chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe, Additional Details: Patient reported on 10/11/21 extreme dizziness, nausea and lack of energy following 3rd dose of pfizer administered and was asking is this was normal. Patient had some of these symptoms following second dose, but not nearly this bad nor long lasting. Stated that she will never get another dose of this vaccine if it is recommended later
hives on her left forearm; Warmth at injection site; Redness at injection site; Fever; feel pain where she received her vaccine; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid 19 vaccine (received 1st dose of Covid 19 vaccine followed by a second dose of Covid 19 vaccine then a booster of the Covid 19 vaccine in right arm on an unknown date). Concomitant products included INFLUENZA VACCINE.   On 24th October 2021, the patient received the 1st dose of Shingrix. On 24th October 2021, immediately after receiving Shingrix and an unknown time after receiving INFLUENZA VACCINE, the patient experienced injection site pain. On 25th October 2021, the patient experienced injection site warmth, injection site erythema and fever. On 28th October 2021, the patient experienced hives. On 28th October 2021, the outcome of the injection site pain and injection site warmth were recovered/resolved. On an unknown date, the outcome of the injection site erythema, fever and hives were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema, fever and hives to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. A few weeks ago from reporting date, the patient received one flu shot in right arm. The patient received a dose of Shingrix and immediately began to feel pain in the right arm where she received her vaccine. The pain was resolved. The following morning of 25th October 2021, 1 day after vaccination, she described that she had fever, redness at the injection site and warmth at injection site. The fever and redness at the injection site had not resolved. The warmth at the injection site was resolved. Finally, she noted on morning of 28th October 2021, 4 day after vaccination, she had some hives on her left forearm and they had not resolved. The reporter was provided with medical advice disclaimer and she said she had been in contact over the phone but would try to make an appointment to see her in person. The reporter gave permission to contact healthcare professional. The reporter consented to follow-up.
Tinnitus - ringing/noise in both ears. Started after the vaccine was administered. Began noticing sensitivity to sounds shortly after receiving the vaccination(ex. dishes clinking together when putting them away, etc.) Then, noticed a background noise in my ears when it was quiet throughout the day which has persisted since the summer(June/July) of 2021 until now. In the last few weeks (starting in January 2022) all the previous symptoms have increased. The background noise in my ears has increasing to include a ringing as well. The tinnitus has grown louder, the ringing is noticeable when it is quiet or when there are other noises in my surroundings. It has become extremely difficult to fall asleep, rest, concentrate, relax, etc. because of the constant ringing sound in my ears.   IVF Treatment - underwent a frozen embryo transfer 08/31/2021 which resulted in a chemical pregnancy on 9/15/21. Underwent a second frozen embryo transfer on 11/15/21 which ended in a miscarriage on 01/08/2022. Second miscarriage was tested for genetic abnormalities which came back negative.
This is a 76-year-old Laotian male with reported cirrhosis of the liver, whom we are consulted on for septic shock. All history was obtained from the ICU RN & from the chart, given the patient is intubated. Was driving down to another State. He presented to the ER on 9/3 with generalized weakness and abdominal pain.   In the ER, he was hypotensive & confused. CT C/A/P demonstrated cirrhosis of the liver & suspected gastric bleeding. GI was consulted for an EGD, however, the patient was too unstable to undergo endoscopy, hence this procedure had to be canceled. Initial Hgb was 9.7. Unknown baseline. He was transfused. Placed on pressors. He was intubated for respiratory distress.
Started with low fever/body ache/and slight HA evening of shot (9pm), went to bed. Woke up with fever/chills took Tylenol approx 12 am and went back to bed. Woke up off and on with HA worsening, but by   8 am I took Topirimate (regular med I take for migraines), pantoprozole, and another Tylenol and went back to bed. Woke up with full on Migraine and tried to tuff it out. Around noon had to take an Ubrelvy (abortive migraine medicine). I noticed around the same time that the left side of my face was hot and itchy.  I asked my husband if I had hives on my face and he said yes. I got up and looked and I did have raised welts along my left cheek, chin, and throat area.  About an hour later I ended up taking a benedryl because it was getting worse. That made me sleepy so I went back to bed. Later I woke up and my migraine was not as severe. I took another benedryl and Tylenol and went back to bed. By Wednesday morning the hives were down to two smaller (approx some sized welts) still on my left chin/cheek area.  My migraine was gone and I just had a lingering HA /body aches, and alternating fever and chills throughout the day. I noticed Wednesday that my injection site had a huge bruise (half dollar sized) over the area. That bruise is still lingering after 2 weeks. It has been very prominent on my arm, and has been shocking to see. I have picks of the hives from Wednesday morning and various shots of my bruise over the past two weeks.
Dizziness, faint, vomiting, diarrhea, injection site itchy, red, hot and swollen.
This case was reported by a healthcare professional and described the occurrence of chest pain in a 62-year-old male subject who was vaccinated with Twinrix vaccine for prophylaxis.  The subject's medical history included diverticulosis, hyperlipidemia and obesity. Concurrent medications included Hydrochlorothiazide (HCTZ), Folic acid, Simvastatin and Aspirin (Baby aspirin). On 06 February 2007 at 12:15 pm, the subject received 2nd dose of Twinrix in the left arm. When the 2nd dose of Twinrix was being pulled out of the subject's skin, some of the vaccine squirted into his face and mouth. As a result of the accidental exposure, the subject did not received the entire, 1 ml, dose of Twinrix. On an unspecified date on or after 06 February 2007 and on or before 09 February 2007, less than one week after vaccination with Twinrix, the subject experienced chest pain and shortness of breath and was seen in an emergency room. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with oxygen. At the time of initial reporting, 09 February 2007, the events were ongoing.
Patient received Second dose Moderna Covid 19 Vaccine at 1537. Patient requested to be vaccinated while laying down due to him having an adverse reaction last time ( abd pain and near syncope).  Immediately after vaccine patient reported experiencing Dizziness.  Patient provided with water and continued position of comfort.   VS checked after 15 minutes and are as follow   BP 151/79 HR 79 RR 16 O2 Sat 99%.   Patient followed to report intermittent left sided chest discomfort.  MD STAT called per protocol and team responded.  Dr and Nurse  responded to patient.  Recommended patient be taken to Clinic to perform EKG. Patient refused wheel chair and walked out of Vaccine clinic towards family medicine clinic.
feeling in tongue had changed; skin turned rosy on face; lip swollen; digestive issues; gas; Itchy skin; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 26Jan2021 at 11:00 at 73-years-old at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On 26Jan2021, the patient experienced events and outcomes: feeling in tongue had changed (non-serious) with outcome of recovering, skin turned rosy on face (non-serious) with outcome of recovering, lip swollen (non-serious) with outcome of not recovered, digestive issues (non-serious) with outcome of not recovered, gas (non-serious) with outcome of not recovered, itchy skin (non-serious) with outcome of not recovered; all of which required an emergency room (ER) visit. The patient stated that immediately after the vaccination, he came down with a mild reaction. The patient stated the feeling in his tongue felt off, skin turned rosy, lower lip was swollen, and he has had some gas and digestive issues. The patient stated that he spent an hour and a half in the emergency room (ER), and everything calmed down there, and he was able to go home. The patient stated that he may not take the second dose.
flu; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) flu (influenza), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past 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 not reported) via an unknown route at an unknown administration site prophylactic vaccination.  On an unknown date, the patient flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Immediately after Tdap - pt vomited, turned pale, felt dizzy, BP 138/82. For next 2-3 wks, pt c/o HA, dizzy overall which resolved. New allergic rhinitis symptoms. Asthma exacerbation 10/20/11 after no albuterol in 4 yrs.
severe fever 104-chills, malaise adm to hosp for work-up fever;
mild pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (mild pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    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 PAIN (mild pain). At the time of the report, PAIN (mild pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
cellulitis / skin reaction developing 4 days later Started cefadroxil for cellulitis and resolved completely after 2 days. Back to normal
Acute generalized urticaria. The patient was placed on Benadryl for urticaria which progressed as any other problems. He received no other vaccines on that day, he is on no regular meds has had 3 other recorded flu shots, but has never before had an adverse event to any vaccine.
I had both doses /  had two cases of shingles / in August, and / in September/ Suspected vaccination failure; shingles / in September / on my lower back; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (once every couple months). Concurrent medical conditions included stress.   In May 2020, the patient received the 1st dose of Shingrix. In August 2020, the patient received the 2nd dose of Shingrix. In September 2020, between 4 and 5 months after receiving Shingrix and between 1 and 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, but could be 77 or 78 years old. The patient had both doses, one in May and then the second three months after the first dose and had two cases of shingles occur. One last month in August, and now one this month in September, and patient was wondering if she should report this to the pharmacy where she got vaccination, or to her doctor; she was under the understanding that the vaccine would prevent her from getting the shingles, but she still getting shingles. The patient had a history of shingles, stating if she was under a lot of stress she used to get shingles maybe once every couple months, and it would just be slight breakout might be the size of a dime, nickel, or quarter, on my lower back. It had been happening off and on for the past 40 years. Consumer gave consent to contact her pharmacy and her physician, though limited contact information was available at the time of call. The reporter also granted consent for safety to follow up with her directly. Consumer was not provided the product lot numbers, but stated she received both vaccine did at the pharmacy. No further details were provided at the time of callback. This case was considered as suspected vaccination failure as time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
1/23/21  12:00 Noon noticed red, hot, raised swelling at injection site @ 1 inch in size. Fever 102.3 1/26/21 2:10pm Red, hot, raised swelling has spread to 5x original size 15 x 20 cm.
upper thigh to knee with swelling, minimal warmth, no redness or rash, not tender to palpation
pt recvd vax & devel Lt bells palsy; palsy noted 9oct94;
Two weeks post vax, pt experienced fever as high as 103F for three days. Each evening of these 3 days, the pt had 1-2 seizures. Pt's mother describes these seizures as similar in character to previous epileptic seizures the child has experienced.
Information has been received from a physician, via a company representative, concerning a 12 year old female patient, who was vaccinated (date not specified) with the first dose of Gardasil, and following vaccination, felt like she was going to faint. The physician confirmed that the patient did not actually faint, though she had dilated pupils and she "lost sight" for approximately 10 minutes. The patient was instructed to lie down for 10 minutes, and then reported "she was okay." Upon internal review, "lost sight for approximately 10 minutes," was determined to be serious as an other important medical event. Additional information has been requested.
12:05 pm red skin, itching, hand numbness upper body ache and light headed, 152/96 pulse 18. 12:25 pm increase vertigo, chills, moderate back/shoulder pain resulted in severe pain. 12:37 BENADRYL 25 mg by mouth 12:45 no change BENADRYL 25 by mouth. 12:50 balance returned tingling, pruritus, rash decreasing.
Patient received vaccines at about 0900 in the clinic.  Later in the evening, started looking more tired and less energy. At about 7pm that evening, dad noted eyes rolled back and had generalized tonic clonic seizure lasting for about 1.5 minutes.  911 contacted and taken to ER.  Noted fever of about 102 at that time.  No further work up.  No further symptoms, seizures or fevers since discharge from ER.
Information has been received from an LPN concerning a 6 month old white female pt who on 5/25/00 was vaccinated with a 3rd dose of Hep-B, 1 3rd dose of DTAP and a 3rd dose of HIBTITTER. "Soon after vaccination", on 5/25/00, the pt experienced injection site redness. The pt's parents noted "bumps on both legs", post vax. The bumps on the right leg resolved, however, the bumps on the left leg worsened and became red and there was pus. On 7/5/00, the pt was dx'd with cellulitis (considered an Other Medical Event) and placed on Duricef. On 7/10/00, the pt showed no improvement and was continued on Duricef. The pt subsequently, was seen by a surgeon for incision and drainage. Subsequently, the pt recovered from cellulitis.  Follow up on 03/05/2001: "A nurse reported a 6 month old female received Acel-Immune, Hib-Titer, and Recombivax HB vaccines on 05/28/2000.  Subsequently, the infant developed "bumps" at the sites on both legs.  The "bumps" on the right leg resolved, but the "bump" at the Acel-Immune injection site persisted.  On 07/05/2000, the injection site reaction on the left leg became red with purulent drainage.  A diagnosis of cellulitis was made and the infant was trated with Duricef (cefadroxil).  No improvement was noted by 07/10/2000, so the infant was seen by a surgeon for incision and drainage of the area.  She recovered.  A copy of this report has been forwarded to the manufacturer of Recombivax."
Significant shaking/trembling, chills yet hot, severs fatigue, muscle aches especially in neck area. No fever. If husband hadn?t been home, I would have gone to the emergency room. Symptoms subsided within 8 hours. Ibuprofen really helped.
Vaccine not authorized for use in patients under 18 years of age. Administered to this patient with no reported side effects, adverse effects or any reported concerns. Parents and child aware of situation. Patient primary care physician informed and healthcare team consulted with Moderna Clinical information support line who advised that since patient between age of 16-17, can offer second dose in 28 days, considered off-label use.
Information has been received from a physician concerning a patient who was vaccinated with a dose of ROTATEQ.  The physician stated that she had two different patients who developed colitis after receiving ROTATEQ. (WAES # 0901USA03138)  This is one of two reports received from the same source.  Additional information has been requested.
Tested positive one month after vaccine. Took COVID-19 home test came up positive. Called my Dr. and they asked me to come in to officially test and it came back positive. Breakthrough case.
Information has been received from a medical assistant concerning a patient who on 15-AUG-2008 was vaccinated with a first dose of ROTATEQ vaccine. It was reported that the patient had "thrown up" right after receiving the vaccination. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/25/2008. Follow-up information has been received from a medical assistant indicated that the child "simply spit up." At the time of the report the patient's status was unknown.
headache that is still going on; lot more fatigue than before; soreness in the arm a lot more; Inadvertent administration of more than two doses; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache that is still going on), FATIGUE (lot more fatigue than before), MYALGIA (soreness in the arm a lot more) and EXTRA DOSE ADMINISTERED (Inadvertent administration of more than two doses) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Inadvertent administration of more than two doses). On an unknown date, the patient experienced HEADACHE (headache that is still going on), FATIGUE (lot more fatigue than before) and MYALGIA (soreness in the arm a lot more). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 19-Aug-2021, EXTRA DOSE ADMINISTERED (Inadvertent administration of more than two doses) had resolved. At the time of the report, HEADACHE (headache that is still going on) had not resolved and FATIGUE (lot more fatigue than before) and MYALGIA (soreness in the arm a lot more) outcome was unknown.            Relevant concomitant medications were not reported.  The treatment information was  not provided.   This case was linked to MOD-2021-293631, MOD-2021-293637 (Patient Link).
Was administered a pediatric dose in error and was instructed to return to receive correct dose from Pfizer.
Chills, fever, nausea, body aches for a week after vaccination. Headache since the vaccination with no relief.
2 days after - mid back ache (right shoulder blade).; Soreness under right arm; radiating into right breast; Sleep interrupted by mid back ache; mid section of body just feeling sick; Motion has not impeded; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264), via an unspecified route of administration in the arm right on 28Mar2021 at 14:00 hours (at the age of 66-year-old), as a single dose for COVID-19 immunisation. Medical history included eczema (mild), itching had subsided, now just had dull ache and was just getting over a flare on back shoulder blade pain. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have allergic to food, medication or other product and did not received medicine generally. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 12:00 hours, after 2 days the patient experienced mid back ache (right shoulder blade). soreness under right arm, radiating into right breast, sleep interrupted by mid back ache, mid-section of body was just feeling sick and motion had not impeded. The patient did not receive any treatment for the event. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events mid back ache, soreness under right arm, radiating into right breast, sleep interrupted by mid back ache, mid-section of body was just feeling sick and motion had not impeded were not recovered.    No follow-up attempts are possible. No further information is expected.