chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reconstituted with sterile diluent not accompanying diluent; reconstituted with sterile diluent not accompanying diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number Y772R, expiry date 25th May 2023) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 11-Jul-2022 Reporter's comment: The reporter reported that HIberix was reconstituted with sterile diluent not accompanying diluent. The reporter consented to follow-up. Additional supportive information: The Hiberix was reconstituted with sterile diluent not accompanying diluent, which led wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Pain, redness and swelling at the injection site, muscle pain, tiredness, headache. Lasted 4 days and then came down with bronchitis.
pt reports small red bump on medial side of rt knee 1wk a/vax;p/vax spread into rash extending w/circular lesions up both legs-dermatologist felt it was a lymphatic, systemic rxn to sometheing;rash now going away but MD wanted vax info;
104.6 Fever Lasting 3 days**. Inablity to walk on right leg  lasting 3days**. Severe pain in right leg red swelling one inch around injection site. Fatigue. Loss of appitite. **Most concerned.
2OCT92 6-7PM cold sx 3OCT92 p/12PM flushed, eyes blood red, throat, eyes & lips swelled rapidly; hands & feet swelled & ached; called family had difficulty breathing & passed out 215PM; family found pt & took to ER;
This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with unspecified number of doses of VARIVAX (Merck) which were administered to the patients which were exposed to the temperature outside of range. The patient was vaccinated with VARIVAX (Merck) Lot# J009165 (Expiry: 24-JUL-2015) which was exposed to 26F for 82 days. No further information was provided. This case is linked to the case 1403USA009275 and 1404USA002681 (same reporter link). Additional information has been requested.
11 x 12 cm erythema and pruritus left deltoid region, appearing approximately 24 hours after DTaP/IPT administration.  No interference with function.  No systemic symptoms.
I had both the booster shots for Pfizer (Pfizer COVID-19 Vaccine), I tested positive.; I had both the booster shots for Pfizer (Pfizer COVID-19 Vaccine), I tested positive.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had both the booster shots for Pfizer (Pfizer COVID-19 Vaccine), I tested positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive; Negative, notes: it came back negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that patient had both shots and had both the booster shots for Pfizer (Clarified as Pfizer COVID-19 Vaccine) and was kind of feeling kind of sluggish yesterday and got one of those tests and it came back negative so called the doctor and and he said taken your pills (Paxlovid) and the patient wanted to know what are the side effects of pills is to be is like kind of, like lazy oozing often and stuff like that is that normal. Consumer stated, It's the tablet, trying to figure with it what they gave Paxlovid. When Probed for testing Positive for COVID: Consumer stated, That's the medicine the doctor prescribed yes, but right tested positive that's why he prescribed this medicine. yeah I mean like, I will be sitting in the chair and I am oozing off you know oozing off like you I just feel to sluggish I just want to if this part of medicine (Paxlovid). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-SEP-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to an exact T not recorded but noted as equal to or >13C for an estimated total time out of range of 72.0 hours. On 10-SEP-2013 at 17:30, ZOSTAVAX lot # J003360 was exposed to -13C for an estimated total time out of range of 10 hours. On 16-SEP-2013 at 17:30, ZOSTAVAX lot # J003360 was exposed to -14C for an estimated total time out of range of 10 hours. On 25-SEP-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to 11C for an estimated total time out of range of 14 hours. On 07-OCT-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to an exact T not recorded bu tnoted as equal to or <12C for an estimated total time out of range of 42.5 hours. On 07-OCT-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J003360, Exp. Date: 21-JUN-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested
Last Thursday she received her second vaccine for Shingrix. She tells me within 1 hour she developed a fever, aches, pains and chills. She says that her temperature was 102. She says during the day she has low grade temp 99 and at bedtime it went to 102.1. She went to the hospital on September 3rd. She had an IV and labs and was sent home.
awful cough/Horrendous cough; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 12:15 (at the age of 53-years-old) (Batch/Lot Number: EN1201) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing diabetes, hypothyroidism (from 2000) and blood pressure. Concomitant medication included metoprolol tartrate taken for blood pressure from 2003 and ongoing. Patient previously took first dose of bnt162b2 (Batch/Lot Number: (F or E) L3248, No Expiry or NDC) administered in left arm on 29Jan2021 at 02:30pm (at the age of 53-years-old) for covid-19 immunisation. The patient experienced awful cough/horrendous cough and shortness of breath on unspecified date in 1st week in Mar2021. It was reported that She received her second dose in the middle of Feb2021 and 2 weeks after experienced an awful cough and shortness of breath. The shortness of breath has resolved, but she still has a cough. She is a diabetic for the past 50 years. Her doctor follows her closely and she had an insulin pump, the Dexcom System. Callers husband and she thinks it was coincidental that a few weeks after the second dose, she developed a cough. She contacted her doctor and her primary care provider advised her to stay home. She went to a Cardiologist and had a chemical stress test done on 18-19May2021, and he found that she had 3 blockages between 30-40%. But the doctor felt that was not the cause of the shortness of breath. States that no one has been able to tell her why she had shortness of breath. Previous to finding the blockages she didn't had any problems. She knows with having the diabetes for so long that it was just a matter of time, but it was a little to coincidental in her opinion. She doesn't remember exactly when, but the shortness of breath resolved in either Apr2021 or May2021. The patient underwent lab tests and procedures which included cardiac stress test showed 3 blockages between 30-40% on unspecified date in May2021, sars-cov-2 test was negative on an unknown date and on unspecified date in Dec2020. Outcome of the event shortness of breath was recovered on unspecified date in 2021 and outcome of event cough was recovering.
Pain and swelling in joints of feet,  hips and shoulders with a settling into hands as time went on.
Delayed allergic-type reactions starting around 1800 on 2/5/2021.  Symptoms included: hives, SOB, fever, and rigors lasting for a few hours. Pt. had extreme fatigue and fell asleep a little past 2000. Pt. woke up around midnight and symptoms were gone. Pt. is a nurse and cared for self at home. Did not seek medical care.
Pain/soreness/arm hurts really bad; Diarrhea; Neck ache; Back ache; Headache; Feel so tired/Extreme fatigue/Exhausted; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain/soreness/arm hurts really bad), DIARRHOEA (Diarrhea), NECK PAIN (Neck ache), BACK PAIN (Back ache) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain/soreness/arm hurts really bad), DIARRHOEA (Diarrhea), NECK PAIN (Neck ache), BACK PAIN (Back ache), HEADACHE (Headache), FATIGUE (Feel so tired/Extreme fatigue/Exhausted) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Pain/soreness/arm hurts really bad), DIARRHOEA (Diarrhea), NECK PAIN (Neck ache), BACK PAIN (Back ache), HEADACHE (Headache), FATIGUE (Feel so tired/Extreme fatigue/Exhausted) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-022431 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-022431:Crosslinked (MOD21-022232)
Moderate low back pain; This is a spontaneous report from a contactable physician (patient). A 49-year-old male patient received first dose of BNT162B2 (Lot number: ek5730), via an unspecified route of administration, in left arm, on 22Dec2020 07:30 A.M. at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccine was received within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. Medical history included mild asthma. No allergies to medications, food, or other products. Concomitant medication included esomeprazole sodium (NEXIUM), cetirizine hydrochloride (ZYRTEC), doxycycline, mometasone furoate (ASMANEX), ergocalciferol (VIT D). The patient experienced moderate low back pain on 25Dec2020 09:30 A.M. The event was reported as non-serious. Treatment of the event included ibuprofen and valium (for muscle relaxant effect). The outcome of the event was recovering.
fever, chills, arm pain, fatigue but mainly swollen lymph nodes continuing to swell for two days
Fever of 101.8 plus body aches and severe headache on 3/31/21 resulting in inability to work. Sore arm On 4/1/21, mild symptoms, sore arm, mild body aches and mild headache  On 4/2/21 same mild symptoms as previous day plus some shortness of breath followed by an asthma attack at 5:30pm. An asthma attack is extremely unusual for me and I haven?t had an asthma attack in 20 years
still caught the Flu; Initial information received on 29-Nov-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-health-care professional.  This case involves patient of unknown demographics who still caught the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient still caught the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local authorization  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (still caught the Flu).  At time of reporting, the outcome was Unknown for the event still caught the flu.; Sender's Comments: Sanofi company comment dated on 05-Dec-2022:This case involves patient of unknown demographics who still caught the flu while receiving vaccine INFLUENZA VACCINE.. Furthermore information regarding medical history, past medical treatment, vaccinations, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
This spontaneous report as received from a registered nurse refers to a currently 5 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-APR-2018, the patient was vaccinated with an improperly stored dose of PROQUAD recombinant Human albumin (rHA) or human serum albumin (HSA) of lot # N015623 with an expiry date of 15-NOV-2018 (Strength, frequency, route and anatomical location were not reported) for prophylaxis. On 03-APR-2018, a 11 minute temperature excursion of -13.3 degrees Celsius occurred as advised by the nurse. All other temperatures were in range and average temperatures remained stable. The vaccine was in the freezer at the time of excursion (Product storage error). The nurse advised that this was a "supported temperature excursion" since it was between -10 and -14 (Units unspecified) for a period of 11 minutes and that the supply could remain in stock and was viable. No previous temperature excursion occurred. No adverse vaccine reactions were reported. The call was because of a data logger. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter.
I woke up on 9/2 and was congested so on 9/5 I decided to go get an iv at an iv bar just to help get me over what I was thinking was a cold or allergies. Then on 9/5 I went and got my first dose of the covid vaccine and on 9/6 I woke up with no smell and no taste at all. For the next week I was congested, it was hard to breathe and I was very fatigue. I did get covid tested since I lost my taste and smell and I was negative on all 4 of them in the next 12 days. Now, it is time for my second dose and I still have no smell or taste at all so the doctors don't know if I should or should not get my second dose.
Client come in for immunizations accompanied by his mother and brother.  Mother requuesting menigiococcal vaccine for him.  PHN is also present in the exam room for this vaccine, as she was helping with his brother who also had a adverse event.  After obtaining written permission and supplying VIS to mother , vaccine was given to him in L deltoid while sitting in a chair.  He did fine with the procedure and had good color, but as soon as he stood up to leave he stated he was going to faint and became very pale.  With the help of three we got him onto the exam table and he continued to be very pale, hot and diphoretic.  We applied cold compresses and tok his blood pressure and pulse which were 110/70 and 60.  After he felt better he sat up and had some vitamin water and a graham cracker.  His color was better.  He had not eaten this am and was up late last night.  He ad passed out one other time after giving blood.  That time it was right after football practice and he had not eaten or drank anything but went right from practice.  Also his father has a history of passing out when getting shots and his borther fainted right before him while getting his shots.  We wheeled him to the front door in a wheel chair and his mother helped him out to the car.  Mom advised to tell any other providers that he should lay down when giving blood or receiving immunizations.  mother advisied we would be doing vaer.  Called mom after they left clinic and she said they were both doing better as they had eaten.
This spontaneous report as received from a registered nurse refers to a 70 years old female patient with asthma, tuberculosis and no drug reactions/allergies. The patient was intramuscularly vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot number reported as 1947A, expiry date: 20-OCT-2013) on 29-OCT-2012. No other co-suspects were reported. Concomitant medications included: hydrochlorothiazide, losartan potassium. On 29-OCT-2012 the patient could not lift her arm after receiving PNEUMOVAX 23. The patient called the physician, who advised that she take BENADRYL (unspecified strength and amount) and alternate hot and cold compresses on the affected arm. There were no laboratory diagnostics studies performed. She was recovered on 31-OCT-2012. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown demographics. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates beginning in December 2015, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L027733, expiration date: 13-SEP-2017 and lot # L033343, expiration date: 13-SEP-2017; dose and route were not provided). The vaccine was exposed to temperature of 32 degrees Fahrenheit for 30 days. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received for the Pregnancy Registry for GARDASIL vaccine (yeast) from a 35 year old female with no pertinent medical history or drug reactions/allergies who on 16-APR-2008 was vaccinated with the "first dose of three doses" of GARDASIL vaccine (yeast) (lot# 0152X) injection. Concomitant therapy included RHOGAM. On 16-APR-2008 the patient was administered GARDASIL vaccine (yeast) instead of another injection the patient was supposed to be receiving. On an unspecified date an ultrasound was performed. No adverse side effects were reported as a result of this. The patient's gestation was 28 weeks. The date of the last menstrual period (LMP) and the estimated date of delivery (EDD) was unknown. Follow-up information was received from a registered nurse RN. The RN reported that the patient should have received RHOGAM injection for Rh negative on 16-APR-2008 but instead received the GARDASIL vaccine (yeast). The RN stated that the nurse who administered the GARDASIL vaccine (yeast) mistakenly did so. There was no product confusion involved. The patient received the RHOGAM injection after the patient received the GARDASIL vaccine (yeast) on 16-APR-2008. On 16-APR=2008, the patient had an ultrasound which was reported as  normal. Follow-up information was received. The patient had a history of 2 previous pregnancies with full-term deliveries. The patient had a history of macrosomia in both previous pregnancies. The birth weights were 9 pounds and 12 ounces and 10 pounds and 5 ounces. The patient's date of her last menstrual period was 06-OCT-2007, the estimated conception date was 20-OCT-2007 and the estimated date of delivery was 13-JUL-2008. On 05-MAR-2008 the patient had an ultrasound for AMA and it was within normal limits. On 14-MAY-2008 an ultrasound was within normal limits. On 09-JUL-2008 the patient delivered a normal, healthy male baby weighing 9 pounds and 15 ounces. The baby's length was 21.5 inches with apgar score 9. His head circumference was 38.7cm. There were no congenial anomalies and no other complications or abnormalities. Additional information is not expected.
Patient got 2 doses of the J&J vaccine (1st: Lot 1802072 on 3/9/21 at Pharmacy. 2nd: Lot 1822811 on 12/9/21 at a different Pharmacy). Patient came in today here asking for the Pfizer booster 3rd dose. There was a language barrier between the patient and staff. The patient was given the adult pfizer vaccine today 12/29/21 without the technician checking the card and vaccination screening/questionnaire form. The technician realized after administering the vaccine that the patient shouldn't have gotten this type of shot. Patient kept saying everybody told them to get the pfizer 3rd dose but didn't understand that the j&j booster suffices. The pharmacist was notified after the vaccine was administered. We told the patient to wait the full 15 minutes after the shot and they had no reactions during that time.