chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 29-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a two-months-old (reported as two months and nine days old) female patient, who was vaccinated with an expired dose of PENTACEL (Batch number: C5401AA, expiration date: 24-Jun-2018, dose in series and route of administration were not reported) in the thigh on 29-Jun-2018. The patient's past medical history, medical treatment, vaccination and family history were not provided. It was a case of actual medication error due expired vaccine used because the patient was administered an expired dose of PENTACEL. 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. Documents held by sender: none.
Significant tenderness, redness and hardened skin beginning within 24 hours of the shot and lasting for 5-6 days.
she may have a heart murmur; Stated that after the first one that they all felt really bad like they had the flu after they had the vaccine. Stated that they all had the Moderna vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC MURMUR (she may have a heart murmur) and INFLUENZA LIKE ILLNESS (Stated that after the first one that they all felt really bad like they had the flu after they had the vaccine. Stated that they all had the Moderna vaccine.) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Down's syndrome (was diagnosed with  Down's syndrome at birth).    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC MURMUR (she may have a heart murmur) and INFLUENZA LIKE ILLNESS (Stated that after the first one that they all felt really bad like they had the flu after they had the vaccine. Stated that they all had the Moderna vaccine.). At the time of the report, CARDIAC MURMUR (she may have a heart murmur) and INFLUENZA LIKE ILLNESS (Stated that after the first one that they all felt really bad like they had the flu after they had the vaccine. Stated that they all had the Moderna vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was on Medicaid. Concomitant medications were not reported.  No treatment information was provided by the reporter. 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.   This case was linked to MOD-2021-626223 (Patient Link).   Reporter did not allow further contact
This spontaneous report was received from a licensed practical nurse referring to a 7 year old patient of unknown gender. Information on his/her pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was in process of getting vaccinated with a dose of M-M-R II (lot # M044350 and expiry date: 04-NOV-2018) (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (manufacturer unknown) (lot # M039641 and expiry date: 16-JAN-2019). The patient pulled away during administration resulting in less than full dose administered. No adverse effects were reported. There was no product quality complaint (PQC) reported.
She was 16 years old and received a Moderna dose on 1/22/21.
101 fever and fuzzy. Gave 5ml of Tylenol. Lasted for 12 hrs.
Approximately, 15 minutes after vaccination, patient reported his hands were itching, red, slightly swollen, and had some hives. Patient had no issues breathing or swelling at any other  location. I provided the patient with diphenhydramine 25mg. He had no other issues during the day and continued to be closely monitored.
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting,  fatigue, chills, subjective low grade fever, h/a, nausea, diarrhea, myalgias, also sore throat and dry cough- refused COVID PCR test Narrative:
patient called the next morning and complained of face flushing. said it was not severe but wanted to know if it was common. also felt a little lethargic
Information has been received from a 64 year old female with a history of shingles and an allergy to PLAQUENTIL who in January 2007, was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included trazodone HCl.  On approximately 30-MAY-2007 the patient developed on and off pain that usually signaled the onset of a shingles outbreak, and a cold sore that went away quickly without treatment.  No lab studies were performed.  No medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
This spontaneous report as received from a health professional refers to a 16 years old female patient with no illness at time of vaccination. The patient was vaccinated with lot # (668051/1262AA) dose 3 GARDASIL, IM on 30-DEC-2011 at 14:34. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient received immunization that was stored at an improper range <32 degrees. There was no adverse reactions. This is one of several reports from the same source. Additional information is not expected.
This spontaneous report was received from a female patient of unknown age. Patient's current conditions and pertinent medical history was not provided. On an unknown date in July 2015, the patient received unidentified Merck HVP vaccine administered (name and lot number not provided). It was unspecified if the patient was vaccinated with "GARDASIL" or "GARDASIL 9". The strength, dosage, dose number, route, lot# and expiration date of the vaccine administered was unknown. Concomitant medication was not provided. The patient enquired how to get the vaccine administered out of her system. After vaccination the patient reported that lots had happened to her, she has also experienced awful side effects. The patient did not elaborate on the actual side effects because she was too upset to continue. The outcome of events were unknown. There was no product quality complaints. No further information was provided. The causality was not reported. Additional information is expected, no contact details were provided.
Mother reports that child has had crying episode after all 3 doses of vaccines; 7/13/04, 9/29/04, and 12/07/04. Tells me on 5/17/05 that episodes have lasted 3 hours or more and child ran 101 temp. Said she mentioned it to pediatrician but was told that happens sometimes and didn't think anything of it. Reviewed DTaP VIS form with mother on 5/17/05 and told mother I will find out if ok to continue to receive DTaP with next vaccines. Spoke with doctor and medical director and she stated unless other SE to go ahead and give DTaP (preferably DTaP/HIB) and next immunization visit but to fill out VAERS form.
Dizziness, tachycardia, bells palsy, neck pains, fainting,, fainting  after eating, trouble speaking,  swollen lymph nodes, dysautonomia , chest pain, anxiety, weird stretchy feeling in the neck, diarrhea like morning sickness, nausea, spasms in throat while speaking
This spontaneous report as received from a consumer refers to herself, a currently 87-year old female patient. On an unknown date in 1941 (also reported as when the patient was 11-years-old) she had an allergic reaction to an unspecified sulfa medication which caused her face to swell. On an unknown date in 2004 or 2005, the patient was participated in a clinical trial (There isn't enough information in the case details to determine the clinical trial referenced by the patient/subject) and vaccinated with ZOSTAVAX 19400 PFU for preventing shingles (unknown lot and expiry date). Other suspect therapies included sterile diluent (MRK INJ). On an unknown date after 2005 but before 2010, the patient had an outbreak of shingles. The painful rash started on the left side of her back between her waist up to and above her shoulder blade. The size of the rash was 8 inches by 11.5 inches the same size as typing paper. The patient sought medical treatment from her doctor, 5 days after the rash appeared. The doctor performed an unspecified blood test and treated her with prescription pain medication consisting of ADVIL and codeine with little relief. The patient reported that she walked around her apartment topless because she was not able to wear clothes that would cover the rash during the total recovery period which was "5 weeks". No further clarifying information provided. The outcome of herpes zoster was reported as recovered. Causality assessment was not provided. No PQC was involved.
8 days after the injection, my left arm where the needle went in because itchy. I looked at it, and it was red, inflamed and hot to the touch. The affected area grew to a circular 3" in diameter, puffy, blotchy, itchy, hot rash surrounding the injection site. I panicked at first because I never heard of such a delayed reaction. I did read of this sometimes happens with the COVID vaccine, so I thought I should report it.  As of today, 2 days later the rash is  fading, but it is still there.
This is one case out of a cumulative total of 231 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 07 August 2014. These 231 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report was received on 07 August 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a four year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL; dose one lot number C3588AA received on 11 June2010, dose two lot number C3615AA received on 10 August 2010 and dose three lot number C3713AA received on 14 October 2010 and one dose of TRIHIBIT, lot number U3497CA (ACTHIB reconstituted with TRIPEDIA) on 11 October 2011 (routes and sites of administration for all doses not reported). The subject developed a cough on 20 July 2014, approximately 33 months after the last dose. On 22 July 2014, the subject developed a paroxysmal cough with a whoop. Laboratory testing included positive PCR on 23 July 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 23 July 2014 for five days. The subject was not hospitalized. At the time of final contact on 05 August 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Could not sleep at night; After 1st dose, had a sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA, PAIN IN EXTREMITY, and FATIGUE in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA, PAIN IN EXTREMITY, and FATIGUE. The patient was treated with ALOE VERA for Adverse event, at an unspecified dose and frequency and WITCH HAZEL LEAVES for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA, PAIN IN EXTREMITY, and FATIGUE outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant drugs were provided.  Treatment medication included pain reliever.   This case was linked to MOD-2021-288101 (Patient Link).
like the ear ringing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (like the ear ringing) 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 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 TINNITUS (like the ear ringing). At the time of the report, TINNITUS (like the ear ringing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were reported  No concomitant medication were reported   This case was linked to MOD-2021-092646 (E2B Linked Report).; Sender's Comments:  MOD-2021-092646:Same reporter, for himself
paresthesia in hands and feet that got worst after second dose; fever 100F after 2nd dose; Moderate to severe headache; This is a spontaneous report from a contactable physician (patient). A 67-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot Number: ER2613), via an unspecified route of administration, administered in Arm Right on 23Mar2021 08:15 as dose 2, single for covid-19 immunisation. The patient medical history was not reported and no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on 03Mar2021 as dose 1, single for covid-19 immunisation. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient experienced paresthesia in hands and feet that got worst after second dose and is still present 3 weeks after 1st dose, moderate to severe headache for 3 weeks, fever 100F (2021) after 2nd dose which result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment in response to the events. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
warm to the touch to my injection site; hives worse to my lower body but had them on my face and upper body as well; inflamed area that was warm to the touch to my injection site; large reddened at the injection site; lightheaded ness; A weird numb feeling in my mouth; This spontaneous case was reported by a non-health professional and describes the occurrence of DIZZINESS (lightheaded ness), HYPOAESTHESIA ORAL (A weird numb feeling in my mouth), VACCINATION SITE WARMTH (warm to the touch to my injection site), URTICARIA (hives worse to my lower body but had them on my face and upper body as well) and VACCINATION SITE INFLAMMATION (inflamed area that was warm to the touch to my injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic reaction (anaphylactic reaction to Macrobid 7-8 years ago.). Concurrent medical conditions included SLE. Concomitant products included METHYLPREDNISOLONE (MEDROL DOSEPAK) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced DIZZINESS (lightheaded ness) and HYPOAESTHESIA ORAL (A weird numb feeling in my mouth). On 11-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (large reddened at the injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to the touch to my injection site), URTICARIA (hives worse to my lower body but had them on my face and upper body as well) and VACCINATION SITE INFLAMMATION (inflamed area that was warm to the touch to my injection site). On 16-Jan-2021, VACCINATION SITE ERYTHEMA (large reddened at the injection site) had resolved. At the time of the report, DIZZINESS (lightheaded ness), HYPOAESTHESIA ORAL (A weird numb feeling in my mouth), VACCINATION SITE WARMTH (warm to the touch to my injection site) and VACCINATION SITE INFLAMMATION (inflamed area that was warm to the touch to my injection site) had resolved and URTICARIA (hives worse to my lower body but had them on my face and upper body as well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, Heart rate: elevated Heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient do have an EpiPen. Treatment information was not provided
Anthrax vaccination on right deloid Aug2008. Had other vaccinations on left deltoid at same time. Since that time has had recurrent (daily) small to large areas of urticaria on the right deltoid for over one year. Lasts usually 1/2 to 1 hour. Has had episode of entire upper arm swelling which lasted 2 hours.
Two red area; This spontaneous case was reported by a non-health professional and describes the occurrence of ERYTHEMA (Two red area) 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 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 ERYTHEMA (Two red area). At the time of the report, ERYTHEMA (Two red area) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.  The patient had redness, disappeared after 7 days.   This case was linked to MOD-2021-293079 (Patient Link).
Approximately 7.5 hours after the vaccine I woke up with severe/violent chills/shakes. Fever unknown. I sat in a hot bath for about an hour and they stopped. When I got out I took ibprophen and went back to bed. Soon they started again and I piled on a weighted blanket to get them to calm down and eventually fell asleep. I also had a lot of head heaviness and pressure during this time. The next morning I woke up with body aches from all the tensing up and felt week and still had head pressure. By midday I was back to normal. Still some injection site soreness and swelling her today, Monday 3/15.
3/10/21: site of injection became increasingly sore and fatigue increased throughout the remainder of the day. Then, in the middle of the night, I began experiencing chills. 3/11/21: chills continued through the night and into the morning, lasting all day. I had to sit outside in the sun in 72 degree weather run sweatpants and sweatshirt and drinking hot cocoa to feel warm. Then slept away most of the day. In the middle of the night, once chills subsided, it was immediately replaced with stomach pains l, which woke me up. I got up only to experience a throbbing headache and immediately lied back down. Hoped to sleep the pain away but pain persisted throughout the night. 3/12/21: stomach pains and throbbing head continued throughout the day, slowly subsiding. Stomach pains immediately after eating each meal, headache/sinus pressure whenever I coughed or laughed.  3/13/21: stomach pains are gone but slight headache still lingers. Head throbs in the top back or temples from time to time. However, can feel the beaches trending downwards in frequency and strength.
pt recvd vax 6OCT94 & 4hrs later pt devel redness, swelling & pain @ inj site & fever & exp gen feeling of malaise, muscles aches & chills;pt recovered 8OCT94;MD felt was problem w/vial involved
I got up in the morning on a Thursday morning and my left leg was itching by Friday morning my leg continued to itch worse and swell. I went to an Urgent Care Center and the Doctor prescribed Cephalexin and I took this for three days but my leg was getting worse not better. After one week and a day had past in total my physician had me hospitalized. An IV antibiotic of Cephalexin was prescribed and within two days my Doctor felt I was getting better. I remained a total of four days in the hospital and was then released, I had the remaining Cephalexin prescribed that I took once released from the Hospital until the Cellulitis cleared.
Information has been received from a medical assistant concerning an adult female who was vaccinated with a dose of MMR II on an unspecified date. The patient had titers drawn on an unspecified date. The patient had MMR II as a child (unknown how many doses or when) and was negative for mumps. No adverse effects noted. At the report time the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2, solution for injection), on 04May2022 at 20:15 as dose 4 (booster), single (Lot number: Fk9895), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Mar2021 as dose 1, single (Lot number: O46a21a), in left arm, on 14Apr2021 as dose 2, single (Lot number: O42b21a), in left arm and on 23Oct2021 as dose 3 (booster), single (Lot number: O32f21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; FLOMAX [TAMSULOSIN HYDROCHLORIDE], stop date: 10May2022; MUCINEX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative; (21May2022) Positive, notes: Rebound, return of symptoms 5 days after dealing recovered, Still sick, pos test for Covid 12 days past start of illness, 11days after starting paxlovid. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient received treatment with Paxlovid from 10May2022 to 14May2022 for the treatment of COVID-19.
"Pt w/ hx of allergy/intolerances to amoxapine (Rash), Influenza vaccine (unknown rxn), Sulfa antibiotics (muscle spasm), tamsulosin (Rash), amoxicillin (rash), gabapentin (depression), shingrix (swollen/numb arm) and tramadol (emotional lability). PMH Smoker, Lumbago, left arm pain, impaired fasting glucose, high cholesterol, Hep C, diverticulosis, abnormal pap smear.  Pt received covid vaccination at outside facility on 5/21.  6/1 pt was seen for itchy rash that developed after vaccination and continued through at least 6/1. Pt reported joint involvement and feeling very sick.  Pt declines 2nd dose. Medications at time of vaccination: ? amitriptyline (ELAVIL) 25 MG tablet, 1-2 tabs PO QHS. ? cetirizine (ZYRTEC) 10 MG tablet, 1 tab PO daily. ? fluocinonide (LIDEX) 0.05 % ointment, apply to affected area BID. ? ibuprofen (ADVIL,MOTRIN) 600 MG tablet, 1 tab PO Q8hrs PRN Pain. ? oxyCODONE-acetaminophen (PERCOCET) 5-325 mg tablet, 1 tab PO Q6hrs"