chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 15-month-old male with a history of jaundice at birth, who on 24-JAN-2007 was vaccinated with a 0.5ml dose of ProQuad (lot #656160/1396F, expiration date 16-MAY-2008). Concomitant vaccinations included: Prevnar (lot #B08639A), Tripedia (lot # C2552AA) and Comvax (lot reported as 653660/0257F). Subsequently, on 11-FEB-2007 the patient experienced a mental state change and was hospitalized. The patient underwent a CT scan that was non conclusive at the time of this report. It was reported that the patient experienced unexpected rapid deterioration and died on 12-FBE-2007. An autopsy was performed, however, results were not yet available. The cause of death was unknown at the time of this report. The patients adverse experiences were considered to be life threatening and disabling. Additional information has been requested.  4/24/07 Received medical records from PCP which reveal patient experienced good health on day of vax.  Later on day of vax developed swollen left leg & patient had difficulty walking that day.  Next day was resolved when seen by PCP. Dx suspected Prevnar reaction.  On 1/26 seen in ER for abdominal distention, vomiting & diarrhea.  ER dx w/ileus.  Seen by PCP 1/27 & dx w/resolving ileus secondary to acute gastroenteritis.  Next note is of t/c from parent that patient deceased on 2/12/07.  PCP requested autopsy report on 2/28/07.  Vax record included w/med records from PCP. 4/24/07 PCP also forwarded med records from 2/12/07 hospitalization which reveal patient experienced altered mental status, fussiness, congestion, swollen face, increased sleepiness & pallor.  Patient had been seen at outying Urgent Care center then transported to outlying ER via ambulance for fever, wheezes & respiratory difficulty w/a single apneic period reported.  Child then transported to another hospital for PICU higher level of care. On admit there, very lethargic, pale, crying & opening eyes intermittently.  There was crusty nares, inspiratory wheezing & crackles & coarse breath sounds, no neck rigidity, hypotonia.  Started on antibiotics & LP obtained. Seizures were noted in PICU & loaded w/dilantin.  Emergently intubated following AM for dilated pupils, responsiveness to deep pain w/decerebrate posturing & respiratory difficulty.  Treated w/high dose steroids for possible ADEM.  Condition deteriorated over the day, patient declared brain dead & deceased. ER DX: meningitis vs encephalitis.  PICU Dx: brain stem dysfunction. 10/2/07 Reviewed Autopsy Report which revals COD as undetermined & manner of death as undetermined.
patient had fever, flu like symptoms 2 days after he got pfizer vaccine. took tylenol,
Vaccine remained in the freezer past the recommended guidelines (14 days). Once discovered, Pfizer was contacted but did not have stability data to support acceptability of the product greater than 31 days in the freezer. All patients that were administered vaccine past 31 days were contacted and given an option to be re-vaccinated based on their doctor'S recommendation or Regulatory Authority.
Information has been received from a Medical Assistant concerning a patient who on 28-JUL-2010 was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck). No adverse effect reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
TESTED POSITIVE FOR COVID 19 AFTER SECOND VACCINE.  Persistent Low Grade Fever, Extreme Fatigue & Weakness
This spontaneous report was received from a medical assistant referring to an 8 week old female patient. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 13-MAY-2017 the patient was vaccinated with her first dose of ROTATEQ orally (strength, lot # and expiration date were not reported) for prophylaxis. Subsequently, on 03-MAY-2017, the patient was vaccinated in error with her second dose of ROTATEQ orally, lot # M038717 and expiration date: 24-APR-2017 (strength, was not reported) for prophylaxis. The reporter stated that the patient had not exhibited any adverse effects. Additional information has been requested.
Next day post vax, the pt developed a fever. He recovered. On 9/4/99, he experienced a feeling of hearing loss as though his right ear was clogged.
after receiving the vaccine the patient reported feeling tight chest, lump in her throat and dizzy.  EMS on site and assesssed patient on spot.
Muscle pain, flu like symptoms, loss of taste and smell, weakness, sweating, shaking
I got pains from shoulder to shoulder; After booster, arm was mildly sore ( less than shots 1 & 2).; injection site began to hurt more; injection site began to hurt more; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 15:15 (Lot number: FG3527) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, COVID 19 Pfizer Dose,, lot number=ER8734,, administration date=05Apr2021,, administration time=12:30, location=Left arm), administration date: 05Apr2021, when the patient was 64 years old, for Covid-19 Immunization; Bnt162b2 (Dose:2, COVID 19, Pfizer,, lot number=EW0172,, administration date=26Apr2021,, administration time=12:00, location=Left arm), administration date: 26Apr2021, when the patient was 64 years old, for Covid-19 Immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 31Oct2021 15:00, outcome "not recovered", described as "I got pains from shoulder to shoulder"; PAIN IN EXTREMITY (non-serious) with onset 31Oct2021 15:00, outcome "not recovered", described as "After booster, arm was mildly sore ( less than shots 1 & 2)."; VACCINATION SITE PAIN (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 31Oct2021 15:00, outcome "not recovered" and all described as "injection site began to hurt more". Therapeutic measures were not taken as a result of arthralgia, pain in extremity, vaccination site pain, condition aggravated.  Additional Information:The patient had no known allergies. The patient had no other vaccine in four weeks and no other medications in two weeks. No treatment was received for adverse events. The patient had no COVID-19 prior to vaccination and post the vaccination was not tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
first my arm was sore and swollen and a rash and grew to the size of a grapefruit and was red. i lasted for about a month and spread through out both arms and to other parts of my body like my legs and torso. i had telehealth appointment with my doctor. i took Benadryl to ease the symptoms for about 3 weeks to a month.
Less than 5 minutes after receiving vaccine the left side of my face went numb (same side as injection) as if I had a lidocaine injection. This lasted about 45 minutes to an hr and then self resolved. No slurred speech or facial drooping evident although I didn't look in a mirror.  Later in evening I experienced  pins/needles in left arm similar to reduced blood circulation.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 9:53 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 9:53 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 24.59 for dose administered on 22-Jun-2021.  Batch number 008C21A underwent temperature excursion on 22-Jun-2021 with temperature 36 degrees Fahrenheit at 08:00 AM. This vial was moved to fridge on 27-May-2021 and beyond use date for the vial was reported as 26-Jun-2021. Product moved to clinic on 22-Jun-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degrees Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No concomitant and treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Vomiting blood; muscle pain; Dizziness; vomiting; stomach pain; lack of immunity; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 13:15 (Lot number: EL9269) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number: EL9269, Dose lot unknown: False, administration time: 14:30, Vaccine location: Left arm, ), administration date: 03Mar2021, when the patient was 31 years old, for Covid-19 immunization. The following information was reported: HAEMATEMESIS (medically significant) with onset 24Mar2021, outcome "not recovered", described as "Vomiting blood"; MYALGIA (non-serious) with onset 24Mar2021, outcome "not recovered", described as "muscle pain"; DIZZINESS (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Dizziness"; VOMITING (non-serious) with onset 24Mar2021, outcome "not recovered", described as "vomiting"; ABDOMINAL PAIN UPPER (non-serious) with onset 24Mar2021, outcome "not recovered", described as "stomach pain"; IMMUNE SYSTEM DISORDER (non-serious) with onset 24Mar2021, outcome "not recovered", described as "lack of immunity". The events "vomiting blood", "muscle pain", "dizziness", "vomiting", "stomach pain" and "lack of immunity" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of haematemesis, myalgia, dizziness, vomiting, abdominal pain upper, immune system disorder. Clinical course: Ever since patient received 2 dose series she had random moments of dizziness, vomiting, stomach pain, a lack of immunity to other vaccines causing me to get sick easier and for longer. Vomiting blood, and muscle pains. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment included medications and follow ups. No other vaccine in four weeks. No other medications in two weeks. The patient had not known allergies. No covid-prior vaccination. Facility type vaccine: Hospital.  No follow-up attempts are possible. No further information is expected.
She got her vaccine, was fine, arm was a little sore last night and put some rubbing alcohol on it, took a hot shower and let the water run on it.  Last night her arm was hurting and it started hurting and took Dayquil as it was for fever, aches and pains.  Then she started having cramps in both of her legs which had been a while since she had them.   She went to bed and woke up around 1:30 with her heart pounding and racing.  She took her BP and it was high at 141/8r5 and her heart rate was 118, she had a temp of 100.7.  She was not able to go back to sleep.  She then tried to go back to bed, and felt better, but her heart was still racing.  She saw her PCP and did have an EKG and looked fine and said that it was probably from the vaccine.  Her heart was still racing.  She was told to take her anxiety medicine and lay down and rest.   Her BS was 172, and it has been low for a long time.    The other vaccines she had a fever for a day, a little arm pain or soreness for a little while and that was it.
Information has been received from a physician concerning a 16 year old female who on approximately 31-DEC-2007 was vaccinated with the first dose of Gardasil and experienced a stroke. The patient was admitted to the hospital where she remained for 3 weeks. The patient experienced an unspecified partial paralysis. After 3 weeks, the patient was discharged and could walk with the assistance of a walker. As of 04-FEB-2008, the patient was recovering. The physician felt that the stroke and partial paralysis were disabling. No further information is available.
Pt received 2nd Moderna COVID-19 Vaccine on Friday 9/10/21 and had no issues until she noted on Saturday evening (9/11/21) that her arm started to swell up in 2 areas and was quite red. On Sunday she noted that arm was about the same but thought the redness was spreading. She took some OTC allergy relief pills, acetaminophen, and ibuprofen. Pt reports today (Tuesday 9/14/21) the swelling has improved but there is still some redness and warmth to the area.
red rash w/blisters on lower leg;some swellig & tightness;it appears to be almost gone, now;did not go to MD;
Slight lip swelling sensation, scratchy throat, her skin felt itchy (no visible hives).
pt recv vax 28FEB96 & 5SEP97 pt devel a mild case 20-30 lesions of chickenpox;
Case number PHEH2014US021421 is an initial spontaneous report received from a consumer on 23 Oct 2014. This report refers to an 83 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date. It was reported that she experienced redness from elbow to armpit and soreness in upper arm to shoulder. The event outcome was reported as resolved. The seriousness and causality were not reported.
18FEB90 sore first 3-4days; Swelling, fever & tingling in fingers; To MD pt not to take any more tetanus shots;
diarrhea; arm very painful; felt herself miserable; felt tired at night; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN IN EXTREMITY (arm very painful), FEELING ABNORMAL (felt herself miserable), FATIGUE (felt tired at night) and CHILLS (chills) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LAMOTRIGINE (LAMICTAL), PRAZOSIN, DULOXETINE HYDROCHLORIDE (CYMBALTA), DOXEPIN and HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DIARRHOEA (diarrhea), PAIN IN EXTREMITY (arm very painful), FEELING ABNORMAL (felt herself miserable), FATIGUE (felt tired at night) and CHILLS (chills). At the time of the report, DIARRHOEA (diarrhea), PAIN IN EXTREMITY (arm very painful), FEELING ABNORMAL (felt herself miserable), FATIGUE (felt tired at night) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not take any treatment for the symptoms.
Within an hour, I was having severe pain in my shoulder. I took off the bandaid and noticed the injection point was way higher than it should have been. I had redness in the area (about 1-1.5 inch diameter) too that I have a picture of to show the injection location. I have limited range of motion, severe pain, and shooting pain down the back of my arm. I am unable to use my arm or lift anything that has any weight to it.
Case number PHEH2016US032023, is an initial spontaneous report received from a consumer on 07 Dec 2016. This report refers to a female patient of an unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185887, expiry date: Apr 2017) at a dose of 0.5 ml intramuscularly on 07 Oct 2016. On the same day after vaccination, the patient experienced lips tingly and numb, throat was closing up, and felt like she was going to faint, the patient oxygen level dropped and heart rate elevated. It was reported that, at hospital they gave EPIPEN (x2), SOLU-MEDROL (x2) and ZOFRAN for nausea on an unknown date. The patient said, never had a reaction like this to the flu vaccine. The outcome of the event throat constriction was reported as complete recovery on an unknown date and for tingling lips and feeling faint was reported as complete recovery on 07 Oct 2016 and for other events it was not reported. The seriousness of the events throat constriction, paraesthesia oral and syncope was reported as serious (life threatening) and for other events it was not reported by the consumer. The causality of the events was not reported. The seriousness assessment of the events oxygen saturation decreased, heart rate increased and nausea was upgraded based on information available in the source document. Following an internal review done for the data received on 07 Dec 2016, the following significant correction was done: Updated EPIPEN, SOLU-MEDROL and ZOFRAN should be coded as treatment medications (earlier captured as concomitant medications), added event nausea and removed it from current condition, all events arrangement based on seriousness criteria.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 at 13:00 as dose 1, single (Lot number: 012MO2A), in left arm and on 06Nov2021 at 12:45 as dose 2, single (Lot number: 012A21A) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "allergies Sulfa" (unspecified if ongoing), notes: allergies Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Glomerular filtration rate: (2021) 60. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 15Jul2022 to 20Jul2022.  Clinical course: patient received other medications within 2 weeks. Following first case of Covid-19 patient took paxlovid for 5 days. She tested Negative the 10th day. Also, the Pharmacy gave her the lesser dose Paxlovid because of a GFR test in 2021 that value was 60. Paxlovid 2 pills two times per day for 5 days she did not understand why; she had kidney disease.
pre-drawn syringes that were withdrawn and left out at room temperature for over 12 hours. At least one to three of the doses were administered to patients.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pre-drawn syringes that were withdrawn and left out at room temperature for over 12 hours. At least one to three of the doses were administered to patients.) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pre-drawn syringes that were withdrawn and left out at room temperature for over 12 hours. At least one to three of the doses were administered to patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pre-drawn syringes that were withdrawn and left out at room temperature for over 12 hours. At least one to three of the doses were administered to patients.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up information received on 07-jul-2021 contains non significant information as another reporter added.
Forgot all about it so I did not have a second shot/at the time had shingles shot; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on 30th September 2020).   On 1st May 2022, the patient received the 2nd dose of Shingles vaccine. On 1st May 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 01-May-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient self reported this case. The patient had first shingles shot and forgot all about it so he/she did not had a second shot. At the time, the patient had the shingles shot. Additional Supportive Information: At the time, the patient had the shingles shot later than the recommended interval, which led lengthening of vaccination schedule. Follow-up could not be possible as no contact details were available. Note: As per verbatim, 'At the time the patient had the shingles shot', it seems that the second dose was administered, therefore conservatively drug dose administration interval too long was captured as event.
Patient got dizziness and sweating  and headache while sitting at the waiting after the shot. Pharmacy staff gave her gatorate  to drink. Pharmacist and walked by OB doctor helped her laying down on the floor and gave her one chewable benadryl. Paramedics team arrived check her pulse and pressure.