 2019SA196353, 2019SA224145, 2019SA224142, 2019SA224139, 2019SA224143, 2019SA224140, 2019SA224136, 2019SA224076, 2019SA224144, 2019SA224137 and 2019SA224141 same reporter.  This case involves patient of an unknown demographics who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot- C55608AA, expiry date-25-01-21; Lot- C5585AA, expiry date-10-03-21) via intramuscular route in unknown administration site (received between the date 26-Mar-2019 - 24-Jun-2019) which had been frozen and thawed.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  There were no side effects.  Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 Celsius range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C.Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred. Caller states that a new thermometer with fluid was ordered so that the readings can be more accurate now. Caller would like to know what are the next steps that she needs to take in ensuring that her patients are properly vaccinated.  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.  Documents held by sender: none.
had not received dose up to the moment, date of start drug: (24-JUN-2019); This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received 1st dose on 24th June 2019,Batch number:7457P,Expiry date:23rd June 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-JUN-2022  Reporter's Comment: The patient had not received second dose of Shingrix up to the moment of this report. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix,which led to incomplete course of vaccination.
Thrombosis in Left Leg and Pain; Back pain; he still felt sick; Thrombosis in Left Leg and Pain; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 47-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 21Jul2021 (at the age of 47-years-old) (Batch/Lot Number: EW0198) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (lot number: PA7484, vaccine location: Left arm) on 02Jul2021 for covid-19 immunisation. The patient states that he had pain in his back, so he went to the ER, he still felt sick, so he went to another ER at a different hospital (probably 2 weeks later from  the vaccine) and they told him that he had a thrombosis in his leg (on an unspecified date in 2021) and gave him prescriptions and he left the same day. The patient states his second trip to the ER was on 14Aug2021. As the patient still had the same pain (Pain in leg on an unspecified date In Jul2021) so he went back to an ER for a second time because the first time they didn't check his blood or anything. Caller clarifies that he was not admitted to the hospital, he was treated and released from the ER Caller states he is supposed to go to the hospital today, but he has no one to drive him. Regarding treatment reporter stated they gave him Norco for Pain and Xarelto. patient stated he will probably have to go back to the hospital because he did not see any change in this leg, patient stated he will see if they can see him again for more pain medicine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of back pain was recovered on an unspecified date in 2021. The outcome of still felt sick was unknown. The outcome of the other events was not recovered.   Follow-up attempts are completed. No further information is expected.
Initial misuse report received from a healthcare professional on 23 December 2013 and on 21 March 2014. A '4.5 year-old' patient (no information was provided regarding the patient) had received a dose of FLUZONE HD on an unspecified date, and no adverse event was reported, i.e. inappropriate age at vaccine administration. List of documents held by sender: none.
Patient reported yesterday Nov. 1, 2018 that she has been having itching on her right arm for the past 6 days after receiving her flu shot on Sat. Oct. 27th. She reported that the itching feeling has been happening 2-3 times per day at the site of the injection and that the itching feeling progresses down her upper arm to her elbow.
Pt woke up @ 0200, 28 Oct 04, with increased redness, swelling and induration to SPV site.  The redness/swelling had spread to the front and around to the inner arm with a  "pseudopod" appearance.  No increase in pain but the "pseudopod" was tender to touch.  No fever noted.  Area without increased warmth.  SPV eschar approx 1.5cm with induration 9cm x 9.5cm and pseudopod approx 2-3cm x 6cm.  No lymphadenopathy on exam but pt noted some soreness in his L armpit earlier in week.  Pt appears to, also, be experiencing an adhesive reactions around the SPV site.  He states that on 25 Oct 04, he was slugged in the arm directly over the SPV site.  He has kept the site covered continuosly by gauze adhered with surgical tape or cloth bandaids.  Pt placed on Gatifloxacin, 400mg QD x 10d, due to imminent travel out of the area.  Pictures are available upon request.
Fever of 102 degrees for 16 hours ongoing. Chills.  Headache. Lower back pain. Fatigue. Injection site pain.   Using 440mg of naproxen sodium po every 6 to 8 hours to relieve symptoms.   Fever does not break with naproxen administration.
Sore throat, sensitivity to swollowing, with increasing discomfort; by 10/28/11 noticed a lump in back of throat; has not been seen by her Dr.
Swollen up in the chest; Rapid Heartbeat; Muscle sore; Stomach ache; Headache; This is a spontaneous report from a contactable consumer. A 61-year-old patient of unspecified gender received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0162), via an unspecified route of administration, on 06Jul2021 in the morning, as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in Jul2021, the patient stated that took the shot 4 days ago and experienced swollen up in the chest, had a rapid Heartbeat and just muscle sore and got like stomach-ache and Headache. Second dose vaccination due date was reported as 27Jul2021. The patient asked is that would be alright. The outcome of the events was unknown.
2nd Vaccination shot received 3/15/2021 at 8:44am.  3/15/2021 6pm, fatigue and general malaise began.  By 8pm, extreme fatigue and joint pain.  Took 600mg Motrin to alleviate pain.  Unable to stay awake despite best efforts, joint pain worse in shoulder and elbow on left arm of vaccine injection site.  3/16/2021 12am, fatigue continues, joint pain severe enough to warrant a dose of Tylenol, some muscle pain and chills.  3/16/2021 4am, joint pain, muscle pain severe, fatigue severe, unable to sit up for more than a few minutes.  Took another 600mg of Motrin. 3/16/2021,6am  joint pain, muscle pain, and fatigue continue, difficulty staying awake to send a text to call out of work.  Chills begin, no fever.  Continue with course of Motrin/Tylenol alternating every 2-3 hours, joint and muscle pain breaks through over the counter pain relieves, no fever, chills persist, extreme fatigue persists.  Pushed fluids, water, Gatorade, Body Armour.  Slept most of the time from 8pm 3/15/2021 to 6pm 3/16/2021.  By 6pm 3/16/2021 fatigue lessens a bit, able to eat dinner, care for children a bit, muscle aches and joint pain still persistent.  Continue Motrin/Tylenol rotation.  11pm 3/16/2021 Fatigue lessens a bit, able to get up and shower.  By 10am 3/17/2021 fatigue is gone, minor joint and muscle pain present, able to manage pain with Motrin every 6 hours.
Had the shot three times and still gets it/Suspected vaccination failure; Had the shot three times and still gets it; Had the shot three times; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The reported this case for his/her uncle. The age at vaccination was not reported. The patient received 3 doses of shingles vaccine and still experienced shingles. As per global schedule of shingles vaccine only 2 doses were recommended however patient received total 3 doses of vaccine, which led to extra dose administration. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Information has been received from a registered nurse concerning a pt who was vaccinated with varicella vaccine live. The exact date of vaccination was not known. In approximately June 2001 (reported as about 2 weeks ago from 06/14/2001), the pt developed chickenpox. Another child was exposed to the pt and subsequently developed chickenpox (WAES01061305). Unspecified medical attention was sought. Additional specifics were not known. Additional info is not expected.
Patient reported symptoms of: tachycardia, shakiness, vision changes, tongue numbness and shortness of breath following the first dose of the COVID19 Pfizer-BioNTech Vaccine on 2/5/2021. Patient said that historically has experienced tachycardia and shakiness after getting a flu shot or booster a few years ago. Symptoms reported by patient were enough to suspect potential anaphylaxis, and patient consented pharmacist to administer epinephrine. Patient was then advised by the pharmacist to follow-up with her primary care doctor as soon as possible to report the incident and to discuss the risk versus benefit of the vaccine, whether recieving the second dose would be appropriate for her. Patient returned to assisted living facility for her second dose of the COVID19 Pfizer-BioNTech vaccine on 2/26/2021. Patient said that she discussed the incident with her doctor, was told it would be appropriate to get the second dose despite her reaction and was advised to take "cautious measures". Pharmacist reviewed the patient information and screening questions, discussed the potential side effects and reiterated her risk of experiencing the same reaction with the second dose. Patient stated that she decided on getting the second dose because "her boyfriend is high risk and I'm doing this for him". Patient stated that she decided on getting the second dose because "her boyfriend is high risk and I'm doing this for him". Pharmacist asked patient if she had any questions/concerns or additional information to add prior to getting her vaccine, and patient denied having any at that time. After administering her second dose, pharmacist instructed patient to stay in the observation area for at least 30 minutes and to ask the staff for water given her experience with the first dose.  Patient asked pharmacist how common it was for someone to get a reaction from the vaccine, and then mentioned that her family memeber had to drive her to the emergency room after her first dose becuase her throat was "burning", and was told that her throat was "a little swollen" and recieved a second dose of epinephrine at the emergency room. Patient included this information after the fact her second dose was already administered.  Approximately 5 minutes after receving her vaccine, the patient reported similar symptoms that she experienced on 2/5/2021: tachycardia, vision changes, shortness of breath and chest tightness. After monitoring patient with no resolvement of her symptoms, patient was then given a dose of epinephrine by the pharmacist, and the paramedics were called in to assess patient and take her to the emergency room.
painful shot, will hurt; sick; flu like symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain, sickness and influenza-like symptoms. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the sickness and influenza-like symptoms were not recovered/not resolved.   It was unknown if the reporter considered the pain, sickness and influenza-like symptoms to be related to Shingles vaccine.     Additional Information: GSK receipt date: 20-Jul-202 Reporter's comment: The case was reported by the consumer via interactive digital media. The patient reported that he/she had most painful shot ever and would hurt for 3 to 4 days. The patient had been sick since with flu like symptoms. The follow-up could not be possible as no contact details were available.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 07-JAN-2019, the patient was vaccinated with improperly stored dose of PROQUAD (lot # R017800, expiration date: 19-DEC-2019, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of PROQUAD experienced temperature excursion between -14 to -10 Celsius degrees for 30 minutes. There was no previous temperature excursion reported. Digital data logger was involved. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1901USA009536.
Information has been received, concerning a female patient who was vaccinated with a dose of Varivax twice as an adult and has not been able to develop immunity. No additional information was provided.
After 45 minutes I started getting a mild allergic reaction. I know this because my upper lip started tingling and it swelled a little bit. The next day I had a headache and my left arm hurt. Friday I started feeling like I was going to get a cold but no headache. Saturday I didn?t feel so bad but that night to Sunday morning I got a migraine, depression, and anxiety. Sunday I had a migraine the entire day. Today I feel extremely tired.
A few days later I got covid; A few days later I got covid; This is a spontaneous report from a contactable consumer (patient). A 24-year-old patient of an unspecified gender received the first dose of bnt162b2 (BNT162B2, lot number unknown), via an unspecified route of administration (at the age of 24-years-old) on 19Jan2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated "I got the vaccine (Unspecified Vaccine) on 19Jan (complete date not clarified); and then a few days later (in 2021) I got COVID and my mom also got COVID so I was wondering do I still; can I still get the second vaccine and how long should I wait from having covid to get the second vaccine?" The outcome of the events was unknown.  Information on the batch/lot number has been requested.
no pmh of headaches.  started having headaches daily, every evening, through today (11/10/09).  normal bp & neuro exam.
Right after vaccine had a metallic taste.  About four hours later started itching.  That evening overnight  face became numb tongue swelling .  Next morning  metallic taste linguered.  Was able to swallow  but more difficult.  Drank a lot of water continually.  These symptoms lasted into the next day.  Felt better by Sunday.  Itching continue on and off.  Feelin Better.  Contacted the Health Dept.  and left a message for primary care doctor.  Plan to follow up with him this week.
Dizziness, nausea, low oxygen from hyperventilating for 20 minutes solumedrol 125 mg administered im to right vastus lateralis patient was sent to er for observation and was released home on the same day.