chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax;w/in few hrs exp itching, red welts all over & rash on trunk; to er; tx w/ dph;
Case number PHEH2013US013318, is an initial spontaneous report received from a nurse on 18 Jun 2013. This report refers to a 13 year old male patient. His medical history and concomitant medications were not reported. The patient received Men A lyophilized conjugate component diluted with sterile water, and not Men CWY liquid conjugate component of MENVEO (batch number: M12118) on 18 June 2013. No adverse event was reported following this medication error.
Left thigh swollen and left inguinal area, swollen, red, warm erythematous.
Initially red, "very purple" (L) thigh area recommended ice, ibuprofen seen today (1-14-11) -> lacy like purplish rash approximately 2 x 2 inches (L) thigh. No paresthesia no cellulitis.
On the evening following the vaccination, Ifelt tired and dazed.  The next morning it was the same all day, and I started to cough just as I had when I had covid.  On the second day, symptoms improved, but the cough remained.   On the third  energy returned but the cough is much worse.  Painful and deep in my lungs.  No expectorant.   All that night I coughed and couldn?t sleep. Tiredness and cloudy head has disappeared, but the cough is not painful and tiring.
This initial spontaneous report was received from the daughter (who is also a company employee) of a 66 year old female patient. The patient had no pertinent medical history and was taking no concomitant medications. Allergies included intravenous VALIUM. On 13-JUL-2017, the patient received a dose of PNEUMOVAX 23 for the indication of "recommended vaccination" (route and lot # not provided). On 14-JUL-2017, the patient developed nausea, sweating, hypotension, low heart rate, and her arm was swollen and hot to the touch. When asked if the patient sought medical attention, the reported stated "yes, phone call to physician". No treatment was given. The patient was recovering from the events. Causality assessment was not provided. Additional information was not expected as the reporter did not provide consent to follow up.
Acute urinary tract infection; A spontaneous report was received from a physician on 14JUN2023 regarding a patient of unknown age and gender who had an "acute urinary tract infection" (PT: Urinary tract infection) during the administration of Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient was having an acute urinary tract infection while on therapy with Vivotif.  The outcome of the reported event was unknown, at the time of this report.  The action taken with Vivotif with respect to the reported event was unknown.  No additional information was reported.  Company comment: It was reported that a consumer has an acute urinary tract infection (urinary tract infection) during the course of administration of Vivotif. Further information regarding event is limited. Based on unclear information regarding the temporality with Vivotif, the causality of urinary tract infection is assessed as unlikely with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer has an acute urinary tract infection (urinary tract infection) during the course of administration of Vivotif. Further information regarding event is limited. Based on unclear information regarding the temporality with Vivotif, the causality of urinary tract infection is assessed as unlikely with Vivotif. The case is considered non serious as per medical assessment.
Headache, Temp of 101.7, Pulse rating 145, Neck and Shoulder Pain,  Injection site sore, chills  and muscle aches
Patient's left arm extremely painful with tingling. She was unable to move it without pain, felt paralyzed. ON 10/2/19 She called the pharmacy and spoke to the manager who stated shots should not have been given in same arm and to use ice and ibuprofen. She was in excruciating pain. She went to pharmacy on 10/4/19 and spoke to pharmacist who advised her to see a doctor. Patient's doctor was on vacation. She went to Urgent Care and received no treatment. She went to ER where they took an x-ray of her shoulder and disperse Norco for the pain. Patient was told to keep moving arm by doctor.
Redness, Swelling at the site. Fever of 101. Saw Dr. in office. Antibiotic ordered.  Swelling described as softball size, now tennis ball size.
REDNESS, HEAVINESS AND HOTNESS OF PUNCTURE AREA, ACOMPANIED WITH ENDURATION
This is a spontaneous report from a contactable nurse via a sales representative. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA on an unspecified date, at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fever and achiness, both on an unspecified date with unknown outcome.
itching between elbow and shoulder, near the injection site and all around that area/had Itching and bothered where the needle went in and now is red and irritated; had Itching and bothered where the needle went in and now is red and irritated; a little red rash from where it was injected; where the needle went in it was irritated/had Itching and bothered where the needle went in and now is red and irritated; This is a spontaneous report from a contactable female consumer (patient herself) of 90-years-old received second dose of bnt162b2 (BNT162B2 Pfizer-Biontech covid-19 vaccine, Formulation: Solution for injection, Lot number and Expiry date were not reported) via an unspecified route of administration on 28Jan2021 Thursday in right arm and first dose (Lot number: Either EX3246 or EL3246) via an unspecified route of administration in left arm on 07Jan2021 around 13:30 to 14:00 both as single dose for covid-19 immunisation. Medical history includes glaucoma in her eyes, has drip down her nose, sinus, flu shot and includes she got irritated in the area for a day or two whenever the flu shot taken. No family history was reported. The patient's concomitant medications were not reported. Prior to the vaccination, the patient had not received any other vaccine within 4 weeks. On 28Jan2021, the patient experienced irritation and had itching, redness and rash where the needle went in. And later itches between elbow and shoulder in the area where the vaccine went in and around back and front. Patient's lab tests were not reported. No therapeutic measures were taken. The caller asked if the itching was normal and asked what to. The outcome of the events was unknown.   Information about Batch/Lot number has been requested.
Had covid vaccine #1 1/26/21; 2/4/21 developed localized red, warm mildly indurated rash at injection site.  Treated  With ice, rest, elevation, doxycycline added for ? Cellulitis, and took antihistamine; 2/9/21 - spread of reaction in left arm at site of injection; Area of redness has spread from 5cm to 15-20cm covering left lateral upper arm with mild erythema , mild warmth, no pain or itching.  Denies f/c, malaise or pain.
Information has been received from a nurse practitioner concerning a 64 year old female patient with hyperlipidaemia, coronary artery disease and had a Dual chamber pacemaker and a history of Graves' disease and Cardiac arrhythmia and no drug reactions or allergies who on 17-MAY-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # 663888/0627Y) IM. Concomitant therapy included trazodone HCl, CRESTOR, COREG, baby aspirin and influenza immunization. On 18-MAY-2010 the patient developed redness, pain swelling and warmth of the arm, starting about one inch below the injection site after receiving PNEUMOVAX 23. The patient also experienced fever, chills and myalgia. The patient sought medical attention via office visit and was treated with BENADRYL. At the time of this report, the patient had not recovered. The nurse practitioner requested a lot check. A lot check has been initiated. This is one of several reports form the same source. Additional information has been requested.
I had tiredness, muscle ache  and chills for about 20 hours; I had tiredness, muscle ache  and chills for about 20 hours; I had tiredness, muscle ache  and chills for about 20 hours; This is a spontaneous report from a contactable physician.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EK5730), via an unspecified route of administration on 21Dec2020 as 1st dose single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported.  he patient received 2nd dose of (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021.  Patient have concerns about the Pfizer Covid vaccines effectiveness.  patient had an antibody testing with SARS-CoV-2 antibody kit with a reported IgG antibody test that has 99.63% specificity and 100% sensitivity that was completely negative at 16 days following the second dose of Pfizer COVID-19 vaccine, and had the first dose exactly three weeks prior. After the first of shot on 21Dec, patient had tiredness, muscle ache and chills for about 20 hours. Following the second shot on 11Jan no adverse reactions were experienced. Patient have read information from Pfizer indicating that its vaccine exhibits a robust induction of antibody response. The lot numbers of the vaccines I received were EK 5730 (1st Dose) and EL 3246 (2nd Dose). The patient said appreciated advice on how to proceed with concern as a health care provider who was constantly exposed to the virus. The patient wonder if the mRNA already degraded in these lots making the vaccine ineffective.  Also, patient wonder if re-vaccination was recommended. The patient underwent lab tests and procedures which included sars-cov-2 test was negative   on Jan2021. The outcome of the event was reported as unknown.
Weakness in arms, legs  and hands due to muscle deterioration, - diagnosed with Multifocal Muscle Neuropathy
24 hours past injection, pt developed cellulitis right upper arm approximately 5" below injection site.
Patient awoke with significant swelling of left upper extremity where vaccines had been administered.  Overlying skin was intensely pruritic.  No associated fever, difficulty breathing or GI symptoms.  Range of motion at shoulder, elbow, wrist, fingers intact.  Strength intact.  Sensation intact.  Pulses palpable.  Capillary refill <2 seconds.  Extremity warm to touch.
Discharge Provider: PA-C Attending Physician: MD Primary Care Provider at Discharge:  MD  Admission Date: 1/29/2023 Discharge Date: 01/31/2023  PRESENTING PROBLEM: Dyspnea [R06.00] Moderate persistent asthma with acute exacerbation [J45.41] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a 86-year-old female with a history of asthma, hypertension and CKD stage 3 who presented with difficulty breathing x 5 days.  Labs with leukocytosis, known CKD 3, and COVID-19 positive.  Chest x-ray was clear.  EKG showed normal sinus rhythm.   The patient was admitted for an acute asthma exacerbation and acute COVID-19 viral infection. She was started on high-dose IV Solu-Medrol and transitioned to dexamethasone, nebulizers and supportive therapy. She did not require supplemental oxygen and remained stable on room air. She had been using her albuterol inhaler as needed at home prior to admission and did not get much relief from this. She utilized albuterol nebulizers in the hospital with good response. Pulm rehab consulted and arranged for home nebulizer machine, with albuterol neb solution to be prescribed to be utilized as needed upon return home. Given lack of wheezing and stability on room air, she will not be continued on steroids upon discharge.    PT and OT evaluated and recommended return home with family assistance once medically stable. She resides at home with her daughter who is able to assist upon return home. She remained stable on room air and was feeling symptomatically improved on 1/31. She was tolerating a diet and ambulating in her room. Recommend she arrange post-hospital follow up appointment with her PCP to ensure ongoing stability and improvement after hospitalization. Given smoking history, could consider obtaining PFTs to rule out underlying COPD. She was discharged home in stable condition with her daughter on 1/31/23.
I developed two Cerebral Venous Sinuous Thrombosis. Had two strokes which I thought I were migraines. After 3 CT scans the MRI found them.
No additional AEs; vaccine administered after temperature excursion; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications or drug reactions and allergies provided.  On 04-NOV-2022, the patient was vaccinated with a dose of varicella virus vaccine live (VARIVAX) after temperature excursion, 0.5 milliliter, administered subcutaneously (SQ), lot #W017551, expiration date 01-JUN-2024 (anatomical location was not reported) for prophylaxis.   Administered dose of vaccine underwent temperature excursion of -11.7 degrees Celsius (C) for 6 hours and 17 minutes (product storage error). No previous temperature excursion had occurred. No additional adverse events were reported (no adverse event).  This is one of the several reports from the same reporter (linked reports US-009507513-2211USA002447); Sender's Comments:  US-009507513-2211USA002447: US-009507513-2211USA002369:
Information has been received from a health professional concerning a female who was vaccinated with Gardasil.  Subsequently the patient experienced tingling down in her arm and she fainted shortly thereafter.  The healthcare worker also reported on another patient (WAES# 0705USA03439).  No further information is available.
Large, red swollen bump around injection site starting the day after admin in the morning. Patient received KEFLEX as treatment.
Pt. given 3rd dose of seasonal flu vaccine; developed fever of 104 and had febrile seizure. Taken by ambulance to H.
Pt presented to clinic and reports 3-4 hours after receiving first injection she felt fatigue and noticed some swelling in her throat and a noticeable palpable lump with some difficult swallowing. This went away after a few hours. Pt woke up the next morning with abdominal pain and reports standing up and passing out. Pt states she had diarrhea throughout the day also with dizziness.
Localized pain in right arm progressing to pain and weakness in arm then slowly to generalized muscle pain and weakness and extreme fatigue, with difficulty sitting up or getting out of bed.
gets dizzy; This is a spontaneous report from a contactable consumer. This consumer reported for 80-year-old female patient (friend's neighbor). An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced gets dizzy on an unspecified date. She stated the other day she was talking to her friend and her friend said she knows 3 people who have also had similar symptoms as her husband and they all have had the Pfizer vaccine as well. Mentions that her friend's female neighbor is 80. Reporter stated she doesn't know about the neighbor; the friend just said the neighbor gets dizzy too. This report is for the friend's neighbor, the 3rd of the 3 people. She confirms she received the Pfizer COVID 19 Vaccine. Reporter asked if there were any studies being done on the long-term effects of dizziness with the vaccine. Reporter is a consumer. Reporter is calling on behalf of her husband. Reporter and husband received their first dose of the Pfizer COVID 19 vaccine on 09JAN2021 and their second dose 30JAN2021. She reports that her husband began getting headaches, nausea, and dizziness two months ago. They have visited several specialists who cannot determine anything wrong. She said the reason she decided to call was because I was telling a friend of mine about my husband and she knows three other people who are also having dizziness; two have passed out more than once and the other one gets dizzy; all four have had the Pfizer vaccine. Reporter wants to know if there are any studies being done on the long-term effects of dizziness and the vaccine. Caller reports,  that she had a sore arm after receiving the vaccine. Reporter is a 74-year-old female; her husband is a 74-year-old male. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report as received from a certified medical assistant (healthcare worker) refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of ROTATEQ lot number K010222, expiration date 12-MAY-2016 and lot number K009901, expiration date 08-MAY-2016 (dose not reported, route defaulted to oral), that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient was administered improperly stored Daptacel; Temperature Excursion: 0.8°C, Time frame: 35 Minutes/ administered improperly stored Daptacel  with no reported adverse event; Initial information received on 10-Mar-2022 regarding an unsolicited valid  non-serious  courtesycase received from a other health care professional via call center.  This case involves patient of unknown demographics who stated Patient was administered improperly stored Daptacel; Temperature Excursion: 0.8°C, Time frame: 35 Minutes/ administered improperly stored Daptacel  with no reported adverse event while receiving vaccine diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Feb-2022, the patient received an unknown dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine suspension for injection (lot C5829BA, expiry date 01-Mar-2023 via unknown route, frequency, strength, dosage: unknown) in unknown administration site for prophylactic vaccination  On an unknown date there a non-serious event  Patient was administered improperly stored Daptacel; Temperature Excursion: 0.8°C, Time frame: 35 Minutes/ administered improperly stored Daptacel  with no reported adverse event  (product storage error) (unknown latency) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine. Patient was administered improperly stored Daptacel.  Action taken with diphtheria, tetanus and acellular pertussis vaccine (Daptacel) was not applicable.  At time of reporting, the outcome was Unknown for the event  Patient was administered improperly stored Daptacel; Temperature Excursion: 0.8°C, Time frame: 35 Minutes/ administered improperly stored Daptacel  with no reported 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 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.
difficulty breathing, fever, aching all over, swelling  of tongue and lips within 15 minutes of administration
Child was fussy through the night. Difficult to console. When being held, child could not seem to get comfortable. Mother reports she did not see rash or anything different during child's bath 5/7/12. Woke up this AM 5/8/12 with a rash on Lt thigh. Rash sl raised. Unknown if hot to touch, child was at daycare when mother called. Denies any known fever. Child does not seem to bother rash as if to scratch so mother does not feel rash is itchy.  States rash covers area where shot was give. Total rash area about the size of moms hand.
Sore arm, low grade fever, grogginess, extreme exhaustion, sore throat, and head ache. Felt like my body had been hit by a truck. Very out of it. Almost like mono.
rectal fissure; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL FISSURE (rectal fissure) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RECTAL FISSURE (rectal fissure). The patient was treated with HYDROCORTISONE ACETATE (ANUCORT-HC) ongoing since an unknown date for Rectal fissure, at a dose of 25 mg. At the time of the report, RECTAL FISSURE (rectal fissure) outcome was unknown.            No Concomitant Drug details were reported. Patient had rectal fissure they developed a few weeks ago.
Neck and back pain night of vaccine... then 30 hours later Heart Attack (Myocardial infarction); Treatment: blood thinners (TNK and Heparin), Stent in coronary artery.  outcome: hospitalization 3 days and then recovery and fatigue ongoing...
tingling from the tips of my toes and it slowly went up into my head and now it is at the top of my head; My face is kind of like numbish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Aug2021 16:00 (Lot number: EW0198) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Kidney Disease" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; NORVASC; TRULICITY. The following information was reported: PARAESTHESIA (non-serious) with onset 03Aug2021 19:00, outcome "not recovered", described as "tingling from the tips of my toes and it slowly went up into my head and now it is at the top of my head"; HYPOAESTHESIA (non-serious) with onset 03Aug2021 19:00, outcome "unknown", described as "My face is kind of like numbish". Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia.  Additional information: Patient not received prior vaccinations (within 4 weeks). Consumer stated she had not gone to the doctor yet. There was no investigation assessment performed.  No follow-up attempts are possible. No further information is expected.
Pt. states that after receiving the 2nd dose of Phizer 03/25/2021, started experiencing symptoms 04/08/2021 of leg pain (Sciatica). Primary visit (unknown date) diagnosed with Sciatica.
Patient wqas administered Hep A vaccine instead of Pediarix. Reported to DPH and vaccine unit. Parent called. Pt to return for Pediarix next week which was vaccine should have received. MD who saw baby for well child visit today ok'd above.
Waves of nauseous for six hours, at end of six hours vomiting, then felt perfectly fine.