chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In August, I started getting headaches and fatigue; I had disorientation and dizziness. Just feeling a little disassociation. I went to the doctor, and they found that my B12 had gone all the way down. I am doing B12 injections now for that - I was going to do them once a week at most but I am having to do them every four to six days. I am going to see a specialist - a Gastroenterologist today about it. To see why I'm not absorbing B12. If he doesn't know, I'll need to see a Hematologist. Right after the vaccine, I had a sore arm and a fever, headache, chills and was tired. This was just for a couple of days. In May, I had an ear infection. I had antibiotics for that. That resolved with the antibiotics. Just a visual exam for that.
Hives began overnight 5/20 -> 5/21 and worsened over the course of 5/21. Also had fever up to 102.
expired dose was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number H4h53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 2nd February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 2-Feb-2023 Reporter's comment: The reporter declined follow-up and providing additional information. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
pt recvd vax 18NOV94 & 21NOV pt c/o weakness, SOB, difficulty swallow; seen in ER w/numbness, neuralgia-c/o stumbling & falling; 30NOV progressive weakness, GBS; 1DEC intubation;
Information has been received from a registered nurse concerning a 65 year old retired female patient (previously reported as 80 year old female non smoker, with emphysema (since Birth), COPD, hypercholesterolemia, dermatitis (2004), sleep apnoea (1980) and Bi pap, asthma (since birth), lipids high (2001), gastroesophageal reflux disease (2001), diverticulitis (2001), hypertension (2001), arthritis (2001), hypoglycemia (2001), astrocytoma and resection with left eye dominant (1947), strabismus secondary to astrocytoma (1947), unilateral carpal tunnel syndrome (1990), osteoporosis (1990), adenotonsillectomy (1944), cystocele and rectocele repair with hysterectomy (1997), right shoulder operation (1998), arthroscopy left knee (2001), foot operation (2000) and drug hypersensitivity and a history of stress test (2002) and allergies to dobutamine, Sumatriptan succinate (Imitrex), morphine, clarithromycin (Biaxin), ketorolac tromethamine (Toradol), Poly DM, and who is caffeine sensitive and had metal clips in her brain and there fore cannot have an MRI. On Dec 09 2004 the patient was vaccinated IM into the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 650082/0691P). It was reported that there was no illness at the time of vaccination. Several days later the patient developed redness and itching at the injection site. The patients symptoms are resolving, the patient sought unspecified medical attention. No further information was available. Follow up information has been received from a physician indication that the patient was seen in the emergency room on Dec 12 2004 for right upper arm swelling, redness and tenderness to the touch distal to the site of the shot which reportedly started on Dec 10 2004. Her blood pressure was 127/69, pulse 77 and temperature 97.7. Upon exam the patient was alert and in no distress. Her right upper arm had moderate erythema and no warmth. She ws diagnosed with cellulites of the right upper arm. She was discharged from the emergency room on cephalexin (Keflex and was told to follow up with her doctor in 2-3 days. Recovery status was not reported. Additional information has been requested.
pt recv vax 6/7/99 & devel h/a & itching all over body w/hives;took dimetapp & cold shower & felt better;
This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant therapies were not provided. On an unknown date, the patient was inadvertently administered a dose of VARIVAX (strength, dose number, route, lot # and expiration date were not reported), instead of ZOSTAVAX (wrong drug administered) and no adverse effects were reported. No product quality complaint (PQC) was involved in this report. Additional information has been requested.
One month later, detected malignant neoplasm of left breast in mammogram, confirmed by biopsy to be invasive ductal carcinoma, grade 3, diagnosed 06/29/2021.
Patient hospitalized 9/13/21, diagnosed with COVID19 9/14/21, deceased 9/25/21
Incorrect product storage; No additional adverse effect reported for all patients; Information has been received from a medical assistant, concerning a patient (gender and age were not provided). The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 02-JUL-2020, the patient received a dose of Hepatitis A Vaccine, Inactivated (VAQTA), (Lot # S032358, expiration date on 11-JAN-2021), intramuscularly, that was inappropriately stored. The vaccine underwent multiple excursions below 36 grades Centigrade for 75 hours. No previous temperature excursion was reported. The information was obtained because of a data logger.   No additional adverse effect was reported.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA003648: US-009507513-2007USA002536: US-009507513-2007USA003650: US-009507513-2007USA003647: US-009507513-2007USA003651: US-009507513-2007USA003645: US-009507513-2007USA003646: US-009507513-2007USA003005: US-009507513-2007USA002514:
pt. c/o pain and "drawing up" sensation of RLE. Began 11/04/06. Pt. received an injection of menactra and HIB vaccines on 11/03/06 pt. preparing for spleenectomy surgery. 11/8/06-records received. PMH: abnormal liver enzymes-asymptomatic HTn GERD Lupus ITP DTD Osteoporosis
Fatigue same afternoon as injection, fatigue and moderate diarrhea lasting four days after.
Since the fourth of September I began to feel heat inside, but hen I felt a very strong throbbing inside especially in my back, and it made it hard to breath. I had diarrhea, nausea and chills. Every time I went to sleep I felt like a punch inside me that did not allow me to sleep. There was a time when I felt I needed air and lost consciousness for an instant, it was a sensation I have never experienced. I still need to second dose and it terrifies me because I don't know if the side effects will be worse. I went to the emergency room because I felt like I was going to die. They told me it was the vaccine. I am hypertensive and my pressure increased because I can identify when it gets high. They did a urine and blood study at the hospital. Thank God everything went well.
hurting/ a lot of pain.; extremely tired, slept twelve hours; big red mark on stomach; two weeks later woke up early to right hand has huge jelly fish lump on top; extremely tired, slept twelve hours; COVID arm; woke up with golf ball red hard raised lump in perfect circle; tongue felt a little enlarged in the back; started getting rash on right arm; 15 minutes later tremendous heat; face was very red/, redness/top of hand /went from red to purple; weird sensation/ tongue feels weird; throat feels strange; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (15 minutes later tremendous heat), RASH (started getting rash on right arm), ERYTHEMA (face was very red/, redness/top of hand /went from red to purple), PARAESTHESIA ORAL (weird sensation/ tongue feels weird) and OROPHARYNGEAL DISCOMFORT (throat feels strange) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced FEELING HOT (15 minutes later tremendous heat), RASH (started getting rash on right arm), ERYTHEMA (face was very red/, redness/top of hand /went from red to purple), PARAESTHESIA ORAL (weird sensation/ tongue feels weird), OROPHARYNGEAL DISCOMFORT (throat feels strange) and SWOLLEN TONGUE (tongue felt a little enlarged in the back). On 27-Mar-2021, the patient experienced SKIN SWELLING (woke up with golf ball red hard raised lump in perfect circle). On 29-Mar-2021, the patient experienced HYPERSENSITIVITY (COVID arm). On an unknown date, the patient experienced PAIN (hurting/ a lot of pain.), HYPERSOMNIA (extremely tired, slept twelve hours), ERYTHEMA (big red mark on stomach), INDURATION (two weeks later woke up early to right hand has huge jelly fish lump on top) and FATIGUE (extremely tired, slept twelve hours). At the time of the report, FEELING HOT (15 minutes later tremendous heat), RASH (started getting rash on right arm), ERYTHEMA (face was very red/, redness/top of hand /went from red to purple), PARAESTHESIA ORAL (weird sensation/ tongue feels weird), OROPHARYNGEAL DISCOMFORT (throat feels strange), SKIN SWELLING (woke up with golf ball red hard raised lump in perfect circle), HYPERSENSITIVITY (COVID arm), PAIN (hurting/ a lot of pain.), HYPERSOMNIA (extremely tired, slept twelve hours), ERYTHEMA (big red mark on stomach), INDURATION (two weeks later woke up early to right hand has huge jelly fish lump on top), SWOLLEN TONGUE (tongue felt a little enlarged in the back) and FATIGUE (extremely tired, slept twelve hours) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include  two blood pressure medications. Doctor suggested an anti- histamine but the consumer didn't take them.
Information has been received from a certified medical assistant referring to a patient of unknown age and gender. On 25-FEB-2016 the patient was vaccinated with an expired dose of VAQTA (dose not provided; lot # L001627 and expiration date: 11-NOV-2015) intramuscularly. No known adverse effects were reported. Additional information has been requested.
I went to the emergency room on the 27th. i was cardio fibrillated on the 25th, heart complications. and pulmonary edema, I lost 15lb of fluid.  I went to Afib.  I was discharged on march the 1st. I gave Lasix and it made me lose a lot of water.
Local tenderness 24 h after vaccine-mild, without any warmth, redness, or objective visual/tactile signs( tenderness persists through today - day 14-very mild) .  Day 4-5-diarrhea x1, day 11 noted macular erythema, warmth in the area that  had been mildly sore. That evening became pruritic-mild. Margins of redness marked, no progression,   Erythema today (day 14) is fainter,   may just be a temporal relationship-I've noted an increase in 1st metacarpal tenderness since the vaccine
9.5cm X 8.5cm area, swollen/red. Possible cellulitis.
Singleton pregnancy, first pregnancy, no history of miscarriage or stillbirth. Vaccine administered at 34 weeks gestation. Evening following vaccination I developed fever, chills, body aches, lethargy, decreased fetal movement requiring hospital evaluation. Upon evaluation, baby did not meet all criteria for fully healthy biophysical profile. The following day, I required hospital evaluation again for preterm labor as evidenced by dilation, funneling, effacement, bleeding and contractions. Labor unable to be slowed or stopped, baby delivered vaginally at 35 weeks gestation, weight 3 lbs 15 oz , initial APGAR 2, and required 1 0 days in NICU.  I developed mild postpartum pre-eclampsia with no history of high blood pressure.
had to be helicoptered to a medical facility for a massive heart attack after taking the vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1, manufacturer unknown), for Covid-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant), outcome "unknown", described as "had to be helicoptered to a medical facility for a massive heart attack after taking the vaccine.".  Clinical course: The patient had to be helicoptered to a medical facility for a massive heart attack after taking the vaccine. The patient had Covid-19 vaccine and was only alive because a helicopter took him to a hospital 200 miles away. He had a massive heart attack. He got second shot, the patient doesn't know but which vaccine and NDC/LOT/Expiration does not know.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
a hard lump formed off the side of the site of the Injection in the left arm; ago a hard lump formed; redness right after the injection; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 249DB, expiry date 20th November 2020) for prophylaxis.   On 24th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 24th December 2019, immediately after receiving Shingrix, the patient experienced erythema. On an unknown date, the patient experienced mass and induration. On an unknown date, the outcome of the erythema was recovered/resolved and the outcome of the mass and induration were unknown.   It was unknown if the reporter considered the erythema, mass and induration to be related to Shingrix.  Additional details were provided as follows: The patient had a reaction to Shingrix complained redness right after the injection which resolved. However, 4 to 5 days ago a hard lump formed in the arm bigger than a marble but smaller that a pingpong ball. The lump was movable, no current redness and warmth, and it was off to the side of the site of the injection in the left arm. The reporter consented to follow up.
Had patient seated and was observing patient after vaccination. Patient was pale and clammy-asked for wash cloth and then fainted. Caught patient as he fainted. Patient was disoriented for a couple minutes. Applied cool package on back of neck and observed patient for 15 minutes. Patient denied any further care and was walked out to vehicle. Instructed patient's mother to notify me of any other reactions. No reports.
Patient was given DTaP vaccine. Patient should have received the Tdap vaccine because he is 8 years old. No adverse side effects reported.
As per patient an hour later after she got the shot, she started feeling really tired and went to bed. She was not able to get up till 12pm to 1pm next afternoon.  When she woke up she felt chalky feeling in her mouth and spat up blood couple of times. When patient called pharmacy was advised to call PCP. On the follow up call patient informed that doctor advised her to go in if she had those symptoms again. As per patient she didn't have those symptoms again so didn't need to go in. Apart from this, patient had more expected side-effects such as backache, local site pain, and tiredness. On the follow up call patient mentioned that she's feeling lot better and doesn't have any side-effects at the moment.
Within 10 minutes I was nauseous and light headed. Within 1 hour I had a super bad band headed around my head at temple level and I was starting to feel out of it. I also had a slightly elivated temperature.  Within 3 hours I could no longer function at work and had to go home.  I was very confused and cloudy feeling. I couldn't understand simple questions.  I had a really bad headache. I have very high tolerance for headaches and this was really bad.  I was exhausted and very weak. My thighs  were the weakest. I had to use a cane when I had to go to the doctor.  No appetite.  My body felt like it was encased in concrete.  Every inch of my body hurt.  I barely got of of bed for 5 days. I was out of work for a week and a half and even after I went back I wasn't able to work a full day. It wasn't until day 15 that the weakness in my thighs was almost gone. Although I still have moments where they give out of me.   So basically all the stuff they tell you may happen but dialed up to the point it put me totally out of commission for 2 weeks.    This is day 19 and I'm still not 100% back to normal. I am beyond scared to get my 2nd shot.
Lack of Response- Information has been received from a health care professional concerning an approximately 40 year old pregnant female who is approximately 1990 was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Subsequently the patient was negative on titer.  Follow up was received which indicated the reporter did not fell as if this case was and adverse event.  additional information has been requested.
immed upon completion of vax local swelling @ site of vax on the lt deltoid;w/in 3-4min RN gave epi;vital signs were taken BP 188/94, pulse 88;vitals repeated in 5min BP 200/100, pulse 84;911 called;02 via nasal cannula;
On March 25 and received a first dose of the Shingrix vaccine.  In addition to a strong local reaction, I also experienced fatigue, severe headache and muscle pain for the following 3 days.  On March 28 I began to feel better, but I developed severe itching in several locations around my abdomen and hip, on the right side, around the elastic bands of my underwear.  In two of these locations, I developed a  rash consisting of a few small, raised bumps.  Over the next 3 days, the rash developed small fluid-filled blisters.  By April 3rd, the blisters have subsided and have been replaced with small scabs. Redness and itching persists, although the itch is now less severe and starting to subside.  I am otherwise feeling alright, although my energy level has not fully returned and I also have a couple of areas of intense itching that did not develop into visible lesions. I am reporting this adverse reaction because mild shingles is not listed as a possible adverse reaction of the Shringrix vaccine.
3hr p/vax pt had a rectal temp of 40 & then a febrile sz;pt was brought to ER & subsequently adm for observation;
bubble on the skin and then bleeding upon removal of the needle; wrong technique in product usage process; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, immediately after receiving Shingrix, the patient experienced injection site hemorrhage and wrong technique in product usage process. On an unknown date, the outcome of the injection site hemorrhage and wrong technique in product usage process were unknown.   The reporter considered the injection site hemorrhage to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient upon injection into the arm there was a lot of pressure behind the syringe and then after injected in the arm, it caused kind of bubble on the skin and then bleeding upon removal of the needle, which led to wrong technique in product usage process. The pharmacist stated that was sure the injection was intramuscularly. The reporter consented to follow up. This case linked with US2020140254, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020140254:same reporter
Initial report received on 19 July 2007 from a consumer, who is the patient's parents. A  17 year old male patient, with no medical history, received Menactra (lot# unknown) (route/site of administration were unknown) on 01 May 2007. Immediately after vaccination, the patient had passed out. Approximately in June 2007, ("approximately 3 weeks ago") the patient experienced headache and lightheadedness that had been increasing with time. The patient had been evaluated by a physician and was hospitalized for approximately 4 days, however no diagnosis was made. MRI and CT scans were negative. No other vaccines were given at the same time. The patient had no illnesses at vaccination time and was not on any medications. Treatment was not reported. Prior exposure to Menactra was not reported. The patient had not recovered at the time of the report.  08/03/2007 Received patient name from CDC., VAERS database updated w/same. 8/7/07 Received vax records & VAERS database updated w/same. 8/31/07 Reviewed hospital ER records of 7/2/07 which reveal patient experienced dizziness & HA x 3 days.  C/O intermittent lightheadedness, periods of overwhelming fatigue w/tingling/numbness of finger tips since vax 5/1/07.  Tx w/oral antibiotics & d/c to home. FINAL DX: none provided. 10/5/07 Neurologist office does not have any records for this patient. Case closed & will reopen should additional information become available.
Day after injection had arm soreness, injection site redness and swelling, headache and chills
435PM palms of hands, red blotchy color, swelling of hands, sl itching, feeling of tightness of hands;no temp;5PM given DPH prescribed PDH;
Flu like symptoms; Sore throat; Runny nose; Cough; Cold; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), COUGH (Cough) and NASOPHARYNGITIS (Cold) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and NASOPHARYNGITIS (Cold). 13-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and COUGH (Cough). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), COUGH (Cough) and NASOPHARYNGITIS (Cold) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.