chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Physician states that a nurse administered both PENTACEL and ACTHIB to a 2-month old patient/no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician and consumer/non-health care professional via Medical Information (MI) (Reference number- 00854395) and transmitted to Sanofi on 11-Nov-2021.  This case involves a 2-month-old patient nurse administered both DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB (PRP/T) VACCINE [ACT-HIB] (extra dose administered).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect HIB (PRP/T) VACCINE (solution, dosage text 1x) and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [frequency: once, Dose:  0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin TB skin test, strength: standard except for Fluzone HD, lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  It was an actual medication error case due to extra dose administered  (latency: same day)  it was reported "Physician states that a nurse administered both PENTACEL and ACTHIB to a 2-month old patient. Physicians asks if there is information regarding the toxicity of this. Physician states she does not have time to complete an AE report at time of call because she needs to call the patient's mother."  At the time of reporting, no adverse event was reported.  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.  There will be no information available on the batch number for this case.
Within first 6 hours of the shot I had Muscle pain like I was running marathon. My joints felt like they were on fire. Nothing was working for me- not marajuana or Tylenol. It lasted for 5 weeks and mid-April it just stopped. I went to the chiropractor during the 5-week time frame. I seen a rheumatologist and he said he thinks it's a fibromyalgia flare-up. Muscular and joint pain was just terrible. It was almost like the fatigue of working out on days on end and finally getting a break. I seen chiropractor on 04/02/2021 and they suggested trying turmeric ginger and he did an exam but found nothing and found no restrictions.
1/27/22 Chief Complaint: Cough     Context: Pt is a 74 yr/o male who presents with covid symptoms that began Monday. Pt has had nasal congestion, cough, and fatigue. Pt tested positive for covid on Wednesday. Pt has been more confused and generalized weak today. Pt has fallen today but no injuries. Pt was told to come to ED. Pt has had vaccine with booster. No sore throat, HA, sneezing/tearing from eyes, SOA, CP, body aches, V/D, dysuria, rash, or bruising. No blood thinner use. None smoker. No lung disease. Pt has hx of dementia. Physical Exam Constitutional:      Appearance: He is well-developed and well-groomed.  HENT:     Head: Normocephalic and atraumatic.     Mouth/Throat:     Mouth: Mucous membranes are dry.  Physical Exam Eyes:     Conjunctiva/sclera: Conjunctivae normal.  Cardiovascular:     Rate and Rhythm: Regular rhythm. Tachycardia present.  Pulmonary:     Effort: No tachypnea.     Breath sounds: Examination of the right-lower field reveals decreased breath sounds. Examination of the left-lower field reveals decreased breath sounds. Decreased breath sounds present.  Abdominal:     Palpations: Abdomen is soft.     Tenderness: There is no abdominal tenderness.  Musculoskeletal:     Cervical back: Neck supple.  Lymphadenopathy:     Cervical: No cervical adenopathy.  Skin:    General: Skin is warm.  Neurological:     Mental Status: He is alert.     Comments: Awake and alert to person, place, but not time  Psychiatric:        Attention and Perception: Attention normal.
Upper body rash on bilateral arms, chest, abdomen back and neck Rash is itchy and consist of clusters of  tiny red papules.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for supplemental oxygen, cardiac arrest, diabetes, CAD, chf, hyperlipidemia, htn, dementia. Per note 4/21. patient was experiencing decline after cardiac arrest in March 2020. Was taken to Emergency room on 5/14 with a chief complaint of fever and chest congestion by wife. Deceased noted to be 5/14 however no information available.
Info has been received from a registered nurse concerning an adult male pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #641532/1353L). Subsequently, the pt developed swelling, redness and soreness at the injection site. It was reported that the pt sought medical attention. The outcome of the pt's swelling, redness and soreness at the injection site was unknown. The reporter expressed concern regarding the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned a second male pt that had a similar experience following vaccination with pneumococcal vaccine 23 polyvalent (lot #641532/1353L) (WAES #0306USA02624). Additional info has been requested.
extreme shoulder pain; loss of mobility in right arm; weakness; pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (extreme shoulder pain), PAIN IN EXTREMITY (loss of mobility in right arm), ASTHENIA (weakness) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 16-Dec-2020 and the estimated date of delivery was 22-Sep-2021. On 26-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). On an unknown date, the patient experienced ARTHRALGIA (extreme shoulder pain), PAIN IN EXTREMITY (loss of mobility in right arm) and ASTHENIA (weakness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 26-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. At the time of the report, ARTHRALGIA (extreme shoulder pain), PAIN IN EXTREMITY (loss of mobility in right arm) and ASTHENIA (weakness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Pregnancy test: positive (Positive) Positive. On 11-Mar-2021, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Genetic testing was performed on11 Mar 2021 which was normal.
08/05/21, 03:15 PM, received this infor for log "have an unknown exposure started to develop cough, sore throat and low grade fever 8/1/21. Consulted her physician and have sched swab today.  8/5/2021  Notified tested positive.
patient was administered ActHIB vaccine for which the ActHIB vial had not yet expired, but the supplied diluent that was used to reconstituted the ActHIB vial had already expired/No AE; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient who received a 0.5 ml expired dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The Medical history, medical treatments, vaccinations and family history were not provided.   Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 14-Nov-2019, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE [lot U6055AA, expiry date: 19-Oct-2019] via unknown route in unknown administration site.  It was a case of actual medication error due to expired vaccine used.  It was reported as, on 14-Nov-2019,  the ACT-HIB vaccine [lot number: UI909AA, expiry date: 17-Oct-2019] administered to patient was not expired, but the supplied diluent [lot Number: U6055AA, expiry date: 19-nov-2019] which was used as constituent for vaccine had already expired. [unknown latency] [carton lot UI909AAA].  At the time of report no adverse event was reported.  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.
This morning I gave a patient a moderna vaccine. During administration the patient expressed his fear of needles. After the vaccine I asked the patient to have a seat and wait in the waiting area for 15 minutes. He went and sat down for just a couple minutes and stood up to look for his spouse and when he stood up he passed out and hit the floor face first. I ran out there to check on him and he was unresponsive and bleeding a lot. My team immediately called 911. I started tapping him and slightly shaking him and after a few minutes he woke up. He told me the only thing he remembers is feeling dizzy then woke up on the floor. EMS showed up a few minutes later and took the patient to the hospital.
pt admitted to hospital and had a positive COVID test on 10/20/21; given Remdesivir, dexamethasone; COVID pneumonia treated with ABX; pt spiked a fever; sepsis; hypoxic respiratory failure; ICU for worsening hypoxia and altered mental state; on BiPAP; pt began refusing nutrition and medical treatments; mental status deteriorating; became unresponsive; DNR/DNI; compassionate withdrawal of support after discussion with Ethics board; pt expired in the hospital
about 20 minutes after receiving the vaccination patient developed a sore and itchy throat along with tingling of her lips. Patient was given benadryl 50mg PO and observed for 30 minutes. At the end of her observation period patient stated that her symptoms have resolved. Her vitals remained stable throughout her stay in the observation area.
Pt screaming with pain for 5 hours; unable to walk for 30 hours. No mass or erythema. Symptom free after 48 hours.
First dose - no allergic reaction beyond the side effects of a mild fever, headache, fatigue and soreness in my arms.  Second dose - I experienced all the above and had a mild to moderate allergic reaction. I had rashes on my chest, back and arms, itchiness and mild case of hives. This started the second day after taking the vaccine. I put some over the counter anti-itch cream and it felt better in three days.  Third dose - I experienced all the general symptoms from the first dose, though milder than before. 9 days after the shot I began experiencing severe itchiness from my scalp to my toes, I had hives all over my body, the more sever itching and burning sensation was around my neck chest and arms and armpit. I began using Benadryl but it didn?t help. The next day, I spoke with a pharmacist who recommended a combination of Allegra 24hrs once a day and Benadryl every six hours as needed. I also bought Calamine lotion to relieve itchiness. It?s been three days and there?s still no improvement. I still have hives and still itching like crazy.
Vaccine administered 15 days after manufacturer expiration date.  Vaccine stored appropriately.  Moderna advised to report to VAERS, no adverse events reported by patient.
AFTER RECEIVING PFIZER PEDIATRIC VACCINE - PT FELT DIZY AND LIGHT HEADED. TOOK PT'S BP - BP WAS LOW 80/60. GAVE PT SNACK AND WATER AND RETOOK BP 3 MINUTES LATER. BP WAS RISING TO 90/80. WAITED ANOTHER 5 MINUTES AND TOOK THE BP AGAIN - BP WAS 108/75. TOLD PARENT THAT THIS WAS A GOOD BLOOD PRESSURE. THE CHILD STATED THEY WERE NOT DIZZY OR LIGHT HEADED ANYMORE - HAD PT WAIT A HALF  HOUR BEFORE LETTING THEM GO BP WAS NORMAL - TOLD PARENT THAT IT WAS UP  TO THE IF THEY WANTED TO TAKE THERE CHILD TO THE ER OR  URGENT TREATMENT CENTER. THEY STATED THEY WOULD GO HOME AND IF HE STARTED TO GET DIZZY AGAIN THEY WOULD TAKE HIM TO EMERGENCY ROOM. TOLD PARENTS TO GIVE CHILD LOTS OF FLUIDS AND FOOD. CALLED PARENTS 3 HOURS LATER. THEY SAID THE CHILD WAS DOING WELL. TOLD PARENTS TO GIVE US A CALL IF ANYTHING CHANGED.
Slight fever, body aches, headache, injection site swelling/redness/pain.
Nausea; lack of energy; body aches; chills; headache; soreness and swelling at injection site (Upper left arm); All reactions began 26 hours after vaccination; reactions decreased and ended within 60 hours of vaccination; reactions severe enough to have to call in sick to work for one day. Injection site sore for an additional three days after other reactions subsided.  Self medicated with Tylenol for 5 days following injection.
pt recvd flu vax & devel redness, pain & swelling @ the site of inject;
Case previously recorded as MA2009-3372. Initial case report received from a nurse via Med Com on 29 OCT 2009. A 2-year-old female patient was vaccinated with S-OIV FLUVIRIN (batch no 10073802) i.m. into the right deltoid on 28 OCT 2009. No adverse event was reported. Reference no. NA09-007194.
no energy; soreness at injection site; joint pain; This case was reported by a consumer via call center representative and described the occurrence of loss of energy in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 2nd dose of Shingrix. On 12th June 2019, less than a day after receiving Shingrix, the patient experienced loss of energy, injection site pain and joint pain. On an unknown date, the outcome of the loss of energy, injection site pain and joint pain were recovered/resolved.   It was unknown if the reporter considered the loss of energy, injection site pain and joint pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's wife. The patient experinced side effects to the Shingrix vaccine. Consent to follow up was requested.
Heart palpitations and arrhythmia lasted several days after both first and second dose. Second dose produced racing heart rate and concerning palpitations and arrhythmias(flutters), supraclavicular swelling L side baseball sized. Hives broke out over the swelling and down the neck.  NO issues with breathing so I took Benadryl, applied ice and hydrocortisone cream swelling went down significantly and hives disappeared by evening.  9 days post second injection swelling slight/moderate swelling L supraclavicular remains.  Blood pressure spike was noted at Dr. appt. 158/89. I started taking my own blood pressure at home averaging 151/100 . BP has been gradually decreasing and palpitations and arrhythmias have ceased.
Received FLUZONE HD on Sunday. Arm was sore and red rash developed 2 days later. Also feels warm to touch. Pt states it is getting better.
This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 71-year-old female patient who received SHINGRIX  for prophylaxis. On 17th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced sciatic neuralgia and myalgia of lower extremities. On 17th May 2018, the patient experienced injection site muscle pain. On 18th May 2018, the patient experienced stomach pain, tiredness and shivering. On an unknown date, the outcome of the injection site muscle pain, sciatic neuralgia, stomach pain, tiredness, shivering and myalgia of lower extremities were recovered/resolved. It was unknown if the reporter considered the injection site muscle pain, stomach pain, tiredness and shivering to be related to SHINGRIX. The reporter considered the sciatic neuralgia and myalgia of lower extremities to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received the vaccine on left arm. The patient experienced muscle pain at the injection site the same day and it lasted for 1 day or 2. The rest of the symptoms presented the following day. The patient was not sure how long they lasted but she could not do her normal activities during that time. The sciatic nerve pain also presented some time after the vaccination and caused muscle pain in both thighs.   Her physician said that the sciatic nerve pain was not related to the SHINGRIX. The contact details of the physician was provided.
Information has been received from a physician concerning a 4 year old female who on 18-SEP-2007 was vaccinated with her second dose of varicella virus vaccine live (Oka/Merck) (lot# 657789/0731U). On approximately 18-SEP-2007 "shortly after vaccination", the patient experienced breakthrough varicella on her chest and face. It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. Additional information has been requested.
body ache; chills; muscle pain; fever; This case was reported by a physician via sales rep and described the occurrence of general body pain in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On 18th July 2019, the patient received the 1st dose of Bexsero. On an unknown date, less than 3 weeks after receiving Bexsero, the patient experienced general body pain, chills, muscle pain and fever. On an unknown date, the outcome of the general body pain, chills, muscle pain and fever were recovered/resolved.   It was unknown if the reporter considered the general body pain, chills, muscle pain and fever to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient after receiving 1st dose of Bexsero experienced body ache, chills, muscle pain, fever that lasted 2 days. The reporter did not agree to follow up.
NO ADVERSE REACTION REPORTED. A PFIZER VACCINE WAS ADMISNISTERED TO A PATIENT AFTER BUD OF 7/22/22. PATIENT, RECIEVED A PFIZER BOOSTER SHOT 1 DAY AFTER BUD. The medical/safety team at Pfizer WAS CONTACTED AND indicated THE DISCOVERING PHARMACIST they do have stability but not efficacy data on the adult Pfizer vaccine beyond 72 days when stored in a refrigerator. They recommended that our rph contacts the CDC and inquires about repeating doses for these patients. Speaking with the CDC employees, our rph was given the same information as above and referred to the immunization division at the DOH.  Our rph contacted the DOH in the state, but she was asked to confer with Medical Doctor or the standing order physician. Our rph was able to interact with the latter, and she was given the guidance of re-vaccinating . In the context of the guidance from the standing order physician, the patient will need to repeat the dose. Regular schedules for series completion/booster doses will be observed if/when warranted.
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208:
I was fine until two to three hours after the vaccine.  My arm started to swell and it felt like someone was squeezing my heart. I got very tired and felt weak and breathless.  I laid down on the couch for awhile and then went to bed.  It was hurting worse during the first two to three weeks.  I contacted a help line who did some testing and my doctor.  My doctor ordered some tests.