chrisvoncsefalvay/vaers-outcomes huggingface dataset:
have administered expired PENTACEL to a patient with no reported AE; Initial information received on 11-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics who received vaccine DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL] and it was reported that have administered expired pentacel to a patient with no reported ae (adverse event)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2022, the patient received an unknown dose of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (formulation, strength: unknown) lot UJ569AAA, expiration date: 02-Oct-2022 in unknown administration site as Immunization.  On 10-OCT-2022 the patient was administered expired pentacel with no reported ae (expired product administered) same day following the administration of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (have administered expired PENTACEL to a patient with no reported AE).  At time of reporting, the outcome was Unknown for the 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 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.
Heart arrhythmia, skipped beats (usually every fourth beat), and palpitations starting about 2 days after vaccination, and lasting about 4 weeks. Eventually resolved on its own before date of doctor's appointment with cardiologist was reached. In addition, fatigue, flu-like symptoms
Pt received vaccine 10/15/17 pt had redness, swelling and warmth at site (of ZOSTAVAX). Pt went to urgent care and was prescribed BACTRIM DS on 10/17/17.
On 3/20/17 (L) tricep YF-VPX; called today 3/27 with erythema, itchness to site but no fever.
REPORTED SLIGHT LIP SWELLING AND SOME DIFFICULTY SWALLOWING, PATIENT TOOK BENADRYL 25 MG ORAL DR OFFICE NOTIFIED, SPOKE TO EMPLOYEE
Patient complained about soreness in his arm at the site of the injection.  No redness or swelling was observed.  He seemed okay Friday night.  Woke up on Saturday 11/21 with a high fever 104 and cough.  I gave him a warm bath.  He drank some orange juice and had some chicken noodle soup.  I gave him alternating doses of acetaminophen and ibuprofen (2 each).  Within about 6 hours his fever dropped to just under 100.  When he woke up this morning his fever was back up around 102.  I gave him another warm bath and a dose of Acetaminophen.  I just read that he shouldn't be given acetaminophen following the vaccination so I'll switch to ibuprofen as needed.  As of 12:40 PM today Sunday 11/22 his temperature is normal.
06/25/09 - Started with multiple small vesicles on bottom. 6/26/09- Seen in office had started on trunk as well, some vesicles "blistered" culture done. Started on Acyclovir.
Developed myalgia, chills, and erythema and edema 4/7/2021. Erythema spread. Siince injection has been having bone pain, arthralgia, myalgia, headaches, injection site pain and paresthesias and fatigue. Started on cephalexin for cellulitis with some improvement in erythema but did not resolve and other symptoms continue to worsen
Tightening of the left side of the neck from shoulder to back of the ear. Painful burning and needle prick sensation. Pain extended to the left forearm. Very pain. Rapid back to back heart palpitation, dizziness, sweating, my legs weakened and couldn't walk properly. Went to the ED for this event. In the ED, the event happened again but not as intense. I insisted the check for myocarditis and Pericarditis.  I'm not clear if they did or not. Second vaccine dose caused intense pressure and soreness of the sternum and chest.  Difficulty breathing and increased BPN of 138-150 for 2 hours. Went to the ED again after the 2nd vaccine. The first event  occurred 3 days after the first dose. The second event after the 2nd dose. Then I started getting tightening of the sternum and clavicle. Short ness of breath.  Felt sore and tight.  Pain shot to my right breast/chest area.  Still happens to this day.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with an unspecified number of improperly stored doses of VAQTA (strength, dose, route of administration, lot# and expiration date were not reported). No information on patients concomitant medications was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Uncontrollable shaking/shivering, whole body ache, very bad headache, fever, pain breathing when laying on right side, upset.  Shaking lasted about 2 hours.  After taking 2 Tylenol, symptoms improved.
11 year old patient was given Flublok in the thigh, no AE; 11 year old patient was given Flublok in the thigh, no AE; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from Health Authorities.  This case involves a 11 year old male patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site.  It was actual medication error case due to inappropriate age at vaccine administration and vaccine administered at inappropriate site.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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 on the batch number was requested.
Day 1, I had severe muscle aches and stiffness, primarily in my neck. Day 2, started feeling "off" but aching subsided. By day 4, I was concerned to walk without holding onto a wall for fear of falling the dizziness is so bad. I can be simply sitting in bed and become very dizzy and feel "out of body" like I am not connected or something...it is very hard to explain, but I have never felt this way in my life. It is now day 5 and I am beginning to truly be afraid of driving.
I received the vaccine on Tuesday, On Thursday I woke up and my upper eye lid on my left eye was swollen and I couldn't open my eye all the way. My eye seemed to be fine itself. The course of the day, the swelling did not go down and started to get redder. On Friday, I had an appointment to go see my eye doctor. They checked my eye and there didn't seem to be a problem. So, I also had a virtual appointment with my Primary Care Physician and she had me put pressure on different points of my eye to see if there was anything that caused my eye to swell. So, she prescribed Erythromycin ointment to help with a possible bacterial infection with my eyelid. So, I used that 11/5 for a week. And the redness went away in about 24 hours. The swelling started to go away on 11/8/2021 but did not disappear completely until about 11/13/2021.
Two days after immunization, the infant became irritable and had a minor motor seizure. No fever noted and the exams were normal. The pt was observed as inpatient with no problems except for several episodes of vomiting.
Muscle pain and aches, mouth ulcers, vulva ulcers, extreme stomach pain. Headache.
Memory complaints and seizures, generalized tonic clonic x 2 day of vaccination; no prior seizure history.
Unable to urinate; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (Unable to urinate) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch nos. 006M20A, 028A21A, 031H21A and 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, received fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced URINARY RETENTION (Unable to urinate) (seriousness criterion medically significant). At the time of the report, URINARY RETENTION (Unable to urinate) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  It was reported that after the 1st dose either within the same day or the next day she had a hard time while urinating. This led to a lot of consultations with doctors. On 07-Nov-2022, the patient took dose 5 vaccine (062F22A).  Treatment medication was not reported. Company comment: This spontaneous case concerns a female patient of an unknown age, with no medical history reported, who experienced the unexpected and serious (medically significant) event of Urinary retention, on the following two days of the first dose of the mRNA-1273 vaccine, but since the event was reported with no exact onset date, latency could not be properly assessed No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-747047 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747047:SPIKEVAX  2023-2024 case
After receiving the Hib vaccine in the (L) thigh, pt developed a local Rx the size around as big as a baseball, red, swelling and warm to touch. Instructed pt mom to apply cool rag to site and give TYLENOL.
Swelling to the supraclavicular area underneath his armpits and in the suprapubic area as well as some swelling on the dorsal aspect of his feet. No redness tenderness or warmth.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2013, the patient was treated at a hospital for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Patient received second dose of Pfizer COVID19 Vaccine 1 week early. Received first dose on 7/23/21 and received second dose 8/6/21. No known adverse reaction/side effects at this time.
Received pre-employment vaccines (Hepatitis B and MMR) in left arm. The patient discovered a dull ache that extended from shoulder to forearm. No swelling redness or weakness in affected side. Has successfully treated w/ prescribed pain medication and over the counter pain medication. Massage has also been effective. Has not sought medical treatment.
Headache the next morning the light bothered me (it was similar to a migraine); Redness; Swelling; Pain; Rash; Itchy; The area was hot; Burning sensation in the left arm, underarm and left breast; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 08Sep2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, sinusitis, rhinitis and COVID-19. The patient had known allergies to latex. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication was not reported. On 08Sep2021, the patient had symptoms after the first shot which included redness, swelling, pain, rash, itchy, the area was hot, burning sensation in the left arm, underarm and left breast. Symptoms lasted more than three weeks. On 09Sep2021, the next morning, the patient had headache and the light bothered her (it was similar to a migraine). She still felt burning sensation sometimes (at the time of this report). The events resulted in doctor/other health care professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with an unspecified cream to control the skin reaction and paracetamol (TYLENOL) for other symptoms. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events redness, swelling, pain, rash, itchy, the area was hot, burning sensation in the left arm, underarm and left breast and headache the next morning the light bothered her (it was similar to a migraine) was resolving at the time of this report.
Seizure 1: Patient was having bilateral upper and lower extremity shaking, hands had rhythmic twitching and he was drooling and slumped over. Taken to emergency room, test revealed no apparent reason, referred to neurologist. Neurologist devised testing. MRI of the brain on Feb 2 was normal EEG on February 14, 2016, revealing generalized spike and slow wave discharges activated by hyperventilation and sleep. Second seizure: February 19, 2016, an episode of staring and falling to the ground with tonic-clonic movement lasting 1 minute. Diagnosed with epilepsy and put on KEPPRA 1000 mg b.i.d. and vitamin B6 25 mg daily.
PT STATED SHE WAS FELT DIZZY 15 MINS AFTER VACCINES WERE GIVEN. LAY PT WITH WITH BOTH FEET ELEVATED, PT STILL COMPLAIN OF TIGHTNESS IN THE THROAT. 7/22/2015 @1114  Code Blue called overhead to Immunizations Clinic. @1115  LCDR, HMCS, NP, RN, LVN, and MA at the bedside w/ pt. VS noted. 29 y/o DEP female c/o "tightness in throat" s/p MMR vaccine L tricep SQ by MA. No c/o SOB. Per LCDR, lungs CTA all lobes. Heart RRR. No oropharyngeal edema noted. Up O2 NRB @15LPM, SaO2 100%. @1125  Pt updated to POC by NP. Pt v/u and agrees to POC. Per NP's v.o., pt given Benadryl 50mg, IM INJ, L deltoid, by this RN. MANF: WESTWARD. LOT: 015383. EXP: 01/2017. Pt tolerated well. BP 104/60. HR 65. Per NP exam, lungs CTA, all lobes. No congestion. O2 stable on room air trial, SaO2 100% on RA. NRB d/c'd at this time. @1134  Pt c/o returning s/s of throat tightening feeling. Pt updated to POC by NP. Pt v/u and agrees to POC. Per NP's v.o., pt given EpiPen 0.3mg IM INJ, R thigh, by this RN. MANF: MYLAN. LOT 4GM460. EXP: MAR2016. Pt tolerated well. Up O2 NRB @15LPM, SaO2 100%. @1136  BP 110/68, HR 72, 100% NRB @15LPM, @1140  Pt transported to Tx room via W/C. Pt placed on gurney, side rails up x2. Blankets provided. @1145  SaO2 100% on NRB @15LPM. HR 72. MA and HN at the bedside. @1200 - Per MA, NP at the bedside. O2 NRB d/c'd at this time. @1210 - Pt resting comfortably. No c/o SOB, or tightness in throat at this time. BP 106/62, HR 86, O2 99% on RA.  Will continue to monitor. @1219 - BP 106/70, HR 83, SaO2 100% RA. @1225 - Pt up OOB to BR via W/C. No c/o at this time. NP at the bedside. @1230 - BP 106/60, HR 94, SaO2 100% RA. @1245 - Per NP's v.o., discharge instructions reviewed w/ pt and pt friend. Strict 911/ED precautions reviewed. Advised to f/u w/ PCM as needed. Pt/pt friend v/u and agree to POC. Pt d/c'd to home w/ friend to drive pt home. Pt transported to POV via W/C. NP updated.
Patient was transferred to me at 2:04pm reporting that she had her COVID-19 vaccine at OTC op center with you around 11:30 today- About 1.5 hours later, around 1pm, she noted slight itching at the injection site that had progressed to a ?warm feeling? in her neck with hive type rash.  She denied any breathing issues and reported having an allergy to strawberries, has rec?d vaccines in the past with no issues. She was on her way into town from home to get Benadryl and Zyrtec and was planning to stay in town to see if her symptoms resolved and stay by the clinic/hospital just in case. We called her back at 3:23pm and she reported feeling better-advised her to sign up for VSafe app., continue monitoring and f/u with ED if symptoms warranted.  She gave you permission to submit reaction into VARES on her behalf.
MOTHER REPORTED PATIENT BROKE OUT WITH RASH HEAD TO TOE SATURDAY EVENING- 24 HOURS RECEIPT OF VACCINATION. MOTHER TOOK PATIENT TO URGENT CARE THAT EVENING AND WAS INFORMED BY THE URGENT CARE MD THAT IT WAS AN ALLERGIC REACTION TO THE VACCINES RECEIVED ON 8/10/2018. HE RECEIVED PRESCRIPTION FOR ALLEGRA AND BENADRYL. MOTHER REPORTS THAT RASH IS GETTING BETTER WITH THE MEDICINE.
PT RECEIVED  BOOSTER DOSE OF MODERNA WHEN NOT AUTHORIZED FOR HIS AGE GROUP. MOTHER REPORT NO UNSUAL SIDE EFFECTS OTHER THAN SORE ARM AND BODY ACHE
Patient received vaccine for Influenza A/B on 11/5/2002.  Upon recent admission, respiratory culture was obtained and came back positive for Influenza A by FA.
Patient was vaccinated on 4/10/2021, with the Johnson & Johnson (Janssen) Covid-19 Vaccine. On 4/14/2021, patient had a stoke and collapsed, falling on her head & face at approiximately 3pm. No signs/symptoms prior to stroke & collapsing. Patient became hospitalized with internal bleeding in her brain and is still unresponsive. Unresponsive' in this case is defined as but not limited to: unable to be mobile / stationary in a reclined bed postion since the incident / no movement of upper & lower extremities / minimal reactionary response in eyes / unable to ingest food by mouth
Information has been received from a 28 year old female with latex allergy who on 01-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23. On 01-OCT-2010 ("within a few hours" of the vaccination), the patient noticed redness, swelling, pain within 2 inches from injection point. She also had soreness in her muscle and headache. There was no lab diagnostics studies performed. At the time of the report, the patient had not recovered from these adverse events. The patient sought an unknown medical attention. No further information is available.
circular red warm itchy arm rash around site, approx 10--11 cm diam treatment = antihistamines, topical hydrocortisone
Pt recv vax on 11/17/98; 2 hr post vax pt exp nausea, vomiting, chills, muscle aches & headache
Persistent cough, got progressively worse coughing up yellow phlegm, hot, then severe chills through the night.
Fever 99 degrees F. Sore shoulder, elbow. Left arm. Took MOTRIN. Next day felt nausea, chills, vomiting, headache.
pt recvd vax 2-230PM & awakened about 830PM screaming-high pitched  as if in pain; skin hot to touch & flushed; t98.1 R both legs swollen 2x size; pt began jerking head side to side & arms & legs; muscles spasm
Varicella Information has been received from a registered nurse concerning a 7 year old male with no pertinent medical history and no drug reactions/allergies who on 02-DEC-1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. There was no concomitant medication. On 08-SEP-2005 the patient was seen by a physician for a rash scattered over his trunk, axilla, and groin. No rash was noted on his face. No fever or other complaints were noted. The physician prescribed isolation for 5 days and treated symptomatically. The outcome was reported as no recovered. No lab diagnostic studies were performed. There was no product quality complaint. Follow up information received from a registered nurse indicated that the office note indicated "florid varicella rash in crops: trunk red axilla red groin". Total number of lesions was noted to be greater than 150. The patient was afebrile. Symptomatic treatment was noted. The outcome was recovered on 11-SEP-2005. There were no adverse events following prior vaccinations.  No additional information is expected.
Headache, congestion, then a very persistent cough.  Very productive cough as well. Lungs were clear the entire time, however. Then got conjunctivitis, likely a 2ndary infection.   Everyone in my house got this, but my toddler and I were the only ones that got conjunctivitis.   Received antibiotic eye drops, steroids, allergy medications.
Arm more sore than with flu shot; Woke up very nauseous; light headed; achy; Threw up twice; This is a spontaneous report from a contactable healthcare professional (the patient). A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm on 30Dec2020 at 19:15 (at the age of 23-years-old) as a single dose for COVID-19 immunization. Medical history included asthma and peanut allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: montelukast sodium (SINGULAIR), fluticasone propionate/salmeterol xinafoate (ADVAIR), cetirizine hydrochloride (ZYRTEC), all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 31Dec2020 at 05:00, the patient experienced arm more sore than with flu shot, woke up very nauseous, light headed, achy, and threw up twice. No treatment was given for these events. The clinical outcome of arm more sore than with flu shot, woke up very nauseous, light headed, achy, and threw up twice was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
PT REPORTED SIDE EFFECTS , TIRED, BODY ACHES, ALMOST PASSED OUT IN BATHROOM ON 10-12-2023. HE IS STARTING TO FEEL A LITTLE BIT BETTER TODAY10/13/2023; HE GOT SPIKEVAX ON 10/11/2023