chrisvoncsefalvay/vaers-outcomes huggingface dataset:
if a patient experienced an allergic reaction to the first dose is there anything prophylactically needing to be done when administering the second dose of the Covid vaccine; delayed hyper sensitive reaction; Angioedema; Urticarial rash; This is a spontaneous report from a contactable other hcp. A 47-years-old male patient received first dose of bnt162b2 (BNT162B2), unknown on 18Dec2020 (lot number: EK5730) at SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller is a Physician Assistant. Caller states that she is calling about the Covid Vaccine. She had a patient received his first dose of the vaccine on Friday 18Dec2020, 3 days later on 21Dec2020 he had an urticarial rash that persisted, The urticarial rash was treated with prednisone and resolved by 27Dec2020, it has not reoccurred. The allergist said it was a delayed hyper sensitive reaction that was Prompted by the immune simulation from the vaccine. The Patient was treated for the urticaria.  Caller would like to know if a patient experienced an allergic reaction to the first dose is there anything prophylactically needing to be done when administering the second dose of the Covid vaccine? Caller is very upset and frustrated and stating she wants to speak to someone that is a clinician with the clinical trial team who can give her recommendations for a specific patient. Caller asks if they should do Prophylaxis with antihistamines for the second dose. He did not have anaphylaxis but he had angioedema. Caller states that she did a Vaers report on 22Dec2020, but no one contacted her. He started taking Zyrtec and Vistaril. The Allergist said it was fine and he will still need the 2nd Booster Dose. The Angioedema started on 22Dec2020, it was also treated with prednisone, in addition to being administered Benadryl IM, and Vistaril. The outcome of the event urticarial rash was recovered on 27Dec2020 and Angioedema was recovered on 22Dec2020.   No follow-up attempts are needed; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the angioedema and the other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including serum tryptase level and complement panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
On day of vax mom states pt screaming episode @ about noon; this cont til about 4PM; pt unable to be comforted; also vomited x 2;
40 year old male without any prior medical history, followed by PCP for yearly exams, who presents with complaints of chest pain for the past few days. Pain is described as left sided chest discomfort, first associated with exertion as it started with walking 2 days ago, symptoms resolved when he got home. Again yesterday symptoms returned with walking but after symptoms improved but remained, described some numbness to left hand.  He denies SOB, DOE and syncope. He does report palpitations. He was seen by PCP and underwent EKG which was unremarkable however symptoms continued so he came to ED for evaluation.  EKG with ST elevations ECG: Sinus tachycardia:Otherwise normal ECG   Normal sinus rhythm with sinus arrhythmia:ST elevation, consider early repolarization, pericarditis,   He had a stress test and an echocardiogram which were reassuring (see results below). Pain/ discomfort had almost entirely dissipated. He was discharged home with NSAID.
The patient was here to recieve the 2nd booster and got 0.5mL or 100mcg of vaccine.  No symptoms or additional treatment required.
Initial unsolicited report received from a consumer (patient's parent friend) on 04-Dec-2015. This case is linked with 2015SA206305 and 2015SA206306 (same reporter). This case involves a female patient (age not reported), who was vaccinated with Meningococcal vaccine (manufacturer: unknown, batch number: unknown, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, after vaccination, the patient experienced encephalitis and mentally challenged. Laboratory investigations and corrective treatment were not reported. The outcome of the event encephalitis was reported as recovered with sequelae and the outcome of mentally challenged was reported as not recovered. Upon internal review, the case was considered as serious due to important medical events encephalitis and mentally challenged. Documents held by sender: none.
Arrhythmia; palpitation; site is warm to touch; Injection site is silver dollar in size and get double size in the evening; Red in colour; Headache; Pain all over body; Very swollen hand; Painful rash; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Diabetes, Acid reflux (esophageal), Arthritis and Hyperlipidemia.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (Very swollen hand), RASH (Painful rash), MYALGIA (Pain all over body) and HEADACHE (Headache). On 01-Apr-2021, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant), PALPITATIONS (palpitation), VACCINATION SITE WARMTH (site is warm to touch), VACCINATION SITE SWELLING (Injection site is silver dollar in size and get double size in the evening) and VACCINATION SITE ERYTHEMA (Red in colour). On 31-Mar-2021, HEADACHE (Headache) had resolved. On 01-Apr-2021, ARRHYTHMIA (Arrhythmia) and PALPITATIONS (palpitation) had resolved. At the time of the report, PERIPHERAL SWELLING (Very swollen hand), RASH (Painful rash), VACCINATION SITE WARMTH (site is warm to touch), VACCINATION SITE SWELLING (Injection site is silver dollar in size and get double size in the evening) and VACCINATION SITE ERYTHEMA (Red in colour) outcome was unknown and MYALGIA (Pain all over body) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pt reports generalized body aches beginning Saturday am.  Pt endorses he worked out before the vaccine so wasn?t sure if the body aches were due to the vaccine or working out.  Pt endorses on Sunday, worsening muscle pain, + headaches.  Pt continued with muscle pain and headaches Monday pm and reported feeling ?flu-like? symptoms last night (Tuesday), denies fever.   + mild sore throat beginning Monday, no change or improvement per Pt.    After following the algorithm, Pt meets criteria to be COVID tested due to symptoms Pt is experiencing.  Pt notified he has been taken off of work and he is not to report to work at this time and to remain home quarantined.  Pt provided with Facility phone number to call to schedule for testing.  Pt reports he has called the Facility twice today with no answer or return of voicemail.  Pt encouraged to continue to call Facility and to be patient for a return phone call, Pt verbalized back understanding.  Pt verbalized back understanding of next steps and denied further questions at this time.
This spontaneous report has been received from a pharmacist concerning an elderly female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. The patient received a dose of ZOSTAVAX (strength, unit, frequency, lot # and exp. date not reported) subcutaneously at unspecified time in 2012. On 28-DEC-2015, she inadvertently received the second dose of ZOSTAVAX subcutaneously (lot # L026415 and exp. date 15-OCT-2016) (Extra dose administered). No adverse effects reported. Additional information has been requested.
The patient was diagnosed with mumps on 10/25/2018 in the ER.
1/15/20 1200pm Spouse called, Stated Patient (L) arm sore & warm to touch - MMR + tdap given to that extremitity - given clinic number and fax PCP/Res/Tylenol/OTC benedryl Follow up 1/16/20 9:00AM called spouse states feels better today, Stated did not call PCP. told to F/U with PCP.
That night about the time I went to bed I started with cold chills and felt like I may be running a low fever. In the morning about 4 AM I could not sleep I achedall over and just felt generally unwell. I did run a low-grade fever and I could not work because of it.I was a bit foggy lightheaded dizzy at some points. It might be worth noting that I am a redhead and overall we are very sensitive.
Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. The patients were vaccinated with improperly stored doses of ROTATEQ (lot # L025598, expiration date 13-JAN-2017, route and dose not provided) on multiple unspecified dates after 17-NOV-2015. No adverse effects were reported. Additional information has been requested.
Ankle pain started and got continually worse throughout the day Friday with no acute injury. Could not sleep due to intensity of pain and went to Urgent Care Saturday morning. Prescribed diclofenac potassium and told to go to orthopedic doctor in 3-4 weeks if not improved. X-rays taken and negative for bone breaks. Constant and severe pain has continued.
4 hrs p/shot pt begins high pitch screaming-cont until past MN on same date; shakes head back & forth continually;
This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # M035486, expiry date: 05-JUN-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 degree C to 1 degree C for 8.25 hours. It was reported the exact temperature and time below 0 degree C was: -1.9 degree C for 15 minutes, -1.2 degree C for 15 minutes, -1.0 degree C for 15 minutes, -0.8 degree C for 15 minutes, -0.4 degree C for 15 minutes and -0.2 degree C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
This case was reported by a pharmacist and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received 2nd dose of HAVRIX (unknown). After vaccination with HAVRIX, the subject was non-reactive (did not respond to therapy). No additional details were provided and no adverse events were noted.
Headache; injection site reaction (redness, swelling, pain). (R) arm/deltoid injection site (PNEUMOVAX).
Left arm is swelling and pain; Hard at injected site; Patient has fever and chill.
Patient received Covid-19 vaccination 9 months early from 18 yr old birthday. No complaints or adverse effects occurred since 2 weeks post vaccination. Patient presented himself with his father for a pre-scheduled  Jannsen Covid-19 vaccination appointment. After answering identifier questions, vaccine was given in accordance to manufacturer guidelines (route, volume and vaccination location). Patient had no complaints after vaccination and left after a 15 minute waiting/monitoring period.   Noticed that patient was 9 months short of meeting the age requirements after the patient left and was entering patient information into the registry and company's billing system.
within 15 mins.a rxn at inject site of red, raised, circular rash measuring 2 to 3 inches in diameter.
Redness on left arm; Itchiness on left arm; Swelling on left arm; Little uncomfortable; Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Little uncomfortable), PAIN IN EXTREMITY (Little sore arm), ERYTHEMA (Redness on left arm), PRURITUS (Itchiness on left arm) and PERIPHERAL SWELLING (Swelling on left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced FEELING ABNORMAL (Little uncomfortable) and PAIN IN EXTREMITY (Little sore arm). On 04-Apr-2021, the patient experienced ERYTHEMA (Redness on left arm), PRURITUS (Itchiness on left arm) and PERIPHERAL SWELLING (Swelling on left arm). On 29-Mar-2021, FEELING ABNORMAL (Little uncomfortable) and PAIN IN EXTREMITY (Little sore arm) had resolved. At the time of the report, ERYTHEMA (Redness on left arm), PRURITUS (Itchiness on left arm) and PERIPHERAL SWELLING (Swelling on left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient received an expired vaccine. It was noticed after patient got the vaccine. Called and notified patient, he doesn't experience any adverse event. Did recommended patient to come back to re-vaccinate per CDC and manufacture recommendation.
Information has been received from a physician concerning a 14 year old male who on 29-AUG-1996 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported).  On 03-NOV-1999, the patient was vaccinated with a second dose of MMR II (route, site, dose and lot number not reported).  On 29-DEC-2009, the patient experienced mumps (thought the date diagnosed was reported as 10-DEC-2009).  The patient was afebrile and had parotitis.  The outcome for mumps was not reported.  This is one of several reports from the same source.  No further information is available.
Patient was seen at a clinic over the weekend and stepped on a fish hook and received DTAP.  Mom came in 2 days later because patient had a large knot of mild swelling and redness around the site of injection.
Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium
report an adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (report an adverse event) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (report an adverse event). At the time of the report, ADVERSE EVENT (report an adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Reporter stated that the adverse event happened to his cousin and that is wasn't an emergency.
Nurse gave 24 Moderna booster doses out of 1 vial, So 4 patients received a booster dose after vial was needle punctured 20 times. Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Nurse gave 24 Moderna booster doses out of 1 vial, So 4 patients received a booster dose after vial was needle punctured 20 times.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Nurse gave 24 Moderna booster doses out of 1 vial, So 4 patients received a booster dose after vial was needle punctured 20 times.). On 10-Nov-2021, ACCIDENTAL UNDERDOSE (Nurse gave 24 Moderna booster doses out of 1 vial, So 4 patients received a booster dose after vial was needle punctured 20 times.) had resolved.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No Concomitant product use was reported.No treatment information was provided.The reporter informed that 4 patients received a booster dose after vial was needle punctured 20 times. Doses were injected into deltoid muscle.
This spontaneous report was received from the registered nurse refers to multiple, unspecified patients of unknown age and gender. No medical history and concurrent conditions of the patients were reported. On an unknown date, multiple unspecified patients were administered improperly stored M-M-R II (lot # L020189 and expiry date: 03-JUN-2017, lot# L024264 and expiry date: 01-JUL-2017, lot# L009213 and expiry date: 17-MAR-2017, lot# L012479 and expiry date: 10-APR-2017) (dose, route, therapy type not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
24 hrs p/inject area sl swollen & sl red; 17JAN92 areas swollen very large, very red, very warm to touch; pt had no fever but very irritable; no screaming carried pt to ER; MD dx sterile abscess; given ATB x 3 days;
Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, RHINORRHOEA (Runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Reporter did not allow further contact
1st shot 6 weeks today but have not had a chance to go get my 2nd; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st shot 6 weeks today but have not had a chance to go get my 2nd) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st shot 6 weeks today but have not had a chance to go get my 2nd). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st shot 6 weeks today but have not had a chance to go get my 2nd) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Next day post vax, the pt experienced a red, swollen, and hot area 1-2 inches in length, about 4 inches below the injection site.
The pt experienced a rash and itchiness. Rash was noted on arms, legs, chest and some of the abdominal areas. Pt complained of itching. Treated with Benadryl and hydrocortisone cream for itching.
Fever, headache, chills, dizziness, fatigue, body aches, swollen lymph nodes  under arm,   cervical nodes. Started at 2 AM. After vaccine lasted until 1/23/2021
Patient said she started itching all over a couple of hours after getting vaccine. She tried multiple BENADRYL and ended up using an EPI-PEN, was still taking BENADRYL the next day.
Patient presented to the pharmacy on 11/5/17 with redness, tenderness, and swelling in the right lower arm around the elbow. Patient stated that it had started late 11/3 but that it actually was improving. I advised patient to take some BENADRYL and call us here at the pharmacy on Monday if there was no improvement.
Temp 100.9 for 4 hours on 2/14/08, 12cm heterogeneous pink, slightly indurated area on left leg.  3cm erythematous area on right leg.  Temp 98.0 oral on 2/15/08 in office.
One week after injection, my arm was swollen with a rash and pain up to my shoulder. It is still painful to use my arm and shoulder. I have had Rotator Cuff repair twice on Rt. Shoulder and the pain I feel there is like it is in my rotator cuff. I cannot lift my arm up above my waist without feeling the pain. When I do not use my arm, there is not pain. I do not have a rash any longer but feel there must be swelling in the shoulder. Ocassionally I have some itching in injection area but try not to scratch at all.
bone pain in arm where shot was done in my deltoid; arm pain; muscle aches; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (bone pain in arm where shot was done in my deltoid), PAIN IN EXTREMITY (arm pain) and MYALGIA (muscle aches) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced BONE PAIN (bone pain in arm where shot was done in my deltoid), PAIN IN EXTREMITY (arm pain) and MYALGIA (muscle aches). At the time of the report, BONE PAIN (bone pain in arm where shot was done in my deltoid), PAIN IN EXTREMITY (arm pain) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medication was provided. No treatment  was provided.    Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Non-Significant follow up