chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On 12-Sep-2021, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning a 38-year-old female patient with current medication of Adalimumab, who experienced the unexpected non-serious adverse event of special interest COVID-19, in the context of the first dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date was not provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The co-suspect drug Adalimumab, which is an immunosuppressant, increases the susceptibility of patient to acquire COVID-19 infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 38-year-old female patient with current medication of Adalimumab, who experienced the unexpected non-serious adverse event of special interest COVID-19, in the context of the first dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date was not provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The co-suspect drug Adalimumab, which is an immunosuppressant, increases the susceptibility of patient to acquire COVID-19 infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a 71 year old female with allergic to Codeine , History of allergic to dust and many other things, who on 04-Nov-2008 was vaccinated with ZOSTERVAX. Concomitant therapy included NEXIUM, ALLEGRA, NASONEX and unspecified thyroid medication. On 04-Nov-2008 the patient experienced tingling sensation on the top of her head shortly after receiving ZOSTERVAX. The next day it became a burning and stinging pain. The patient went to the emergency room and they felt that it could be shingles out break but were unsure because there was no rash along with the pain. Many unspecified tests were performed. The events have not been recovered. Additional information is not expected.
10:47a went into a room to wait for 15 minutes directly after the injection. Began to feel somewhat dizzy right afterwards. Continued back to my office. Informed my supervisor that I was feeling dizzy but informed him that I had a couple bites of oatmeal, and a few cups of coffee and was going to try and eat something and hydrate and I?m sure I would feel better. I went back to work for about an hour (I work at a desk). For about an hour I continued to feel dizzy and noticed I was cloudy and was staring off. After an hour I really became dizzy and walked to my supervisors office and informed him. It felt as though I was walking on the moon to get to his office. I also felt like I had a uti. I sat down in his office and informed him of what happened. As I was talking to him I began to pass out. I did not go out the whole way but he began speaking to me more. After feeling a little better I walked back over to my office. I felt waves of dizziness and being hot and cold. My husband came and picked me up around 1:30p from work. I felt better after getting in the car and going home. Once I was home I ate and had began to feel better. Around 6:00p I began to go through another wave and was experiencing body aches, hot and cold sweats, loss of appetite, tingling all over my body but mostly in my legs and feet. At that point I went in and laid down in bed for the rest of the night. Probably around 9:00p I began to feel better. I attempted to fall asleep around 11:00p but when I closed my eyes I felt like they were racing back and forth. So I got back up and watched something in tv until I fell asleep maybe about 30 minutes later. I woke up the next morning around 8:45a. I tossed and turned most of the night, however I felt better. It was like I had the flu for a few days and on the last day I felt better but was under the weather. At this point in the morning I was fatigued. I was able to perform some tasks around the house.  I then laid back down in bed for a few hours because I was beginning to feel dizzy and was experiencing hot and cold sweats. After a few hours I got up from bed and performed a few more tasks around the house. Then was able to sit down on the couch and watch some tv. At this point I?m still expediting tingling in my body at times. Still a little dizzy but able to focus and hot and cold sweats.
Pt recvd measles vax 2JAN91 & pt exp a sore arm for one to 2 days following vax; subsequently pt recovered;
Patient stated pain became extreme around 3 am in the morning of 11/30 and was slowly progressing to that point during the day of the immunization. I can not pinpoint a definite time during that day in which the pain exactly started but it did become extreme around 3 o'clock in the morning.
Large red, swollen, hot to touch. Cool compressed, non aspirin pain reliever every 4 hrs.
Sore Arm within few hours after injection which went away after 2 days. The next day woke up with  migrane like headache, took  2 Advil and within an hour felt better. Also felt very tired for several days.
Covid; Covid; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown; manufacturer unknown), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2023, latency 8 days after the suspect product(s) administration, outcome "unknown" and all described as "Covid". Clinical course: Covid vaccine fall 2023, received and 8 days later came down with Covid in a crowded amusement park. Patient second Covid vaccine in 5 months. Never had Covid before.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Pt has a 2" across bruise at injection site which appeared the next day. Also had a 3"x3" red area 2-3" below injection site which went away 2 days later. Pt has no plain with bruise, takes daily aspirin.
the excursion was Negative 40 degrees C and 22.7 degrees C. Caller stated that these invalid Adacels were given to 3 pregnant patients, no side effects; the excursion (caused by Human Error) was Negative 40 degrees C and 22.7 degrees C. Caller stated that these invalid Adacels were given to 3 pregnant patients, no side effects; Initial information received on 06-Sep-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to case ID: 2019SA250873 and 2019SA250866 (same reporter).  This case involves a 49 year old female pregnant patient who was exposed to a second dose vaccine of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (dosage form: Prefilled Syringe) lot U6273AA, expiry date: 24-Apr-2021 via intramuscular route in the right arm on 23-Aug-2019.  The patient was exposed to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at 32 weeks of pregnancy, during third pregnancy trimester.  The date of last menstrual period was reported as 09-Jan-2019.  The estimated due date is 16-Oct-2019.  The patient previous pregnancy was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant vaccines were given.  It was a case of actual medication error due to product storage error and patient received it. It was reported that The Excursion (caused by human error) was Negative 40 degrees C and 22.7 degrees C. Caller stated that these invalid Adacels were given to 3 pregnant patients.  It is a case of vaccine exposure during pregnancy.  There were no side effects during this prenatal visit.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  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.  Documents held by sender: none.
Right arm 14 cm redness from shoulder to elbow. No induration around injection site - none.
Tested positive; Tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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) all with onset 03Aug2022, outcome "recovered" (2022) and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Aug2022) Positive, notes: 3 out of 9 of us tested (+) on Wednesday 03Aug2022; (unspecified date) Positive, notes: 2nd time having COVID. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical information: Was attending a small family gathering 30Jul for a week. 3 out of 9 of us tested (+) on Wednesday 03Aug2022. Individual female 65 fully vaccinated (Pfizer) and 2 boosters (Pfizer) recovered w/o Paxlovid. 2nd time having COVID for female 65.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a Pharm. D. concerning a female who in the 1950's was vaccinated with MMR. In approximately 1950 the pt had an anaphylactic reaction. Additional info has been received from the Pharm. D. The Pharm. D. reported that the pt was an employee who had reported to employee health dept that she had an anaphylactic reaction after she had received the MMR II in the 1950's (vaccine was not available until 1978). The Pharm. D. reported t hat she was unsure what vaccine the pt had received and did not have any further info on this case. Upon internal review, anaphylactic reaction was considered to be an other important medical event (OMIC). Additional info is not expected.
Left thigh is about 33% more swollen than usual. Circular indurated area is about 10 cm in diameter. Area is warm and mildly tender.
Case number PHEH2014US016852, is an initial spontaneous report from a health care professional received on 21 Aug 2014 with a follow up information received from a physician on 25 Sep 2014. This report refers to a 16-year-old male patient. Past medical history and concomitant medications were not reported. On 14 Aug 2014, approximately at 8:30 am, the patient received an initial intramuscular dose of MENVEO (batch number: M13054) into right arm where MenA lyophilized conjugate component reconstituted with a diluent (other than MenCWY). No adverse event was reported following this administration error. Follow-up received from a physician on 25 Sep 2014: Patient demographics (height and weight), vaccination site and vaccination time updated.
left side of face numb/nose numb; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (left side of face numb/nose numb) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced HYPOAESTHESIA (left side of face numb/nose numb). At the time of the report, HYPOAESTHESIA (left side of face numb/nose numb) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: No new information was provided.
Systemic: Convulsion-Severe, Additional Details: Patient went into a 3 second convulsion episode within a few seconds of receiving the vaccine. She had trouble seeing for about 4 minutes afterwards. 911 was called and paramedics took her vitals, all in range. Her mom had an episode in the past (possible Family History), and she has not eaten since the night before, shot was administered at 10:30AM.
This spontaneous report as received rom a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with M-M-R II (dose, route, lot# and expiry date not provided). On an unknown date the patient had unknown titers drawn, which showed the patient was immune to measles and rubella, however, was not immune to mumps. The reporter could not clarify if the patient had received a dose of M-M-R II prior to the titers being drawn. The outcome of the event and causality assessment was not provided. No product quality complaint (PQC) involved. No further information provided. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On 9th February 2019, the patient received SHINGRIX (intramuscular). In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and injection site pain. The patient was treated with ADVIL. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the medical doctor for herself. The patient received SHINGRIX in the upper gluteal or hip region rather than in the deltoid. The reporter indicated that the responsible physician and nurse practitioner suggested the alternative injection site due to the patient being petite with little muscle mass in the deltoid region. The patient subsequently experienced marked local reaction with significant swelling, redness and pain which had increased progressively over the past three days of reporting. The patient had been taking ADVIL with little relief of symptoms. Batch number, date of birth and administration facility address were not provided.
This spontaneous report as received from a physician refers to a male patient of unknown age. On an unspecified date, the patient was vaccinated with ZOSTAVAX one single shot, (lot number, dose and route not reported) for prevention of shingles. On an unknown date, five days after receiving ZOSTAVAX, the patient developed a rash. At the time of the report, the patient's outcome for rash was unknown. Additional information is not expected.
arm got red, hot, 2" x 6" reddened area same day;saw MD 3 days p/vax on Claritin for allerg rxn;
arm soreness not at the injection site, underneath the arm; pain is unbearable with movements/resonating pain when they move the arm; This spontaneous case was reported by a pharmacist and describes the occurrence of AXILLARY PAIN (arm soreness not at the injection site, underneath the arm) and MYALGIA (pain is unbearable with movements/resonating pain when they move the arm) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced AXILLARY PAIN (arm soreness not at the injection site, underneath the arm) and MYALGIA (pain is unbearable with movements/resonating pain when they move the arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, AXILLARY PAIN (arm soreness not at the injection site, underneath the arm) and MYALGIA (pain is unbearable with movements/resonating pain when they move the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The pharmacist believes the issue is related to nerve pain.
husband had myalgia for several days.; This case was reported by a pharmacist via sales rep and described the occurrence of myalgia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was unknown.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's wife. The patient received the dose of Shingrix and experienced myalgia for several days. It was stated that patient did not receive the 2nd dose of Shingrix and patient was fine. The reporter did not consent to follow up. This case was linked with US2021AMR101778 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101778:master case for the unspecific number of patients
This spontaneous report as received from a other health professional refers to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 05-OCT-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N014371, expiration date 09-MAY-2019 or lot# 019133, expiration date 22-JUN-2019 (dose was not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees Fahrenheit for 1 hour and 45 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA009100: US-009507513-1710USA009098: US-009507513-1710USA009022: US-009507513-1710USA009101.
body discomfort; pain; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (body discomfort), MYALGIA (pain) and FATIGUE (tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (body discomfort), MYALGIA (pain) and FATIGUE (tiredness). At the time of the report, DISCOMFORT (body discomfort), MYALGIA (pain) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  No treatment medications was provided   This case was linked to MOD-2021-194183 (Patient Link).
Patient passed out about 5-7 minutes after getting the vaccine.  She came to but appeared to struggle to stay alert.  Her skin was very pale and clammy.
Patient received VARIVAX (chicken pox) vaccine on 1/8/09 and came in 1/21/09 complaining of a rash. Dr diagnosed the rash as chicken pox caused by the vaccine.
Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 7UA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 4th October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comment: Reporter stated that a nurse inadvertently administered an expired Havrix expiry date 30 September 2022 to a patient. The reporter called to inquired for any recommendations for this. The reporter unable to provide any patient details. Reporter did not consent to follow up. Additional supportive information: A patient was administered expired Havrix vaccine, which led to expired vaccine used.