chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 17-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA004381: Original Case: 1808USA001261; US-009507513-1808USA004383: Original Case: 1808USA001261; US-009507513-1808USA004384: Original Case: 1808USA001261; US-009507513-1808USA004380: Original Case: 1808USA001261; US-009507513-1808USA004379: Original Case: 1808USA001261; US-009507513-1808USA004376: Original Case: 1808USA001261; US-009507513-1808USA004377: Original Case: 1808USA001261; US-009507513-1808USA004378: Original Case: 1808USA001261; US-009507513-1808USA004385: Original Case: 1808USA001261; US-009507513-1808USA004362: Original Case: 1808USA001261; US-009507513-1808USA004386: Original Case: 1808USA001261; US-009507513-1808USA004387: Original Case: 1808USA001261; US-009507513-1808USA004388: Original Case: 1808USA001261; US-009507513-1808USA004363: Original Case: 1808USA001261; US-009507513-1808USA004364: Original Case: 1808USA001261; US-009507513-1808USA004389: Original Case: 1808USA001261; US-009507513-1808USA004390: Original Case: 1808USA001261; US-009507513-1808USA004391: Original Case: 1808USA001261; US-009507513-1808USA004392: Original Case: 1808USA001261; US-009507513-1808USA004393: Original Case: 1808USA001261; US-009507513-1808USA004394: Original Case: 1808USA001261; US-009507513-1808USA004395: Original Case: 1808USA001261; US-009507513-1808USA004396: Original Case: 1808USA001261; US-009507513-1808USA004365: Original Case: 1808USA001261; US-009507513-1808USA004366: Original Case: 1808USA001261; US-009507513-1808USA004367: Original Case: 1808USA001261; US-009507513-1808USA004397: Original Case: 1808USA001261; US-009507513-1808USA004398: Original Case: 1808USA001261; US-009507513-1808USA004399: Original Case: 1808USA001261; US-009507513-1808USA004400: Original Case: 1808USA001261; US-009507513-1808USA004368: Original Case: 1808USA001261; US-009507513-1808USA004369: Original Case: 1808USA001261; US-009507513-1808USA004401: Original Case: 1808USA001261; US-009507513-1808USA004370: Original Case: 1808USA001261; US-009507513-1808USA004371.
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that on an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (product lot#, expiration date not reported). No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same source. Additional information has been requested.
Itchy, burning, hot rash over chest, clavicles, and neck.  Spreading slowly and have had for over a week.
Sore right arm Headaches Muscle aches Right armpit painful Tiredness  Irritability  Lack of appetite
She had a cold or a couple weeks and then recovered. Then, she woke up with a headache and I gave her Tylenol. She went to the mall and passed out and threw up in a store. We took her to the ER, and they ran some tests, and everything came back normal. They think she had a viral infection and gave her some saline solution to hydrate her. No other medications were prescribed.
Throat felt itchy and irritated after first vaccine; Bumps on her tongue, after first vaccine; her tongue was irritated with bumps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 26Aug2021 (Lot number: FF2588) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ear infection", start date: Jun2021 (unspecified if ongoing), notes: she went to the ENT doctor and Caller states the doctor sprayed a medication in her left ear. The patient's concomitant medications were not reported. The following information was reported: THROAT IRRITATION (non-serious) with onset 26Aug2021, outcome "unknown", described as "Throat felt itchy and irritated after first vaccine"; TONGUE DISORDER (non-serious) with onset 26Aug2021, outcome "unknown", described as "Bumps on her tongue, after first vaccine"; GLOSSITIS (non-serious) with onset 26Aug2021, outcome "unknown", described as "her tongue was irritated with bumps". Therapeutic measures were taken as a result of throat irritation, tongue disorder, glossitis.  Additional information: Caller stated that after the first vaccine, she waited 15 minutes and felt fine, then when she got home, her throat felt itchy and irritated. she had bumps on her tongue. she wasn't sure at that time, it was a reaction, from the vaccine. she took generic Claritin at that time, and it did help with that reaction. she was scheduled for second dose on 16Sep2021, and the provider felt uncomfortable to administer it today, 21 days from first dose, due to previous reaction.     No follow-up attempts are possible. No further information is expected.
Patient received  Moderna first dose on 10/27/21. In error, patient received a dose of Pfizer on 11/1/21.  Patient was examined and is feeling well. She will continue to be monitored.
Blurred vision; Hives on neck; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection), intramuscular, administered in Arm Left on 12Jul2021 13:05 (Batch/Lot Number: EW0181) as SINGLE for covid-19 immunization. Medical history included EMR colon surgery from 01Jun2021 to an unknown date. This was 3 weeks before the vaccine and polypectomy from 17May2021 to an unknown date. There were no concomitant medications was reported. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection), intramuscular, administered in Arm Left on 21Jun2021 13:00 (Batch/Lot Number: EW0180) as SINGLE for covid-19 immunization and developed Covid arm rash. On 14Jul2021 18:30, the patient had hives on neck whereas, blurred vision on 15Jul2021 18:30. The patient underwent lab tests and procedures which included EKG as normal on 28May2021, pregnancy Test (Blood work) as normal on 28May2021. Also, the patient underwent covid test as negative on 16Nov2020, 14May2021, 30May2021 and on 13Jun2021. The outcome of events was recovered on an unknown date.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 16-year-old male patient of unspecified race/ethnicity received on an unspecified date TRUMENBA at 0.5 ml single dose in the left arm for immunization. Medical history and concomitant medications were not reported. Day after the administration, the patient went to ER with a red line around the left arm below the administration site. The patient reported also pain around the red line and below armpit. Outcome was unknown.
Information has been received from a nurse practitioner concerning a "16 year old" female patient with no pertinent medical history who on approximately 20-SEP-2010, was intramuscularly vaccinated with the first 0.5 ml dose of GARDASIL. Concomitant therapy included ZOFRAN. The nurse practitioner reported that on approximately 20-SEP-2010, the patient experienced vomiting after vaccine administration. No lab tests were performed. The patient sought unspecified medical attention. It was noted that the nurse practitioner decided to stop the series of GARDASIL for the patient because of the reaction experienced. It was reported that the patient was treated with ZOFRAN and she was recovering. Follow up information received from the nurse practitioner indicated that the patient was a female student, with no illness at the time of vaccination nor preexisting allergies, birth defects or medical conditions, who in the morning of 27-SEP-2010 was vaccinated with a first dose of GARDASIL (lot # 666931/037Z) intramuscularly in her left deltoid. In the afternoon of 27-SEP-2010 the patient developed abdominal pain and vomiting, these continued for two days. The patient was better on day 3. On 30-SEP-2010 the patient recovered from abdominal pain and vomiting. No further information is available.
Diarrhea, stomach too upset to eat anything other than tea and toast for 2 1/2 days. Felt better by 10/9 in evening.
On Feb. 2, 2021 I began experiencing frequent palpitations. A holter monitor was placed on 2/4/2021 and on 2/5/2021 it was interpreted as multiple PVCs. An ECHO was ordered and was okay. I was started on Toprol 25mg 1/2 -1 tablet daily. I am still on this medication.
some chills; shoulder is pretty darn painful/ if try to lift it up and do anything, it hurts; lethargic; no appetite; shoulder soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (some chills), ARTHRALGIA (shoulder soreness), ARTHRALGIA (shoulder is pretty darn painful/ if try to lift it up and do anything, it hurts), LETHARGY (lethargic) and DECREASED APPETITE (no appetite) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ARTHRALGIA (shoulder soreness). On 27-Jan-2021, the patient experienced CHILLS (some chills), ARTHRALGIA (shoulder is pretty darn painful/ if try to lift it up and do anything, it hurts), LETHARGY (lethargic) and DECREASED APPETITE (no appetite). At the time of the report, CHILLS (some chills), ARTHRALGIA (shoulder soreness), ARTHRALGIA (shoulder is pretty darn painful/ if try to lift it up and do anything, it hurts), LETHARGY (lethargic) and DECREASED APPETITE (no appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. No medical history was provided. On 13-FEB-2017, the patient was vaccinated with a dose of PROQUAD subcutaneously (dose was not reported) (lot # M037011, expiration date: February 2018, albumin status: rHA) and a dose of M-M-R II subcutaneously (dose was not reported)(lot # M028131, expiration date: June 2018, albumin status: rHA) for prophylaxis. No temperature excursion and no adverse effects were reported. No concomitant therapies were reported. Additional information is not expected as no further information can be obtained.
Information has been received from a physician concerning a female patient who on 26-OCT-2007 was vaccinated with the first dose of GARDASIL (Lot # 659435/1265U) 0.5ml. On 18-JAN-2008 was vaccinated with the second dose of GARDASIL (Lot # 658556/1060U) 0.5ml. On 23-MAY-2008 was vaccinated with the third dose of GARDASIL (Lot # 660389/1968U) 0.5ml. Concomitant therapy included YAZ. The patient experienced headaches in the form of severe migraines specifically during her periods after receiving GARDASIL. At the time of the report, the patient had not recovered from the adverse event. The patient sought unspecified medical attention. Additional information has been requested.  3/25/09 MR and vax rec recwived from PCP. OV 10/26/07 for c/o heavy periods q 2 weeks.  Placed on OC and given HPV#1. OV 1/18/08 for c/o headache x 4 days with ear congestion and rhinorrhea.  Assessment:  Sinusitis.  Eustachian tube dysfunction.  HPV#2 given. Returned 1/31/08 with c/o RLQ pain, initially acute and sharp, now persistant. Slightly decreased appetite. PE (+) for guarding and mild rebound in RLQ. Sent for pelvic sono which was (-). Returned 4/9/08 with c/o dizziness and shakiness x several weeks. Pt always feels cold, has had some blurred vision which lead to brief black-outs of vision. (+) nausea. Assess:  Anemia. Seen 4/22/08 for dysmenorrhea. Seen 5/23/08 with c/o headache x 1 week. Assess:  Anemia.  HPV#3 given. OV 9/9/08 with c/o headaches which began in March/April intermittently, now constant with blurred/double vision. Sent for CT and ophth consult. Still reporting migraines with period. Stopped med due to loss of taste and hand and foot numbness. Seen 1/13/09 for bloody nose and bruising on upper extremities. CBC OK. Started on Celexa.
A non-serious spontaneous report of "mistakenly administered FluMist to a one-year-old" was received from a licensed  practical nurse concerning an 11-month-old male. On 05-Oct-2009, the patient received FluMist. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.
pt recv vax 19FEB97 &  2MAR97 pt devel 2-3 lesions @ the inj site & 18-20 over rest of body;the lesions were erythematous & pruritic;
Pt. was given Tdap first in the right deltoid, MCV4 next in the right deltoid, then Hepatitis A was administered in the left deltoid. Pt. said his eyes "felt funny" and that he felt sick to his stomach. His skin then got white/pale and he started vomiting. Red blotchy spots popped up across his shoulders and he became very weak. I got him a cold wash cloth and wiped his face and on the back of his neck. After vomiting, his coloring started coming back and he stated he was ready for the last shot which would have been GARDASIL but I did not administer this vaccine. I gave him some cold water, a popsicle and mom requested a dose of BENADRYL. I gave him 25 m of BENADRYL. After the medication and a cold drink, the patient "felt" better. I did not see any immediate reactions locally where the vaccines were given nor did he seem to be in respiratory distress.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information on the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date in June 2017, reported as "approximately one month ago", the patient was vaccinated with a dose of GARDASIL 9 lot # N001533, expiry date 16-OCT-2019 (dose, route of administration were not reported).. On an unknown date in 2017, the patient experienced injection site mass. On 02-JUL-2017, she came to the pharmacy and the reporter palpated a "solid bump under the skin" at the injection site. The patient did not complain of any itchiness or pain at the injection site, and there was no redness at the injection site. There were no lab studies or diagnostics performed. The outcome of injection site mass was unknown. The relatedness between the event and GARDASIL 9 was not reported.  Additional information has been requested.
Dizzyness, vertigo, nausea. Feeling of being ?out of it?. Has lasted a day so far. Started 2 and a half days after receiving the first shot. Also had regular reaction first 1-2 day/night after vaccine (headache, nausea, fatigue).
THROWING UP; WEAK BODY; FATIGUE; This spontaneous report received from a parent concerned a 47 year old female. The patient's weight was 95 pounds, and height was 60 inches. The patient's concurrent conditions included alcoholic, and smoker, and other pre-existing medical conditions included the patient had no known allergy and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207a21a, and expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced throwing up. On 29-MAY-2021, the subject experienced weak body. On 29-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throwing up, fatigue, and weak body. This report was non-serious. This case, from the same reporter is linked to 20210627858.
patient tested positive for Covid after receiving the first dose; patient tested positive for Covid after receiving the first dose; his is a spontaneous report from a contactable consumer. This consumer reported similar events for seven patients. This report is for the sixth of seven patients.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, also reported as Pfizer Covid vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid after receiving the first dose of the Pfizer Covid vaccine on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045622 same drug/AE, different patient.
Severe allergic reaction. Rashes, bumps and itchiness all over the entire body. Patient had the symptoms for 2 weeks and finally went to see the doctor. She was prescribed steroid cream.
Patient reports severe headache within 5 minutes of Moderna COVID vaccine administration, L side of face and chest edema, L arm edema within a few hours of vaccine.
2-18-21: no adverse reactions to this date / none.  .  I am 9 days out.  Site now red, tender, swollen and HOT.   Red area in a circle around injection site.   Measures 2.1/4" in diameter.  Went to MD.  He said could be a very delayed reaction or cellulitis..  Said I was the 3rd person in 2 weeks who had come to see him with this type of what he presumed was  a delayed reaction.   Said  he looked at CDC articles and could not find any reference to this type of reaction.  As a precaution I was prescribed Keflex for possible cellulitis. MD said wait it for a few days and take ATB if site gets bigger.  Also mark with a pen on my arm the current size of red area so could determine if it gets larger.  1 day later site was much bigger but slightly less red: now looked like a cloud shape, size now measured 2 1/2 "  by 31/2 " at the largest point.  still hot and red.  I never took the ATB.  Eventually all subsided by today 2-23-21.  Just minimal red area left.
imeediately after vaccination, patient lost conciousness, had a period of muscular jerks similar to seizure, for about 30 seconds.  After that, could respond (had no memory) but was generally not lucid for another 90 seconds.  At that point, the patient could respond, wanted to lie down, started sweating profusely, and after about 5-10 minutes was generally recovered.  Patient stated that they have had previous issues while giving blood.
Pt c/o (L) arm feeling "hard" on the day the vaccines were administered (after receiving the vaccines). The next day (6/18) the arm was red. Today c/o tenderness, redness, and warmth of (L) arm. Started cefadroxil antibiotic today.
This is a serious spontaneous case, initially received from other health professional on 02-May-2019, concerning a male neonate patient. The patient's mother was a 29-year-old who had 2 previous pregnancies reported with two previous elective abortions. The patient's maternal and paternal history with major congenital malformations were none. The concomitant medication of the patient's mother included OB complete one (iron-folic acid-Dha-fish) for healthy pregnancy. The patient's mother did not use tobacco, alcohol or illicit drugs during pregnancy. The mother's last menstrual period (LMP) date was 14-Aug-2018. On 08-Oct-2018, at the gestational age of 8 weeks, the patient's mother received FLUCELVAX QIVc [route of administration: transplacental, batch number: 252232, dose, frequency, anatomical location and expiry date: not reported) for an unknown indication. The foetus was exposed to FLUCELVAX QIVc via transplacental route (coded as foetal exposure during pregnancy) for an unknown indication. On 05-Nov-2018, the patient's mother had undergone cystic fibrosis mutation analysis, first trimester screening and no major congenital malformations were noted. On 03-Dec-2018, the patient's mother had had undergone second trimester screen and no major congenital malformations were noted. The patient's mother experienced A1 diabetes mellitus (since 28-Feb-2019 to ongoing). On an unspecified date, after vaccination, the patient's mother went to emergency department with flu, fever and unspecified test was performed which confirmed Flu. The patient's mother was prescribed with Tamiflu (oseltamivir phosphate, 75 mg, bid, orally, from 03-Mar-2019 to 08-Mar-2019) for flu and Tylenol (paracetamol, 325 mg, every 6 hours, orally, from 03-Mar-2019 to 10-Mar-2019) for fever from emergency department. The patient's mother was asked to finish the course of Tamiflu as instructed by ER. The patient's mother gave a live birth to a male neonate at the gestational age of 36.1 weeks via vaginal method of delivery (coded as premature baby). The characteristics of the neonate included birth weight: 2693 grams, head circumference: 33 cm, length: 47 cm and appearance, pulse, grimace, activity, and respiration (APGAR) scores were 9 (at one minute and five minute). No major congenital malformations (MCMs) were identified at birth. The outcome of the event premature baby was unknown. The mother's estimated delivery date (EDD) was reported as 21-May-2019. This case (201903265) is linked to 201902763 (mother case).; Reporter's Comments: A male neonate patient experienced premature birth (at 36.1 weeks of gestation), 6 months 16 days after maternal receipt of FLUCELVAX QIVc (considered as foetal exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported premature birth, the event premature birth assessed as not related. Maternal gestational diabetes is considered as confounding factor for the event premature birth. The event foetal exposure during pregnancy assessed as not related to suspect product considering the intended use of the vaccine. The company assessed the case as serious (medically significant).