chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she got a sore arm with the 1st; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (she got a sore arm with the 1st) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included LAMOTRIGINE (LAMICTAL), OXCARBAZEPINE, GABAPENTIN, QUETIAPINE, HYDROCHLOROTHIAZIDE, OMEPRAZOLE, NALTREXONE HYDROCHLORIDE (NALTREXONE [NALTREXONE HYDROCHLORIDE]), PROBIOTICS NOS, LYSINE, COLECALCIFEROL (D3), MELATONIN, NATTOKINASE, RESVERATROL, GLYCERINE MONOLAURATE, INOSINE (MONOLAURIN [GLYCERINE MONOLAURATE;INOSINE]), FISH OIL, ASCORBIC ACID (VIT C), LEVETIRACETAM (LEVRA) and IMMUNOGLOBULIN G HUMAN (IGG) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (she got a sore arm with the 1st). At the time of the report, MYALGIA (she got a sore arm with the 1st) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported concomitant medication as sertiamen.  No treatment medication was reported by patient.
Lots of crying/whining/clinginess. Crying that her neck and legs hurt. No appetite at all, low energy. By 4pm, 102.7 degree fever, listlessness, burning up. The next day, diarrhea all day, couldn't leave the house. Today, less diarrhea but still explosive when it happened first thing in the morning and right before bed. Treated homeopathically throughout the whole illness.
Patient had a DVT for the first time ever, 2 days after #2 Moderna vaccine. Please report.
Jynneos vaccine was administered intradermally, past beyond use date ; Jynneos vaccine was administered intradermally, past beyond use date ; Case reference number US-BN-2023-000316 is a spontaneous case report initially received on 21-Feb-2023 from other health care professional via Communications (reference: USBAV23-0295) and concerns a male patient.  The patient's medical history and concomitant medications details were not provided.  On 31-Jan-2023, the patient was vaccinated with the first dose of Jynneos vaccine (batch number: FDP00015; expiration date: 30-Sep-2024), at a dose of 0.1 mL, at unknown site of administration, intradermally (explicitly coded as 'intradermal injection'), for smallpox/monkeypox prophylaxis, with beyond use date of 26-Jan-2023 (explicitly coded as 'expired vaccine used').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 22-Feb-2023 from Bavarian Nordic included local BN case ID.  This case is linked to US-BN-2023-000317, US-BN-2023-000318, US-BN-2023-000319, US-BN-2023-000320, US-BN-2023-000321, US-BN-2023-000322, US-BN-2023-000323 and US-BN-2023-000324, concerning same reporter.; Reporter's Comments: A male patient was vaccinated with the first dose of Jynneos vaccine on 31-Jan-2023, at a dose of 0.1 mL, at unknown site of administration, intradermally, which is considered as intradermal injection, for smallpox/monkeypox prophylaxis, with beyond use date of 26-Jan-2023, which is considered as expired vaccine used. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Expired product administered and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient was vaccinated with the first dose of Jynneos vaccine on 31-Jan-2023, at a dose of 0.1 mL, at unknown site of administration, intradermally, which is considered as intradermal injection, for smallpox/monkeypox prophylaxis, with beyond use date of 26-Jan-2023, which is considered as expired vaccine used. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Expired product administered and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
I responded to a call from help in the lobby. Patient had apparently received vaccination a few minutes prior. He reportedly had told his mother he needed to sit down but before he could he passed out and reportedly fell to the floor in the lobby, striking the top of hit head on a nearby wheelchair. Upon my arrival at the scene, patient was responsive to voice, spontaneously opened his eyes and did not complain of any injury. He denied pain in his head. He was able to answer questions and respond to commands. On exam he was pale. He had a superficial abrasion to his left knee and no visible or palpable wound to his head where he indicated he hit the chair. Nursing had also responded and he was treated with sugar (safety sucker) and ice packs to his head and neck. His color improved. I reassured his mother this a know side effect to vaccines in adolescents and he should recover without difficulty. I left him in the care of nursing, who observed him until he was recovered.
expired vaccine given to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was given. It was reported that patients received an expired dose of the Moderna COVID-19 vaccine. The vial was punctured on 28-DEC-2021 and used for up to 17 hours post puncture. No patients have reported any side effects from this dose.
T102.5, BP 70/42, P60;T103, BP 90/60, P72;T103.5, P72;10:50 BP 112/60, P96;pt given 02;pt had sz immed p/MMR vax;3" diam reddened area @ site-disappeared p/ice application x 20min;given DPH, adrenalin;
Blood in stool; Loss of taste; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool), AGEUSIA (Loss of taste), HEADACHE (Headache) and FATIGUE (Fatigue) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced HAEMATOCHEZIA (Blood in stool), AGEUSIA (Loss of taste), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, HAEMATOCHEZIA (Blood in stool), AGEUSIA (Loss of taste), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment: This is a Spontaneous case concerning a 23-year-old, female patient with unknown medical history, who experienced the unexpected non serious (AESI) event of . The event occurred approximately 1 day after one dose of mRNA 1273 vaccine.  Patient also experience hematochezia with no more information. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 23-year-old, female patient with unknown medical history, who experienced the unexpected non serious (AESI) event of . The event occurred approximately 1 day after one dose of mRNA 1273 vaccine.  Patient also experience hematochezia with no more information. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
The day of vaccination my top lip started to swell and small rashes formed on my arms, neck and butt around 8:30 pm. The following day my bottom lip started to swell and so did my left cheek at 8:30pm. Around 11:30 pm I started to develop a fever, feel soreness and weakness throughout my whole body, and a migraine. In the morning at around 8 am I noticed that I broke out in a severe rash all over my body. It has continues to spread all over.
Sudden onset of severe tinnitus with hearing loss in right ear. Diagnosed by ENT doctor with Sudden Sensorineural Hearing Loss
Passed Out, has concerns; This serious case was reported by a physician via sales rep and described the occurrence of passed out in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced passed out (Verbatim: Passed Out, has concerns) (serious criteria GSK medically significant). The outcome of the passed out was unknown.   It was unknown if the reporter considered the passed out to be related to Shingrix.     It was unknown if the company considered the passed out to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-APR-2023 Customer relationship management request sent in by sales representative on behalf of health care professional reported two patients within 1 month that passed out post Shingrix vaccination shot and had concerns.  The vaccine administration facility was the same as primary reporter. No additional details were provided.  Unknown if follow up was permissible. This case has been linked to the case US2023061661 reported by the same reporter.; Sender's Comments:  US-GSK-US2023061661:Same reporter
Post menopausal bleeding, not thought to be related to the vaccine by primary care provider, MD. I Am scheduled to see GYN specialist to determine cause and diagnosis
Patient was given Engerix-B vaccine Lot 99B32 Exp 6/1/15 in the left deltoid in error.  Patient was given Boostrix Lot 9443E Exp 3/7/16, the correct vaccination, immediately following Engerix B, into the right deltoid.  A follow-up call was placed that evening to make sure the patient was well.  He did not complain of any side-effects from his vaccination.  His physician was contacted and provided with the information of the error.
Started in the middle of the night, when I woke up with tremors and nausea. Then the nausea got so bad that I had to go vomit, and then I had about 4 bouts of vomiting. Then I was feeling cold, I couldnt get warm. The vomiting was making my throat sore and giving me heartburn. Then eventually after a few hours, I dont know how many, I was then able to get back to sleep. ***I do not have the lot number on the paper.***
Progressive neuropathic/encephilitis?/hyperalgesia, urinary retention, diplopia decrease LE reflexes. A.D.E.M.
75 y.o. female who presented to the ED complaining of fatigue and shortness of breath.  Plain film of the chest suggested bilateral infiltrates.   Oxygen saturation was 86%  and she was initially placed  on 4 L nasal cannula and eventually increased to 5 L nasal cannula.  She also received dexamethasone 6 mg IV daily.    Oxygen was weaned off and patient was discharged after a 2 day hospital stay.  She was prescribed dexamethasone to complete a 10 day course of therapy.
Left arm pain and decreased range of motion in all directions. Shooting pain from neck down to fingers (left side).
Patient reports immediate pain at administration from site of injection up to area in neck.  Still felt this way after approximate 15 minute wait at pharmacy.
On 11/21/2022 I received my Covid-19 vaccine. On 02/07/2023 I began with a slight fever and sore throat. The next day my fever was 102 with mild body ache, sore throat, sinus congestion and flu like symptoms. After contacting my doctor office, I tested positive for Flu B. I was prescribed bromphen, and TESSALON for approx. 5 days. Symptoms lasted 7 days.
some side effects after first dose; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (some side effects after first dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (some side effects after first dose). At the time of the report, VACCINATION COMPLICATION (some side effects after first dose) outcome was unknown.        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.   No concomitant medications were reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-281160 (Patient Link).
7am swelling with redness. No pain to palpation, mildly warm. Itchy x 2 days. Advised to ice, BENADRYL, and Hydrocortisone cream.
Surveillance for Rates of Pertussis Disease Among persons Birth through 59 months of Age Receiving PENTACEL or Other Pertussis Vaccines. Initial report received on 11 January 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 16 month old, male subject (initials not collected) was identified by the investigator based on review of data from the system. The subject's vaccine history included 4 doses of PENTACEL: lot number C3362AA received on 29 June 2009, lot number C3362AA received on 26 August 2009, lot number C3469AA received on 26 October 2009, and lot number C3662AA received on 26 July 2010 (route and site of administration not reported). Approximately 4 weeks after the last dose, on 22 August 2010, the subject developed paroxysmal cough with whoop. The subject also experienced cold-like symptoms, posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 24 August 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 25 August 2010. The subject was not hospitalized. At the time of final contact on 15 September 2010, the subject's cough had resolved. The duration of the cough was reported at that time as 14 days. According to the investigation, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Loose stool; In the beginning it was just my bowel were a little soft they were like mud; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose stool), FAECES SOFT (In the beginning it was just my bowel were a little soft they were like mud) and CONDITION AGGRAVATED (Condition aggravated) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced DIARRHOEA (Loose stool), FAECES SOFT (In the beginning it was just my bowel were a little soft they were like mud) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, DIARRHOEA (Loose stool), FAECES SOFT (In the beginning it was just my bowel were a little soft they were like mud) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.    This case was linked to MOD-2021-275346 (Patient Link).
I broke out in hives starting the afternoon of the vaccine. There are about 20 on my left shoulder, neck, arm, wrist, and hand and another 10 on my trunk, both legs, and front/back of trunk. They are continuing to form.
Woke up shivering uncontrollably for one hour. Wrapped self in blankets then woke up one hour later with night sweats. While awake in the middle of the night, when standing I became nauseous and light headed. The next day I was extremely exhausted and my whole body aches. Every move I made hurt and I had to leave work after 2 hours due to the inability to function at normal capacity secondary to pain and fatigue. Did not feel normal again until 7 PM the next day.
Patient is a 77-year-old male who presented to the ER with shortness of breath. He'd been feeling sick for about 2 weeks. Symptoms included fatigue, body aches, shortness of breath, cough, loose stools. He had a chest x-ray prior to admission but it was outpatient and he did not have the results. He started to feel worse, more short of breath. He came to the ER after discussing with his doctor. On arrival he was 84% on room air. Temperature 100.2.
A physician reported that a 7 year old male received an injection of Prevnar on 7/18/00. He was hospitalized due to sickle cell pain crisis and was receiving antibiotic therapy at the time of immunization. One day, post vax, the child developed swelling of an elbow. He recovered.
This case was reported by a healthcare professional and described the occurrence of spitting up in a 2-month-old male subject who was vaccinated with HEPATITIS B vaccine (manufacturer unspecified), PREVNAR (non-gsk). Concurrent medical conditions included anemia, gastroesophageal reflux disease, heart murmur and prematurity. Concurrent vaccination included combined diphtheria, tetanus acellular pertussis and inactivated poliomyelitis vaccine; GlaxoSmithKline; unknown; right thigh given on 8 June 2012 at 17:00; haemophilus influenzae type b vaccine (non-gsk); Sanofi; unknown; unknown given on 8 June 2012. Concurrent medications included POLY-VI-SOL w/ iron and Ranitidine hydrochloride. On 15 June 2012 the subject received unspecified dose of HEPATITIS B VACCINE (details unknown), unspecified dose of PREVNAR (details unknown). On 15 June 2012, less than one day after vaccination with HEPATITIS B VACCINE and PREVNAR, the subject experienced spitting up. On 16 June 2012, the subject was evaluated in the emergency room (ER). At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was unrelated to vaccination with HEPATITIS B VACCINE and PREVNAR. According to the healthcare professional, the "spitting up in the ER was not considered an adverse event associated with the vaccines". The subject had a case involving KINRIX. See A0982926A for details for KINRIX case. The healthcare professional reported a second case with another subject for KINRIX. See case A0982921A for details.
Some sore arm; Achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Some sore arm) and PAIN (Achy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Some sore arm) and PAIN (Achy). At the time of the report, PAIN IN EXTREMITY (Some sore arm) and PAIN (Achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information mentioned.
Instead of receiving the second dose I received the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Instead of receiving the second dose I received the booster shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Instead of receiving the second dose I received the booster shot). On 22-Nov-2021, ACCIDENTAL UNDERDOSE (Instead of receiving the second dose I received the booster shot) had resolved. Not Provided          No concomitant medication was reported. No treatment medication was reported.
This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received DTP vaccine for prophylaxis. On an unknown date, the patient received DTP vaccine at an unknown dose. On an unknown date, unknown after receiving DTP vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to DTP vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient cut their finger five years before the reporting date and needed tetanus shot. The patient received that shot along with DPT vaccine and so was sick. The patient was almost hospitalized from the reaction. The patient would never recommend it but the patient needed the tetanus booster and it was not given alone.
A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a four-year-old male.  The patient's medical history included no history of asthma.  Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications).  There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error.
Redness and swelling at side. With a lump at injection site. Pt complained of fever and headache.
Gave him Benadryl because he had welts on his back, belly, legs. No other symptoms though. (Could breathe fine and no fever).
Breakthrough COVID infection. Patient tested positive on 9/4/2021. Patient was fully vaccinated on 3/21/2021. It is noted that patient lost sense of taste and smell.