chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired pentacel was given with no reported adverse event; Initial information received on 07-Jul-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 1-year-old male patient to whom expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE for Prophylactic vaccination; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination.  On 05-Jul-2023, the patient received 0.5 ml total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (strength: unknown) (lot: UJ672AAA, expiry date: 27-Apr-2023) via unknown route in unknown administration site for immunization.  On 05-Jul-2023 the patient had an event of expired pentacel was given with no reported adverse event (expired product administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  It was unknown if any lab data/test results available.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  Outcome: Unknown    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 the 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.
I had a fever, headache, aches and chills the next day post vaccine administration. A felt flushed throughout the next week. A week after my booster shot I became tachycardic in the 160s while standing. I worked out later that day and had to stop - it felt as though I had a cylinder block sitting on my chest. The last few days I have had a dull ache in my chest.
This spontaneous report as received from a physician refers to a 14 year old male patient with no pertinent medical history. On 11-JUL-2014 the patient was vaccinated with GARDASIL, injection (lot# and expiration date not provided) (1 single shot), intramuscularly. On 11-JUL-2014, after receiving GARDASIL the patient stood up, became dizzy and went to the bathroom to throw up. No diagnostic tests were reported. The patient did not seek medical attention. There was none treatment given for the all events. The outcome of "stood up, became dizzy and went to the bathroom to throw up" was reported as recovered/resolved, on 11-JUL-2014. The relatedness between the events and GARDASIL was not reported. Additional information is not expected, because there was no permission to contact the doctor.
At a mobile vaccination clinic event, the patient presented asking for the Bivalent Pfizer COVID-19 vaccination. She showed a picture of her COVID-19 Vaccine Record Card showing her primary series and monovalent booster. She did not report, nor show record of the bivalent booster she received on 9/2/22 at another facility. Patient was instructed to monitor for side effects and to report them to us, along with any questions she may have.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 03Feb2021 as dose 2, single (Lot number: EL3247), in right arm and on 30Sep2021 as dose 3 (booster), single (Lot number: FF2985) at the age of 33 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "gastric bypass 2018" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Wellbutrin, reaction(s): "known allergies: wellbutrin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: the patient was treated with Paxlovid for Covid-19 from 12Dec2022 (also reported as 13Dec2022).; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event Vaccination Failure and COVID-19 cannot be ruled out.
Injection site reaction. Left upper arm has cluster of 5mm red circular, raised bumps. Area of 5 cm swollen, painful and pruitic. Patient reports weakness and achy joints. Patient denies fever.
Whole body was very sore, like I had been doing a very rigorous full body workout. Also I had a very bad headache.
received shot on Friday by Monday night had 101 temp.  Chills, Headache, body aches, fever reached 102.6  called Dr. received Zithromax. Every syptom of the flu.  Now have cough. Out of work 2 days (should have stayed out longer, couldn't).
Hives on hands after injection, and hives in random places every other day since injection; This is a spontaneous report received from a non-contactable reporter (consumer). The reporter is the patient.   A 32-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 04Nov2021 at 15:45 (Batch/Lot number: UNKNOWN) at the age of 32 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history included: "Hypothyroidism"; "Herpes simplex type II", notes: (hsv2); "Fruit allergy", notes: Known allergies: Bananas; "Milk allergy", notes: Known allergies: Milk; "Egg allergy", notes: Known allergies: Eggs and "Allergy to plants", notes: Known allergies: Cilantro, lemongrass (unspecified if ongoing). Concomitant medications included: LEVOTHYROXINE; WEGOVY and OMEPRAZOLE. Past drug history included: Codeine, reaction: "Drug allergy", notes: Known allergies: Codeine. The following information was reported: URTICARIA (non-serious) with onset 04Nov2021 at 18:00, outcome "unknown", described as "hives on hands after injection, and hives in random places every other day since injection". Therapeutic measures were not taken as a result of urticaria.   Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I received the Moderna COVID-19 Vaccine EUA on December 28 at 3:30 PM.  Starting at 4:30 AM today (December 29), I started to have chills, followed by fatigue, headaches, muscle pain, joint pain, chills, nausea and vomiting.  I vomited twice.
pt recvd MMR vax & had a syncopal or vasovagal episode; pt recovered w/o any residula effects; No further details were provided; MD reported 20 pts;
I received the Covid booster 09/19/21 at 12:30 PM ,was light headed and nauseated at 6PM 9/20/21. BP at 6:03 PM 89/70,83/64,89/70. AT 0600 started to have severe abdominal pain,unrelieved by Nexium,TUMS,Bentyl. I called for help to go to ER and it wasn't till 0830 that neighbors came. I was in severe pain and had mushy stools and emesis and they called emergency. I was taken to Hospital  around  0930-10:30 and given Tylenol  and Pantaprazole infusion without relief and given Morphine drip.I was admitted and I started to have bloody diarrheaat 4:30 pm that continued till 0130 on 9/22.  Colonoscopy and EGD done and Dx : Ischemic Colitis. Discharged 9/23/21
PAIN DEVELOPED IN VACCINATED ARM THE DAY AFTER THE VACCINE.  PAIN HAS PERSISTED FOR 1 WEEK.  PAIN MOVES FROM VACCINATION SITE UP THE SHOULDER.  CONCERNED THAT PAIN HAS PERSISTED SO LONG.  THERE ARE NO VISIBLE SIGNS OF PAIN.  NO RASH OR REDNESS.
Severe aching at joints or arms and legs, severe chills, 104.3 fever.
I feel weird, kind of spacey; metallic taste; Blood pressure 133/90.; This is a spontaneous report from a contactable nurse.  A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), intramuscular on the left arm on 22Dec2020 14:15 at SINGLE DOSE as COVID-19 vaccination at the hospital.  Medical history included reactive airway disease, attention deficit hyperactivity disorder (ADD) and asthma. The patient also had allergies to sulfa. Concomitant medications included losartan potassium (LOSARTA), methylphenidate hydrochloride (CONCERTA) and unspecified inhaler for asthma.  On 22Dec2020 14:25 (10 minutes after injection), the patient felt weird, kind of spacey and had metallic taste. The patient also had blood pressure of 133/90 (unit of measure not reported) on 22Dec2020 but denies urticaria, itching, pain, shortness of breath, and chest pain. The patient was brought to the emergency room/department or urgent care further evaluation due to the events. It was unknown if treatments were received for the events. Outcome of the events were unknown.   No follow-up attempts are possible. No further information is expected.
Pt recvd 1st Engerix-B 18SEP91 & exp urticaria x 1 wk;
Patient called that evening complaining of severe pain, nausea and chest discomfort. It had started a few hrs after vaccine administered. Patient planned on seeking medical attention.
This spontaneous report as received from a pharmacist refers to a female patient. The pharmacist reported that the patient was vaccinated with LIQUID PEDVAXHIB at ages of 2 months, 4 months, 6 months and 15 months. Dosing information, route of administration and lot numbers were not provided. No adverse effect reported. No other information was provided. Additional information has been requested.
Symptoms: red at injection site, stiff/swelling around injection site; painful to touch only at injection site. Developed the following day after injection.  Treatment - continue to monitor, ice as needed.
Information has been received from a physician concerning a 67 year old male with pertinent medical history and drug reactions/allergies reported as unspecified who on 06-Dec-2006 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot#655152/0889F). Concomitant therapy was unspecified. On 06-Dec-2006, the patient could not use his arm for almost a day. The patient sought medical attention. No lab diagnostics were performed. At the time of requesting, the patient was recovering. The phyisican considered the event to be disabling. Additional information has been requested.
14DEC93 pt recvd shot & that evening could not be touched w/o screaming, had a low grade fever 98.9-99.9; was taken to ER, was given liquid advil & colace stool softener to move bowels; fussy
Patient was fine after the Hep A vaccine but passed out 10 minutes after the shot. She fell into a chair in the office and knocked out her 2 front teeth. After the bleeding slowed and the nurses reviewing her, she was released but in a lethargic state from the adverse reaction to the vaccine. The lethargic state continued for 3+ hours after returning home with her making groaning noise and not seeming herself.
Patient was admitted on 10/2/2021 after being fully vaccinated in Feb 2021.
Beginning on Feb 10 at 4:15pm, my left upper arm where vaccine was administered began to itch mildly. Upon waking on Feb 11, I noticed 2-3 centimeters to the right of where the vaccine was administered was a swollen lesion  three inches in diameter. The itchiness has increased from the day before. The lesion is warm/hot to the touch.
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting,  Fatigue
4 days after vaccination fever 100.1, (Sat 3/28/15) night sweats the following evening. Fever resolved the following evening (Sunday 3/29/15).
Shoulder pain began approximately 48 hours after injection.  It has persisted for over 3 weeks, and is now worsening.  I cannot lift my left arm without significant pain, and the pain also is causing sleep disturbance.  The injection was quite high on my shoulder, near the shoulder joint.  The person who administered the shot was standing and I was seated.
Client received Pfizer in January and had a significant reaction, including hives for several days and a chest pain with a subsequent diagnosis of cardiomyopathy.  She consulted with her provider who recommended that she try to take some Miralax to see if she had a reaction, which she did, including swelling of her face/lips.  She states that her provider then recommended the Janssen as a second dose instead of the Pfizer.  Client received the vaccine at 12:12 pm, noticed two small hives on her left forearm a few minutes later, and then reported that she did not feel well at 12:20 pm.  She was placed on a cot with a BP reading of 130//72, P -88, O2-99%.  She took some oral Benadryl that she brought at 12:30 pm.  She reported that her face felt "funny" and she felt hot, but started to feel better when she laid down.  12:40 pm BP 118/76, P-82, O2 98%.  Client reported that her throat felt a little scratchy, but that she was also very anxious.  12:50 pm Client reported that she started to feel better.  12:52 pm O2 98%, P - 80. 1:00 P- 85, O2 99%.  Client felt well and left with her father.
PATIENT GIVEN MORE THAN PERSCRIBE DOSAGE,  10/19/23 @ 4:39 PM. NO SYMPTOMS TO REPORT
Chills, fever, extreme muscular pain all over enter body, extreme fatigue, migraine, stabbing pain in inner ears. Most severe symptoms persisted for 2 days and began to subside on day 3. Fatigue remained for an additional 2 days for a total of 5 days.
Patient received PREVENAR 13 shot on 9-22-18. On the next day she returned with a noticeably swollen arm. She says that she had an immediate reaction to the shot. Re: right arm. Her arm has shades of red and blue.
Initial report received from a healthcare professional on 27 October 2014. A 60-year-old female patient had received a dose of FLUZONE QIV, batch number-UI196AA, intramuscularly in left arm (dose and dose in series was not reported) on 29 September 2014. It was reported that the patient had denied the illness at the time of vaccination and had allergies to PCN. Cipro and Tetracycline. The patient had yearly received the flu shots vaccine. On 30 September 2014, one day after vaccination the patient experienced fever 101, nausea, 'dizziness', 'achyness', increased sensitivity to noise, irritability and burning sensation down both forearms. Reporter initially did phone evaluation on 30 September 2014. Nausea was reported on 10 October 2014 and other symptoms on 15 October 2014 during routine visit. The patient was vaccinated. Complementary investigations were not reported. On an unspecified date TYLENOL and ibuprofen was prescribed for fever and aches. On an unspecified date the patient was recovered from the event. Documents held by sender: none.
After waking up this morning, I initially felt fine, but now at work, I am feeling muscle soreness in my back. It's most prominent in my lower back, but I can also feel it in the center of my back. Pain is maybe a 2 or 3, so not serious. I did not experience any symptoms after my first 2 doses except a sore arm.
Feet are swollen and she has some purple color marks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Feet are swollen and she has some purple color marks".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started experiencing tingling April 21st. Bell's Palsy April 29th. Started to see peripheral neuropathy over next couple months. Diagnosed CIDP in August
blurred vision in my left eye due to extreme dryness; blurred vision in my left eye due to extreme dryness; have difficulty raising and lowering my arms at times; arms and legs below the knees developed small sores that then became rough textured rash that sort of looked like eczema; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jul2022 at 14:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hyprthyroidism" (unspecified if ongoing); "cancer" (unspecified if ongoing); "CHF" (unspecified if ongoing), notes: CHF. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EL3246, Vaccine location: Left arm), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: EL3246, Vaccine location: Left arm), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FE3590, Vaccine location: Left arm), for COVID-19 immunization. The following information was reported: ECZEMA (non-serious) with onset 04Aug2022 at 12:00, outcome "not recovered", described as "arms and legs below the knees developed small sores that then became rough textured rash that sort of looked like eczema"; VISION BLURRED (non-serious), DRY EYE (non-serious) all with onset 2023, outcome "unknown" and all described as "blurred vision in my left eye due to extreme dryness"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 2023, outcome "unknown", described as "have difficulty raising and lowering my arms at times". The events "arms and legs below the knees developed small sores that then became rough textured rash that sort of looked like eczema" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eczema.  Additional information: For about two weeks the patient's arms and legs below the knees developed small sores that then became rough textured rash that sort of looked like eczema but not quite. Her dermatologist ordered creams to apply, but after three tubes of use there were no changes. Has not abated as of this date. She also now have blurred vision in her left eye due to extreme dryness. She had difficulty raising and lowering her arms at times. She was a retired nurse and this skin condition does not look like any eczema she had ever seen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination were prescribed medications.
Client became nauseated and  lightheaded .Skin pale, warm and dry to touch. Alert with no loss of consciousness. Assisted to floor mat, legs elevated and provided with food and water. B/P monitored. Peripheral radial pulse strong and regular. Respiratory status nonlabored. Client felt better gradually and then released after verbalized feeling better.
breakthrough bleeding after the Moderna booster dose after being menopausal for 4 years; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (breakthrough bleeding after the Moderna booster dose after being menopausal for 4 years) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004FZ1A, 041L20A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Menopause (for four years.), Heartburn, Nausea and Rheumatoid arthritis. Concomitant products included OMEPRAZOLE for Nausea and Heartburn, PREDNISONE for Rheumatoid arthritis, LEVOTHYROXINE SODIUM (SYNTHROID), ACETAZOLAMIDE, GABAPENTIN, BENZONATATE, CLONAZEPAM, FOLIC ACID, LEFLUNOMIDE, FAMOTIDINE (PEPCID AC), MILNACIPRAN HYDROCHLORIDE (SAVELLA), VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]), ZINC and RITUXIMAB (RITUXAN) for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (breakthrough bleeding after the Moderna booster dose after being menopausal for 4 years). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (breakthrough bleeding after the Moderna booster dose after being menopausal for 4 years) had not resolved.            No treatment medication was reported.   This case was linked to MOD-2021-406624 (Patient Link).
flu like symptoms; chills; body aches; fever; nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Hospitalisation) in January 2020, Hospitalisation from 05-Jan-2021 to 13-Jan-2021 and Limb hyperextension. Family history included Polycystic kidney.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Oxygen saturation: 20% (abnormal) 20%.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Family history included PKD. Patient remained negative.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-413845 (Patient Link).
pt recvd vax 8JUN95 & 26JUN95 devel a fever, malaise, stiff neck, h/a, skin rash on face, shoulders, breast, scalp, arms & legs;no further details were provided;
Information has been received from a licensed practical nurse referring to an unspecified patient of unknown age and gender. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9 (lot# was reported as L014239, expiration date 21-JUL-2017, dose and route were unknown). No adverse effects reported. Additional information has been requested.