chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hot flashes; night sweats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jul2021 15:00 (Lot number: EW0176) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE, Batch/lot number: EW0176 , administration time: 18:30,, Anatomical location: Arm left), administration date: 18Jun2021, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: HOT FLUSH (non-serious) with onset 11Jul2021, outcome "not recovered", described as "Hot flashes"; NIGHT SWEATS (non-serious) with onset 11Jul2021, outcome "not recovered", described as "night sweats". Therapeutic measures were not taken as a result of hot flush, night sweats.  Additional information: No other vaccines received within 4 weeks prior to the covid vaccine, no covid prior vaccination, no covid tested post vaccination. No seriousness criteria provided.  No follow-up attempts are possible. No further information is expected.
nausea, malaise, GI upset, diarrhea;  redness, swelling, warmth, pain at injection site
I developed fairly intense itching throughout my body, primarily arms , legs and torso. I did not develop a rash or bumps. This lasted from Wednesday April 7 to Thursday night April 8. By Friday this had resolved. Other than that I was very fatigued the night of the shot and somewhat achy the next day.
3 inch circle of red skin, tenderness, warmth, feeling of malaise, fatigue.
severe body aches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female (Age: 34, unit: Unknown) patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: unknown) via unspecified route on an unspecified date as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. On an unspecified date the patient experienced severe body aches. It was reported that the first dose patient had severe body aches, she take hardcore pain medications, the body aches were so bad her medications didn't touch it, they lasted 8 days. Therapeutic measures were taken as a result of pain. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hospitalization: 12/31/2022 - 1/1/2023 (23 hours) Presentation to the ED: palpitations, generalized weakness, cough, congestion, and dysuria.  COVID + date: 12/31/22. Treatment: No indication of steroids. Patient refused remdesivir.  Discharge to: left against medical advice (AMA).   FF2588 8/28/2021 FC3182 9/16/2021
I fainted, my blood pressure dropped dramatically, heart palpitation and three days of vomiting culminating in left upper leg/hip numbness that lasted 7 years. I was told it was permanent nerve damage.
vomiting; pain in her stomach; severe headache; sweats; chills; sinuses were messed up; Booster; she had Covid; she had Covid; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received 3rd dose (booster) of BNT162B2 (COMIRNATY, Lot Number: FE3690; Expiration Date: 31May2022), via an unspecified route of administration on 22Oct2021 (at the age of 65-year-old) as single dose for COVID-19 immunization. Medical history included back and neck issues, now her neck was tight. Concomitant medications included she had a practice for her back where she got injections all the time. The injections were trying to fake the nerves in to thinking they were dead. She had this injection at 10:30AM on the same day she received booster shot. The patient previously took 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730) on 27Mar2021 (at the age of 64-year-old) for COVID-19 immunization; 2nd single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734) on 19Apr2021 (at the age of 64-year-old) for COVID-19 immunization. Caller stated she (patient) and her husband both received the Comirnaty booster dose last Friday. Caller said they experienced side effects which she guessed were normal because they were listed on the paper given to them but she still wanted to speak to someone about this because their doctor won't see her. Their doctor was saying she had Covid (in Oct2021). Caller asked if there was any information as to why they would say it was Covid. Caller mentioned she had not been tested and there was no positive test. The symptoms she experienced developed on the same day (on 22Oct2021) were vomiting, pain in her stomach, severe headache, sweats, chills, and her sinuses were messed up. Caller added she couldn't understand why she couldn't go in her doctor's clinic. It was also reported that patient and her husband had the last COVID booster shot on Friday and both were experiencing symptoms that han't gone away. She called her local physician who won't see her because they said she had COVID. Reporter stated she was calling because she wanted to let Pfizer know the symptoms. She guessed they were normal because they were on the paper, but they hadn't gotten any better. Reporter clarified her symptoms started on Friday (on 22Oct2021). It was shortly after she ate. She didn't have any in the clinic where she got it. Started with vomiting, pain in her stomach, severe headache, and sweats. Since then her sinuses were really messed up. She didn't have any problems with sinuses until she got booster shot. She had the chills. Reporter clarified that all symptoms started on 22Oct2021 and had not gone away. Reporter clarified she had not been tested for COVID since the booster. She had had multiple COVID test due to her work in the past. The outcome of the events was not recovered.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient who was vaccinated with the first and the second dose of CERVARIX on 09-AUG-2011 and 19-JUL-2012 respectively received the third dose of GARDASIL (Lot number and expiry date was not reported), 0.5 milliliter (ml), intramuscular in the left arm on 10-SEP-2013. No adverse effect reported. Additional information has been requested.
09/04/22 presents to ED for "worsening cervical fracture". PMHx of "recent fall" "CAD s/p CABG X4, AF (xarelto), PPM, HTN, and HLD"
Pt recvd vax NOV92 & nubmness & tingling of the rt side of face followed by swelling of face; swelling of tongue;  dorsum of lt hadn & bottom of rt foot were swollen;
pt recv vax 5MAR97 & same day exp soreness @ the inj site;
On Day 2 & 3 after my first shot of Pfizer, my hips felt odd as I was jogging on treadmill (but, still OK to run).  By evening of Day 4, we went for a walk and I was starting to hurt in lower back.  By morning of Day 5 - I had severe lower back, hip joint and lower abdomen pain.  At times, it felt like a UTI too.  It was the worst pain I've felt since child birth (many years ago).  It was worst in morning.  I called my doctors and they just said: take ibuprofen (they won't even see you; my primary care didn't even call me back).  Ibuprofen didn't even cut it.   I was doubling up on Tylenol and ibuprofen.  I had a heating pad on my back all this week.   It is now Day 9 and for the first time this morning I'm feeling OK.  I'm certainly not ready to go jogging yet; but, I'm much better (and I haven't had ibuprofen or Tylenol yet today).   Now, I'm scared to go get the second shot of Pfizer in a couple weeks.  What do I do?  The doctors here don't know what to say.
Child had had URI sx's x1 month before vaccine. Night of vaccine administration's he developed a temp of 105 and lethargy, was seen next day temp down 101 with Ibuprofen Dx'd with O.M.
Pulse weak. Thready, Lips pale, Fainted. Refused transport. Evaluated by EMS-Cleared
Left arm and swelling at injection site, diffuse rash on trunk, malaise and diffuse myalgias. Mild leukopenia and thrombocytopenia.
Chills, fever, headache, diarrhea (that was yellow and clear), entire body ache, weakness, loss of appetite, loss of taste, runny nose, itchiness on injection site.
fussy since 4 hrs p/office visit & Hep B inject; would not nurse well; appetite down 11DEC92; APAP was to be given every 4 hrs;
Severe diarrhea, lumbago, headache symptoms started 4 days after vaccine.
mom states that pt had a temp elevation of 103.2 R for 2 days despite APAP; leg doubled in size for 2 days & had a cont cry until that evening; pt taken to MD 24MAy93 because of the inconsolable cry; MD advised pt not to have pertussis vax
Hurts to abduct left arm and move it over her head.  Feels like it may be weak.  The ache comes and goes.  She has taken advil as needed and it does help. She exhibits decreased range of motion, tenderness and bony tenderness. She exhibits no swelling, no effusion, no crepitus, and no tingling.
This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (sunburn in mouth), GINGIVAL DISCOMFORT (sunburn in gums), CHAPPED LIPS (lips began to chap), CHEILITIS (around lip has a rash) and DRY MOUTH (mouth is dry) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced ORAL MUCOSAL ERYTHEMA (redness around the lips like someone punched him in the mout). On 01-Apr-2021, the patient experienced ORAL DISCOMFORT (sunburn in mouth), GINGIVAL DISCOMFORT (sunburn in gums) and CHAPPED LIPS (lips began to chap). On an unknown date, the patient experienced CHEILITIS (around lip has a rash), DRY MOUTH (mouth is dry), DYSGEUSIA (metal taste in mouth) and APTYALISM (saliva is not producing). At the time of the report, ORAL DISCOMFORT (sunburn in mouth), GINGIVAL DISCOMFORT (sunburn in gums), CHAPPED LIPS (lips began to chap), CHEILITIS (around lip has a rash), DRY MOUTH (mouth is dry), DYSGEUSIA (metal taste in mouth), APTYALISM (saliva is not producing) and ORAL MUCOSAL ERYTHEMA (redness around the lips like someone punched him in the mout) had not resolved. Treatment medications included Antibiotics and Prednisone. Patients had appointment with dermatology in September. Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Added reporter details and added event. On 27-Jul-2021: Follow-up received and contain non-significant information.
improperly stored temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 03-AUG-2020, the patient was vaccinated with improperly stored doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot# S020160, expiration date 30-JUN-2021, 1 (units not provided); strength, dose detail and route were not reported) and varicella virus vaccine live (Oka/Merck)(VARIVAX) (lot# S038175, expiration date 26-NOV-2021, 1 (units not provided); strength, dose detail and route were not reported) for prophylaxis.    The temperature excursion was of -50 Fahrenheit degrees, time frame was -6 Fahrenheit degrees to 14 Fahrenheit degrees (10 Fahrenheit degrees) for 1 hour and 15 minutes; 15 Fahrenheit degrees to 46 Fahrenheit degrees (44.8 Fahrenheit degrees) for 1 hour and 30 minutes; 47 Fahrenheit degrees to 77 Fahrenheit degrees (50 Fahrenheit degrees) for 2 hours and 30 minutes. There were no previous excursions reported. The digital data logger was involved.
Within 3 d of receiving varivax, pt developed BM suppression (ANC 400) and blanching rash on face, trunk, extremities, possibly 2/2 concurrent viral illness.
Left Arm began to swell day of vaccination. Swelled to 3 times normal size of arm, "hard as rock" and hot.  Child also experienced fever 101.7. Admitted to hospital and was given antibiotics.  MD diagnosed as Cellulitis.  Today still with Fever.  04/02/2007 MR received for a 2 day hospitalization (3/22-24/2007)  for c/o redness, swelling, and soreness of the right arm where vax. were given the day before.  The child is febrile and is having malaise, and had nausea and vomiting.  PE:  Definite area of redness, swelling, and tenderness from the right deltoid down to the elbow.  Warm and tender to touch.   Txd with IV antibiotics. Impression:  Cellulitis of Right shoulder, probably 2' to an immunization.  Mild eczema.
9 hours later headache and fatigue started. Slept for 11 hours. Had headache, fatigue, fever, joint aches, loss of appetite  that last 5-7 days.
Fever (~101) Aches Chills Diarrhea Nausea Pain at injection site Chest pains
pt recv vax 29OCT97 & 27JAN98 pt devel a blind spot in both the lt & rt eye, as well as extreme sensitivity to light;pt referred to a clinic & later to a neurologist;eval by MRI revealed optic neuritis;
My arm got red by injection site & blew up - pain in my arm for one week. I also slept for four (4) days, I had fever around 101 degrees.
PATIENT HAS NOT HAD ANY SYMPTOMS TO THIS POINT WHEN TALKING TO THEM ON 6/2/2021. PATIENT WAS GIVEN A DOSE APPOXIMATELY 2.5 HOURS AFTER THE GOOD BY DATE AND TIME. VIAL WAS FIRST PUNCTURED AROUND 752 AM AND EXPIRED AT 152 PM WITH 6 HOUR GOOD BY TIME
No additional AE's and no PQC's were reported.; patient received 2 doses of GARDASIL 9 five days apart on 7/13/2022 and 7/18//2022; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.   On 13-JUL-2022, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), lot # 1780876, expiration date 09-NOV-2023, to prevent Human Papillomavirus infection (dose, route of administration, injection anatomical location, lot # and expiration date were not provided).   On 18-JUL-2022, five days apart, the patient received another dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), lot # 1780876, expiration date 09-NOV-2023, to prevent Human Papillomavirus infection (dose, route of administration, injection anatomical location, lot # and expiration date were not provided) (Inappropriate schedule of product administration). No additional adverse events were reported (No adverse event).
Patient developed autoimmune encephalitis 2 weeks after vaccine.  He was severely affected and never recovered.  One year later committed suicide.
Information has been received from a physician concerning a patient who on an unknown date was vaccinated with a second dose of VARIVAX (Merck). On an unspecified date, following the second dose, the patient developed a rash on both upper arms. At the time of the report the patient's status was unknown. A product quality complaint was not involved. The reporting physician stated she believes there has been an increase in the frequency of calls to the local health department regarding second dose AEs, particularly rashes in patients who have received a second dose of VARIVAX (Merck). She indicated that other physicians in the region also felt they were seeing an increase in second dose rashes as compared to what they observed following the first dose. With respect to specific types of AEs, the physician stated she saw reports of generalized rashes, injection site reactions and cellulitis. She has spoken with the reporting healthcare providers and all doses of VARIVAX (Merck) were stored and administered appropriately, and all patients involved were normal healthy children. This is one of several reports received from the same source. Additional information has been requested.
Initial report was received 01 July 2009 from a health care professional.  A 14-year-old female patient with a history of vomiting following a prior vaccination, had received a first dose left deltoid intramuscular injection of MENACTRA, lot number U2922A on 30 June 2009, and immediately following vaccination, she momentarily passed out.  She also developed fever, chills and vomiting later that same day.  She had not received any other vaccines within four weeks of MENACTRA.  At the time of the report, she continued to have fever and nausea and her recovery status was reported as unknown.  The reporter for this case is the same as for case number 2009-02918.  Documents held by sender:  None.
I had soreness in my arm, but nothing more than body aches. I felt fine and had no serious symptoms. I woke up Saturday with a cough that I couldn't get rid of. I called telehealth who advised me to get tested for COVID. I went to the pharmacy to get tested and found out the next day that I tested positive for COVID. I was eventually hospitalized for 5 days and I still have a cough that I haven't been able to get rid of yet.
I received the shot in the morning on Jan. 21, 2021 and had no issues until 12:20am (Jan 22)when I woke up sweating profusely and had major chills.  My body ached all over and had a hard time sleeping due to all of this the entire evening.  I woke up and tried to get ready but quickly realized I was weak, my joints hurt, body ached, headache and couldn't do it.  This continued throughout the morning and part of the afternoon.  Then around 2pm, I was still tired and achy but my joints didn't hurt as bad and I was able to manage the headache with ibuprofen.  The body aches continued through most of the next day (Jan. 23) as well.  By Jan. 24th I was perfectly fine and back to normal.  I had covid early in the year on Nov. 6 which kept me out of work for almost 3 weeks.  These few days were very similar to how I felt when I had covid but not as intense.
Pt given flu vaccine left deltoid. 48 hours later pt has quarter size ecchymotic area and large area of redness and sl. swelling.
SYNCOPE EVENT IMMEDIATELY AFTER ADMINISTRATION OF VACCINE. STATES "HE WAS NERVOUS
devel red raise pinpoint rash @ inj site & enlarged on thighs-both legs;
Patient felt dizzy about 15 mins after her vaccine was administered. Initially her Heart rate was 70, oxygen 99, and blood pressure 163/120. Patient was given water. Patient was asked to lay down and her feet were elevated on a chair. after about 15-20 mins patient felt better so was asked to sit up, given water and after few mins of sitting her blood pressure was 133/112. patient was feel good  not too dizzy. Patient left he pharmacy with a friend.
feet pain; It began with my legs feeling very heavy; I had a difficult time walking.; Troubles sleeping due to the pain, burning, tingling.; Troubles sleeping due to the pain, burning, tingling.; Troubles sleeping due to the pain, burning, tingling.; Troubles sleeping due to the pain, burning, tingling.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, single), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "feet pain"; LIMB DISCOMFORT (non-serious), outcome "recovering", described as "It began with my legs feeling very heavy"; GAIT DISTURBANCE (non-serious), outcome "recovering", described as "I had a difficult time walking."; BURNING SENSATION (non-serious), PAIN (non-serious), PARAESTHESIA (non-serious), SLEEP DISORDER (non-serious), outcome "unknown" and all described as "Troubles sleeping due to the pain, burning, tingling".  Additional information: Patient stated that I began to experience leg and feet pain after my 2nd dose. It began with my legs feeling very heavy, I had a difficult time walking. That feeling has mostly gone away but I continue to feel pain in my legs and feet. Troubles  sleeping due to the pain, burning, tingling. Random pains in my legs and feet At times my right foot falls asleep. I am an active individual. Now I can no longer exercise with constant struggles related to the pain.   No follow-up attempts are possible. No further information is expected.
10:00pm on 1/26/21 (day of vaccination): Fever over 100, severe chills.  After 12:30 am on 1/27/21 and lasting all day: neck and back stiffness and severe pain, joint pain, Fever over 100, chills, fatigue, and swollen lymph node in axillary area. Fever and majority of symptoms subside with acetaminophen but fever and symptoms return when Tylenol wears off.
Primarily, extremely weak on the next day--in particular for several hours during the afternoon in which I lay down and did not wish to move.  Soreness and aching throughout my body, not unlike when one experiences influenza; however, I had no other flu symptoms, no nausea or indigestion.  There were occasional headaches, and a few times, light-headedness.  Weariness, and lack of physical drive continued, on and off, for another ten days.  On one day, one week later, during this period, I was able to function fairly normally, but I may have over-extended..  The next day, Friday, the weakness resumed.  Last night when I went to bed, I felt light-headed again, but slept soundly for seven hours.  Today, I feel much better, and I feel that I am returning to normal.
Soreness at injection side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at injection side".  Additional information: The product was used by the patient. The patient did not reported any other medical information.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Moderna COVID-19 Vaccine EUA  Chills, cough, body aches, congestion, runny nose, run down body 3 days post first vaccination. Itchy lump at injection site 7 days post vaccination. Sickness lasting 7 days post vaccination.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On 28-APR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # L014458, expiry date 11-FEB-2017, dose and route of administration were not provided). No adverse effects were reported. No product quality complain was involved. Additional information has been requested.
hives occurring 10 days after injection. initially at vaccine site, then on back/chest (self resolved at the time of evaluation)
Case number PHEH2016US023409 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 26-year-old patient of an unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 01 Dec 2015. It was reported that the patient received FLUVIRIN that had temperature excursion. The patient did not experience any adverse events following vaccination.