chrisvoncsefalvay/vaers-outcomes huggingface dataset:
missed the second dose; shingles; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the second dose) and HERPES ZOSTER (shingles) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the second dose) and HERPES ZOSTER (shingles). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the second dose) had resolved and HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information reported.
Case number PHEH2014US003859, is an initial spontaneous report from a consumer received on 21 FEB 2014. This report refers to a 9-year0-old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: unknown) intramuscularly on an unknown date in NOV 2013. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
Extreme fatigue, headache, swelling discomfort redness and pain at and around injection site in right arm, fever and chills, nausea, numbness and extreme weakness in left arm.
The cases were received on 21 March 2014 at GPV. Initial misuse report received from a health care professional on 24 September 2013. A patient under 65 year of age had received FLUZONE HD. No adverse event ws reported. List of documents held by sender: none
itching/hives at injection site and torso starting approx. 5 hours post injection. Treated with oral benadryl
arm swelling and redness in the area; arm swelling and redness in the area; swelling and irritated and it was itchy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 12Apr2021 (Lot number: EW0151, Expiry date: not reported) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiry date: not reported) and experienced expected the area to be warm to touch, hot to touch and red with the 1st dose. The patient stated that she had a question, she got her second dose of the vaccine on Monday (12Apr2021). On Tuesday (13Apr2021), she had arm swelling and redness in the area. Yesterday (unspecified date in Apr2021) she had swelling and irritated and it was itchy. The patient stated that she expected the area to be warm to touch, hot to touch and red with the first dose and was asking if we had been getting reports of that on the second dose also. The patient stated that she knew some was normal the second day and several days out like that another day or 2 and was wondering when to call out to her healthcare provider as she did not want to freak out and call and thought she would ask the question. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Patient called pharmacist (me) today to report she had a rash on arm of injection site starting two days after administered. It progressed to back. She spoken with her doctor that recommended Benadryl and hydrocortisone cream. Her rash has gotten better but still exists. No fever.
Hospitalized;  COVID-19 positive (fully vaccinated);  patient expired during hospitalization.    Active Hospital Problems   Diagnosis Date Noted POA ? Acute respiratory failure with hypoxia  08/30/2021 Unknown ? Intertrochanteric fracture of right femur, closed, initial encounter  08/25/2021 Unknown ? COPD (chronic obstructive pulmonary disease) 06/08/2021 Yes  Date of Death: 8/30/21 Time of Death: 10:43 PM Preliminary Cause of Death: COVID-19 Discharge Disposition:  expired  HOSPITAL COURSE: The patient is an 87 year old male history of emphysema, MCA CVA, vascular dementia, hypertension admitted 8/25 to the orthopedic service for right comminuted hip fracture that occurred after a fall at his living facility. He tested positive for covid 19 on 8/20 after an exposure at his nursing facility. He received his J&J vaccine in June 2021.    At the time of admission, he was fairly asymptomatic from covid 19 infection.  Patient was initially stable with no significant chest x-ray findings.  Patient was scheduled for OR on August 26th.    Overnight on 8/25, patient had rapid escalation in his oxygen needs, going from room air to requiring 5-6 liters NC and later to HFNC. Unable to obtain CTA thorax due to kidney function, so CT thorax without contrast performed, only showed severe emphysema. VQ scan obtained which was not suspcious for PE. Patient was started on a heparin gtt due to concern for PE vs. Fat emboli.  As V/Q scan came back negative for PE, heparin drip was discontinued.  Orthopedic team transferred service to hospitalist team and were waiting for improvement in respiratory status before proceeding with surgery.   Patient was started on decadron.  As patient's oxygen requirements increased, patient was placed on BiPAP to help with workup breathing.  Code status confirmed with patient's son wants patient to remain as do not resuscitate.  He also reported that guardianship is being pursued patient was made incapacitated at nursing facility. Due to worsening oxygen requirements, Pulmonology was also consulted. Patient was continued on BiPAP with worsening respiratory status and eventually died.
A few minutes after vaccine administration , while the patient was sitting in the waiting area for observation, Patient lost consciousness and started convulsing/ spasms. RPh ran outside to attend to patient. Pt's eyes were rolled back and looked very pale. RPh asked staff to call 911 while attending to patient. Patient came to after about 30 seconds- 1 minute and was scared and confused. RPh calmed him down and took his BP. BP and HR was normal. Paramedics arrived shortly after and retook patient's vitals and made sure he was ok before leaving. There were no signs of anaphylaxis and paramedics think it was anxiety- related. Advised patient to have 2nd dose ok'd by MD and if yes, get it at a clinical setting.
Swollen lymph node under both arms and a welp like rash developed on my right arm 3/31/2021. It is hot to the touch and lt was not changed with Benadryl and has gotten larger
Painful injection. Very sore at injection site that continued. Upon inspection 48 hours later, realized that it was swollen, warm, sore & tender, along with extreme redness extending with about a 6 inch radius. Tried applying ice with no effect.  Redness and swelling diminished after 5 days.  I have never had a reaction to any kind of immunization before.
Left facial and left upper lip angioedema, uncertain if related. Started 9/18/19 at 12 noon after having ricola cough drop denies any other changes
A little bit of a headache; Soreness of the arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 10:30 (Lot number: EW1058) at the age of 67 years as dose 1, single and administered in arm left, administration date 28Apr2021 (Lot number: EW0162) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Back pain" (unspecified if ongoing), notes: Caller stated he has back pain from back surgery that he, had years ago.; "Back surgery" (unspecified if ongoing), notes: Caller stated he has back pain from back surgery that he, had years ago. The patient's concomitant medications were not reported. Vaccination history included: Flu shot (Caller stated he usually gets the flu shot and pneumonia shot around October or November.), for immunization; Pneumonia shot (Caller stated he usually gets the flu shot and pneumonia shot around October or November.), for immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Apr2021, outcome "not recovered", described as "Soreness of the arm"; HEADACHE (non-serious) with onset 28Apr2021, outcome "not recovered", described as "A little bit of a headache". The events "soreness of the arm" and "a little bit of a headache" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, headache.  Additional information: : Caller stated he is calling about the two shots he got. Caller clarified the two shots he is referring to is for the COVID 19 vaccine. Caller stated he has had the two shots and he knows the side effects like all the side effects of what one can get after the shot. Caller stated he got the vaccine last month and he still has soreness of the arm and headache. Caller stated he went to his doctor in (withheld) and his doctor is an old guy and is part time for withheld. Caller stated the doctor told him that he could have side effects up to 6 months and wants to know was that true or not. Caller stated he was retired from working for the government. Caller stated the reason why he wasccalling for the arm pain and little headache. Caller stated he has a primary care doctor but he can't remember off hand the doctors name or information but knows he comes from (withheld).  The soreness of the arm, caller stated this started with his first shot and continued on when he got the second shot on 28Apr2021. Caller stated he still has pain in his arm and a little minor headache but it was not serious and just wants to make sure this was safe. Caller stated the soreness of the arm happens off and on and is a little better.  Regarding the treatment caller stated he has taken over the counter Tylenol and it helped a little bit. The patient did not require emergency room visit for AEs. There were no additional administered vaccines  No follow-up attempts are possible. No further information is expected.
This non-serious consumer report (initial; receipt 24-Jul-2015) concerns an unspecified patient. On an unspecified date, the patient received CSL Bio/Therapies influenza vaccine (batch number not provided). On an unspecified date, the patient developed an unspecified reaction site of hives. Outcome was not reported.
5 hours after injection pt experienced soreness at injection site, increased soreness/stiffness in right upper arm with extension of arm. Denies fever, redness, states no relief from discomfort from pain. Small area of induration. Discomfort persisted for 72 hours. Pt called private MD who stated this was NOT allergic reaction; MD stated was common side effect.
PM not feeling well & slept later next AM;inc temp on awakening 12FEB tx w/APAP;14FEB flat splashed appearing rash, progressed to maculo papular rash;worse over knuckles;joints of knees, ankles & hands & also itch;hives
Pt called on 6/11/21 stating she has experienced pain at the side of her chest that comes and goes after receiving the Pfizer COVID-19 vaccine on 6/10/21. She currently does not have PCP and referred her to see a physician as soon as possible. She said she will contact urgent care first.
Day after receiving vaccines - rash on face, back, and legs. Seen in office 2 weeks after vaccines given treated with ORAPRED.
TC on 11-17-14 reporting "red rashy itchy "area with a painful lump back at (L) lower arm with onset evening 11-13 approx. 5 hours after receiving vaccines. Taking ibuprofen q 6 hours and states "symptoms have been staying the same". Applying ice and cortisone cream as well which PHN advised to stop. Enc. warm wet compress and no topicals and con't ibuprofen. FU TC's 11-19-14, 11-26-14 and 12-2-14 with gradual resolution of symptoms.
Hospitalized 01/06/2022; COVID-19 positive 01/05/2022; fully vaccinated  Admission Date: 1/6/2022 Discharge Date: 01/11/2022  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Diarrhea for about 10 days. See H&P from 1/6/2022 for full details    HOSPITAL COURSE: Patient was admitted at the hospital for treatment of c. Difficile colitis. She received 5 days of oral vancomycin while inpatient and will be discharged with an additional 5 days. Her diarrhea resolved about 24 hours prior to discharge. She had a mild AKI on admission, her demadex was held, this was restarted and she remained euvolemic. She also had urinary retention on admission, a foley was placed. This was removed morning of discharge and patient was able to urinate without issue. Patient tested positive for COVID 19. She was out of the window for Remesivir and was never short of breath nor hypoxic so she did not receive steroids. She was evaluated by physical and occupational therapy and they recommended subacute rehab. Care management found her placement at a rehabilitation facility, she was discharged in stable condition via transportation service.
Covid 19 treatment; Covid 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EN5318), in left arm, on 18Feb2021 as dose 2, single (Lot number: EN5318), in left arm, on 20Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 28Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FH8028) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Lastacaft, reaction(s): "Known Allergy:Lastacaft". The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Covid 19 treatment".  Therapeutic measures were taken as a result of suspected covid-19, drug ineffective. Clinical course: Started treatment Friday (03Jun2022) evening. Will finish Wednesday (07Jun2022) morning. Leaves metallic/tinny taste in the mouth. Woke up with severe headache Monday (06Jun2022) morning. Treatment taken includes ibuprofen.  Investigation report: The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FH8028, FF8841 and EN5318 the bulk formulated drug product. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Patient had hives on sides of body 6 days after receiving 1st dose; Patient's lips were swollen 3 days after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Patient's lips were swollen 3 days after receiving 1st dose) and URTICARIA (Patient had hives on sides of body 6 days after receiving 1st dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (cataflam). Concomitant products included TAMSULOSIN, FISH OIL and HYDROCORTISONE (GENKORT) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 13-Feb-2021, the patient experienced LIP SWELLING (Patient's lips were swollen 3 days after receiving 1st dose). On 14-Feb-2021, the patient experienced URTICARIA (Patient had hives on sides of body 6 days after receiving 1st dose). On 20-Feb-2021, URTICARIA (Patient had hives on sides of body 6 days after receiving 1st dose) had resolved. At the time of the report, LIP SWELLING (Patient's lips were swollen 3 days after receiving 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Benadryl.  Patients primary care physician advised not to get second dose.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 7-MAY-2021:  Reporter address was updated, patients race, medical history height, weight, concomitant medication (Tamsulosin) dose, vaccine batch number, event urticaria stop date were updated.
tested COVID-19 positive; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 28Apr2021 as dose 1 single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated that he received the 1st dose of COVID-19 vaccine last 28Apr2021. but tested COVID-19 positive today, 10May2021. He had his 2nd dose scheduled on 19May (exactly 21 days apart) but requesting that to be moved due to his current situation. The patient underwent lab tests and procedures which included COVID-19: positive on 10May2021. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be obtained.
Given the Janssen brand for his second dose; 14 days interval between first and second dose; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Given the Janssen brand for his second dose) and INCORRECT DOSE ADMINISTERED (14 days interval between first and second dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (14 days interval between first and second dose). On 07-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Given the Janssen brand for his second dose). On 07-May-2021, INTERCHANGE OF VACCINE PRODUCTS (Given the Janssen brand for his second dose) and INCORRECT DOSE ADMINISTERED (14 days interval between first and second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.
Irregular menstrual cycles following vaccine (March 2021 through present) - have had 43-90 day cycles after several years of regular 28-30 day cycles. Rapid weight gain associated with anovulation/PCOS. In September a ruptured ovarian cyst after no previous history of ovarian cysts (despite PCOS diagnosis).
A covid vaccine vial was reconstituted twice, this patient received a diluted dose of the vaccine, the patient was contacted about the issue, and we are waiting for the patient to come into to be revaccinated.
During the night time I started getting numbness on my legs, pinching needles for a week and headache for a week and my vision was black I couldn't see anything. My eyes were open open but I couldn't see and move my body. All my vaccine had the same adverse event. It went slowly. Every time I take vaccine it happens. I've never had it happen before.
24 hours after injection, i had lab work done.  i received a call about the platelet level of 92 which is extremely low for me.  they suggested I report this adverse event.
This case was reported by a healthcare professional, via the regulatory authority, and described the occurrence of swollen tongue in a 34-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous medications included unspecified antibiotics which the subject reported having a reaction to in 2007/2008. Concurrent medications included SUBOXONE. On 9 October 2012 the subject received an unspecified dose of TWINRIX (injection, 1 ml, batch number AHABB254AJ). On 9 October 2012, approximately2 hours after vaccination with TWINRIX, the subject experienced a swollen tongue, difficulty breathing and became anxious as result. The regulatory authority reported that the events were clinically significant (or requiring intervention). No medical intervention was sought. The subject reported that the events lasted 4.5 hours whereby symptoms improved. At the time of reporting the events were resolved. MHRA Verbatim Text: Patient was administered TWINRIX vaccine. No adverse effects noted whilst in consultation in clinic. Patient reported symptoms of tongue swelling two hours later whilst at home. They experienced affect on breathing and became anxious as result. Patient reported duration of symptoms lasted 4.5 hours whereby symptoms improved. No medical intervention was sought by patient. No further symptom experienced. Medically Significant Details: Patient experienced affect on breathing and associated anxiety post vaccine administration.
About 7 hours after receiving the vaccine, began to feel ill. Vaccinated arm so sore, could not lift it. Early evening and throughout the night, muscles shivering. Ached all over, including feet muscles. Got up once during night to go to the bathroom. Very dizzy. Had to hold onto furniture for support. Due to fatigue, did not get out if bed til 3 p.m. the next day (3/30). Now at 9:30 p.m. Starting to feel more like my normal self.
Patient has been experiencing stomach pain and diarrhea since a few days after receiving vaccine. Patient has a doctor appointment today to discuss with doctor to determine whether some other issue is occurring.
Lymph node in Left axilla was swollen for 3 days, slight induration, measuring 6 cm across.
Pt c/o chest tightness and SOB 10 mins after receiving her Booster dose of Pfizer vaccine.  A&O x 4, no labored breathing or airway compromise noted, skin warm and dry with no notable skin changes. Pt was monitored for additional time until improvement in symptoms before being discharged from clinic in stable condition by provider. Pt advised to go to nearest ER if symptoms got worse.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of an unknown gender and age. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored (Oka/Merck) VARIVAX lot#K011082 and expiration date: 08-AUG-2016, lot#L019124 and expiration date: 27-MAY-2017 (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
day 6:  developed left axillary tenderness resolved by day 9 day 8:  developed rash at injection site--warm, raised, slightly itchy. resolved in 48 hours (by day 10)