chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pentacel  has been out of range and the max temperature reached was 10.1C with no reported adverse event; Initial information received on 14-Dec-2022 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a patient of an unknown age and gender and reporter reported Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] has been out of range and the max temperature reached was 10.1c with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection has been out of range since 09-Nov-2022 and the max temperature reached was 10.1c with no reported adverse event (product storage error) (latency: unknown) (With an unknown strength, administration site, route, dose, lot number and expiry date) for immunization.  It was reported Caller reporting a temperature excursion at their facility. The caller advised there was an issue with their data logger and it did not flag them that the temperature in the refrigerator was to warm. The caller requested stability data. Extended stability does not cover the excursion. The caller reported there has been a patient to receive the vaccine post excursion.  Action taken: not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
All over body itchy rash; recommended Benadryl PO and present to clinic if no relief.
Information has been received from a nurse concerning an unspecified patient (age and gender was not reported). The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date, the patient was vaccinated with a dose of VARIVAX (dose, strength, frequency and anatomical location were not reported) (lot N010107 with expiration date 28-MAR-2019) reconstituted with sterile diluent (unknown lot# and expiration date) and with M-M-R II rHA (dose, strength, frequency and anatomical location were not reported) (lot M039914 with expiration date 26-SEP-2018) reconstituted with sterile diluent (unknown lot # and expiration date) both intramuscularly, for prophylaxis. No adverse effects reported. No further information provided.
Information has been received from a medical assistant (MA), concerning a 39 year old female patient who on 17-JUL-2007 was vaccinated, SC in the right arm, with a dose of PNEUMOVAX 23 (Lot #657039/0698U).  Subsequently the patient developed redness, pain and warmth at the site of the injection that radiated into the right axilla.  At the time of this report, the patient had recovered from the events (duration not specified).  The patient sought unspecified medical attention.  The MA reported that of the 6 vaccinations with PNEUMOVAX 23 administered from Lot #657039/0698U, (3 male and 3 female patients with an age range from 28-61 years), 3 additional patients experienced symptoms similar to the events described above (WAES 0709USA03054, male; WAES #0707USA04634, male), and 1 additional patient experienced a "minimal reaction" (WAES 0708USA00702).  The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory.  The lot complies with the standards of the center, and was released.  Additional information is not expected.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates the patients were vaccinated with doses of improperly stored doses of M-M-R II (Lot# L012480; Expiration date: 10-APR-2017, Lot# L003856; Expiration date: 05-FEB-2017, Lot# reported as L009544; Expiration date: 19-MAR-2017). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Product information, event information and the narrative had been updated.
PT STATES SHE FELT SOME TINGLING IN HER TONGUE FOLLOWING THE VACCINATION.  SHE DENIES ANY ISSUE AFTER THE FIRST DOSE.  SHE ARRIVES ON MED OBS 1 AT 0801. 08:05 -- HR 84 BP 120/80 RESP 16 OXYGEN SAT 100% ROOM AIR. WHILE SHE WAS BEING OBSERVED SHE STATED THAT SHE HAD WORKED ALL NIGHT, HAD NOT EATEN ANYTHING FOR BREAKFAST. SHE STATES THE SYMPTOMS HAVE GONE AND WOULD LIKE TO GO.  SHE WAS ESCORTED TO THE EXIT BY STAFF AS SHE LEFT WITH A FRIEND AT 08:15.
Excessive yawning. Tightness in chest, trouble taking deep breaths but not all the time.
Patient complaining of soreness and stiffness in right arm a day after getting the immunization. States it started towards the back of the shoulder (deltoid) and has now progressed to the side of shoulder where shot was administered.
A spontaneous report was received from a consumer conerning a 78-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed a lot more difficult to think and plan things that were easy to do before/mental impairment, intense nightmare/nightmare, I was very confused; woke up not knowing where I was/confusional state, brain fog/mental fatigue, headache like an ice cream headache/headache, disorientation, loss of taste/ageusia and loss of smell/anosmia. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin daily, vortioxetine daily, calcitonin nasal spray daily not specified. The patient received the first of two planned doses of mRNA-1273 (Batch number: 037K20A) on 04 Jan 2021. On 01 Feb 2021, approximately 15 days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 04 Jan 2021, on first dose, the Patient developed symptom of pain at the site of injection in patient's left (nondominant) arm patient was not able to lift objects weighing more than a few pounds. This symptom resolved spontaneously approximately 2 days later. On 15 Feb 2021, the patient had brain fog, including confusion, nightmares, disorientation, slowed thought and reasoning processes, and difficulty planning. Caller also reported slight loss of taste and smell as well as intermittent headaches. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received a pediatric dose of pfizer vaccine instead of the bivalent pfizer vaccine requested.
This spontaneous report was received from certified medical assistant refers to unknown number of patients of unknown age and gender. Since 20-FEB-2015, the patients were vaccinated with a dose of VARIVAX (Merck) which was previously exposed to temperatures outside of the recommended range (dose, route of administration and lot # were not reported). No adverse effects reported. Additional information has been requested.
Flushed; Malaise; Fatigue; She is diaphoretic; feel short of breath; Nausea; This is a spontaneous report from a non-contactable other health care professional. A 49-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number:EN6205) via unspecified route of administration on16Mar2021(at the age 49-year-old) and the patient had previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown)on an unspecified date via an unspecified route of administration as a single dose for COVID 19 immunisation .The medical history included patient was morbidly obese. On 16Mar2021 the patient had stayed for 15 minute waiting period after the injection and asked to stay another 5 minutes. The patient felt fine until she reached the front doors, then she had experienced flush, nausea, malaise/fatigue shortness of breath and diaphoretic. Therapeutic measures were taken as the result of the events included treatment with water and snacks. The patient responded to the treatment excellently. The patient was stable to go home and was discharged and advised to follow up with Primary care physician. The clinical outcome of flush, nausea, malaise/fatigue shortness of breath and diaphoretic were unknown. No follow-up attempts are needed. No further information is expected
Injection site pink spot; Injection site warm; Injection site itchy; Injection site pain; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Injection site pink spot), INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE PRURITUS (Injection site itchy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). On 14-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Injection site pink spot), INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE PRURITUS (Injection site itchy). On 09-Feb-2021, INJECTION SITE PAIN (Injection site pain) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Injection site pink spot), INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE PRURITUS (Injection site itchy) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information and concomitant medications were not provided.   Reporter did not allow further contact; Sender's Comments: The reported event(s), [arm pain, injection site pink spot, injection site raised, injection warm and injection site itchy], were considered medically significant to mRNA-1273. (As listed for the study drug)
Arm still itches below the injection site; Swatch that is stll reddened and discolored; discolored; Reaction to artificial sweeteners; This case was reported by a consumer and described the occurrence of injection site itching in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2019, the patient received the 1st dose of Shingrix. On 26th September 2019, less than a day after receiving Shingrix, the patient experienced injection site itching, injection site erythema, injection site discoloration and reaction to drug excipient. The patient was treated with benadryl (nos) (Benadryl Cream). On an unknown date, the outcome of the injection site itching, injection site erythema, injection site discoloration and reaction to drug excipient were not recovered/not resolved.   The reporter considered the injection site itching, injection site erythema, injection site discoloration and reaction to drug excipient to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient received Shingrix last Thursday and it said side effects are 2 to 3 days. The patient's arm was still itches below the injection site and there was a swath about 3 X 6 that was still reddened and discolored. The patient putting Benadryl cream on it. The patient wanted to know why the patient had reaction after 8 days. The patient asked if there was something in vaccine that giving a reaction, was there any latex involved in the packaging, vial top, or in the vaccine or any artificial sweetner? The patient did not see that it did not have preservatives and no phenol. The pharmacist stated that Shingrix does not contain preservatives. The vial stoppers were not made with natural rubber latex. Each dose also contains 20 mg of sucrose (as stabilizer), 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80. The patient asked whether the virus itself causing the reaction. The pharmacist stated that unsolicited adverse events that occurred within 30 days following each vaccination were recorded on a diary card by all subjects. Unsolicited adverse events that occurred in more than 1percentof recipients of SHINGRIX and at a rate at least 1.5-fold higher than placebo included chills (3.5percentversus 0.2 percent), injection site pruritus (2.2percentversus 0.2 percent). The patient reported that polysorbate is a sorbitol derivative and that is an artificial sweetener and the patient had reactions to artificial sweeteners.
Redness and swelling w/ tenderness to arm from injection site to just below elbow. Low grade temp.
Generalized itching with eczematous rash which has persisted for 2 weeks so far.
Patient received the orig. Pfizer Vaccine instead of the Pfizer Bivalent Dose!!
Patient was brought in by EMS and was paranoid and said everyone was out to get him; Tested for C19 before admission; Inpatient; Multivitamin
Body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache) and HEADACHE (headache) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products AMOXICILLIN for Infection and ADALIMUMAB (HUMIRA) injection for Ulcerative colitis.    No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started AMOXICILLIN (unknown route) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 09-May-2022, the patient experienced MYALGIA (Body ache) and HEADACHE (headache). At the time of the report, MYALGIA (Body ache) and HEADACHE (headache) had resolved.            No concomitant medication was reported. Dose number was reported as Dose 4. On an unknown date in 2022, the body aches and headache resolved. No treatment information was provided.   This case was linked to MOD-2022-587443 (Patient Link).
Patient states she is unable to recall when symptoms started. She states she has a rash over face and body. Per patient, rash is not red or inflamed. She has no other symptoms and feels well at this time. She states she has had this rash before and is unsure if it is directly related to vaccine that was given as she has other allergies that have caused the same reaction.
Large red rash on the left arm that is warm To the touch.  Low grade fever, headache and all over body aches.
Case number PHEH2015US000670 is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 64-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN, (batch number: 145205) intramuscularly at a dose of 0.5 ml on 11 Oct 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist did not believe that the vaccine was frozen instead thought it was thermometer malfunction. No adverse event was reported following the maladministration (incorrect storage of drug). No further information was provided.
First 3 days migraine ,fever, extreme pain  all over. Could barely move injection arm. Still sore all over currently.
Chest pain, redness to the face and hives to neck.  25 mg Benadryl PO by Paramedics, EMS called  Signs/symptoms subsided. Person refused EMS transport to hospital
Discomfort at injection site; Lymphadenopathy; Nausea; Headache; Severe fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included ovarian cancer, diabetes, hypertension and adhesives allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 16:00, the patient experienced severe fatigue, headache, lymphadenopathy, nausea and discomfort at injection site. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of severe fatigue, headache, lymphadenopathy, nausea and discomfort at injection site was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
scared; Her husband was also positive and is scared/COVID-19; This is a spontaneous report from a contactable consumer. This consumer reported the similar events for two patients. This is the second of two reports.  A 38-years-old male patient (Husband) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 08Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that her husband was also positive (Apr2021) and is scared (unspecified date). The reporter asked when it's time for the second dose, if they would benefit from getting it. The reporter got the vaccine because she plans to travel to her country, but she doesn't know if she should get the second dose. Her husband (patient) didn't want to receive it. The patient underwent lab tests and procedures which included COVID-19: positive on Apr2021. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021423321 same reporter/drug, different patient and similar event
I had a migraine for three days starting  on wed and burning tingling and numbness in my hands feet back of my calf also, my veins in my wrist hurt and felt tight and  by Friday night my face was starting to get numb. I also have a bad sore throat.  I went to the hospital they ruled out blood clot and stroke.  My Covid test was negative.
Had full body numbness and tingling about 6 minutes after administration, while waiting in observation area. Felt lightheaded, dizzy. Laid down, symptoms resolved about 5 minutes after, except bilateral Upper extremity tingling. This resolved after an hour, with tingling then localized only to left arm.  This also resolved within 2-3 hours from time of administration  (estimate)
Information has been received from a registered nurse concerning a patient who on 26-FEB-2002 was vaccinated with a dose of Varivax. Subsequently, on 13-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Chills, aches, fatigue, fever of approximately 101.7 that lasted approximately 24 hours after starting. No medical treatment necessary. Not a reaction that seemed dangerous or overly onerous, but one that prevented normal activity for about 24 hours.
Tiredness; chills; leg weakness; confusion; This is a spontaneous report from a contactable consumer (patient). This 96-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 23Jan2021 at 12:15 PM (at the age of 96-years-old) as a single dose for COVID-19 immunization.  The patient's medical history was not reported. The patient's concomitant medications included atorvastatin from an unknown date for an unknown indication; atenolol from an unknown date for an unknown indication; losartan from an unknown date for an unknown indication; buspirone from an unknown date for an unknown indication; and "levot" from an unknown date for an unknown indication. The patient had not received any other vaccines in the four weeks prior to vaccination and did not have COVID prior to vaccination. On 25Jan2021 at 11:00 PM the patient experienced tiredness, chills, leg weakness, and confusion. The clinical outcomes of tiredness, chills, leg weakness and confusion were recovered in Jan2021. It was also reported the patient had not received a COVID test post-vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a certified medical assistant concerning a 13 year old male patient with no past medical history who on 30MAY2003 was vaccinated subcutaneously with a first dose of varicella virus vaccine live. There was no concomitant medication. Subsequently in 2003, the patient developed 20 spots on his face. Unspecified medical attention was sought, but no treatment was required. A product quality complaint was not involved. Additional information has been requested.
This is a spontaneous report by a contactable pharmacist through a Pfizer sales Representative. A 74 year old male patient was administered with PREVNAR 13 intramuscular injection as a single dose on arm for prevention of pneumonia on 26Oct2013. Relevant medical history was unknown. On the same day the patient received an influenza vaccine. Vaccines given within the last four weeks were unknown. On 26Oct2013 the patient mentioned that his arm was sore and had trouble lifting his arm. On 26Oct2013 he stopped PREVNAR 13 as he took just one single dose. Relevant lab data was unknown. At the time of the report the patient had not recovered from the above mentioned events. Follow-up (06DEC2013): Follow-up attempts completed. No further information expected.
I previously had the Covid 19 virus on December 7, 2020. I received my first shot on October 1, 2021. Upon receiving my first dose of the Pfizer-Biontech Covid-19 vaccine I have had diarrhea since the shot. Severe abdominal, like some one is stabbing a knife into me while I am sleeping, and lower back pain, so bad I thought I cracked a vertebrae. This has caused so much pain I have gotten about 4 hours of sleep a night and I also went to my Dr because I have been in so much pain I thought I may have had appendicitis. I also have had consistent joint and muscle pain else where.