chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old female patient received the first, second, third and fourth dose of PREVNAR 13, (lot number and expiration date unknown) all via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the physician reported that the 16 year old patient who completed her childhood series of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) recently had pneumonia. The physician was querying if the patient should receive a pneumococcal 13- valent conjugated vaccine (diphtheria crm197 protein) now. The outcome of the event was unknown. The following information on the batch number has been requested. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13- valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative pathological/serotype results and vaccination schedule are needed for full medical assessment.
fever 105, taken by mom w/ear thermometer lasted approx 14hr;lethargy during fever;irritable & crying-maximum of 1 cont hr;
DEVELOPED HERPES ZOSTER 5 MONTHS AFTER RECEIVING VARICELLA VACCINE. UNILATERAL VESICULAR RASH FROM MID ABDOMEN ALL THE WAY AROUND TO MID BACK, PAINFUL, PRURITIC. NO PREVIOUS EXPOSURE TO WILD VARICELLA IS KNOWN.
Needle separated from syringe causing vaccine leakage.  Patient was successfully vaccinated with another dose.
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for herself and her husband.  This is the first of two reports. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient tested positive for COVID-19 and had minor symptoms on an unspecified date. Outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021111850 same reporter/drug, similar events, different patient.
Patient came in for her flu shot yesterday and when she went to bed her left arm started itching really bad. Today after work she noticed her deltoid had noticable raised rash and redness down her arm. She wanted to have someone evaluate her arm to see if she did have a reaction to the vaccination. It was confirmed she had a reaction. Patient denies SOB, fever or swelling of her tongue or throat. She was advised to take Benadryl, ice the area and use Benadryl or some anti itching cream. She was also advised if any symptoms discussed above occur she is to go to ED. This will be reported to the VAERS. Patient understands the instructions provided.
Admission Date: 1/28/2023 Discharge Date: Jan 30, 2023  PRESENTING PROBLEM: Elevated troponin  HOSPITAL COURSE: The patient is a 67 y.o. female with past medical history significant for nonischemic cardiomyopathy, diet controlled DMT2, PVD who present to the ED on 01/27/2023 with shortness of breath.  Patient found to have hypoxia from mild CHF, lactic acidosis and was COVID positive.  She also had elevated troponin that increased to 120. She improved quickly while still at the hospital  but was transferred to another hospital for Cardiology consult and echo. Echo showed worsening EF of 30 along with moderate mitral regurgitation and aortic regurgitation.  Cardiology recommended cardiac MRI and right heart catheterization but due to active COVID plan to arrange as outpatient. She was discharged on Lasix 40 mg daily with close cardiology follow-up.
redness, swelling left upper arm 12-13cmx6cm Tylenol, warm compresses.
LUE with 6.5" superiorly, 6" inferiorly; 4.75" in length, hot, tense area of hot erythema
Sore right arm immediately and progressed to difficulty moving arm.  Most painful at night.  Patient iced, used heat, massage acupuncture.  Then went to primary care provider who prescribed physical therapy.
Patient received DTAP, Prevnar, HIB and IPV on 1/04/2001. Mother called office on 1/06/2001 at 10:45AM to report that patient had been inconsolable and crying from 6PM to 6AM the previous night.
PATIENT EXPERIENCED FLU SYMPTOMS STARTING 3 HOURS AFTER RECEIVING VACCINATION (SORE ARM, CHILLS, FEVER, VOMITTING, ETC). SYMPTOMS LASTED APPROXIMATELY 5 DAYS.
Since receiving the vaccine, the patient has had severe pain at the injection site and says that she can feel a lump under the skin where the injection was given. She has had difficulty using her arm because the pain is so bad. It is still on going. She saw her PCP and was offered a sling, but she declined.
On  09/03/2022 began with nausea,  abdominal and back discomfort, felt bloated applied heating pad to back and took extra strength Tylenol.  On 09/04/2022 pain in back and abdomen  increased very nauseous,  decreased appetite  and belly felt harder. By 2:00 a.m. on 09/05/2022 could not sleep,  pain increasing and belly getting  more bloated and felt rock hard. Went to the Emergency room at hospital.  CT scan  and blood work done. Diagnosed with Splenic thrombosis.  Kept over 24 hours for further observation  and testing.  Was placed on blood thinner and sent home.
Case number PHEH2015US026948, is an initial spontaneous report   received from a nurse on 22 Dec 2015. This report refers to a 40 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into right deltoid on 26 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Case number PHEH2014US024982, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 38-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 30 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Headaches, fatigue, worsened my hives I had and made them spread.  Caused my lips and face and scalp to dwell on 11/18/21.
No known adverse event, but we wanted to report that the immunization was given to someone who was only 15 years of age. The VAR was signed off on by we assume a parent, and the patient additionally signed the back of the  VAR.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-NOV-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokwTip 10Pk" and lot # L014876 with expiration date 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius)for 336 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
PATIENT CLAIMS DEVELOPED A SEVERE RASH 1 DAY AFTER SECOND SHOT OF MODERNA WHICH WAS GIVEN ON 05/24/2021.  PATIENT CLAIMS THAT HE BROKE OUT IN  ANOTHER RASH ON 08-06-21. PATIENT SPOKE TO HIS DOCTOR WHO TOLD HIM TO TELL THE PHARMACY TO REPORT IT AS A POSSIBLE ALLERGY. PATIENT CLAIMS DID NOT BREAK OUT IN RASH AFTER FIRST DOSE OF MODERNA ON 05/26/21 BUT FELT FLU LIKE SIDE EFFECTES.
I had immediate swelling in the proximate lymph node (left armpit) up to approximately grape size.  Swelling and localized pain did not abate until 3 days later.  Lymph node returned to normal size one week later.
received Pfizer pediatric dose (10mcg) combined with 40mcg of Moderna vaccine; parent ended up with the Pfizer pediatric dose administered (10mcg) combined with 40mcg of Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (received Pfizer pediatric dose (10mcg) combined with 40mcg of Moderna vaccine) and PRODUCT ADMINISTRATION ERROR (parent ended up with the Pfizer pediatric dose administered (10mcg) combined with 40mcg of Moderna vaccine) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 40 microgram. On 29-Nov-2021, the patient experienced OFF LABEL USE (received Pfizer pediatric dose (10mcg) combined with 40mcg of Moderna vaccine) and PRODUCT ADMINISTRATION ERROR (parent ended up with the Pfizer pediatric dose administered (10mcg) combined with 40mcg of Moderna vaccine). On 29-Nov-2021, OFF LABEL USE (received Pfizer pediatric dose (10mcg) combined with 40mcg of Moderna vaccine) and PRODUCT ADMINISTRATION ERROR (parent ended up with the Pfizer pediatric dose administered (10mcg) combined with 40mcg of Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   the patient was given Pfizer pediatric dose of 10 mcg by the pharmacist and then gave 40 mcg of a Moderna COVID-19 booster dose to equal out 50 mcg, Patient did not not experience any symptoms, No concomitant and treatment medication reported.   This case was linked to MOD21-167912 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: the follow-up received contains significant information which includes Patient demographic updated and dose details updated.
sinus infection; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date was unspecified) via an unspecified route of administration on 23Jan2021 (at the age of 67 years old) in a single dose for COVID-19 immunisation.  No Medical history or concomitant medication reported.   The patient experienced sinus infection on an unspecified date.  The patient was prescribed Cefdinir 300mg, twice daily and Methylprednisolone 4mg once daily for 7days. The patient wanted to check about the medications that her doctor has given her for the sinus infection to see if it will override the effects of the COVID vaccine. Outcome of event sinus infection was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Pt had 2nd dose Pfizer and had left building.  We were called to parking lot accompanied by EMTs.   pt cc:  itchy arms and hands.  Pt brought back into structure to triage 1.  Met by MDs.   16:08 pt given Zyrtec, 10mg PO.  16:30 pt feeling better and cc: lower lip a little numb.  Pt offered Benadryl 50mg, he declined as he is driving.  16:45, pt left in stable condition.  Instructions provided if symptoms come back to go to ER, if airway closing
Arms itched from wrist to elbow on both arms after first dose. Arms itched worse in the same spot after second vaccination. after second vaccination, had to go to primary care physician and get a steroid injection because of face swelling.
No additional AE reported; Physician reports VARIVAX was reconstituted with PEDVAX HIB instead of sterile diluent and administered to a patient on 10JAN2023. No further information provided. No additional AE reported. No PQC reported.; VARIVAX was reconstituted with PEDVAX HIB instead of sterile diluent; This spontaneous report was received from a physician referring to a 15-month-old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 10-JAN-2023, the patient was vaccinated with one varicella virus vaccine live (oka/merck) (VARIVAX) (lot # W018837, expiration date 14-JUN-2024; dose and route were not reported) for prophylaxis, which was reconstituted with one haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# W021181, expiration date 21-FEB-2025; dose and route were not reported) instead of sterile diluent (product preparation error, wrong product administered). No additional AE was reported (no adverse event).
AT 1:30PM, patient got first Moderna shot. Around 2:15pm, felt numb/tingling in the left arm then spread to the right hand. Monitored patient for 1 hour with no signs of improvement. Patient states pain level is 6-8 out of 10. At 3:15pm, referred patient to seek urgent medical care. Patient does not want to contacted.
fatigue lasting 4 days and counting, headache, nausea,; headache; nausea; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch no: FR8730) via unspecified route of administration in the left arm on 26Mar2021 at 10:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine headaches. Concomitant medications included citalopram (MANUFACTURER UNKNOWN), erenumab (AIMOVIG), simvastatin (MANUFACTURER UNKNOWN) and mirabegron (MYRBETRIQ); all from unspecified dates for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch no: EN6206) via unspecified route of administration in the left arm on an unspecified date in Mar2021 at 12:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 06:00, the patient experienced fatigue that lasted 4 days and counting, headache and nausea. No therapeutic measures were taken for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue, headache and nausea were recovered with sequalae.   No follow-up attempts needed. No further information expected.
Started 5 days after vaccine with dizzyness, nausea, sever headache, stabbing pain in left thigh, and continued soreness left arm at injection site. Has doctors appointment on 03/15/2021
pt recv vax vax 4NOV98 & 1 1/2-2hr p/vax arm became sore;several hr later swelling to arm w/redness & heat;to local ER had allerg rxn;arm red, swollen above elbow, hot to touch;
PATIENT DEVELOPED ITCHING, REDNESS, SWELLING, AND HOT TO TOUCH ON INJECTION SITE. REACTION MEASURED ABOUT 50MM IN LENGTH AND 40MM IN WEIGHT.
Information has been received from a doctor of dental science concerning a patient who on 26-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (therapy route and lot # not provided). The patient developed a 4 cm red and swollen area at site of injection after administration of ZOSTAVAX (Merck). The patient also developed oral herpes simplex 1. Patient sought medical attention via office visit. At the time of reporting, the patient was recovering. Additional information has been requested.
Information has been received from a physician via a company representative referring to a 63 year old male patient. On 13-MAY-2016 the patient was vaccinated with ZOSTAVAX (dose unknown, lot # L037790, expiry date: 30-DEC-2016, subcutaneous). On 24-MAY-2016, the patient exhibited unspecified symptoms of Guillain-Barre syndrome. The patient was admitted to an unspecified hospital on 24-MAY-2016 for an unspecified length of time. There was also treatment given for the event. Magnetic resonance imaging (MRI), electrocardiogram (EKG) and computerized tomography (CT) scan were performed and the results were not reported. The patient had not recovered from the event. Causality was not provided. Upon internal review, Guillain-Barre syndrome was determined to be medically significant. Additional information has been requested.
Tingling fingers on side of injection. No pain at site elsewhere in arm. Felt fine on injection.
Patient is a 24-year-old male with a history of hearing loss who presents with chest pain x7 days.  Patient reports achy chest tightness is nonradiating times 10 days.  It is worse early in the morning.  He reports that is improved now but does report some gas and burping.  Patient denies any fever chills or body aches.  Patient denies any family history of cardiovascular disease.  Patient does report receiving his COVID vaccination 12 days ago.  This was the 2nd of 2 of Moderna.  Patient works as a landscaper.  Pt was admitted for evaluation and discharge with diagnosis of Viral Pericarditis with instructions for follow up with Cardiology.
This spontaneous report as received from a pharmacist via Poison and Drug Center (Case # US16-002654), refers to a patient of unknown age (reported as possibly over 65 years old) and gender. The patient's medical history, concurrent conditions and concomitant medication were unknown. On an unknown date (reported as approximately 3 to 4 weeks ago), the patient was accidentally vaccinated with a dose of VARIVAX (Merck) (route of administration, dose, frequency, lot number and expiration date were unknown) instead of ZOSTAVAX. ZOSTAVAX was not administered. The patient's lab diagnostic studies were unknown. At the time of reporting, the outcome of the event was unknown and it was unknown if the patient would continue VARIVAX (Merck) vaccination. Additional information is not expected as the reporter declined to provide her contact details.
Pt recvd vax 27APR92 & w/in 30 mins following vax exp chest tightness, bronchospasm & wheezing; also exp weakness, aching sensation throughout & general washed out feeling;
Pt vax /w Engerix B 1st dose, sameday felt burning sensation down arm & to middle finger which continued for a wk. 23Jun90 felt tired, had rapid heart beat, dizziness, nausea, Saw Dr results of labs normal, condition resolved /w out tx.
pt rcvd vax; area of vax was reddish, endemic, itchy & painful to touch;
Patient has 2 Immunization Information System profiles. The profile checked prior to vaccine administration had 1 moderna vaccine listed. The other profile (discovered when looking up this dose) had the primary series listed. Vaccinator thought the patient needed a second dose and administered that dose. However, patient should have received a bivalent booster because the patient had a primary series documented on another profile in Immunization Information System.    On February 24th, nurse was called to resident's room at 1440 with reports from the CNA that he "wasn't breathing." Upon approach, resident found to be pulseless and without respirations. At 1345, resident was awake and alert, as CNA stated that he gave him fresh water at that time. At 1442 CPR and AED initiated as well as oxygen via ambu bag with manual resuscitator. 911 called, as resident was a full code. Dr. present in room at 1450. Family called at 1452 (this RN spoke with sister) and informed her that resident was found pulseless and without respirations and that CPR had been initiated, and continued despite no return of spontaneous circulation. Sister was tearful during call, but agreed to stop CPR. TOD: 1454, resident was pronounced by Dr.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 27th February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a day after receiving SHINGRIX, the patient experienced fever, shivering, stomach pain, headache and tension headache. On an unknown date, the outcome of the fever, shivering, stomach pain, headache and tension headache were not recovered/not resolved. It was unknown if the reporter considered the fever, shivering, stomach pain, headache and tension headache to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient's wife who stated that the patient had fever, shivering, stomach ache, headache and he felt like wearing hat way too small. The reporter inquired if the patient could TYLENOL or something else for treatment. The reporter denied providing the prescribing physician's information.
4/5/08 - When she got the vaccine, her legs had swollen moderately and were real sore/stiff that night.  Then that night she threw up a lot in her bed/hair and did not wake up. Then several nights over the next 8 wks she threw up at night twice, awoke crying/moaning 3 nights, wet her bed once.  Then 6/2/08 she slept in our room and awoke at 4:45am with a shreak, we found her with increase tone, choking on her tounge, then had tonic/clonic movement of her whole body (seizure) for 60 sec.  Pt was found to have B inguinal hernias 5/30/08 - appt with peds Neurology felt the seizures likely exacerbated a congenitally weak area.  My husband and I are family physicians wanted to think the seizures were unrelated to her shots until a class mate had a witnessed seizure 3 wks after her shots and an acquaintance at church's 5 year old had new onset seizures.   Prior to this we have had 2 kids (one with shots at our office and one at the health dept) with marked local swelling/stiffness/pain lasting 2 days. My husband and I continue to give shots - but with trepidation - our fear is the varicella booster is causing some type of encephalitis. 7/1/08-records received for DOS 6/10/08-Impression:recent onset seizures  consistent with partial epilepsy. Seen for neurological evaluation regarding seizure spells. Doing well until one week prior to visit with witnessed seizure, turned to left side, rhythmic clonic activity involving left side with eyes turned upwards and to right side. Teeth clenched, breathing pattern erratic. Later C/O abdominal pain and leg soreness. In May woke up several times during night C/O headache or abdominal pain. Follow-up: Pt continues to have abnl EEG, Dx as partial complex seizure multifocal foci. She taken to hospital 2x/day recently increased due to night terrors and sleep walking. We were planning to apply to the Vaccine Compensation Program prior to getting this with the encouragement of our pediatrician.
On January 29 patient notice his upper right arm developed redness, swelling, warmness and tenderness to touch. He went to Hospital and the Physician diagnosed him as having a cellulitis. He was admitted immediately and treated with I.V. antibiotics. He stay at Hosp 4 days.
I experienced braxton hicks contractions that would not subside, the estimated date of delivery is 12/22/2021.