chrisvoncsefalvay/vaers-outcomes huggingface dataset:
101.5 temperature; This case was reported by a consumer via call center representative and described the occurrence of fever in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2020, the patient received the 2nd dose of Shingrix. On 7th February 2020, 1 days after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had fever.  The patient treated with Ibuprofen tablets.  The reporter asked what should we expect from here.
Expired Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 8th August 2022, unknown after receiving Bexsero and Bexsero 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: 08-AUG-2022 Reporter's comment: The chat visitor reported that a dose of Bexsero was given today (on the day of reporting) to the patient and it was already expired in July 2022, so the vaccine was expired by 8 days. Chat session ended by visitor with no additional details provided.  The reporter ended chat before additional details could be collected. Entered country of occurrence as United States, however this was not confirmed as chat visit did not respond. Additional Supportive Information: The use of Bexsero dose which was already expired on 31st July 2022, which led to expired vaccine used.
first dose prior to hospitalization for COVID; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lung cancer and herpes virus infection.   On an unknown date, the patient received the 1st dose of Shingrix. In February 2022, less than 6 months after receiving Shingrix, the patient experienced covid-19 (serious criteria hospitalization). On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Linked case(s) involving the same patient:  US2022115888   Additional Information: GSK Receipt Date: 12-Aug-2022 Reporter's Comments: The reporter stated that the patient still had left-side pain.  The patient plans to see a specialist for the pain.  She mentioned her first Shingrix dose was the end of 2021, prior to hospitalization for COVID in FEB-2022.  The patient also mentioned second Shingrix dose was given in her left deltoid.  Additional supportive information: For tolerance of 2nd dose refer case US2022115888. .; Sender's Comments:  US-GSK-US2022115888:Same reporter
Tongue felt strange. Couldn't taste anything.  On 10/19/2012 woke up with left side of my face paralyzed.  Diagnosed with Bell's Palsy at Hospital.
patient is administered an extra dose of Adacel after receiving it one year prior with no reported adverse event; inadvertently administering an extra dose of Adacel vaccine with no reported adverse event; Initial information  received on 10-Jan-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 65 years old female patient and it was reported that patient administered an extra dose of adacel after receiving it one year prior and inadvertently administering an extra dose of adacel vaccine with no reported adverse event after receiving Diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Jan-2023, the patient received a booster dose, 0.5 ml (milliliter) (1x) (once) of suspect Diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (lot number: U7549AA, expiry date: 04-Nov-2024) (with unknown strength) via intramuscular route in the left deltoid for immunization.  On 09-Jan-2023, Nurse reported that patient inadvertently administered an extra dose of adacel vaccine with no reported adverse event (extra dose administered) and patient administered an extra dose of Adacel after receiving it one year prior with no reported adverse event (inappropriate schedule of product administration) (latency: same day) following the administration of Diphtheria-2/tetanus/5 AC pertussis vaccine.  It was also reported that "Caller is requesting information on the possible side effects that can occur due to receiving the vaccine too soon".  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both events.   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.
Redness. Edema and pain centered on elbow and upper arm near inject site. Warm to touch. Assessment: Cellulitis secondary to anthrax vac.
This spontaneous report as received from a certified medical assistant refers to an unknown age female healthcare worker patient with unspecified pertinent medical history, drug reactions or allergies. On 17-JUN-2015, the patient was drawing up a dose of vaccinated with ZOSTAVAX (lot number and expiration were not reported) and some inadvertently splashed in her eye and got on her skin. Her eyes were flushed with water for 15 minutes and were fine but some of her facial skin currently had a burning sensation but no redness. The outcome of burning sensation was reported as not recovered/not resolved. Additional information has been requested.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). An 18-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# 301308A), at the age of 18, on Sep 1, 2021, single dose, for COVID-19 immunisation.  Medical history and concomitant medications not reported. The patient experienced dizziness, onset 2021, with outcome of unknown. Additional information: Patient received his first dose of the vaccine on Sep 1, 2021. He hasn't had the second dose of the vaccine because he experienced dizziness since the first dose. No follow-up attempts possible. No further information expected.
Spikevax 2023-2024 & Fluzone HD 2023-2024 were received 10/6/23.  Patient woke up itching during the night.  Discovered hives in the morning of 10/7/23 which began on the right side of hip/buttocks.  Hives then developed on left hip & inner thigh. Visible hives & itching were only symptoms. Pt was seen by a provider at her Dr's office on Monday morning 10/9/23. Hives were fading at that point.
Information has been received from a registered nurse concerning a 19 year old female with no drug reactions/allergies who on 04 Apr 2006 was vaccinated SC with a 0.5mL dose of rubella virus vaccine live (lot #0317R). It was noted that the patient was vaccinated post delivery of a premature infant by Cesarean section. On 04 Apr 2006 (also reported as 18 Apr 2006) , the patient experienced rash on her abdomen. No description of the rash was available. There were no lab diagnostic studies performed. The outcome was reported as not recovered. Unspecified medical attention was sought.  There was no product quality complaint involved. No further information was available. Additional information has been requested.
No fever and no problem until today when mom noticed swollen (L) thigh. (4 1/2" x 2 3/4"). Injection sites appeared like "boils" and drained clear, gray fluid.
1st dose: Bitter taste in back of throat for half day on date of administration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 09:30 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing); "known_allergies: Sulfur based antibiotics" (unspecified if ongoing), notes: Sulfur based antibiotics. Concomitant medication(s) included: MULTIVITAMINS [VITAMINS NOS]. The following information was reported: DYSGEUSIA (non-serious) with onset 03Apr2021, outcome "recovering", described as "1st dose: Bitter taste in back of throat for half day on date of administration". Therapeutic measures were taken as a result of dysgeusia.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination except Multi vitamins, collagen peptide powder. Prior to vaccination, the patient was not diagnosed with COVID 19, since the vaccination, the patient had not been tested for COVID 19. Treatment included alternated Advil and Tylenol. The case was reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fever; chills; headache; fatigue; severe pain; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe pain), PAIN (body aches), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced PAIN (severe pain), PAIN (body aches), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PAIN (severe pain), PAIN (body aches), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient called and said she and her other two sons already got the vaccine. Her youngest son side effects included fever chills, severe pain, trebles, headache.  No Concomitant drugs were reported.  No Treatment information  was reported.   Reporter did not allow further contact
Fluttering, twitching muscle spasm in both calves. They do not hurt, they're not constant, but felt all day long whether I'm sitting or standing. First noticed them a few days after the first dose.
The pharmacist gave me the shot and there was a sharp burning feeling.  He put pressure on it and took it off and I was bleeding profusely.  He applied pressure again, then when he turned to get the bandaid blood was running down my arm.  When I went home, and looked in the mirror, and realized the shot was not in the right spot.  Then as the day went on, I was having pains in my arm and pain radiating down my arm.  Thumb and index finger became numb.  Also woke me up out of sleep that night.  By day three, I was still  having the same problems and I went to urgent care.
REACTIVE ARTHRITIS; This spontaneous report received from a patient via other manufacturer (Abbvie) concerned an adult female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  The patient received non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) citrate free, frequency, and therapy dates were not reported for ankylosing spondylitis. No concomitant medications were reported.  On an unspecified date, the patient experienced reactive arthritis, difficulty in walking (duration 1 week), and some pain after physical activities (dose number in series 1). The patient received booster dose of Pfizer BioNtech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin was not reported, intramuscular, batch number: unknown, expiry: unknown) dose and start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with Pfizer BioNtech covid-19 vaccine (tozinameran) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of reactive arthritis was not reported. This report was serious (Other Medically Important Condition)
Headache; Taste of metal in mouth; Ringing in the ears; Elevated heart rate; Blurry vision; Arms soreness; Muscle, bone and joint pain.; Muscle, bone and joint pain.; Muscle, bone and joint pain.; This is a spontaneous report from a contactable healthcare professional, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 03Apr2021 at 11:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer and bi lateral mastectomy. The patient had known allergies to iodine, all antibiotics, shellfish, latex and gadolinium. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 12:30, the patient experienced headache that lasted a week, taste of metal in mouth that lasted a week, ringing in the ears, elevated heart rate, blurry vision, arms soreness, muscle, bone and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache and taste of metal in mouth was recovered on 10Apr2021; while that of the ringing in the ears, elevated heart rate, blurry vision, arms soreness, muscle, bone and joint pain was recovered on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a physician and refers to an approximately 22 year old female patient (4-5 years older than her 17 year old sister). The patient's concurrent conditions included an immunocompromising condition of idiopathic autoimmune hearing loss, which is being treated with methotrexate. On unknowns dates, the patient was vaccinated with the three doses of  GARDASIL 9 or with GARDASIL (unidentified Merck hpv vaccine administered) since the reporter did not know which for prophylaxis (frequency, route, lot number and expiration date were not reported). On an unknown date, the patient developed cervical dysplasia with one of the Human Papillomavirus (HPV) serotypes that the HPV vaccination series protects against (vaccination failure). The outcome of cervical dysplasia and vaccination failure and the causal relationship between the aforementioned events and both vaccines were not reported.
My explanation of issues after getting the flu shot this year on October 4, 2013. I was given my flu shot on Friday, October 4th in the afternoon. By Saturday I was feeling a little under the weather. By Sunday afternoon it was hitting me full force. By Monday morning I could hardly get out of bed. I went to the urgent care. She put me on Levaquin and Prometh/Cod for cough. She also put me off of work for a week. I still was not ready (feeling well enough) to go back to work but my FMLA papers were only for a week. I have continued with the severe cough and had an appointment with Dr. on Monday, October 21st. In our conversation he said that the flu shot did exacerbated my system into a full asthma attack. Dr. put me on Prednisone and more cough syrup. This is my third week of this after missing a full week of work and 2 trips the doctor and 2 rounds of medication.
Hives on neck legs  that started 2 days after injection.  Took OTC Benadryl for two days and hives resolved Please note I have gotten the flu shot annually without any issues.
Information has been received from a consumer concerning her 73 year old mother with allergies to AZITHROMYCIN, ANCEF, CODEINE, "DELOITTE", CEPHALEXIN and a history of knee replacement, who on 14-JUL-2008 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included LIPITOR, PLAVIX, ENAPRIL, SYNTHROID and baby ASPIRIN. The caller stated that on 30-NOV-2009 her mother developed shingles after getting the ZOSTAVAX (Merck). She started with the rash and itch on her back on the left side and breast. The reporter indicated that the patient was hospitalized. The patient had a CT scan test done (results not reported). At the time of this report the patient had not recovered. Additional information has been requested.
On my arm is a bruise and itches bruise; On my arm is a bruise and itches bruise; hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15May2021 (Batch/Lot number: unknown) at the age of 23 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "if covid_prior vaccination Yes" (unspecified if ongoing), notes: if covid_prior vaccination Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right), administration date: 17Apr2021, when the patient was 23 years old, for COVID-19 Immunisation. The following information was reported: CONTUSION (non-serious), PRURITUS (non-serious) all with onset 2021, outcome "not recovered" and all described as "On my arm is a bruise and itches bruise"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "hurts". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of contusion, pruritus, pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with PNEUMOVAX 23 on 22-OCT-2012 (route of administration and anatomical location were not reported). No other co-suspects were reported. No concomitant medications were reported. On 05-DEC-2012 the patient received another dose of PNEUMOVAX 23. No treatment information was reported. No symptoms reported. The outcome of received one dose of PNEUMOVAX on 22-OCT-2012 and another dose on 05-DEC-2012 is unknown. No other details. Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Clinical course: Unknown if there are other medication in 2weeks. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pfizer vaccine   Dull and occasionally sharp chest pain in upper left quadrant of chest. When these pain come in they will last 2-4 hours at a time. It is not clear what triggers these episodes of chest pain.  This pain was never experienced prior to the Covid vaccine.  Late menstrual cycle - 3+ days late and am never late. I track my periods with the flow app. Still have not got my period, this may be longer
Within 20 minutes of receiving the vaccine, I became very hot and dizzy. I was driving at the time and was barely able to make it home before I felt that I was unsafe to drive. I developed a fever of 102, was extremely weak and dizzy, had a rapid heart rate, and was had a tight chest for several hours after the injection. The next morning the injection site was very red, painful and swollen with swelling spreading to my entire shoulder and arm. The weakness was no longer whole body but now localized to my arm to the extent of not being able to raise my arm more than a few inches. The swelling lasted for 3 days and the arm pain and weakness lasted for 3 weeks before fading completely.
Patient is pron to seizures. She received the Covid shot. At about 4:00 pm that afternoon she began to have a seizure. I was very atypical of her previous seizures. She began the seizure at a very low level (no outward signs other than total confusion and unable to speak. This condition lasted until about 8:pm. Now and again she would do her normal "shake".  The seizure eventually stopped. Additional dose of Keppra was given as well a a few drops of Lorazapam.
Moderna vaccine given at 11:14. Approximately 3 minutes post Moderna vaccination, the patient reported mild, non-radiating chest tightness and throat tightness.  Able to swallow, speak. No SOB ,dizziness or lightheadedness. No headache. + Anxiety.  VSS. Afebrile. B.p 120/80's HR 75  25 mg po benadryl given at 11:18.  11:20, pt reported numbness to frontal head/forehead and left side of face and left palm of hand.  Good csm, not focal neurological deficits.  Continues to deny SOB.  Airway patient. speaking in clear sentences.  EMS called.   Patient transferred to Hospital via EMS with EMT and Paramedic.
Administered Moderna Covid Vaccine to 15 year old patient, instead of Pfizer Covid Vaccine.