chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a LPN concerning a 36 year old white female social worker with no pertinent medical history and no known drug allergies who on 15Nov04 in the PM was vaccinated IM in the deltoid with a first dose of hep B virus vaccine rHBsAg (yeast) (lot 647301/0433P). At the time of vaccination, the pt c/o not feeling well, and noted he felt crappy. While the nurse was vaccinating the pt, the hub came loose and some vaccine squirted out. The nurse indicated that the hub of the vial was not tightened properly. The pt was then revaccinated IM in the left arm with a dose of hep B virus vaccine rHBsAg (yeast) lot 647301/0433P). On 16Nov04, the reporter indicated that the pt was feeling better at the time of the report. the outcome was reported as recovering. There was no product quality complaint. Follow up information received from a LPN indicated that on 16Nov04 the pt c/o muscle aches, nausea, vomiting, and generalized weakness for 2-3 days. The outcome was reported as recovered on 19Nov04. On 23Nov04, the pt had a comprehensive metabolic panel (ALT 66 IU/L high), a urinalysis normal, lipids (total cholesterol 238 mg/dl high; HDL cholesterol 11mg/dl high; LDL cholesterol 115mg/dl high), and a TSH. There were no adverse events following prior vaccinations of the pt or her siblings. No additional information is expected.
End of January into Febuary  developed shortness of breath, neck and back pains, cardiac palpitations. Marsh 27 2021.  Went to the emergency room for chest pressure and shortness of breath. syptoms have worsened greatly.  Diagnosed with paracardial effusion, & hypothyroidism.  Refered to cardiac Dr. who informed me that this could be a side effect of the vaccine.  Continued to have thyroid issues incuding weight gain and throat complications.  Endocrinologist now has Diagnosed myself with Hashimotos Disease  9/8/2021. Said this was also a side effect to recieving the vaccination and to report.
Headache, soreness at injection site, minor body aches, chills, acetaminophen 500mg taken with improvement, symptoms subsided after 24 hours from onset.
Received the first dose 12:30pm Thursday(2/11). Around 6pm that same night I notice the first symptom. I had a super strong headache that lasted the next 24 hours or so. Still lingering now but not as bad. Around 3am Friday (2/12) I woke up with chills and the inject spot was extremely tender. All day Friday I had signs of a fever. Chills and felt cold but body was hot to the touch. This lasted all day and it kept Me in bed the whole day.  Around 6pm Friday night, my injection spot was extremely sore , and there was a red circle, about the size of a gold ball around the spot. That?s also when I  noticed I had shortness of breath and was having a little difficulty breathing. Around 8pm I noticed I had really high anxiety that was abnormal. It went away in about 30 mins or so. I thought it was strange as I normally don?t have anxiety that bad. I went to sleep around 10pm and woke up at 5am itchy with a red rash/hives on the upper half of my body, mostly the neck and chest area. Also the red circle around the injection site grew to the size of a baseball. The headache is still there but not as bad . Maybe 2/10 Severeness. I feel better in terms of the fever and breathing today (2/13).  However the rash/hives has gotten worse and seems to be spreading slowly. I plan on taking Benadryl when I grab it from the store in 30 mins or so
My midwife ran labs for preeclampsia do to swelling in my legs, hands and face. The labs came back showing low platelet counts (124 L). I have no history of that ever being an issue, and it was not something I experienced with my first pregnancy.  I was due to have the baby on November 8th 2021. On October 21, 2021 in the evening, I went into labor. I labored at home for 5 hours (with help from my doula to breathe through the pain). I was admitted to the hospital  at around 3:00 am on October 22, 2021. I was dilated to 7 and begged for an epidural. They decided to do labs to check my platelet levels again. They were at 109, which was just above what was acceptable for giving me an epidural. After the epidural my Platelet levels dropped again. I pushed for 2 hours and then my baby's heart rate started to drop. They rushed me in for an emergency c-section where I lost 4 1/2 liters of blood. During recovery, my blood volume continue to go down. The OB determined that I needed a blood transfusion. I do not know when my platelet levels begin to drop before I was first tested, but it affected my and my baby's health. I was in the hospital for 4 days before we were released to go home.  I am still recovering from the emergency c-section (the surgery itself and the trauma). Baby is healthy.
This was my second dose. I had a mild reaction the day after the second dose. Fatigue and some chills.  Then I was perfectly fine.  A little after three weeks later I was hit with intense vertigo, nausea, diarrhea and all over weakness. Vomited everything I tried to take in.  No ear infection.  Five days later vertigo has subsided but still off balance.
Information has been received from the manufacturer indicating that stability data supports the use of this product through Oct. 19.
This case was reported by a pharmacist via call center representative and described the occurrence of red blotches in a 66-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 22nd August 2018, the patient received the 1st dose of SHINGRIX .5 ml. In August 2018, 7 days after receiving SHINGRIX, the patient experienced red blotches, raised rash and generalized rash. On an unknown date, the outcome of the red blotches, raised rash and generalized rash were unknown. It was unknown if the reporter considered the red blotches, raised rash and generalized rash to be related to SHINGRIX. Additional details were provided as follows: The caller was a pharmacist reported that about one week receiving SHINGRIX, the patient experienced red blotches on her hands and feet that eventually spread to all over her body. The caller stated that the red blotches were raised and per the patient they wax and wane, more noticeable after she gets out of the shower.
Patient had her first dose of Pfizer and after she sat down she became nauseous, head pounded, very hot and sweaty, coughing, her lips, face and arms got tingly. She said her heartbeat was fast and she felt like she could faint. EMT was called but they did not take her to the hospital just suggested her parent get her checked out.
Pt recvd vax JUN92 & devel burning sensation upon injection as well as soreness & or an aching sensation in the arm; heaviness in the arm also;
arm soreness; pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced pain in arm and pain. Shingrix was discontinued. On an unknown date, the outcome of the pain in arm and pain were unknown.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not reported. The age group has been selected as per vaccine specification. Reporter claims that he knows of 5 different people that did not get the second Shingrix shot because of arm soreness and pain. The soreness in arm and pain AEs came after the first dose of shingrix. This is 1 of 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021054377:same reporter US-GLAXOSMITHKLINE-US2021AMR055618:Original Case : US2021054379 US-GLAXOSMITHKLINE-US2021AMR055621:Original Case : US2021054379
Numbness of left side of body, arm, face and tongue.  Treatment-rest and liquids.
Fever of 104. Feeling faint the evening after TRUMENBA. The next day, symptoms resolved.
Fever 102.3, chills, body aches, nausea, headache, fatigue.
The day after my vaccine, I went for a normal walk and my heart rate quickly got up to 180 bpm. For the rest of the walk (~2 hr), I had to walk VERY slowly and take breaks every 20-30 min just to get and keep my heart rate below 160 bpm.  I thought it might be related to the vaccine, so I went easy on my workouts for a few weeks, but it didn't really stop. Over the summer, I stopped walking outside because of the weather, and when I tried to resume the walks in the fall, I found that my heart rate was even worse--getting up to 185 with minimal effort and staying in the "peak" zone (above 170) for 65+% of my walk. In the past month, after a short trip to Bangladesh, where I developed a cough (not COVID) that lasted 4 weeks, it has gotten much worse--my heart rate gets up to 120 bpm and I become short of breath when doing minimal activity (e.g., washing dishes), and I can't walk faster than a 20 min mile without getting dizzy/short of breath. I've also begun feeling chest pains. I've been to the doctor twice and have an appointment with a cardiologist in November.
on 6/10/21, case experienced low blood pressure and increased heart rate. Tested positive for Covid-19 on 6/11/21. Case first visited emergency room at local Hospital due to low blood pressure, increased heart rate. Hospitalized 6/11/21 to 6/13/21. Fatigue, Shortness of Breath, and Cough also developed. Cough still persists as of 6/15/21
the following day (10/04/19) after being administered the Flu vaccine on (10/03/19), my dad went from being able to walk without assistance to not being able to stand on his own and had to use a wheelchair. Severe pain in both legs, no energy and coughing up bloody mucus. On 10/05/19 the symptoms progressively got worse, breathing became weaker, no appetite, limited urinating, extremely tired, pale face.  On 10/09/19 he went to medical center via ambulance and was released same day.  10/14/19 went to Nephrologist and she stated to immediately take my dad to ER and as soon as we arrive, they tested him and they admitted him into ICU after test results showed Pulmonary Edema, Oxygen was 71% and heart rate was low. They diagnosed him with ESRD, CHF, AFib, Pulmonary Edema, Hypokalemia and started Dialysis in ICU.
This spontaneous report was received from a pharmacist, who referred to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, lot# N011867 and expiration date: 08-NOV-2018 or lot# N014946 and expiration date: 01-FEB-2017 or lot# N020688 and expiration date: 09-MAR-2019 (dose, frequency, route of administration were not reported) for prophylaxis. The vaccine was improperly stored at a temperature of -1 degree Celsius (C) or colder (-10 C) for 6 days. Through 6 cycles multiple temperature excursions were involved. There were no previous temperature excursions. The temperature excursion was detected by a digital data logger. No adverse event was reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA003734:
Rigors, chills, back and hip pain.  Temp up to 103.  Patient required hospitalization.  She also developed pancytopenia.
approx 48hr p/vax pt exp nausea & loss of appetite;72hr p/vax pt blacked out, had severe flu like sx & was hosp & treated;
pt recv vax; low grade fever 99.6; induration & erythema at inject site; apap reduced fever;compresses relieved erythema & induration; all resolved in approx 72 hr;
Information has been received from a registered nurse for the Pregnancy Registry for GARDASIL concerning a 25 year old female who is a Guillain Barre syndrome carrier with a history of one pregnancy and a live birth and no known medical history or allergies who on 04-DEC-2006 was vaccinated with the first dose of GARDASIL (lot no. 653978-0955F), on 21-SEP-2007 second dose was administered (lot no. 653735/0688F) and on 17-OCT-2007 third dose was administered (lot no. 658282/0929U). Concomitant medication included prenatal vitamins. Subsequently, she became pregnant on 30-AUG-2007 (40 weeks from LMP) delivered a normal, healthy male baby weighing 8.68 pounds, APGAR SCORE 7/9. LMP on 22-NOV-2006, EDD 29-AUG-2007. The nurse also reported that the patient gained excessive weight during pregnancy and experienced edema. On 30-AUG-2007 the patient experienced cesarean section because the patient failed to progress after induction. The patient recovered from cesarean section. Labs and diagnostic test included: on 08-FEB-2007 an ultrasound performed showed unengaged. On 06-Mar-2007 serum alpha-fetoprotein test was negative. Upon internal review failure to progress resulting in c-section was considered an other important medical event. No further information is available.
Started with slurred speech, difficulty with balance, weakness on 5-1-21.  Symptoms worsened on 5-2-21 with garbled speech, inability to walk without assistance, weakness.  Admitted to hospital and was diagnosed with stroke.
At the site of injection, patient experienced red flare ups at the upper right arm all the way down to the elbow lasting 3 days.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. The nurse reported that the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot, batch # L015414, expiry date 01-AUG-2016, dose, strength, dose number, vaccination site, route of administration unspecified) since 01-SEP-2015. Concomitant medications were not provided. No adverse events were reported. No additional information was provided. The outcome of the reported events was unknown. Product quality complaint (PQC) was not reported. This is one of two reports from the same reporter. Additional information has been requested.
Patient woke up at 4am with shortness of breath, pulse ox 75 on 3.5L oxygen. No improvement with increased oxygen so patient was transported by ambulance to the hospital. When patient arrived to hospital heart rate was over 200.
7/28/10 Client called stating when taking off band-aid noticed red swollen bumps on left arm where both shots were given in left arm. No rash ROM - normal. Will take BENADRYL come in to clinic on 7/29. On 7/29 at 10:00 AM - 20mm knot area with no redness in the upper outer tricep area of left arm. A 40mm X 40mm red swollen area noted on the left deltoid muscle. No fever noted. Client states discomfort when sleeping on that arm. Took BENADRYL last night & will take another today and call back if not better tomorrow. 7/30/10 - client said much better after BENADRYL.
Muscle fatigue in legs; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 30Mar2021 13:00 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Allergies to penicillin and sulfa drugs" (unspecified if ongoing). Concomitant medications included: NORVASC; TYLENOL. Past drug history included: Erythromycin, reaction(s): "Allergies". Vaccination history included: Bnt162b2 (DOSE 1; 01:00 PM; left arm), administration date: 09Mar2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: MUSCLE FATIGUE (non-serious) with onset 31Mar2021, outcome "recovering", described as "Muscle fatigue in legs". Therapeutic measures were not taken as a result of muscle fatigue.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a workplace clinic facility. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Very painful axillary (left) lymph node; Swollen axillary (left) lymph node; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 24May2021 at 10:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. No relevant medical history was reported. The patient did not have allergies to medications, food, or other products. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 03May2021 at 10:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 25May2021 at 01:00, the patient experienced very painful and swollen axillary (left) lymph node. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the adverse event. The clinical outcome of the event very painful and swollen axillary (left) lymph node was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
generalized 'ick' feeling of being unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59-year-old female patient received bnt162b2 (BNT162B2), on 17Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "obese" (unspecified if ongoing), notes: obese and have taken Levothyroxine for hypothyroidism; "hypothyroidism" (unspecified if ongoing), notes: obese and have taken Levothyroxine for hypothyroidism. Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. Vaccination history included: bnt162b2 (DOSE 1, SINGLE), administration date: 27Mar2021, for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "generalized 'ick' feeling of being unwell".  Additional information: The patient had experienced what she believed to be a side effect from the COMIRNATY shot she received on 20Sep2023. Previously she had the Pfizer Covid shots on 27Mar2021. The only other side effect she had was after shot #2 (17Apr2021) that gave her a generalized 'ick' feeling of being unwell. She was obese and had taken Levothyroxine for hypothyroidism for over 20 years. Other than that she had no other prescriptions or conditions.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300173023 same patient, different dose number/events;
Several small bruises appeared on legs next day that only lasted for two days then gone,  fever for 5 days continued for two weeks, low grade headache for 2 weeks, dizziness, fatigue 3 weeks, slight cough intermittent
Information was received from a registered nurse concerning a 24 year old female who on 16-APR-2016, was vaccinated with either GARDASIL (HPV4) or GARDASIL 9 (lot number, expiration date, dosage and route of administration unknown) and became pregnant. There was no concomitant medication. Past medical history was unknown. Last menstrual period (LMP): 24-APR-2016. Estimated date of delivery (EDD): 29-JAN-2017. The patient's pregnancy was confirmed with a "urine test and ultrasound" on unspecified dates. The patient delivered a full-term infant at an unspecified facility and had a "normal delivery" (Apgar scores, gender, weight, length and head circumference not provided). The nurse reported the baby was in "normal health."  No further information was provided. Additional information has been requested.
Devel period of unconsolable crying lasting 5-6 hrs, starting approx 24 hrs p/vax; seen by MD no other cause identified;
Discharge Provider: MD Primary Care Provider: MD Admission Date: 1/17/2023 Discharge Date: Jan 22, 2023 COVID positive date: 1/17/2023 PRESENTING PROBLEM: COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 78 y/o with advanced Alzheimer's dementia diagnosed 7 years ago, hypothyroidism, anxiety who presented due to generalized weakness and worsening confusion.  Family had been unable to get patient out of bed.  He had been in a recent car accident.  Tested positive for COVID however asymptomatic outside of possible fatigue.  CT head did show age indeterminate left occipital infarct.  No injuries identified from car crash. In setting of covid suspected acute stroke however MRI showing basal ganglia and occipital stroke.  Patient was started on aspirin and statin.  Difficult to keep tele on patient no however no evidence of AFib and wife not wanting ZIO patch on discharge. Echo obtained with EF 45% with mildly dilated left ventricle and dyssynchronous septal wall motion.   Plan for follow-up with memory Clinic neurologist and stroke clinic. He initially remained in bed in hospital. ON working with physical therapy was able to stand. The following morning patient was up and ambulating setting off bed alarm frequently PT. Decreased agitation with spouse present. Her goal was to keep patient at home as long as possible however was unclear if he would be able to return home. On leaving patient rapidly escalated was placed in a posey bed for safety and needing to remain in isolation for covid. Spouse aware of distress and wanting to return home with patient providing 24/7 care with home care giver. Working towards memory placement resources given information for bridging older adults program for additional assistance.
I was observed for 15 minutes in the pharmacy. I was fine. On drive home, I began to feel a "wave" come over my face as though I was being Novocained.  Once home, it persisted, face, nose, lips, tongue all felt numb. I could move face, brows, lips. I did not notice swelling. The numbness lingered for about 4 hours and the numbness around lips and mouth lingered into the next day.  I assumed it may just be an allergic reaction so I kept diphenhydramine handy but never used it.
Started with feverish and achy body in afternoon, then in evening for next 8 days I had severe and debilitating stabbing pains in the side on the left side of my head
7 days after first vaccine I developed a large lump at the injection site.  3" x 3"
This spontaneous report as received from a physician refers to a 11 year old male patient. On an unknown date the patient was vaccinated with a dose of GARDASIL 9, intramuscularly. On an unknown date the patient experienced recurrent nose bleeding after being administered GARDASIL 9. It was not reported which number shot was administered in the series. The physician had lab values from days preceding nosebleeds and platelet count looked good (dates and labs were unspecified). The patient contacted doctors' office to seek unspecified medical attention. The outcome of recurrent nose bleeding and the causality between recurrent nose bleeding and GARDASIL 9 were not reported. Additional information has been requested.
burning sensation in my flank area of left back, extending  from the spine. I couldn't wear clothing because it was unbearable, It lasted until Monday. I texted my friend that is a Dr and he recommended to wait it out. I still get brief sensations but I am more or less over it