chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse reaction; vaccination dates: 05-AUG-2009; 10-OCT-2010; 14-SEP-2012; This spontaneous report has been received from a lawyer and a 63-year-old male patient via a Plaintiff Fact Sheet. On 05-AUG-2009, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacture unknown, reported as PPSV23) (strength, dose, route, lot #, expiration date not reported) for prophylaxis. Then the patient also received the pneumococcal vaccine, polyvalent (23-valent)(manufacture unknown) vaccines on following dates: 10-OCT-2010 and 14-SEP-2012 (dose, route and lot were also unknown) (inappropriate schedule of product administration). There were no adverse reaction or side effects for the patient.   This is one of several reports split from a case in litigation (MARRS# 2010USA001766).; Sender's Comments:  US-009507513-2010USA001766: US-009507513-2101USA012803: US-009507513-2101USA012804:
Swollen lymph nodes; raised rash on upper chest, throat, neck; some pain in throat. Rash is red, painful, and itchy. Has persisted for for at least 5 days with little relief from medication (Advil, Benydryl).
Fever of 105, Chills off and on, swollen glands, stomach ache, vomiting, stuffy nasal cavity, head ache, foul smelling urine.
Reports at 16:30 - 6/8/17 - injection site, warm, tender and swollen, low grade fever, fever continued the next day along with hives/rash - denies itching.
This spontaneous report as received from a registered nurse refers to a 2 months old patient of unknown gender. The nurse reported that on 17-MAR-2014, the patient was vaccinated with the first dose of ROTATEQ, (lot #J008507; expiration date: 13-MAR-2015. Route and dose were not reported. No other co-suspect or concomitant medications were reported. The nurse reported that the vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
.5 dose of FLUQ give to client instead of .25 dose of FLTQ.
Ran a fever that reached 100.8; fever subsided after 16 hours.  Chills at the onset of the symptoms (1-2 hours).  Fatigue (has not yet subsided).  Muscle pain, particularly in the left arm, though was present in the rest of the body. Subsided in the left arm after 16 hours.
Subject received the vaccination to his left deltoid, while sitting in the observation area was noticed to become pale, observer spoke with patient and he stated he was dizzy, his head bobbed back and his eyes rolled. placed in a reclining chair, and rolled to close observation area. vitals obtained. BP 122/81, pulse 68, and SPO2 95%. He was given water and stated he felt better. He stated he was sweaty and light headed, but after he reclined and was given water he felt better. vitals all remained stable and he left feeling  better.
Pain right where the lymph node located on the left side under the chin; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 11Mar2021 at 13:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 09Apr2021, the patient experienced pain right where the lymph node was located on the left side under the chin. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pain right where the lymph node located on the left side under the chin was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a 63 year old female patient with sulfonamide allergy who on 09-FEB-2007 was vaccinated intra-articular in her left shoulder joint with a dose of  Pneumovax 23. On 09-FEB-2007 the patient experienced "terrible pain" that evening. on 12-FEB-2007 she was seen at the physician's office and was prescribed a steroid (unspecified) and pain reliever possibly Celebrex. She also went to the emergency room (ER) but was not admitted. She was given an injection of epivacaine and Kenalog. The physician said that the patient seemed to be doing better. The patient was recovering. The reporter considered the event to be disabling because the patient was unable to perform same physical activities such as gardening and kayaking. Additional information has been requested.
sore arm; This is an initial spontaneous report from a Pfizer sponsored program from contactable consumer (patient). This 81-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose on 19Apr at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on an unspecified date at single dose for COVID-19 immunisation. The patient mentioned that he himself has received both doses of the vaccine and reported that the only side effect he experienced was yesterday, stating he had a sore arm that was "very slight" and "not that bad." He had his 2nd Pfizer shot on 19Apr and had a sore arm. Originating AE Request: REQ-258716. The outcome of the event was unknown.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.
This case was reported by a physician via sales rep and described the occurrence of shivering in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced shivering. On an unknown date, the outcome of the shivering was unknown. The reporter considered the shivering to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. During a phone call, the physician told the field representative that the most common side effect from SHINGRIX that some of her patients have had is shivering. This case was one of the 9 cases reported by the same reporter. It was unknown if any of those 8 patients were the patients to which the doctor was referring generally when she said that some of her patients had shivering. Shivering was not specifically provided in the doctor's spreadsheet of symptoms for other 8 patients which was sent to the field representative. Some of the other 8 cases have the symptom of chills, and it was also unknown if the doctor considered the symptom of chills to be shivering or considered shivering to be a separate symptom. So, the patients of the reporter who have had the specific symptom of shivering were currently unknown.
Chest pain; shortness of breath; headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-years-old non-pregnant female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6708 and Expiration date was unknown) via intramuscular route of administration, administered in left arm on 03Mar2021 at 18:00 hours as dose 1, single for Covid-19 immunization. The patient medical history was not reported. Patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient received unspecified medications as concomitant medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 01May2021 at 00:00 hours, patient experienced chest pain, shortness of breath and headache. Patient did not receive any treatment for the events. The outcome of all the events was unknown.  Information on the lot/ batch number has been requested.
he had sciatica after his shot; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (he had sciatica after his shot) in a male patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SCIATICA (he had sciatica after his shot). At the time of the report, SCIATICA (he had sciatica after his shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
2hr p/vax devel sore arm, 3hr p/vax devel resp problems which indicated some difficulty breathing & deep, raspy, non productive cough;by 5hr later felt throat swelling & inc resp distress;went to ER 7PM;felt like asthma;poss allerg react
Quadracel vial for the DTap-Ipv part and mixed it with the ActHIB from the Pentacel, no Ae; patient meant to receive Pentacel but accidentally nurse grabbed Quadracel, No AE; Initial information was received on 04-May-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 month old female patient who was meant to receive DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot number: UJ217ADA and expiry date: 04-Apr-2021) but accidentally nurse grabbed DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] 0.5 ml (lot number: C5688AA and expiry date: 26-Nov-2021)via intramuscular route in the left thigh) vial for the DTap-Ipv part and mixed it with the HIB (PRP/T) VACCINE [ACT-HIB] lot number: UJ217AD and expiry date: 04-Apr-2021) from the Pentacel and this was given on 29-Apr-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient's past medical treatment included QUADRACEL on 30-DEC-2019 and 02-MAR-2020.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) for immunisation.  It was actual medication error due to Inappropriate reconstitution technique and Wrong vaccine administered.   No adverse event reported at the time of reporting.  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.
MUSCLE PAIN, HEADACHE, SHIVERING, FEVER, LOSS  OF APPETITE  RASH ON BACK, SENSITIVE  AREAS ON BACK HAVING HAD SHINGLES 15 YEARS AGO, THE CURRENT SYMPTOMS ARE MUCH MILDER
SLIGHT FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight fever on 06-MAR-2021. This report was non-serious.
This is a spontaneous report obtained from a contactable Health Care Professional. A patient of an unspecified age and gender received, on an unknown date, PREVNAR 13, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient developed atrial fibrillation (Afib) after receiving pneumococcal 13-val conj vac (dipht crm197 protein). Clinical outcome of the event was unknown at time of this report. The information on the lot number has been requested.; Sender's Comments: Current limited information does not allow a full medically meaningful assessment, especially lack of medical history, concomitant medications and concurrent illness.  However, a causal relationship between the serious event atrial fibrillation (Afib) and PREVENAR 13 might not be completely ruled out considering the plausible time association.  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.
In the day after the booster shot was received, patient experienced chills and fatigue; In the day after the booster shot was received, patient experienced chills and fatigue; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).  A 30-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 23Dec2021 (Lot number: 32030BD) at the age of 30 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EL3247; Route of administration: Intramuscular), administration date: 28Jan2021, when the patient was 29 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EL3247; Route of administration: Intramuscular), administration date: 18Feb2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021, outcome "unknown", described as "Dose number: 3"; CHILLS (non-serious) with onset 24Dec2021, outcome "recovered" (24Dec2021), described as "In the day after the booster shot was received, patient experienced chills and fatigue"; FATIGUE (non-serious) with onset 24Dec2021, outcome "recovered" (24Dec2021), described as "In the day after the booster shot was received, patient experienced chills and fatigue". Therapeutic measures were not taken as a result of chills and fatigue.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
had some mild symptoms after the shot that were constitutional in nature; It has now been 6 months since their first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (had some mild symptoms after the shot that were constitutional in nature) and PRODUCT DOSE OMISSION ISSUE (It has now been 6 months since their first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had some mild symptoms after the shot that were constitutional in nature) and PRODUCT DOSE OMISSION ISSUE (It has now been 6 months since their first dose). At the time of the report, VACCINATION COMPLICATION (had some mild symptoms after the shot that were constitutional in nature) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (It has now been 6 months since their first dose) had resolved.        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 treatment was reported.  It was reported that, patient subsequently received steroids & was told to delay 2nd dose further. It had now been 6 months since their first dose.    Reporter did not allow further contact
Rt varicella vaccine given 12/16/04 reaction came out red with a bump x3wks.
TIRED; LITTLE SORENESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 08:30 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the patient experienced little soreness. On 14-MAR-2021, the patient experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little soreness on 13-MAR-2021 and tired on 15-MAR-2021. This report was non-serious.
Rash in my arm where I received the shot; Muscle still swollen.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash in my arm where I received the shot) and VACCINATION SITE SWELLING (Muscle still swollen.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash in my arm where I received the shot) and VACCINATION SITE SWELLING (Muscle still swollen.). At the time of the report, VACCINATION SITE RASH (Rash in my arm where I received the shot) and VACCINATION SITE SWELLING (Muscle still swollen.) outcome was unknown.            No concomitant or treatment reported
pt recvd vax;10jul95 exp fever & on 17jul95 exp three lesions on chest that were compatible to varicella;
Vaccine recipient was administered the vaccine at 11:30 am and then around 1:30 pm started to feel dizzy with hives and itching to his arms. The vaccine recipient was sent to the emergency department for further evaluation. There was an erythematous macular/papular rash on bilateral arms. He was administered diphenhydramine 12.5 mg IV, famotidine 20 mg IV, and methylprednisolone 125 mg IV. After reexamining, the patient felt much better, no dizziness, no itching, and no rash. He was discharge to home at 4:57 pm same day.
Patient reported a headache, nausea, intermittent left facial cheek tingling, fatigue/tiredness, and left arm discomfort the day after the vaccination. They also reported feeling "warm all over" shortly after getting the vaccine. The patient reported their symptoms to Moderna and received a case number MOD20-02598.
I began to experience intense itching , runny nose, and patches of hives on both arms and legs, back and stomach area.  My sleep pattern was disturbed to the point that I had to search the internet seeking relief.   I then took 2 Allegra allergy tablets for the itch and used Hydrcortisone creme topically on the hive patches.  After doing both, I got relief in about 3-4 hours.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 16-AUG-2017, the patient was inadvertently administered a properly stored but expired dose of M-M-R II injection, lot # L029266 with expiration date on 04-AUG-2017, for prophylaxis. The vaccine was reconstituted with sterile diluent. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.