chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in neck; headache; nausea; joint ache; jaws hurting; rapid heartbeat; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3248), via an unspecified route of administration on 08Jan2021 14:30 (reported as 02:30 PM) at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. Medical history included Attack cardia, reflux and arthritis. Concomitant medications (other medications in two weeks) included amoxicillin, verapamil, omeprazole, estradiol (ESTROGEN) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No other vaccine in four weeks. The patient previously took morphine, Remeron, azithromycin and digoxin and experienced allergies. No COVID prior vaccination. The patient experienced soreness in neck, headache, nausea, joint ache, jaws hurting, rapid heartbeat and fatigue on 09Jan2021 8:00 AM. No treatment received for the events. Outcome of the events was recovering. Patient was not tested for COVID post vaccination.
Patient was vaccinated on 1/2/21 and 1/25/21 with the Pfizer COVID-19 vaccine. He began to develop symptoms on 7/21/21 (fever, cough, GI sx).  He test positive for COVID on 7/27/21
The pt was administered MMR SQ per recommendation. The pt stated, "I feel lightheaded." Then she fainted, as she began to faint this RN was helping her lower her head to her legs and called for other staff for help. She then began to pasture with her arms and ha dapprox. 5 sec of seizure acitivity involving her extremities and the nurses lowered her to the floor.
Initially, fevers and night sweats with loss of taste and smell.  Fevers resolved but loss of taste/smell + fatigue/malaise, unintentional weight loss persist to this day.  In the ED, found to have metastatic colon cancer and multiple pulmonary emboli.
No additional AE reported; PEDVAXHIB was administered subcutaneously on two different patients, who are twins; This spontaneous report was received from a medical assistant and refers to a 15-month-old twin of unknown gender. No information about the patient's medical history, concomitant medications and concurrent conditions was reported.  On 25-JAN-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter, lot #U012705, expiration date: 16-SEP-2023 administered subcutaneously for prophylaxis (intramuscular formulation administered by other route). No additional adverse event was reported (no adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA007587:
Developed fever, rapidly rising to 102.5.  Stayed between 102.3 and 102.5 for approximately 42 hours despite Tylenol taken at rate of 1 gram per 6 hours.  Accompanied by swelling in injection site sufficient to make arm movement painful, along with tenderness, redness and heat.  Fever did not completely return to normal until approximately 75 hours after injection, though last 24 hours of fever it was dropping rapidly.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored dose of VARIVAX (lot# reported as M009766, expiry date 23-FEB-2018). No adverse symptoms reported. No further information provided. This is one of two reports received from the same reporter. Additional information has been requested.
This case was reported by a healthcare professional (also the mother of the subject) via a sales representative and described the occurrence of red rash on arm in a 11-year-old female subject who was vaccinated with Tdap (manufacturer unspecified), Meningitis vaccine and Varicella vaccine. On 11 July 2011 the subject received unspecified dose of Tdap in an unknown arm, unspecified dose of Meningitis vaccine in an unknown arm and unspecified dose of Varicella vaccine in an unknown arm. At an unspecified time after vaccination with Tdap, Meningitis vaccine and Varicella vaccine, the subject experienced red rash on arms, swelling arms and puffy skin (on arms) the size of approximately three inches by three inches. At the time of reporting the events were resolved. A note was made that one vaccine went in one arm and two in the other arm. The medical assistant did not know which vaccine went in which arm. Follow-up information was received on 08 August 2011 via the healthcare professional/mother of the subject. It was reported that the events of red rash on arms, swelling of arms and puffy skin (on arms) began on 12 July 2011, just one day following administration of Tdap (manufacturer unspecified), Meningitis vaccine and Varicella vaccine. The mother specifically stated that both of her daughters arms were red and rashy. The events were resolved by approximately 19 July 2011. The mother questioned a possible allergy to the latex in the gloves or bandaids used since the events involved both arms.
Tested positive for Covid 19. Required 3 days hospitalization, treated with Regen Cov
This spontaneous report was received from a female patient of unknown age regarding herself. The patient's concurrent condition, concomitant medication and historical condition was unknown. On 11-JAN-2019 the patient was vaccinated with pneumococcal PNEUMOVAX 23 injection, intramuscularly (also reported as subcutaneous) (therapy type, dose, dose unit, strength, frequency, lot #, expiry date unspecified) for prophylaxis (immunization for the prevention of pneumococcal disease (pneumococcal immunization)). On the same day of vaccination, the patient experienced Pain and swelling in injection arm from the shoulder to the elbow (pain in extremity and peripheral swelling) and a rash at injection site (injection site rash). Patient did not receive any treatment for the events till the time of this report. The outcome of pain in extremity, injection site rash and peripheral swelling was reported as not recovered. Causality assessment was not provided. It was reported that no PQC was present.
Site redness, edema, induration, reported fever, malaise, body aches.  Reported started with malaise on 8/19 by 8/21 felt body aches , fever and sore throat.  Seen my MD on 8/23 the day she reported symptoms.  Dr Prescribed prednisone. Follow up on 9/5/2019 symptoms resolved.
Information has been received from a physician concerning her daughter, a female (age unknown) with unknown medical history, who on an unknown date was vaccinated (route unknown) with three doses of GARDASIL (Lot # unknown).  Subsequently, on an unknown, after receiving the third dose the patient experienced redness, tightness, and pain in her arm where she received injection.  The physician reported that "the patient had also experienced this after the first and second dose of the series, but the experience she had with the third dose was more severe".  Subsequently, on an unspecified date, on therapy, the patient recovered from redness, tightness, and pain in arm where received injection.  The patient sought unspecified medical attention.  No product quality control was involved.  Additional information has been requested.
Initial report received from a health care professional on 11 May 2011. A 15-month-old female child, with a slight rash on the chest at the time of vaccination, received an injection (route and site not reported) of DAPTACEL, sanofi pasteur, lot number not reported, and four other vaccines (name, manufacturer and lot numbers not reported) on 11 May 2011. After a few minutes, the patient's face became all red and she developed a rash. The patient was sent to Urgent Care Center. No other information reported at this time. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 17 May 2011. The patient had a possible rash at the time of vaccination. The patient's medical history and concomitant medications were reported as unknown. It was reported as none known in regard to the patient receiving any other vaccinations within 4 weeks. Prior to vaccinations the patient's mother pointed out small pinpoint rash near right axilla. On 11 May 2011 at 10:30 AM the patient received the following vaccines: an intramuscular left thigh (dose 4) injection of ACTHIB, sanofi pasteur lot number UH172AA and sanofi pasteur SA lot number E1030-1, an intramuscular left thigh (dose 4) injection of DAPTACEL, sanofi pasteur Ltd. lot number C3380AA, a subcutaneous right thigh (dose 1) injection of MMR II, Merck lot number 0872Y, a subcutaneous left thigh (dose 1) of VARIVAX, Merck lot number 12792, and an intramuscular right thigh injection of PCV13, "WAL" manufacturer 915252. Following the 5 immunizations, after approximately 10-15 minutes on 11 May 2011, the mother returned to the clinic with the child who presented with raised rash covering most of chest and with a blotchy red face. The patient had no respiratory problems and was not crying. The mother was to seek treatment at a doctors or urgent care. It was unknown if the treatment was sought or if any diagnostic or laboratory testing was performed. The outcome was reported as unknown. Follow-up information was received on 08 June 2011 from a health care professional. According to the reporter, no additional information to add, unable to contact client. No further information was provided at the time of the report. The patient's outcome was not reported. Follow-up information was received 21 June 2011 from a health care professional. The PCV13 vaccine had been manufactured by Wyeth Pharmaceuticals. According to the reporter, the patient's outcome, and their physician's contact information, were unknown. No additional information was provided. Documents held by sender: None.
Faint/dizzy, blurry vision, itchy throat.  Ate crackers, and drank water felt better.
Within 5 minutes of getting vaccines Left leg (injection site) broke out with whelps spreading to the abdomen. Patient given 1/4 tsp. of Benadryl po and observed for 20 minutes before being allowed to leave office.
Father reported that patient developed massive headache, nausea, and couldn't keep eyes open while in car leaving our office. They drove straight to emergency room. ER told father that patient was dehydrated and father said patient received, "a couple bags of fluid." They monitored patient and sent home. I followed up with father the following day and patient resting at home doing well. Father stated ER and father both thought unrelated to vaccine.
Swelling, mild discomfort and tenderness of underarm where vaccine was given as well as soreness of arm in general. Symptoms gradually disappeared over about 5-7 days.
a bad headache for 3 days; grand mal seizure; Grand mal seizure; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) and GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seizure. Concomitant products included LACOSAMIDE (VIMPAT) and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for an unknown indication.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) (seriousness criterion medically significant). On 01-Sep-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (a bad headache for 3 days). On 19-Aug-2021, GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) had resolved. On 01-Sep-2021, GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure) had resolved. At the time of the report, HEADACHE (a bad headache for 3 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included use of magnet to swipe across their chest when a seizure occurs.  It was reported that patient had a DNS on the left side of their chest. Lab data included Blood tests.  Company comment: 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. However, underlying medical history of seizures and use of concomitant medication are cofounder.; Sender'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. However, underlying medical history of seizures and use of concomitant medication are cofounder.
Hives; Rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and RASH (Rash) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives) and RASH (Rash). At the time of the report, URTICARIA (Hives) and RASH (Rash) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  Action taken with respect to mRNA-1273 was not applicable.
A non-serious spontaneous case of body ache, fever and malaise has been received from a physician in an eight-year-old male. No medical history or drug history information has been reported for this child. The child received FluMist on 28-Oct-2007. The child's mother, a physician, who reported this case indicated the child received FluMist and within five hours experienced body aches, fever with a temperature of 103, and malaise. His mother indicated that after 12 to 24 hours, the symptoms resolved and no other problems were noted. The adverse events resolved within 24 hours. The child has been dosed with FluMist in the last four seasons, the reporter stated she did not remember the child experiencing adverse events in the past seasons. The child's older brother received FluMist out of the same box as his brother and had no issues. The reporter did not provide a causality assessment for this event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion"; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion") in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion"). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion") outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Caller was an Office Manager. There have been no power outages that would have impacted the Moderna vaccine. She stated that because their facility had not been able to download the digital data logger for the months of Dec2021, Jan2022, and Feb2022. Thus, they considered need to treat this issue as a temperature excursion. No adverse event was reported. No treatment medications were reported.
This spontaneous report was received from a pharmacist, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ with lot # L033693 and expiration date of 31-MAY-2017 (strength and dose were not reported) for prophylaxis, however no adverse effects were reported. It was reported that multiple unspecified doses of the vaccine were exposed to room temperature of 47 Fahrenheit degrees (°F) to 77 °F for a time frame of 3 hours. The temperature excursion was not recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. Additional information has been requested.
received 2nd pediatric dose of Havrix when having 19 years old; received 2nd pediatric dose of Havrix when having 19 years old; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 19-year-old male patient who received HAV (Havrix pediatric) (batch number EP47E, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th December 2021, the patient received the 2nd dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. On 16th December 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received dose of Havrix pediatric at the age of 19 years old, which led to underdose and adult use of a child product. The reporter did not consent to follow up.
Client states that the next day after the injection, she had some redness about 2 inches below the injection site. The area was red, painful, and warm. She came to me today to show me (3/19/19) that the area was still painful and hardened. She also had a small penpoint scab  below and to the right of left of the induration. She complaints that her whole arm has been sore since the injection. She also stated that she had a migraine headache one day after the injection.
Case number PHEH2013US005305 is an initial spontaneous report received from a medical assistant on 25 Feb 2013 with a follow up information received on 25 Mar 2013. This report refers to an adult male patient. it was reported that he was vaccinated intramuscularly with 0.5 ml of MENVEO (batch number: M 11051, expiry date: 31 Mar 2014) that experienced temperature excursion on 25 Feb 2013. The first temperature excursion happened on 23 Jan 2013 and the vaccine was in a temperature of 54 F for less than 4 hours. It was reported that MENVEO was not reconstituted at the time of excursion. The reporter confirmed that the patient did not experience any adverse events as a result of temperature excursion. The patient would be re-vaccinated. No further information was reported. Follow up information received on 25 mar 2013: Reporter's comment updated.
High blood pressure, pain lower back, vision problem; urinary frequency; skin rashed; pain joint and back, pain leg, pain chest; sinusitis.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 12:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 12:13 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 25.25  Concomitant products were not provided.  On 12-Feb-2021, Excursion time were 09 AM, 10 AM and 11 AM temperature were 29, 35 and 35 respectively, total doses given for the day was 55, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 12-Feb-2021. 3 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.