chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After vaccine injection a tingling sensation spread down my left arm into my finger tips, and up my deck leaving me with a sharp headache. However, it has been 7 days since the vaccine and my left arm is still tingling as if it has "fallen asleep"; Sharp headache; Maternal Exposure During Pregnancy, third trimester; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the arm left on 13Aug2021 at 16:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. The patient was 33 weeks pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication were not reported. On 13Aug2021 at 16:15, after vaccine injection the patient experienced a tingling sensation spread down left arm into finger tips, and up deck leaving with a sharp headache. The patient took Tylenol for the headache and the headache was gone within 24 hours. However, it has been 7 days since the vaccine and the patient's left arm is still tingling as if it has "fallen asleep". The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of headache and included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sharp headache was recovered on 14Aug2021, after the duration of 24 hour, while the event after vaccine injection a tingling sensation spread down my left arm into my finger tips, and up my deck leaving me with a sharp headache. However, it has been 7 days since the vaccine and my left arm is still tingling as if it has "fallen asleep" was not recovered at the time of this report.
Started to develop a clogged ear feeling 2 weeks after shot and started to hear ringing in the ear that seems to change in its frequency
Headache Fatigue  Nausea lower cramping Diarrhea Felt Feverish Sore at the injection site chills
Patient describes symtoms related to "Covid Arm" .  Redness, swelling, and itchy in three different areas at or below injection site down to elbow.  Advised patient to apply topically benadryl and if necassary also take oral benadryl.  Also told if condition worsened or signs of lips swelling, throat swelling, or wheeze; go to er or urgent care immediately.  But, Covid arm is one of the possible side effects and should subside in  5-10 days.
Patient was screened using the COVID vaccine screening and eligible to receive first dose, which was administered at 6:37 PM in the L Deltoid.  Patient was instructed on anticipated side-effects from this vaccine, and to wait in clinic "Rest & Recovery" for a minimum of 15 minutes post-vaccination.  RN in Rest & Recover area was observing and checking in with patients during waiting period, patients were instructed to honk or get staff's attention if not feeling well.  Patient indicated at around 6:50 that her ears were "ringing", so was instructed to wait an additional 10 minutes past initial wait time.  At approximately 6:59 patient reported feeling a lump in her throat and having  more difficulty breathing and hearing.  At 7: 03 RN called over clinic staff radio system "Medical-Rest & Recovery",  and staff person in R&R called 911, while grabbing anaphylaxis emergency kit.  Two Lead RN's from Vaccination station came running to R&R and found patient holding her throat and shaking uncontrollably, with increased respirations.  Patients mask was removed and epinephrine was administered in patients right thigh via auto injector at 7:05 PM, BP taken simultaneously was 215/85, P-130,  O2 sat. 99% on room air.  Patient breathing rate started to decrease and vitals at 7:10 BP-211/90, P-114, R~28, O2 98% on RA.  First Responders arrived on-site at 7:15 PM, report given.  7:18 PM BP-207/92.  Patient stated to develop increased respirations again, and began shaking; First Responders administered half dose of epinephrine via auto injector in right thigh at 7:25 and applied non-rebreather mask w/15L O2  BP 203/93.  Ambulance arrived at 7:28 and transported patient to nearest hospital.
1 week post my 1st Moderna covid vaccine I developed a rash on the immunized arm. The rash was tender, and itchy.  It has hives, and developed a ring around it that is best describes as a hive  shaped as a large circle that outlined a large, indurated area. It started small and then got larger. The rash subsided in about 5 -6 days.
This is a spontaneous report from a contactable other health professional (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 14Jan2021 14:30, at left arm, at single dose for covid-19 immunization. Medical history included migraines from an unknown date, Allergies to medications, food, or other products: penicillin, sulfa. Concomitant medication included propranolol. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899) via an unspecified route of administration on 23Dec2020 15:00 at left arm, at single dose for covid-19 immunization. The patient experienced Severe rash, red skin and hives across my abdomen and legs. Hot to the touch, all on 16Jan2021 16:00. Treatment was reported unknown. The outcome of the event was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
1st dose April, 2nd not  yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose at the end of April).   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: 13-Dec-2022 Reporter's comment: The patient stated that he just learned  that it was a 2 dose series.  The patient asked that if he should get his second dose now. Education provided per content.  Medical disclaimer was provided. Mailing package insert and referred to health care professional. Did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Concomitant medication was not reported.  Nurse reported that patient received bivalent booster from vials that were put in the fridge and after that refrozen and thawed again. Moderna COVID19 vaccine bivalent, dosage given in ml unknown to the HCP. HCP wanted to know if the vaccine was ok or if they should be revaccinated. Treatment medication was not reported.  This case contains information for the 97th of 100 adult male patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-697752:Master case
Woke up from sleeping in the middle of the night to go to the bathroom, fainted on floor.  Woke up on bathroom floor. Not sure how long I was there. Couldn't get up was sweating, nauseas and had the chills. Crawled back to bed. Slept another 8-10 hours. Woke up at 2PM. Wanted to see if I had a concussion given I'd fallen on a tile floor. Was seen at Sollis Health they discovered I was likely dehydrated so they gave me an IV to hydrate and my platelets were very low (they're usually normal). Was tired, chills, nausea, weak and slept a ton until Sunday when I woke up feeling fine. Had platelets checked later that week and they were fine. After first shot got "covid arm" on day 10. Arm still hurts in the area, thought less than it did after the second dose.
Patient states he had excessive fatigue to the point of not being able to get out of bed starting 3/12/21 Friday.  and has had motor issues/dizziness since.  Experienced puking and was not able to get out of bed until Monday 3/15/21. This is still occurring but improving since he has been able to move around since Monday.
I couldn't breathe. I went to the Er. I was diagnosed with massive blood clots in my lungs and legs. I had no health issues for blood clots prior to this diagnosis. I was told later by the hospital doctor that this was a life threatening event. I am still recovering 03/22/23 and have not regained my total health.
diarrhea and some nausea beginning at 7:30 am lasting approximately 4 hours. urinary retention beginning at 7:30 am.  after 8 hours went to ER and had Foley Catheter inserted.  after 6 days (11/23) catheter was removed for voiding trial.  by mid-afternoon trial seemed successful.  by the following day (11/24) urinary retention recurred and, due to holiday, another ER visit was required to insert another catheter.  catheter remained in place until 12/12 when another voiding trial was attempted, this time with successful results.  no further symptoms.
Induration and redness around injection site 6cm X 6cm, warm and tender. Increased erythema over 2 days.
HYPERtension & Angina  Narrative: C/o chest tightness. BP 180/90. HR 85. 02 100%. Quickly passed. BP 160/90, HR 60, 02 100%
The pt felt dizzy, had blurry vision, right after vax. The pt also felt tired, but was talkative. No SOB. Epinephrine given and symptoms resolved. The pt also sweated.
No fever, felt very cold, shaking. Had to put extra clothes on. Was in bed with extra blankets. Room 72 degrees (not cold). Event lasted about 1 1/2 hr - until I had put on enough layers. When I woke up during the night I took off extra layers and had no recurrence.
This spontaneous report was received from a radiologic technologist refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unspecified dates, the unspecified number of patients were vaccinated with improperly stored doses (incorrect product storage) of GARDASIL 9 (lot# L036301 and expiry date unknown) (dosage regimen was unknown). No adverse effect reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
On 11/24 the patient first noticed symptoms at 3 am when getting up to walk to the bathroom. She reported tingling and numbness in her feet and hands at that time. That same day around 11am the patient noticed difficulty lifting her legs to walk up the stairs. By the evening her left leg appeared to be dragging. She then started to get intolerable pain in her legs and back that evening when going to bed. By saturday the patient ended up in the emergency room of hospital. There they did thoracic x-ray and general testing. In conclusive results at the time and she was prescribed hydrocodone-acetaminophen, prednisone, ibuprofen and cyclobenzaprine. She was told to follow up with primary and orthopedic. Unable to sleep saturday night due to pain and called on call service on sunday. Md called back and thought it may have been guillain-barre sydrome and suggested the patient go to hospital to seek further treatment. Hospital refused spinal tap due to the fact that she had limited mobility and reflexes in the legs. Monday morning the patient went back to hospital due to persistent pain. Attempted a spinal tap but unable to get. The patient was walking with a cane at this point due to loss of function in the legs. Patient was admitted to Hospital. Tuesday patient went to x-ray and then underwent a spinal tap where results came back positive for guillain-barre syndrome. Was using a walker on Tuesday and then by Thursday had complete loss in function of legs with some numbness and tingling of the tongue/face. Wednesday started on IVIG treatment.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On unspecified dates, the patients received an improperly stored dose of ROTATEQ (lot #N003392, expiration date 11-OCT-2018, lot N011648 expiration date 01-DEC-2018), or M-M-R II (lot N004433, expiration date 07-FEB-2019, lot M011667, expiration date 08-MAR-2018), or LIQUID PEDVAXHIB (lot N012920, expiration date 07-FEB-2020, lot M034188, expiration date 20-MAY-2019) . The sterile diluent (manufacturer unknown) (lot N006804, expiration date 11-MAR-2018) to reconstitute measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was properly stored. The time frame was 1 hour 14 minutes with temperature of 9 degree Celsius (C) to 25 degree C (10 degree C). Digital Data Logger was involved. There was previous temperature excursion (9 degree C to 25 degree C (10 degree C) for 2 hours 15 minutes). No adverse effects were reported.
When administering the vaccine the needles detached from the syringe causing the vaccine to not enter the patient.
positive with COVID virus/getting cold/ lost taste and smell; positive with COVID virus/getting cold/ lost taste and smell; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 27Feb2021 as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced positive with COVID virus/getting cold/ lost taste and smell. 14 days after the first dose of the vaccine, the patient thought she was getting cold. That following Sunday, she lost taste and smell. She went in to get tested and was positive with COVID virus. Patient still didn't have taste or smell. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive. The clinical outcomes of the events positive with COVID virus/getting cold/ lost taste and smell was not recovered.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild
12/22 Vaccine 12/23 ER. Admitted to hospital for 7 days. Dr stated was due to fluid. Radiology stated no fluid present. Couldn't breath. Pulmonologist put on 2nd inhaler. Coughing a lot. Not able to walk more then 6 steps without stopping to catch breath.  *Has had 2nd vaccination on 1/13/2020
?Covid arm.? Large, red, swollen, rash at injection site, 5.5 inches in diameter. Joint pain, weakness, tiredness.
pt reports nausea & light-headedness approx 30min p/vax;pt started sweating & arm started to burn up & down;burn radiated across back & neck & shoulders were very stiff;
body aches in back and sides; fatigue; chills; body aches in back and sides; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced general body pain, fatigue, chills and back pain. On an unknown date, the outcome of the general body pain, fatigue, chills and back pain were recovered/resolved.   It was unknown if the reporter considered the general body pain, fatigue, chills and back pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after 1st dose vaccination, the patient had body aches in back and sides, some chills and fatigue. The symptoms were recovered in 2 days. The reporter consented to follow up. For the tolerence of dose 2 refer case US2021AMR032160, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR032160:same reporter
chills, extreme fatigue, arm pain, headache, fogginess, lightheaded; chills, extreme fatigue, arm pain, headache, fogginess, lightheaded; chills, extreme fatigue, arm pain, headache, fogginess, lightheaded; chills, extreme fatigue, arm pain, headache, fogginess, lightheaded; chills, extreme fatigue, arm pain, headache, fogginess, lightheaded; chills, extreme fatigue, arm pain, headache, fogginess, lightheaded; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 (Lot number: EL3248) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known_allergies" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose number:1, vaccine location: right arm, lot number: EN6203), administration date: 01Mar2021, when the patient was 43 years old, for COVID-19 Immunization.  The following information was reported: DIZZINESS (non-serious), CHILLS (non-serious), PAIN IN EXTREMITY (non-serious), HEADACHE (non-serious), FEELING ABNORMAL (non-serious) all with onset 25Mar2021, outcome "recovering" and all described as "chills, extreme fatigue, arm pain, headache, fogginess, lightheaded"; FATIGUE (non-serious) with onset 24Mar2021 20:30, outcome "recovering". Therapeutic measures were not taken as a result of dizziness, chills, fatigue, pain in extremity, headache, feeling abnormal.  Additional information: Patient had vaccine on 24th and fatigue started that night. The next day on the 25th is when the other symptoms started. Prior to the vaccination, patient not had COVID-19. The patient was not tested positive for COVID-19 post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. OTC allergy medications were received within 2 weeks of vaccination. Ethnicity information was available. Race information was available.  No follow-up attempts are possible. No further information is expected.
Pt stated that at  5pm weakness came on.  At 730-830 pm Pt had chills and sweats and was very tired and weak.  Pt had  chills  and muscle aches.  Pt stated that his Girlfriend had on shorts and a tank top.
Tingling, nausea, headache day of vaccination. Brain fog for following 36 hours.
This spontaneous report was received from a consumer as part of a Market Research program refers to one of her daughter's friend a 13 year old female patient. The patient was reported to be healthy. On an unknown date in 2000, the patient was vaccinated with GARDASIL (route and lot# were not reported) dose 1. On an unknown date in 2000, the patient experienced pain lasting a week and the patient in bed for a week after GARDASIL injection. None of her other friends choose to take GARDASIL because of stated events. Action taken was reported as interrupted as the patient did not receive the second dose. On an unknown date in 2000, the patient recovered. The reporter considered pain to be related to GARDASIL. The reporter considered the seriousness of the event pain lasting a week and the patient in bed for a week to be disabling. This is one of the two reports from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 39, via an unspecified route of administration, on May 4, 2021, single dose, for COVID-19 immunisation. No medical history, known allergies or concomitant medications reported. Prior to the vaccination, patient was not diagnosed with COVID-19. On May 4, 2021, at 23:00, patient experienced difficulty sleeping, flu-like symptoms, body aches, feeling hot and cold, headache and sweating at night. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of difficulty sleeping, flu-like symptoms, body aches, feeling hot and cold, headache and sweating at night: resolving (at the time of this report). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.