chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; an administered VAQTA vaccine that was expired; had a recent temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.   On 08-FEB-2020 (also reported as 10-FEB-2020), hepatitis a vaccine, inactivated (VAQTA) 1ml (lot# S012250, expiration date 07-JUL-2020) had a temperature excursion with temperature above 47 degrees Fahrenheit (F) (66 F) and time frame of 26 hours.  On 03-AUG-2020, the patient was vaccinated with the hepatitis a vaccine, inactivated (VAQTA) (1ml, once) that was expired and had recent temperature excursion via unknown route for prophylaxis (expired vaccine used and improper storage of product in use).    No additional adverse event (AE) or product quality complaint (PQC) reported. The outcome of the events was unknown. The causality assessment was not provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S012250; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; serialnumber: 100030884661; udinumber: GTIN:00300064096026; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Chills, pain between shoulder blades, pain at injection site, headache, flu like aches
Fever to 103-105, vomiting, headache. Evaluated by doctor. Diagnosed with viral illness; doubt reaction to vaccines.
Patient had severe pain on injection and has had persistent right arm pain causing pain with movement/position, radiation of pain into the right shoulder.  Pain is causing difficulty with driving, teaching, reaching overhead. Pain is getting progressively worse since injection. No history of arm or joint issues.
Welts on same arm as injection site.  I am told it is hives.  Six welts are linear and 1/4 - 1 1/2 inch long.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact doses, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 28-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot number reported as L07560, expiration date: June 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
She received a dose of PNEUMOVAX 23 (dose #1) on 24 September and 24 hours later complained of onset of local pain and swelling at the vaccination site on her right shoulder. Over the past 48 hours she notes increased redness, swelling, and tenderness affecting her shoulder and upper arm. For the past 48 hours she has complained of fever (99.9 F), chills, headache, fatigue, malaise, and muscle and joint aches. She denies generalized cutaneous, lip/tongue/oral/laryngeal, pulmonary, GI/GU, and cardiovascular symptoms. She has been taking ZYRTEC and MOTRIN.
This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a female patient who received DTaP (Reduced antigen). In September 2016, the patient received the 1st dose of DTaP vaccine. On an unknown date, less than a month after receiving DTaP vaccine, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were unknown. It was unknown if the reporter considered the swelling arm and pain in arm to be related to DTaP vaccine. Additional details were provided as follows: The case was received as a public comment on Facebook. The patient received DTaP vaccine and experienced huge knot on her arm that also sore. The reporter stated that, after reading some of the complaints she guessed that could not really complain.
Little red bumps on abdomen and on top and sides of feet. First noticed in the AM of 10/04/00. None are itching or painful. Has a rash. Mom reported at 14:00 on 10/4/99. Mom denies increase in diameter of rash or any respiratory distress. No treatment. Mom was instructed to report to physician if condition persists or worsens.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and gender three patients who received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received a 0.5ml dose of suspect Influenza Quadrival A-B Vaccine, lot UT6301NA, expiry date 30-Jun-2019 via unknown route in unknown administration site. It was an actual medication error due to vaccine underdose and syringe leak. It was reported by nurse that they had 3 of 0.5ml prefilled syringes that leaked around hub during administration/ nurses were unable to deliver full dose to those 3 patients. It was unknown whether patients experienced any adverse reaction after the injection. 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. List of documents held by sender- none.
Information has been received from a physician and a nurse referring to a 17 year old male patient. The patient had no pertinent medical history or drug reactions/allergies. The physician and the nurse reported that on 12-OCT-2015 the patient was vaccinated with a dose (dose number unspecified) of GARDASIL (dose not reported, lot # K016966 with expiration date in May 2017, intramuscular). There were no concomitant medications. The nurse noted that on an unspecified date after receipt of the GARDASIL (in October 2015), the patient began to experience intermittent heart palpitations and tachycardia. The nurse noted that the patient's father recorded the patient's beats per minute (while at home) to be 177 (in October 2015). The patient came to the office on 27-OCT-2015 to be assessed, and it was noted that the patient's blood pressure and heart rate were within normal limits. The patient was sent home and on 28-OCT-2015, the patient again came to the office complaining of heart palpitations and tachycardia. The nurse stated that the patient's assessment was again within normal limits and an electrocardiogram (EKG) was conducted and no results were available at the time of the call. Unspecified laboratory work would be conducted. The nurse stated that the patient would have an echocardiogram conducted "tomorrow" (29-OCT-2015) at the Hospital and had an appointment "next week" with a cardiologist. No product quality complaint (PQC) was involved. No treatment was given for the events. Outcome of the events was reported as not recovered. The reporter considered the events to be disabling due to the patient not going to school. Additional information has been requested.
I got a Pfizer booster a couple; Armpit on that side is all swollen like it is full of fluid; 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) (Batch/Lot number: unknown) 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: 1st), for COVID-19 immunization; Bnt162b2 (DOSE: 2nd), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "I got a Pfizer booster a couple"; SWELLING (non-serious), outcome "unknown", described as "Armpit on that side is all swollen like it is full of fluid".  Additional Information: Patient got a Pfizer booster a couple of days ago and armpit on that side was all swollen like it was full of fluid and asked if that was normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a non-contactable consumer. This female patient of an unspecified age received a single dose of TRUMENBA in the arm on an unspecified date in Mar2015. The patient medical history and concomitant medications were not reported. The patient mentioned that her arm started swelling and turned red and hot to the touch on an unspecified date in Mar2015. She wanted to know if this adverse reactions were normal with TRUMENBA. Outcome of the reported events was unknown. No follow-up attempts possible. No further information expected.
ACCIDENTAL OCCUPATIONAL EXPOSURE TO PRODUCT; This spontaneous report received from a health care professional concerned a female 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, topical, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for an unspecified indication. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced accidental occupational exposure to product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of accidental occupational exposure to product was not reported. This report was non-serious. This case, from the same reporter is linked to 20210317249.
pt recv vax 22OCT98 3PM & that noc pt had chills;no fever;felt hot during noc;did not take temp;vomited x 1 23OCT98 & 25OCT98;nausea several days;
Erythematous papules - upper extremities, chest, back - following skin fold, positive pruritus - seen by a dermatologist. Clinically Pityriasis Rosea
received only the dtap-ipv potion of the product and would like to know if the acthib component of pentacelwith no reported adverse event; received only the dtap-ipv potion of the product and would like to know if the acthib component of pentacelwith no reported adverse event; Initial information received on 28-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had received only the dtap-ipv potion of the product and would like to know if the acthib component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On an unknown date the patient developed a non-serious event of received only the dtap-ipv potion of the product and would like to know if the acthib component of pentacle (strength, formulation, dose, route, administration site, batch number and expiry date was unknown for prophylactic vaccination) with no reported adverse event (single component of a two-component product administered, product preparation error) (latency: same day).  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 guidelines. 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.
Ongoing? Severe migraines, severe joint pain, nausea, diarrhea, GI distress, vision changes
Myalgia, Diarrhea, NauseaVomiting, hot and cold flashes, fatigue Narrative:
Received pneumonia and flu vaccines on 1/30/01. Complained of right arm where pneumonia shot was given as being swollen and painful to touch. Site edematous and warm to touch.
Pain, hardness and swelling of left arm to almost double the size of right arm, starting from the triceps muscle that spread all the way down forearm. Blister noted at injection site. Saw Dr. on 12/17/2011 at about 12 noon, prescribed Clindamycin 300mg every 8 hours plus Ultracet.
This spontaneous report as received from a patient's mother refers to a 25 year old healthy female who is allergic to amoxicillin and sulfur (reported as sulfer). The patient had no pertinent medical history. On an unknown date, (reported as she received as a child) the patient was vaccinated with a dose of VARIVAX (lot#, strength, dose and route were not reported). None of concomitant therapy was reported. On 29-JAN-2015, as the result of the patient's routine blood test, was found that her Varicella Zoster levels were equal or less than 135. The patient saw the physician, who suggested revaccination with VARIVAX because her immune system had not responded to the initial dose of VARIVAX. No treatment was given for adverse event. The outcome of the patient's event was not reported. The relatedness between vaccination with VARIVAX and the patient's event was not reported. Additional information has been requested.
Approximately 2 minutes after the vaccine was administered to the patient's left deltoid, a 4cm diameter red swelling with pain appeared at the injection site.  The patient was immediately given 50mg of diphenhydramine.  Within 30 minutes, the swelling was reduced to 3cm.  Patient was sent home with 50mg of diphenhydramine given every 6 hours for 2 days, and was also given 600mg of ibuprofen to take every 6 hours as needed for pain.  With the clinic closing for the weekend, we explained when to seek medical attention if needed over the weekend.  We followed up with the patient 3 days later (on Monday), and the patient said the injection site was still tender with a bruised coloration.  She had not taken the OTC pain medication and did not seek further medical attention.  Five days later, we followed up again, and the patient said the pain was tolerable, the coloration was now yellow, and that she did not require any pain medication.
Pentacel exposed to 27F for more than 3 hrs, due to temp was manually changed in the refrigerator, no adverse event; Initial information was received on 01-Jun-2020 regarding an unsolicited valid non-serious case from the other health professional.  This case is linked to cases 2020SA174880, 2020SA174885, 2020SA174942, 2020SA174941, 2020SA174940, 2020SA174932, 2020SA174906, 2020SA174911, 2020SA174910, 2020SA173110 and 2020SA172973 (same reporter).  This case involves a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ262AA and expiration date 14-May-2021) which was exposed to 27 F for more than 3 hours and vaccinated a dose of this vaccine to a four-month-old female patient via an unknown route at an unknown administration site on 11-May-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.   The patient's concomitant medication was not reported.  It was an actual medication error case due to product storage error temperature too low. This error occurred due to temp was manually changed in the refrigerator (human error).  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 holder's 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.
Painful swollen lymph nodes collar bone and underarm of Left side. Started 1/2 Injection site raised lumpy and itchy started 1/4 Raised itchy rash on R hip started 12/31.
so many people got COVID and have lost their sense of taste and smell, like her brother had for the last two and a half years; so many people got COVID and have lost their sense of taste and smell, like her brother had for the last two and a half years; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), as dose number unknown, 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "so many people got COVID and have lost their sense of taste and smell, like her brother had for the last two and a half years".  Clinical Course: Reporter called from the clinic and trying to find out as she's thinking about how so many people got COVID and have lost their sense of taste and smell, like her brother had for the last two and a half years, and luckily she has not. The caller is asking if somebody is working on a solution on how to get back the sense of taste and smell and if we have a solution for that.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: The causal association cannot be excluded between the reported event of drug ineffective, suspected COVID 19 and BNT162b2 use.
Patient received Pediarix, PedvaxHib, Prevnar and Rotateq on 10/30/06 and 12/28/06. She received all except PedvaxHib on 2/28/07 with each set of immunization she has had an erythematous rash starting the day after immunization on both legs which lasted 10 days.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; exposed to Covid positive patient; This is a spontaneous report from a contactable nurse (patient).  A 44-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was exposed to Covid positive patient on 15Jan2021. She tested positive for Covid 19 the following Monday 18Jan2021. The patient wanted to know if now that she was positive, she should still proceed with the second dose in February. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. Occupational exposure to SARS-CoV-2 is most likely related to an intercurrent condition which is not related to the suspected drug.  The case will be reassessed if additional information becomes available.
29 yo male employee who received 3rd TWINRIX on Friday 3/11/2016. Sat evening 3/12/2016 he c/o bilateral ankle edema, redness and tenderness to touch (entire ankle L>R). Sunday there was no change or addition of any other symptom. No fever, rash, ha, increase in swelling or limitation in ROM. Monday 3/14/2016 he went to medical where nurse called Immunization Healthcare Branch to discuss possible vaccine reaction. Based on her statements then of sudden onset ankle swelling and sweating and elevated BP at 156/90 I advised these were not common side effect to TWINRIX and suggested he see MD there - they recommended he see his PCP or go to ER. He called his HCP and went. BP 156-90 Temp 98.3F HR 90 RR20. Pt's ankle appeared mildly edematous. Color was within normal limits. Pt. was sweating. Since he rode his bike to work this am I could not determine if this was medical or from exercise. Dr. suggested that the pt. be seen by his primary care MD or outpatient facility. I followed up with him 3/15/2016 to clarify symptom complaints: description of his ankles, and more details on the sweating. He states he is a big man (like Hoss Cartwright) and sweats a lot normally and suggested his bp up after riding his bike to work. His reports his BP was normal at medical facility. Today 3/16/2016 his redness and swelling are gone. He is on day 3 of 5 steroid dose (60 mg/day). Your reaction was discussed with Dr. of vaccine safety and allergist. While reported vaccine side effects do list swelling, redness, joint pain and sweating as reported post vaccine side effects to TWINRIX thereby suggesting a temporal association to the vaccine (timing of reaction <24 hours after vaccine administration); the localized reaction does not support an allergic reaction to the vaccine or it's ingredients (ankles only). Reactions typically include more than one site (unless a local injection site reaction). You said your vaccine site was okay.