chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got sick bad every year after getting it; their fevers were so high and kept going up after flu shot; Initial information was received on 20-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (under reference number: US-SA-SAC20211026000924).  This case is linked to cases 2021SA354487, 2021SA350364 and 2021SA356107 (cluster).  This case involves 3 childrens with an unknown age and gender who got sick bad every year after getting it (illness) and their fevers were so high and kept going up after receiving INFLUENZA VACCINE (pyrexia).  The patients medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.  The other two patients had no medical history, concomitant disease or risk factor.   At the time of the event, the one of the patients had ongoing peanut allergy.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site prophylactic vaccination.  On an unknown date the patients developed non-serious events got sick bad every year after getting it (illness) and their fevers were so high and kept going up after flu shot (pyrexia) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was reported "every time I have gotten the flu shot I ended up in the hospital that week from severe dehydration. Not everyone's bodies are the same! My brother gets it and does well! Swears by it keeping him from getting flu bad! So people do end up in the hospital from the flu vaccine. No one should be pressured to make medical decisions for themselves! The first two times I had the flu vaccine I thought it was coincidence that I ended up with the flu that bad same week. After the third time I ended up in the hospital after I said to myself never again! I have not had the flu bad like that since. Same for my kids. They got sick bad every year after getting it. Have gone a couple of years now without getting it! No 105 fevers, No throwing up, no diarrhea bad at the same time! I have triplets so when they all get bad sick like that and I do too it is exhausting! Never again! They had to go to the emergency room also because their fevers were so high and kept going up after flu shot! One of my triplets has peanut tree nut allergies so not taking chances anymore."  There were no lab data/results available.  It was not reported if the patients received a corrective treatment for the events.  At time of reporting, the outcome of events was reported as unknown.  There will be no information on lot number for this case.
pt started crying about 30 mins later & cried a high pitched scream for 5 hrs; slept all noc & cont the next day; nothing soothed pt; cried more when moved; legs were not red or swollen; started getting better the 4th afternoon;
SOB,BACK/RIB/LEG/JOINT/MUSCLE PAIN, NAUSEA, DIZZINESS, RASHES, HEADACHES, LIGHT/SOUND SENSITIVITY, GASTROPARESIS, PETECHIA RASH, HEAVY PAINFUL IRREGULAR MENSTRUAL CYCLES, LYMPHENDOPATHY, COLD PURPLE FEET, CHRONIC CONGESTION, CHRONIC SORE THROATS, CHRONIC EAR PAIN, HEARING LOSS, CHRONIC FATIGUE,
Noticed intermittent tingling/numbness in lips, arm and fingers a little over a month after receiving the second dose. Also intermittent vertigo on same timeline.
Patient reported immediate numbness and tingling to fingers of right hand and up into neck.  Has continued to develop pain and induration at injection site to this date, when she was referred to Occupational Medicine for follow-up.
Few hives the next day, now resolved and calling in to doctor's office for advice. Counseled patient that could consider prick testing or pretreating with benadryl and prolonged observation with second dose if he wants to continue with vaccination series and serious adverse events are rare with shingrix.
MIGRAINE; NOT FEELING WELL; LACK OF ENERGY; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (MIGRAINE), MALAISE (NOT FEELING WELL) and ASTHENIA (LACK OF ENERGY) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Migraine.   On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 01-Dec-2021, the patient experienced MALAISE (NOT FEELING WELL). 01-Dec-2021, the patient experienced ASTHENIA (LACK OF ENERGY). On an unknown date, the patient experienced MIGRAINE (MIGRAINE). At the time of the report, MIGRAINE (MIGRAINE) and MALAISE (NOT FEELING WELL) outcome was unknown and ASTHENIA (LACK OF ENERGY) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO KNOWN ALLERGIES. No concomitant medication was reported. On an unknown date, the patient experienced MIGRAINE. On 01 Dec 2021, the patient experienced NOT FEELING WELL and LACK OF ENERGY. On an unknown date, LACK OF ENERGY resolved. Patient had migraines all her life. Patient didn't felt well after covid vaccine and felt lack of energy. Also had a migraine was not sure if vaccine or her normal migraine. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.    Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the event(s) of MIGRAINE and NOT FEELING WELL was not provided. The reporter's causality for the event(s) of LACK OF ENERGY with SKYRIZI(RISANKIZUMAB) was no reasonable possibility  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.
Dizzy; headache; abdominal pain; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jan2022 15:00 (Lot number: 330368D) at the age of 13 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 04Jan2022 06:00, outcome "recovering", described as "Dizzy"; HEADACHE (non-serious) with onset 04Jan2022 06:00, outcome "recovering", described as "headache"; ABDOMINAL PAIN (non-serious) with onset 04Jan2022 06:00, outcome "recovering", described as "abdominal pain"; PYREXIA (non-serious) with onset 04Jan2022 06:00, outcome "recovering", described as "fever". Therapeutic measures were not taken as a result of dizziness, headache, abdominal pain, pyrexia.  Additional Information: There was no Seriousness criteria-Results in death, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. Facility where the most recent COVID-19 vaccine was administered was facility. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 20-JAN-2015, the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported), to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On or about 03-OCT-2016, the patient experienced shingles (Herpes zoster) and was treated by a healthcare provider at a clinic. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (Vaccination failure) and suffered serious physical, emotional, and economic damages (Emotional distress), as a result of patient's injuries on unknown dates. The patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering (Emotional distress) (Pain); extensive 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 included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (Condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The relatedness between ZOSTAVAX and the aforementioned events was assessed as related by the reporter. The reporter determined all the events to be serious due to disability, life-threatening and medically significant.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/18/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient on 5-9 and he will consider getting revaccinated.
Resident received the COVID vaccine on 1/19/21 and noticed a small red circle.  On 1/25/21 she had an itchy feeling with redness and warmth at the site and area slightly raised.  Measurements are 3.5cmL x 4.5cmW.  MD notified and instructed resident to alternate with ice and heat and take Benadryl and Tylenol.
one year later received the second dose of Gardasil 9; No adverse effect reported; This spontaneous report as received from a pharmacist refers to a 17-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, lot # and expiration date were not reported) and on an unknown date one year later, received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, lot # and expiration date were not reported) both for prophylaxis, which was considered to be inappropriate schedule of vaccine administration. No adverse effects were reported.
01/14/22 presents to ED for "slurred speech and shortness of breath". PMHx of "hypertension, A. fib, hyperlipidemia, and CAD"
Rash on face, neck, chest, and legs. Swelling on left eye lid.
Patient was mistakenly administered with Pfizer Bivalent Vaccine on day of this report. Patient had previously received Pfizer Bivalent Vaccine on 10/24/2022. Patient showed no signs or symptoms at time of administration.
Case number PHEH2013US020416, is an initial spontaneous report received from a medical assistant on 27 Sep 2013. This case refers to an 11-years-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: not reported), at a dose of 0.5 ml intramuscularly on 04 Sep 2013. Within 48-hours after vaccination, she experienced redness, swelling and warmth to touch at the injection site. The seriousness, outcome and causality of the events were not reported.
warm to the touch; red bump rash; red bump rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE RASH (red bump rash) and VACCINATION SITE ERYTHEMA (red bump rash) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE RASH (red bump rash) and VACCINATION SITE ERYTHEMA (red bump rash). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE RASH (red bump rash) and VACCINATION SITE ERYTHEMA (red bump rash) outcome was unknown.            Concomitant medication information not provided. Treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.
Moderna vaccine was administered - reported by patient ACUTE RESPIRATORY FAILURE 1/6/2022 PALLIATIVE CARE
30 minutes after vaccination heart started racing very fast and got extremely dizzy. This lasted from 30 mins after injection until the following evening of 4/8/2021. About 1 hour after the vaccination my face, lips and mouth felt numb and were tingling. This lasted a few hours. About 3 hours after the vaccination, was having difficulty breathing. Throat was itchy and felt like was being blocked and my airway closing up. This lasted a few hours. About 3 hours after the vaccination came down with a severe headache that would not subside. This severe headache lasted from day of vaccination 4/07/2021 until Sunday 4/11/2021.
Puncture site pain lasted more than 48 hrs. Within 8 hours of injection began having lateral breast pain that moved in axilla of same side of injection. Swollen axilla and painful at 3-4/10 on pain scale. Treated with ALEVE. Symptoms decreasing in severity but continue at 76 hrs post injection (time of this documentation).
The clinic received the vaccine on 9/15/21 and it was left out and not stored in a refrigerator.  On about 9/20/21 the box was opened and the vaccine was put in the refrigerator.  It was then dispensed and administered.
At pre-vaccine screening patient reported no contra-indications so had the vaccine. Roughly 45 minutes later patient reported shortness of breath, not feeling good and not being able to hear properly. Blood pressure was taken immediately at 1.38pm - 189/96mmHg and pulse -88bpm, and again at 1.43pm -180/90mmHg. Emergency services were contacted and came immediately within 3-5mins. After assessing patient they took her to hospital.
Hives and dermatographism all over body. Coming in increments throughout the day. Occurring daily. Patches of hives lasting 30 mins then moving to other areas of body.
Information has been received from a female patient who in approximately 2006, 4 or 5 years ago, was vaccinated with "shots" of GARDASIL (lot number not reported) and developed a severe yeast infection that she would have for the rest of her life. Unspecified treatment was given for the experience. The patient sought unspecified medical attention. At the time of the report, the patient's had not recovered. Additional information has been requested.
Within 3.5 hours of receiving my 1st Pfizer COVID 19 vaccination injection, I developed a headache, EXTREME lethargy, initial chills and later on sweats, cold sensation at the roof of my mouth, and within 6 hours a sore arm at the injection cite.  I ended up sleeping off and on for the next 29 hours.  The headache, the lethargy and sore arm persisted past 24 hours.   The headache was gone after about 28 hours.  The sore arm was gone by the morning of the 2nd day (Monday).  The lethargy lasted for 36 hours but was completely gone by the morning of the 2nd day (Monday).
Complained of right thigh red-swollen, hot to touch and painful.  Started 2 days ago evening of the vaccine administration.  Given Kefles 250/5ml x 10 days for ?cellulitis and told to do warm soaks.
Rash like flaky, dry, itchy, dandruff, broken skin; rash like flaky, dry, itchy, dandruff, broken skin; Like dandruff; rash like flaky, dry, itchy, dandruff, broken skin; Rash on chest that started like pimples and spread neck, below the scalp, and behind and inside ears; pain in muscle of injection site and soreness; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash like flaky, dry, itchy, dandruff, broken skin), SKIN EXFOLIATION (rash like flaky, dry, itchy, dandruff, broken skin), DANDRUFF (Like dandruff), DRY SKIN (rash like flaky, dry, itchy, dandruff, broken skin) and RASH (Rash on chest that started like pimples and spread neck, below the scalp, and behind and inside ears) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LISINOPRIL, GEMFIBROZIL, OMEPRAZOLE, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D [VITAMIN D NOS], ALPRAZOLAM and EZETIMIBE for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in muscle of injection site and soreness). On an unknown date, the patient experienced RASH PRURITIC (Rash like flaky, dry, itchy, dandruff, broken skin), SKIN EXFOLIATION (rash like flaky, dry, itchy, dandruff, broken skin), DANDRUFF (Like dandruff), DRY SKIN (rash like flaky, dry, itchy, dandruff, broken skin) and RASH (Rash on chest that started like pimples and spread neck, below the scalp, and behind and inside ears). At the time of the report, RASH PRURITIC (Rash like flaky, dry, itchy, dandruff, broken skin), SKIN EXFOLIATION (rash like flaky, dry, itchy, dandruff, broken skin), DANDRUFF (Like dandruff), DRY SKIN (rash like flaky, dry, itchy, dandruff, broken skin), RASH (Rash on chest that started like pimples and spread neck, below the scalp, and behind and inside ears) and VACCINATION SITE PAIN (pain in muscle of injection site and soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included OTC ointment, dry skin lotion, spray on hear, Topical cream  and special shampoo.
Vaccine expired 10/13/2021, but given 10/29/2021.
Dizzy spells when in bed. every night for 6 nights since injection. Have been drinking more fluids, checking blood pressure- but normal readings only. Rash in armpit on left arm. suddenly appeared 24 hours after injection. I have been treating with overcounter hydrocortisone 1%.
Left arm/shoulder extremely sore and getting hard to raise. 5pm- extremely sensitive & hot to touch, immobile, whole body feverish. Aleve for pain & hot baths/cold compresses all night. Dr in the morning.
Had shot Saturday at 10:30. Headache, muscle joint bone ache, chills, sweats, nausea.   Started around 11 pm. Lasted until about noon the next day. Was tired for the remainder of the next day.   Feel normal as of Monday.
Started on 2/8/12 injection site noted with redness, warm, tender and painful to touch. Discomfort lifting forward or moving left arm. Lower area approximately 2 inches below inj. site has redden area of 60mm X 40mm. warmth and painful.
Felt severe pain in leg for over week. Went to hospital. Hospital reported nothing wrong. A week later, ER, Afib,  In ICU for 4 days. Developed completely neuropothy, starting with legs. Feel like "electrical system is fried."
Arm hurt, lost appetite, head ache, lost balance all symptoms last four days.   Benadryl was administration.
Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 26 year old female who was vaccinated with first and second 0.5mL doses of GARDASIL on 29-JUN-2007 and 29-SEP-2007. The physician reported that they believed the patient was pregnant on 10-DEC-2007. On 29-DEC-2007, the patient was vaccinated with the dose of GARDASIL. On 24-JAN-2008 the patient experienced miscarriage. Lab test performed included unspecified pregnancy test. This is one of two reports concerning the same patient. Upon internal review miscarriage has been considered an other important medical event. Subsequently in June 2008 the patient became pregnant again and on August 2008 the patient had another miscarriage (WAES #0902USA04455). Additional information has been requested.
patient got very sick; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious social media case from consumer (patient) via Social media.  This case was linked with 2020SA304713 and 2020SA282884.  This case involved a patient with unknown demographic who got very sick (Illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got very sick (Illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Patient reported that their explanation to the patient was that patient had contact with the flu before got the shot didn't make him/her feel better about getting the shot. They should also tell that patient could still get the flu it depends on the strain and if they guess the combination correctly.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information on the batch number for this case.
21Mar91 Increased T of 102 Ax. Fussy. Vomited X 2
7 days after injection I started having pains under my left breast. This morning (9 days after injection) my left arm in swollen, red, hot to the touch and hard where the injection was.
Next day woke up with some redness, pain to area and chills. No fever or swelling. Read VIS to Pt and told him to ice area and watch temps. No further follow up has been needed since.
R thigh swollen, red, R thigh 35cm round; L thigh 30cm round, R thigh warm to touch.
Approximately 5 minutes after vaccine administration, the patient's mother yelled for help whereupon the patient was observed in a state of syncope. The patient's mother had to hold her to prevent her from falling to the floor. First Aid was administered at this time and 911 was notified. Paramedics arrived shortly thereafter and patient was attended to. It was determined that patient was doing well enough to avoid going to the hospital.
Stuffiness in right ear and increased ringing in ear.  I have been previously had tinnitus, but has gotten worse after vaccine.
Pt received an injection of Acel-Imune and experienced an unspecified adverse event. The reporter declined to provide additional information.
Systemic: Rash (other than injection site)-Medium; symptoms lasted 1 day