chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was received an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 16-Aug-2021 from a Physician via Global Medical Information (Reference number- 00725599) and transmitted to Sanofi on 16-Aug-2021.  This case involves a nine-year-old female patient reported that patient was gave an expired IPV (VERO) [IPOL] with no adverse event (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 02-Aug-2021, the patient received 0.5 mL (total) dose of suspect IPV (VERO) (Oral solution) [lot R1D97, expiry date 17-Jul-2021] via intramuscular route in the right deltoid for prophylactic vaccination.  It was reported that, 'Caller stated they gave an expired dose of IPOL to two children. Caller is wanting to know if the doses will need to be repeated. Both children received the dose on 8/2/21."  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received concerning a male pharmacist who post vaccination experienced some mild flu like symptoms. In follow up the pharmacist reported that the flu was going around, so the injection probably didn't cause the problem
Tested positive with Covid19; Tested positive with Covid19; Fever; Loss of smell; Muscular pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at single dose for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced tested positive with covid19, fever, loss of smell, muscular pain in Jan2021.  The outcome of events was unknown.  Information on the lot/batch number has been requested.
Patient states that she experienced redness, swelling, itching and warmth at injection site. Beginning 2 weeks post vaccination. Patient reports that area of redness was approximately 6 inches in diameter.   Symptoms lasted 3 days.
admitted to 8/10/2021. Case has not been interviewed. As of 8/20/2021,  she is still admitted to a regular nursing unit.
IN 5 minutes the patient  began to have "a wave of tingling, starting in my feet and going to my head.   my tongue feels funny and tingling too"  was given 2  25 mg of benadrly  po with water  watched pt for 10 more minutes and she states it " starting to do it "  Was  placed in a wheel chair and transported to the Emergency room.  There  she was placed on a monitor, IV started and was given  Pepcid 20mg IV and Decadron 10mg .  She was monitored for 2 hours and given a liter of IV fluid   Then was released to go home with Discharge instructions from the ER staff
pt recvd Engerix-B on 28NOV90, 28DEC90, 28MAY90 & pt reported as being a nonresponder;
Tinnitus in both ears, started 01/13/2022 and has not stopped.
After waiting 15 minutes, patient got up and started shopping. She came back to pharmacy and reported feeling ill: dizzy, headache, nauseated. Rx Tech checked blood pressure which was very high and heart rate also.  We called for an ambulance. Rechecked blood pressure after 5 minutes and it was 187/120 which was even higher than initially. Patient was transmitted to the hospital. No additional report on current status.
headache from 2 pm 18th of January to evening 19th of January, fever,  pain in the left arm until 20th of January.  I did not take any medicine, just took a rest home.
On 01/07/2022 the patient, inadvertently received the Moderna booster vaccine (0.25ml) in the left deltoid. Parent expressed she is  a medical doctor and insisted the daughter receive the Moderna booster. Both the site supervisor, Dr. , and the parent of the patient, were notified. When asked if the patient was showing any symptoms the parent explained that the patient had been sleeping. Parent was advised to seek medical attention if the patient developed signs/symptoms.
Vasovagal response after administration of vaccine. It was given in the left arm, patient got up & walked 20 steps, stood still, & passed out. Pupils dilated, pale skin coloring, and dizziness with headache.
HEAD CONGESTION; SINUS INFECTION; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION and SINUSITIS in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION and SINUSITIS. At the time of the report, NASAL CONGESTION and SINUSITIS outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include medication for cholesterol problems, medication for thyroid problems, and pill from keeping the heart raising.  Treatment information include Antibiotics.
extreme body fatigue,  chills (~10 hours); heavy/sore arm (48 hours)
Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with Influenza virus vaccine 2007/2008 (manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient had an antibody titer value of 113, 160, 160, and 160 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient did not have 4-fold increase in titer value and tested negative for seroconversion of A/H3N2 strain but PCR (polymer chain reaction) tested positive. Therefore this patient was considered as an LCI case of Influenza A/H3N2. The outcome was not reported.
This spontaneous report was received from a healthcare worker referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L013064 with expiration date of 14-APR-2017, lot # L024251 with expiration date of 30-JUN-2017, lot # L035124 with expiration date of 14-SEP-2017 and lot # L0141207 with expiration date 20-OCT-2017 (anatomical route of vaccination and dose number were not provided. No adverse event was reported due to vaccination with (Oka/Merck) VARIVAX and no product quality issue was involved. This is one of several reports received from the same source. Additional information has been requested.
Janssen COVID-19 Vaccine EUA Approx 20 hours later the headache and some body aches and feeling tired  Approximately 26 - 30 hours later noticed my hands really swollen and took rings off * Approximately 48 - 52 hours later very heavy dark slightly clotty nosebleed while eating dinner (no previous issues in years of having a nosebleed)
LOC from sitting position approx at 0858 lasting maybe 30 seconds. HX LOC. Possible head trauma with fall. No notable bruising/deformities upon assessment. Patient a&ox4, patient denies thinners. EMS called and arrived 0915.
Patient experienced vivid dreams/hallucinations.  He also experienced fever, shivers and flu like symptoms.
Information has been received from a pharmacist concerning a 4 year old male, with no medical history, who on 05-Dec-2006 was vaccinated with a dose of ProQuad (upgrade process). Suspect vaccination administered on the same day included a dose of hepatitis A virus vaccine inactivated. It was reported that on 05-Dec-2006 the patient had an allergic reaction to ProQuad (upgrade process) or hepatitis A virus vaccine inactivated. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
She got Moderna's covid vaccine first shot and for her second dose she got Pfizer covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (She got Moderna's covid vaccine first shot and for her second dose she got Pfizer covid vaccine) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (She got Moderna's covid vaccine first shot and for her second dose she got Pfizer covid vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (She got Moderna's covid vaccine first shot and for her second dose she got Pfizer covid vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment information was provided.  Reporter's comment: She states that she can not fill out 3-4 pages of the form. She would like for someone from safety to call her and  for safety to fill out the form while on the call with her.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Significant follow up appended On 05-Aug-2021: Non significant follow up. Reporter's comment added. Corresponding fields and narrative were amended accordingly. On 05-Aug-2021: Non-significant follow- up . no new information received.
SPONTANEOUS ABORTION; MATERNAL EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer concerned multiple patients. 'This case reported 49 instances of miscarriages post vaccination.' No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The patients were pregnant at the time of vaccination (maternal exposure during pregnancy). The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. The date of the patient's last menstrual period and expected delivery date were not reported.  On an unspecified date, the patients experienced miscarriage (spontaneous abortion). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spontaneous abortion and maternal exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210924179-Covid-19 Vaccine Ad26.CoV2.s-Spontaneous Abortion. This event(s) is considered un-assessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0-20210924179-Covid-19 Vaccine Ad26.CoV2.s-Maternal Exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Painful, firm, swollen, red region at & just distal to injection site. First appeared ~6 days after 1st dose and again 2 days after 2nd dose. After 1st dose appearance, went to urgent care clinic and was suspected to be cellulitis and prescribed antibiotic.
PATIENT GOT OFF DAD'S LAP AFTER SHOTS STARTED TO HAVE SEIZURE LASTED 20 SECONDS.  ASKED DAD IS THIS EVER HAPPENED AFTER HER SHOTS. HE SAID NOT.  BUT A YEAR AGO HE HAD A SIMILAR REACTION WHEN HE WATCHED HIS MOM HAVE BLOOD DRAWN.  ADIVISED HIM TO SEE HIS PEDIATRICIAN AND A NEUROLOGIST.
Child developed crops of small papules with occasional small vesicular lesions on the trunk and extremities, the day after immunizations were given. Denies any fever. Child is irritable at times, itchy. Mom reports that he is eating, drinking and playing intermittently. Pt was given Benadryl by mouth while at the clinic which he had to continue every 6 hours for the next 5-7 days on recheck. Mom advised to seek medical help at ER as needed over the weekend and at office. Otherwise, will recheck him in 4-5 days.
Swelling, redness, pain right thigh 18 hours after DTaP vaccine at the site.
This is a prospective pregnancy case. This 32-year-old female subject was enrolled in an open label study titled FLUARIX, FLULAVAL, FLUARIX QUADRIVALENT, FLULAVAL QUADRIVALENT Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX OR FLUARIX QUADRIVALENT or FLULAVAL or FLULAVAL QUADRIVALENT during pregnancy or within 28 days preceding conception. On 10th February 2014, the subject received Flu Seasonal QIV Dresden at week 9 of the pregnancy and during the first trimester of pregnancy. On an unknown date, an unknown time after receiving FLUARIX the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the vaccine exposure during pregnancy to be related to FLUARIX. Caller reported that she received a FLUARIX 2014-2015 season vaccine while she was pregnant. No AEs were reported.
102 fever that night body aches that night slight, dry cough  chest tightness/pains stomach pains/cramping loose stools x 4-5 over 2 days nausea (vomited the next morning x 1, but this may have been a migraine??) headache with the fever and the next morning generalized weakness/malaise  Could not go to work the next day.
First night I awoke with shaking chills, woke up the following morning with extreme pain in my left arm and all of the lymph nodes under arm were severely swollen, red, and very painful; had terrible achy joints, fatigue all day. The second night after the shot I awoke drenched in sweat but wasn't hot; awoke the following day with severe aches, lethargy, and lymph nodes still terribly swollen.  The aching joints moved into my left hip where I had a replacement 7 months ago and the pain was horrible. It then moved into my lower back, consuming all of my lower body. I could hardly walk and it hurt to breath. I took OTC meds for pain and applied pain gel to my joints. I subsequently went to my hip surgeon who gave me a pain and anti-inflammatory injection in my hip to relieve the inflammation and discomfort, and has put me on an 8 day regiment of prednisone to address the extreme inflammation.  I then followed up and saw my primary care physician today for a check of my symptoms and to get on my medical records.  I now have a follow up appt. with a back orthopedic doctor to check my back for any damages.
Orchitis (unilateral) rt swelling, discomfort, redness; no fever; No rx necessary;
Shaking in lt hand progressed to lt arm; Then shaking rt hand progressed to rt arm. Eyes rolled back pt non-responsive; Episode lasted 1-2 min, less responsive-sleepy rest of day;
lower abd pain, gas, diarrhea, cramps, upper G.I., lower GI, blood work;
client complained of onset of throat irritation and tingling sensation of tongue approx 10 mins after injection.  Symptoms resolved completely after administration of diphenhydramine IM.
Erythema at injection site began within 24 hours. By 48 hours patient had 20cm x 10cm erythematous, indurated local reaction. This spontaneously resolved over 4 days.
the patient fell and slightly hurt her left arm (same arm she got the first shot in); the patient fell and slightly hurt her left arm (same arm she got the first shot in); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 10Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FALL (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "the patient fell and slightly hurt her left arm (same arm she got the first shot in)".  Additional Information: The patient reported that her arm was still a little bit sensitive because of the slight hurt and she wanted to know if she has to get the second shot in this arm. The patient's second dose was scheduled on 04Mar2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed mild fatigue, headache, body aches within 24 hours of vaccine. Symptoms resolved within 48 hours after vaccine administration. Did not require any medical care and interventions.
p/ pt recv vax pt devel dime sz rash on forehead, then presented @ clinic w/itchy maculopapular rash over body & edema of the forehead. approx 19 days later still had rash, been fussy 6dys. dx w/mild acute gastroenteritis. treated w/meds.
No additional information provided; Primary care Physician has assured to the patient he will write a prescription of gardasil9; This spontaneous report was received from a 60-year-old male physician assistant reporting on himself. The patient's, concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant therapies were not reported .   The physician assistant stated that his primary care physician had assured to he that the physician would write with a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot#, expiration date and route were not reported) prescriptionon on 27-APR-2021, when the phisician would see him. No additional adverse event information reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2104USA001494:
Chills; Fever; Aching; Horrible headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills, fever, aching, horrible headache all on an unspecified date with outcome of unknown.  The patient wanted to know if could take Tylenol.
Stiff Arm  Headache Scratchy Throat Sore Throat  Cough Elevated Tempature  Paleness
This spontaneous report as received from a physician via a field representative refers to a "60-61 years" old female patient with rheumatoid arthritis. "2-3 days ago", in approximately 07-JAN-2013, the patient was vaccinated with 0.65 ml ZOSTAVAX (lot # not reported). The patient developed "mild erythema with itching" after getting ZOSTAVAX. It was unspecified if it was at the injection site. The patient sought for unspecified medical attention. CLARITIN was given for itching. The outcome of mild erythema with itching was unknown. The relatedness for mild erythema with itching was unknown for ZOSTAVAX. Additional information has been requested.
Debilitating pain in left shoulder and neck, extreme fatigue. I had just had blood tests done the prior week and all was fine for all conditions.
This medically confirmed spontaneous report (initial receipt 28-Oct-2014) concerns a 33 year old male patient. On 26-Oct-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-Oct-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-Oct-2014, the patient received temperature excursioned AFLURIA, (batch number: T50507) via intramuscular route at 0.5 ml. No adverse reactions were reported since administration. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Patient received vaccines on Friday afternoon at 3:00 PM and the patient woke up the following morning (Saturday) with localized swelling, redness and pain to both injection sites on the upper deltoids. The following day (Sunday) had full body urticaria rash which subsided only with Benadryl and Allegra but still had localized swelling and redness to upper deltoids. Patient came into the clinic on Monday due to swelling and redness had not subsided on both injection sites.
Employee developed  short-lived "cold symptoms" and had possible exposures Tested positive for Covid 19 on 3/31/21 and on repeat test on 4/2/21
p/vax pt exp an inj site rxn 6 inches in diameter w/swelling, redness & warmth;
Test positive for Covid-19 9-1-21 Fully vax 2w after 6-15-21
1st dose on 02Dec2019 and not received 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 02nd December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by the pharmacy student. The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix at primary reporter's facility. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. No vaccine data was available. The reporter consented to follow up.