chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female with unknown medical history and unknown drug allergies who received all three doses of GARDASIL. Subsequently the patient presented with a high risk HPV. A PAP test was performed. The patient's outcome was not reported. Additional information has been requested.
Vaccine given in right arm. Upper arm from shoulder to elbow turned red. No itching/pain. Arm from Shoulder to wrist swollen Narrative:
20 minutes after hep B, started itching developed raised bumps on neck, back, side. Denies edema, dyspnea, h/a.
pt recvd vax & w/in a wk of immun pt devel hyperglycemia;
Injection site redness. From initial information received on 3/14/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 17 month old female patient received her fourth dose of Tripedix lot number U1310AA, (not a recognized AvP lot number), administered in the right thigh and her fourth dose of ACTIB, lot number UB063A (French lot number W1478), administered in the right thigh on 1/27/05. The routes of administration were not reported. She also received a dose of MMR measles, Mumps, and Rubella Vaccine, lot number 0445P, manufacturer MERCK, administered subcutaneously in her left arm on the same day, on 1/27/05.  One day later, on 1/28/05, the patient developed a red raised area 4cmX2cm on her right thigh. At the time of this report, the patient's recovery status was unknown,
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 34-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Feb-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
HPV #2 administered in left upper arm. Provider was called to room immediately after vaccine administration due to syncopal episode. Pt placed in supine position and vitals carefully monitored. Patient recovered fully and was discharged home.
This is a spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, non-smoker, abstains from alcohol, environmental allergy, allergy, and hypertension, and other pre-existing medical conditions included the patient had history of allergy shots many years ago. The patient had no allergies to foods. The patient experienced drug allergy when treated with fexofenadine hydrochloride/pseudoephedrine hydrochloride. The patient received COVID-19 vaccine AD266.COV2.S (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 12:00 on left arm for prophylactic vaccination. Concomitant medications included pseudoephedrine hydrochloride for seasonal allergies. On 07-MAR-2021, the subject experienced spike in blood pressure. On 07-MAR-2021, the subject experienced rhinitis which went away after 30 minutes. But returned around midnight with slightly more severity. Nose running but no congestion. He was currently feeling fine. Laboratory data included: Blood pressure (NR: not provided) 170/100, 180/103. Treatment medications (dates unspecified) included: lisinopril. The action taken with COVID-19 vaccine AD26.COV2.S was not applicable. The patient recovered from spike in blood pressure, and rhinitis on MAR-2021. This report was serious (Other Medically Important Condition). Additional information was received from patient on 12-Mar-2020 following information was updated and incorporated into case narrative: Event outcome for both events, disease (allergy, environmental allergies), past reaction (ALLEGRA D allergy).
Immediate induration, swelling and pruritus, 30 minutes, post vax. Two weeks later, had 2 areas (2cm X 2cm) of early vesicular lesions on same arm. Rx'd Acyclovir.
severe headaches post vaccination, found to have severe vertebral artery stenosis and jugular vein thrombosis
Patient is a 91 y.o. male patient of, MD with PMH of Parkinson's Disease, DM, BPH, HTN, presented to the ED due to AMS.   Sepsis on POA Bacterial Pneumonia COVID infection SIRS on admit, lactate 2.1 Source includes COVID 19 and pneumonia Date of onset of symptoms: 4/5/23 Symptoms present on admission: fever, shortness of breath, hypoxia Date of covid positive test: 3/27/2023 Vaccination status: Unknown Imaging: CXR new RLL infiltrate/pneumonia Oxygen requirements on admission: RA Current oxygen requirements: 3LNC Medical therapy: remdesivir and steroids; cefepime switched to omnicef Blood cx, urine Ag; MRSA probe negative d/c vanco Consultants following: None Anticipated special isolation end date: 4/14/2023 Discharge on PO decadron to complete course   Anemia of chronic disease Hgb 6.4 from 7-8 baseline Checking iron panel, no active bleed Transfused 1 U PRBC and posttransfusion Hgb 7.5 Suspect increased destruction/consumption with sepsis' No active blood loss noted; Hgb stable 8.3   Hyperglycemia BG 200-300's due to decadron Treated with SSI while admitted Suspect will resolve once off decadron Plan for hospice care at facility   Fecal impaction Constipation High stool burden per CT A/P Started dulcolax, miralax, and senna Added one time glycerin suppository Has had 2 BM on  4/6   BPH with obstruction Suprapubic catheter Follows with Dr.   Has SPC placed 1/2023 CT showing mild to moderate left hydronephrosis and hydroureter to the level of prostate While UA appears pyuric suspect colonization rather than true infection Ucx proteus; switched to omnicef to complete outpatient treatment Dysphagia Protein calorie malnutrition with cachexia Evaluated by speech last admission, reg nectar thick high risk for aspiration recommended nectar thickened Unsure of what diet patient was on at ECF Restarted reg with nectar thickened liquids Added magic cup per last nutrition notes   Parkinson's disease Resume home Sinemet   Neuropathy Cymbalta   Hyperkalemia K 5.2, suspect hemolyzed sample Repeat 4.5 on 4/7   Goals of Care Per paperwork from ECF, patient is a DNRCCA Hospice to eval at facility once discharge
Extremely heavy menstrual bleeding for 27 days  with large clots which resulted in anemia.  Swelling of feet
Patient presented to the pharmacy today 3/12/19 and stated that post immunization she has developed an allergy to garlic and make-up she has been using. Pre-immunization no allergy to garlic or make up. Patient states she developed hives and rash and boils when she eats garlic or when she applies her makeup.
HCF administered an incorrect Covid vaccine by mistake to my six-month-old son, pt. received the bivalent Pfizer dose instead of the first dose in the primary series. Patient had not received any prior doses of the Covid vaccine when he was administered the bivalent Pfizer dose. This occurred at a local health care facility on February 2, 2023.    The below information is from a note in the patient's chart:  Telephone Encounter  RN at 2/2/2023  4:31 PM Spoke with mother, patient received bivalent pfizer in error for primary series dose. Mother was advised that we do not repeat the dose. The primary and booster dosages are the same and bivalent can be counted as a primary dose. Mother advised we will continue with the recommended vaccination schedule. Mother voiced understanding and was appreciative of call back.
Caller notes patient is asymptomatic. No additional AE's reported.; Caller reported a temperature excursion which was administered to a patient on 3/22/2021.; This spontaneous report was received from a nurse and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies, or concomitant therapies was provided.  On 22-MAR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), dose reported as 1, lot # T025505, expiration date 23-JAN-2022 (route of administration was not provided) for prophylaxis. The patient was asymptomatic. No adverse event was reported. Administered dose of vaccine experienced the temperature excursion of 18 Fahrenheit degrees for 11 hours and 40 minutes. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.
Information has been received from a pharmacist referring to an 8 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 24-JUN-2015 the patient was vaccinated with expired doses of MMR II HSA, lot # J006953, (dose and route were not reported). The dose of MMR II had an expiration date of 07-JUN-2015. No adverse events were reported. This is one of several cases from the same reporter. Additional information has been requested.
pt recv vax 4OCT96 as completion of dose started on 6SEP96;fever of 105 began 5OCT96;erythema @ site of inj w/tenderness began 6OCT96;
Information has been received from a health professional concerning a 16 month old patient who on 2/14/2005 was vaccinated with a dose of varicella virus vaccine live (lot 1449P). On 6/18/2005 the patient developed a rash. On 6/22/2005 the patient was diagnosed with breakthrough varicella with less than 50 lesions. The patient was afebrile. There were no complications. The patient had no prior history of chickenpox. The patients breakthrough varicella was not lab confirmed. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Loud tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 at 11:00 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included unidentified autoimmunity issues. The patient did not receive any other medication within two weeks of vaccination. The patient previously took gluten, tree nuts and some antibiotics. The patient previously received varicella zoster vaccine rge (CHO) (SHINGRIX) on an unknown date for immunisation. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 at 11:00 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Apr2021, the patient experienced loud tinnitus. The clinical outcome of the event loud tinnitus was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Fever 105, local rxn @ inject site, & rash 2 days following immun.
Information received from the Varivax pregnancy registry from a physician concerning a 21 year old Hispanic female pt  with a negative varicella antibody on 02-JUN-1999 on 02-JUN-1999 and a negative serum pregnancy test on 08-JUN 1999 who was vaccinated with a first and second dose of varicella virus vaccine live on 11-JUN-1999 (Lot #1656H) and on 08-JUL-1999 (Lot #1656H), respectively. Concomitant therapy included prenatal vitamins. On 16-JUN-1999, the pt had MRI to evaluate the lumbar spine. There was some concern as to whether on not there was x-ray exposure during pregnancy. Therefore, at the time of vaccination pt was 1 month pregnant. EDD 05-MAR-2000. Follow up info from a physician reported that on 11-JUL-1999 an ultrasound was performed and the results were normal. On 28/DEC-1999 a repeat ultrasound was done which indicated polyhydramnios and large for dates. It was also noted that from 15-FEB-2000 to 24-FEB-2000 the pt was placed on amoxicillin 500 mg for the treatment of otitis media and bronchitis. On 27-FEB-2000 the pt delivered a healthy girl, weighing 8 lbs and 9 oz's. There were no congenital anomalies or complications during pregnancy. The rest of the info on this record is about the baby's well check visits and everything is normal
Information has been received from a medical assistant concerning a 4 month old male patient with no pertinent medical history or drug reaction/allergies. On 13-MAR-2015, the patient was vaccinated with a dose of VAQTA (lot# and expiration date not provided), 0.5 ml, intramuscularly. There was no concomitant therapy. On 18-MAR-2015, the patient developed a fever of 100.5 Fahrenheit degree (F). The patient's mother contacted the office by phone to seek medical attention on that date. No treatment was prescribed for the event. No other lab diagnostics studies were performed except body temperature. The outcome of fever was unknown. Additional information has been requested.
This case was reported by the mother of a consumer and described the occurrence of irritability in a neonate (less than 24 hours old) male subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 27 December 2011 at 00:20 the less than 24 hour old subject inadvertently received a dose of FLUARIX in the left leg. This was an inappropriate age at vaccine administration. On 27 December 2011, less than one day after vaccination with FLUARIX, the subject experienced irritability. On 29 December 2011, the event resolved. The mother reported that the hospital intended to give the newborn his vaccination of hepatitis B, but mistakenly administered FLUARIX. This was the wrong vaccine for administration. The newborn was discharged on time from the hospital following birth on 27 December 2011 at approximately 14:)0 and has visited the pediatrician office for normal visits twice since his birth. The mother was notified of the maladministration by phone call after they were home.
This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A 66-year-old patient of an unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history included hypertension diagnosed 25 years ago. The patient's concomitant medications were not reported. On an unspecified date the patient reported that she got pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and it hurt. The outcome of the event was unknown.
Immediate pain in left shoulder and continued pain without resolving especially when abducting and backward rotation.
After the administration of the COVID-19 vaccine, during the observation period, the patient showed a swollen tongue and shortness of breath
muscle pain in the right shoulder and its getting worse; muscle pain in the right shoulder and its getting worse; Swelling; Little sensation; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206, NDC number and expiration date: unknown), via an unspecified route of administration, administered in right arm on 18Mar2021 16:00 (last Thursday) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included ongoing arthritis (probably started off 6 years ago, little by little and got worse over time). Concomitant medication included paracetamol (store brand of TYLENOL 8 HR ARTHRITIS PAIN) taken for arthritis pain (Expiration Date: Jul2022; Lot Number: 81830065M; Count size: 225 tablets, start and stop date were not reported) and CBD oil which helped out with the knees. Patient did not receive any prior vaccine within 4 weeks. The following day on 19Mar2021, patient didn't feel anything but the day after that on 20Mar2021, patient began to have a little sensation and swelling. Patient reported that the little sensation occurred where the Covid-19 vaccine was injected, below the shoulder where they put a shot on a person's arm, and the sensation then moved to the shoulder muscle. Swelling was gone after a couple of days. On 25Mar2021 (from last night), the patient experienced muscle pain in the right shoulder and it was getting worse (myalgia/condition aggravated). Patient was normally hurt everywhere anyway because of arthritis, but the pain in his right shoulder was different now. It was in the muscle not the joint. Patient's second dose was scheduled on 08Apr2021 and he wanted to know should he not take it. Outcome of the events myalgia and condition aggravated was not recovered. Outcome of the event sensory loss was unknown while event swelling recovered in May2021. Investigation Assessment: No  No follow-up attempts are needed. No further information is expected.
HIGH FEVER. SYSTEM WIDE SWOLLEN LYMPH NODES WITH DEHYDRATION AND VIRAL RESPONSE.
3-4hrs after vaccine child had 2 hrs of listlessness, pale & limp, vomited 5 times no fever, resolved. Was treated with tylenol.
Stiff and sore neck started four days after vaccination, got progressively worse over the course of next three days; took Aleve but it did alleviate the symptoms.
urticaria, minimal secondary hypersensitivity rxn;hives on face, arms, flushed, felt warm;
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 16-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 19-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
I had my 2nd dose of Moderna vaccine at approx. 8pm on 2/12/21. The next day, I had chills, fatigue and a sore arm at the injection site. This lasted about 1.5 days. On 2/15/20, Monday morning, I notice a very red rash located approximately 1.5-2 inches below the injection site on my right arm. It was about 3 inches across and extended about 1.5 inches down my arm. It is not painful, nor swollen but it is a very red angry looking rash with some itching. I am taking Zyrtec and famotidine for their antihistamine properties. Today, it 2/16/20 at 5:58PM. Rash is still the same, but not getting any worse.
16FEB97 exp drowsiness;seen by MD 21FEB97 was falling asleep;hosp in ICU;d/c 20MAR97 on med & in an unresponsive state & neuro problems;hosp again on 3MAY97 by then ahd sz & jerky movements to rt side of body;dx SSPE
6 days after the COVID 19 vaccine I started having soreness in my left armpit lymph nodes. 8 days after, my right arm became sore, hot, achy, inflamed and had a rash around the injection sight. This lasted about 2 days.
leg pain; Drug dose administration interval too short; This case was reported by a other health professional via call center representative and described the occurrence of leg pain in a adult female patient who received Herpes zoster (Shingrix) (batch number 44dx9, expiry date 28th October 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 9k4t4, expiry date 8th October 2022) for prophylaxis.   On 10th July 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 21st May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th July 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced leg pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the leg pain was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the leg pain to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 12-Apr-2022 Reporter's comment: A pharmacy student stated that a patient in her 50's reported that she received both of her Shingrix vaccines in left arm and was having leg pain.   The patient was currently having leg pain.   The caller was unsure if the pain began after the first or second vaccine.  The caller had no further information in regard to the patient or symptoms reported. The reporter consented to follow-up. Additional Supportive Information: The patient received 2nd dose earlier than the recommended interval, which led to shortening of vaccination schedule.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022064011:case created in error for 1st dose
Pain at injection site. Unable to properly use arm. Patient claims administration site was to high on arm.
injection site pain, menstrual cramps Narrative:  Employee reports injection site swelling, redness, and itching almost 12 hours after receipt of the vaccine. Also reports "menstrual cramps" after receiving vaccine. No medications were taken per report.  Other Relevant History:
I accidentally administered the adult pfizer vaccine instead of the pediatric vaccine. I should have asked for help as I prepped to administer the vaccine. the error is on me and I want to do Everything in my power to Ensure I Never make this mistake again.
Pt received Pneumo23 at 0830. Report feeling nausea and tightness in chest. No warmth, no redness at site. Lungs clear. Provided ALEVE. Pt to agency.
Pt recv 1st dose of Hep B vax on 10JUL91; 48 hrs p/vax pt devel h/a, nausea & generalized achiness; On 16AUG91 recvd 2nd dose Hep B vax & 48 hrs later sx recurred along w/sore throat; Pt seen by MD:
extremely sore swollen glands w/vax 2JUL98 & 13JUL98;13JUL98 p/vax approx 30min pt had severe bloody nose that was difficult to stop;no further treatment required;