chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax; ant. font very small; gained only 1/2 pounds; jerking; v; would not arouse; could not hold head up; sz; slow growth; congenital defect; poor body control;
Information has been received form a pharmacy tech concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 665903/1427Y) from a multi dose vial. After vaccination the patient had red swollen feverish injection site reactions with temperatures to 103 degrees F and feeling achy. The patient was treated with antibiotics (unspecified). At the time of the report the patient's outcome as unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 665903/1427Y were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
THE PATIENT WAS FAINTING WITH HER EYES ROLLING BACK IN HER HEAD. WE AWOKE HER - MADE HER ALERT AND GAVE HER WATER AT FIRST. SHE THEN SAID SHE WANTED A SODA. SHE STARTED GOING OUT AGAIN, AND  GOT A SODA AND SHE DRANK THAT. SHE HAS HAD A HISTORY OF FAINTING AT SIGHT OF NEEDLES. SHE RESTED AND AFTER ABOUT 15 MINUTES LEFT THE STORE.
Redness and inflammation localized to left arm around injectilon site 8 days after vaccine administered. 10x6inch area of swelling and redness.
A report was received from a consumer on 11/17/03 whom is a 92 year old female vaccinee who developed severe flu like symptoms after receiving influenza vaccine on an unknown date in 2002. On an unspecified date in 2002, the patient developed severe flu like symptoms consisting of fevers, decreased appetite, tiredness, and body aches. At the time of the report the consumer did not know when these symptoms began relative to administration of the influenza vaccine however the vaccinees symptoms lasted approximately 2 weeks. The vaccinee had a similar experience 14 years ago following administration of influenza vaccine. Follow up pending.
Patient was given the Janssen (Covid-19) Vaccine. While he was in the Post Vaccine area after getting the vaccine he became nauseous and vomited. He began to sweat and said he needed to use the bathroom (bowel movement). He was given water and observed for a while. Then we went to the bathroom. Upon returning he said he felt a lot better. He was observed for a few more minutes and allowed to go home.
Vaccination failure; shingles; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 5TH3L, expiry date 30th November 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 5TH3L, expiry date 30th November 2021) for prophylaxis.   On 26th February 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 12th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 27th October 2019, 243 days after receiving Shingrix and 76 days 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 details were provided as follows: The case was reported by the pharmacy intern. The patient received both doses of Shingrix on left deltoid. The reporter consented for follow up.
Throat swelling; pain in whole body; Ever since i got vacited im feelin high fever; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Throat swelling), MYALGIA (pain in whole body) and PYREXIA (Ever since i got vacited im feelin high fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (Throat swelling), MYALGIA (pain in whole body) and PYREXIA (Ever since i got vacited im feelin high fever). At the time of the report, PHARYNGEAL SWELLING (Throat swelling), MYALGIA (pain in whole body) and PYREXIA (Ever since i got vacited im feelin high fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  It was reported that the patient already had consulted physician and he gave some medicines. After using those medicines it was better for sometime but again the patient was feeling same side effects.  Treatment information was not provided.
Received Spikevax on 11/21/23 that was not expired but was past the BUD  of 11/19/23
Woke up 07/11/09 Swelling & cellulitis from left elbow up to his neck including entire upper arm - with multiple blisters at injection site seen 7/11/09 Rx KEFLEX, PEDIAPRED and PO BENADRYL.
Itchiness for 2 weeks at site of vaccination. Made popping noise as well (has improved). Injection site pain that has lasted since 2/4/21 involved shooting pain down (has since improved) - this has improved but still recurs when arm is lifted past 90 degrees or tucking in shirt behind back (stiffness and tenderness when this occurs).
pt was one of two pt who recv vax & had a localized rxn - 2" x 2" area redness & swelling;
Starting feeling very sick and weak. Extreme muscle soreness. Could not lift left arm for several days. Lost control of bowels, involuntary defecated. This symptoms mostly resolved in a little over a week. A few days to a week after the shot is when I started to extreme intense chest pain. Felt like my heart was going to burst inside of my chest. That chest pain lessened in severity after about 1.5 months but continues to this day.
In June of 2022 I began having trouble with constipation.  I went to the hospital and was seen in the ER.  They gave me MiraLAX.  I did not get better.  I had not had a bowel movement for about three weeks.  I went to the ER in July.  They told me to take MiraLAX and I would be fine.  I did not get better.  I went to the hospital in August and was admitted.  I had an MRI and X-Rays, and an impaction was found that was the size of a baseball that was blocking my rectum.  I had several enemas and Golightly (gallon jug of liquid laxative) and was finally able to have a bowel movement.
p/vax pt exp a 2inch swelling & erythema @ the inj site;pt seen by MD & dx w/cellulitis;cellulitis enlarged to 4 inches;tx w/erythromycin;reporter expressed concern w/specific lot of vax;pt recovered from exp
itching on neck line; burning on neck line, starting to burn like a sunburn; burned a little during administration; This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received the 1st dose of Shingrix (intramuscular). In November 2022, immediately after receiving Shingrix, the patient experienced injection site burning. On an unknown date, the patient experienced pruritus and burning sensation. On an unknown date, the outcome of the injection site burning was recovered/resolved and the outcome of the pruritus and burning sensation were not recovered/not resolved.   The reporter considered the injection site burning, pruritus and burning sensation to be related to Shingrix.  Additional Information: GSK Receipt Date: 08-DEC-202 Reporter's Comment: The reporter was the patient.  She did not have email.  She had Shingrix about 2-3 weeks ago.  She did not know the exact date.  She did not have the lot number.  It was given in her left arm (deltoid).  It burned a little during administration.  It was administered at a pharmacy.  She had itching and burning on her neck line.  She said it was starting to burn like a sunburn but there was no rash and it was not red. (She was concerned that the itching and burning might be a case of shingles).  She had not seen a doctor about this yet.  She currently did not have a primary care physician.  The reporter did not consent to follow-up.
pt devel pain, erythema & some induration & inj w/some ?lymphedema axilla & c/o feeling flushed over face & chest all day 4MAR98;pt stated sx resolving;
Atrial fibrillation with tachycardic ventricular rate - Initially was started on on diltiazem infusion.  Consulted cardiology service.  Already anticoagulated with apixaban. Initially was on amiodarone drip but has been changed to sotalol now for rhythm control, started on metoprolol and stopped his Cozaar and holding Lasix now Goal is rate and rhythm control and maintained on anticoagulation Electrolytes including hypokalemia and hypomagnesemia has been repleted Continue to appreciate cardiology follow-up is appreciated, TSH is normal S/p Successful attempt at cardioversion of atrial flutter to normal sinus rhythm  ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Pt reports getting varicella vaccine and noticed earlier that night she developed a red bump that was red, hot and swollen. Symptoms worsened on 1/14/23 and developed low-grade fever on 1/15/23
Developed baseball sized area of redness and very firm swelling, muscle aches, fatigue,  low grade fever (~100 deg F), chills within 24 hrs of receiving the vaccine.  I did take a picture of the redness if needed.
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling on his left arm the length of an egg) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure abnormal. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swelling on his left arm the length of an egg). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Swelling arm, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling on his left arm the length of an egg) had resolved.    Concomitant medication included blood thinner medication and blood pressure medication. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received updated event outcome.
The patient had no adverse effects, the vaccine was administered before the requested age. The patient had no adverse effects to the vaccine. The patient visited the clinic one week after the vaccine was administered.
Started out with waking the next day a fullness in her head, but kind of a headache, and very tired.  Then a couple of hours later she got a severe case of the chills.  She laid down and slept on and off for about 5 hours.  When she got up she took her temperature and it was 101.  She also had body aches in her back and her legs felt very heavy.  She then noticed a rash on her body from a line that went underneath her breast, and redness on the left side of her breast to her belly button, all red around the belly button.   When she realized she had a fever she took Tylenol.  The rash by Saturday was fading and she also had diarrhea on Saturday, persistent diarrhea.  She felt almost normal except that she was tired.  Today, 3/1/21 she has the returned diarrhea, doesn't k now if it was related to the vaccine.  She spoke to a nurse yesterday, and she told that she had a typical side effect from the vaccine.  She was not sure if the diarrhea was from the vaccine.
immediately felt dizzy and lightheaded and talked about blurred vison similar to when she has a MS attack when her body is stressed.  She drank 2 boxes of juice and felt better and went home
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: el3247), on 10Feb2021 as dose 2, single (Lot number: en6201), on 03Oct2021 as dose 3 (booster), single (Lot number: ff2589) and on 23May2022 as dose 4 (booster), single (Lot number: fp4554) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "celica disease" (unspecified if ongoing); "hypothyriod" (unspecified if ongoing); "penicllium" (unspecified if ongoing); "metals" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Neomycin, reaction(s): "Known allergies: neomycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (06Oct2022) Positive, notes: Covid rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2weeks was reported as no. Patient received Paxlovid treatment from 27Sep2022 to 02Oct2022 for Covid-19.
No adverse affects reported; Improper storage of vaccine; This spontaneous report was received from a certified medical assistant (CMA) referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 26-MAY-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (therapy type: Digital Data Logger) (GARDASIL 9) (lot # 1621931, expiration date reported as 26-JAN-2022, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to a temperature of 30.2 Fahrenheit (F) for 1 hour as recorded by a data logger. The vaccine had no previous temperature excursion. No adverse effects reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity:; manufacturerstate: ; manufacturercountry: ; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; 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
febrile rxn, some resp distress, blue lips & hands-shaky;few min 1-2hr p/vax was given;APAP only;
Initial and follow-up information has been received from a physician and a 27 year old female with hypertension, 2 prior pregnancies with 1 full term delivery via cesarean section and 1 miscarriage who on 09-MAR-2007 was vaccinated with the first dose of Gardasil (lot# 655619/1427F). Concomitant therapy included labetaolol HCl. Subsequently, the patient became pregnant within 2 weeks after Gardasil (LMP 07-MAR-2007; EDD 14-DEC-2007). On 01-MAY-2007, an ultrasound revealed a viable pregnancy. The patient was placed on pre-natal vitamins and hydromadinone. On an unspecified date the patient experienced intra-uterine growth retardation (IUGR) and a non reassuring tracing. On 10-OCT-2007, thirty weeks from the last menstrual period (LMP) the patient delivered a normal 1 pound 12 oz premature female. The labor and delivery were uncomplicated. The apgar scores were 5 and 5. At the time of the report the patient had recovered. The infant's outcome was unknown. Additional information is not expected.
This spontaneous report as received from a pharmacist refers to a 68 year old male patient with no medical history, concurrent condition and no drug allergies. On 15-DEC-2014 the patient was vaccinated with a dose of ZOSTAVAX (vial, dose: 0.65 ml, subcutaneous, lot number: K011224, expiration date: 30-NOV-2014). On 17-DEC-2014 the patient experienced an intensely painful, blistered rash on his foot. The patient sought medical attention (saw a physician/podiatrist). There was a treatment given for adverse event. The physician prescribed the patient antiviral medication. The outcome of an intensely painful, blistered rash on his foot was reported as not recovered. The relatedness between ZOSTAVAX and an intensely painful, blistered rash on his foot was not reported. Additional information has been requested.
Appendicitis symptoms started 10/01/2022.  Diagnosed and appendectomy on 10/03/2022.
06may90 pt vax hepta B. pt became itchy at inject site. pt devel rash on arm near inject site. 10may90 pt had generalized rash. seen by md treated w/ antihistamines. lab done.
I have little to no side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I have little to no side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION COMPLICATION (I have little to no side effects). At the time of the report, VACCINATION COMPLICATION (I have little to no side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Patient waiting about 30 mins after vaccination reported shortness of breath and wheezing.  Team applied O2 and administered EPI Pen to Left Thigh and transported to the ED in stable condition
swollen glands on left side of neck, one gland hurt the others didn't. burning/aching pain sensation in both hips down legs, lower neck and lower back areas. Both eye pressure/tired feeling, head pressure/pain when coughing, throat feeling dry. Entire body rash with some raised bumps and some itch randomly. Reactions noticed eight days after injection and continuing with new reactions every few days and currently almost 14 days in on 7/15/2019. Hoping will end soon! Have gone to clinic: benadryl
Moderna 1st dose given to person under 18 years of age. Per documentation appointment scheduled 3/06/21 at 11:10am, Lot #011A21A.
01/13/16 after injection pt reported feeling nauseous and very warm. Pt instructed to lie down - gave pretzel and H20. Pt left office feeling back to normal within 1/2 hr. Pt returned to office 2 days later for PPD read. Injection site of TRUMENBA erythematous, tender. Pt reports pain and difficulty raising her arm for the 24 hours post injection.
Symptoms started with fever. Exhaustion and shortness of breath continues now. I have since been diagnosed with an autoimmune disorder and am on at least 5 new medications , iron deficiency anemia for which I have to have iron infusions, and autonomic hypotension.
Tinnitus and confusion for 1 month after second dose.  Waxes and wanes but does not go away.  Lichen planus, 5 months after vaccine, atypical presentation on abdomen.  Biopsy by dermatologist confirmed.  Treating flare up with medication.
Swollen lip; Lip Soreness; Body Ache; Really Tired; chills; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen lip), LIP PAIN (Lip Soreness), MYALGIA (Body Ache), FATIGUE (Really Tired) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route)  2 dosage form. On 08-Apr-2021, the patient experienced LIP SWELLING (Swollen lip), LIP PAIN (Lip Soreness), MYALGIA (Body Ache), FATIGUE (Really Tired) and CHILLS (chills). At the time of the report, LIP SWELLING (Swollen lip), LIP PAIN (Lip Soreness), MYALGIA (Body Ache), FATIGUE (Really Tired) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pain in arm, tiredness, nontypical emotional feelings of anxiety (I do not have any history of anxiety). Anxiety comes as odd twinges and come on abruptly and then are gone after a few minutes. Never had anything like this in my entire life.
I experienced symptoms of Colitis or diverticulitis that I never had before. The doctor's or test couldn't confirm which of either diagnosis.  I now have to take Muralax everyday.
Itchy throat and dizziness 10 minutes after receiving the vaccine. Patient given one tablet of 25mg Benadryl and said she was feeling fine afterwards
Guillain-Barre syndrome, started 2/14/17 with back pain, progressed to hospital admission and rehabilitation stay. Was in hospital for several weeks, admitted to ICU, intubated. Developed pulmonary embolus due to immobility. Initially walking with walker, neuropathic pain. Improving walking, still with pain, though improving. Tracheostomy site healed.
I received, the third booster shot 2 days ago; I received, the third booster shot 2 days ago; I am having some swelling underneath my arm pit area; It's just swollen underneath my arm pit; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-years-old female patient received bnt162b2 (BNT162B2, formulation: solution for injection, lot number:SC3181, expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 18Aug2021 (age at vaccination 63 years) as dose 3 booster, single for covid-19 immunization.  Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included nifedipine (NIFEDIPINE) 30 mg orally, twice a day taken for hypertension, start and stop date were not reported. Patient had first dose of bnt162b2 (BNT162B2, formulation: solution for injection, lot number: EL9262, expiration date: not reported), via an unspecified route of administration, administered in Arm right on 18Jan2021 single for covid-19 immunization. Patient had second dose of bnt162b2 (BNT162B2, formulation: solution for injection, lot number: EL9266, expiration date: not reported), via an unspecified route of administration, administered in Arm right on 23Feb2021 single for covid-19 immunization. Patient did not have prior vaccination within 4 weeks. On an unspecified date in Aug2021, the patient mentioned "i am having some swelling underneath my arm pit area, it's just swollen underneath my arm pit, i received, the third booster shot 2 days ago".  The patient underwent lab tests and procedures which included blood test: had the antibody on 2021. Patient did not have any treatment for the events. Clinical outcome of the events was reported as not recovered for am having some swelling underneath my arm pit area, it's just swollen underneath my arm pit and unknown for rest events.  Follow-up attempts are completed. No further information is expected.