chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and a school nurse concerning a 9 year old male who on 13-MAY-1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy that day included a dose of measles virus vaccine live (Ender-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 25-OCT-1999 and 05-SEPT-2002. It was also noted that the child was vaccinated with a dose of measles virus vaccine live (Wistar RA 27/3) on 06-JUN-2000.  A school nurse reported to the physician that between 24-MAR-2005 and 09-MAY-2005, the child developed a "more sever case" of chickenpox, noted to be breakthrough with 50 to 250 lesions. Unspecified medical attention was sought. The outcome was recovered. A product quality complain was not involved. No additional information is expected.
pt recv vax 18OCT96 & 8NOV96 pt devel a non-tender, red, raised, firm, grape-sized nodule/swelling about two & a half inches on the upper arm @ inj site;
12/16/21-12/17/21 observation. C/O weakness, lightheaded, HA, tested + in hospital, dx with transient hypotension,  UTI, acute renal failure
Patient was given a High Dose Flu vaccine in error. No symptoms or treatment sought from primary physician office in follow-up.
arm is still red and a little warm; itching; Fever; injection site warmth; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE WARMTH (injection site warmth), ERYTHEMA (arm is still red and a little warm), PRURITUS (itching) and PYREXIA (Fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 28L20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced INJECTION SITE WARMTH (injection site warmth), PRURITUS (itching) and PYREXIA (Fever). On 03-Feb-2021, the patient experienced ERYTHEMA (arm is still red and a little warm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency. On 03-Feb-2021, INJECTION SITE WARMTH (injection site warmth) outcome was unknown, PRURITUS (itching) and PYREXIA (Fever) had resolved. At the time of the report, ERYTHEMA (arm is still red and a little warm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Describes a sensation of lightheadedness and anxiety after vaccine.  Minutes later, this progressed into "involuntary twitching" of all extremities.  Patient was evaluated in urgent care, and ultimately thought to be a sympathetic surge.  Patient was discharged without further complication.  Submitting this primarily since patient required prolonged observation in urgent care setting.
Redness, swelling, large lump (feels like a baseball under the skin), rash, and hot to the touch at injection site. Consistent with descriptions of ?vaccine arm.? Began a couple of hours after second dose; was also present with first dose (went away after 10 days) though is worse with second. Treating with cold compresses and antihistamines.
pt recv vax in 1988 & in 1966 pt was found to have positive core antibody levels w/no other antibody or antigen present;
no additional AE; GARDASIL 9 was administered to a pediatric patient; This spontaneous report was received from a nurse practitioner on behalf of physician regarding a 6-month-old male patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  The physician reported a misuse on 04-FEB-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number reported as 16911806 (expiration date, dose, route and anatomical location were not reported) for prophylaxis. No additional adverse events were reported.
pt recvd 2nd dose of MMR 21DEC92 & 29DEC92 pt exp localized cellulitis of the rt deltoid; 30DEC92 pt was hospitalized & may have been treated w/IV ATB;
I'm still dealing with mass nerve pain in my shoulder all around where I received my shots.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEURALGIA (non-serious) with onset Jun2021, outcome "not recovered", described as "I'm still dealing with mass nerve pain in my shoulder all around where I received my shots.".  Additional information: The pharmacist told to patient to exercise shoulder.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mouth watering 15 mins after being injected with 2nd dose.  Hour later chills and fatigue.  Next day pain throughout my entire body and nausea.  Two days later rash on arm.  Fine now.
Area 2.5 inches x 2.5 inches redness, erythema within 24 after injection, no purulent drainage, considerable discomfort in arm.
her right ear started throbbing and it is constant.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 17Aug2021 (Lot number: EW0217, Expiration Date: 30Sep2021) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Leukemia" (unspecified if ongoing), notes: Verbatim: Leukemia; "Chronic kidney disease" (unspecified if ongoing), notes: Verbatim: Chronic kidney disease; "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: SPRYCEL taken for leukaemia; LEVOTHYROXINE; AMLODIPINE; ROSUVASTIN; CLOPIDOGREL; VIT C; VIT D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (She got the first dose on 27Jul2021 and after that her left ear was hurting), administration date: 27Jul2021, when the patient was 69 years old, for Covid-19 Immunisation, reaction(s): "Ear pain", "burping"; Tetanus shot (Heart rate dropped and the caller passed out Onset Age: 63 Vaccine/Brand Name: , Tetanus Shot; unknown brand Vaccination Date: 6 years ago), when the patient was 63 years old, reaction(s): "Heart rate dropped". The following information was reported: EAR DISCOMFORT (non-serious) with onset 21Aug2021, outcome "not recovered", described as "her right ear started throbbing and it is constant.".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
nausea with diarrhea, body aches,  sweats, increase body temp,  redness, swelling, itching, sore at injection site.
Sore / sore arm; red welt at injection site; red welt at injection site; High fever; chills; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore / sore arm), URTICARIA (red welt at injection site), INJECTION SITE ERYTHEMA (red welt at injection site), PYREXIA (High fever) and CHILLS (chills) in a 12-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205E23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 12-Oct-2023, the patient experienced PAIN IN EXTREMITY (Sore / sore arm), URTICARIA (red welt at injection site), INJECTION SITE ERYTHEMA (red welt at injection site), PYREXIA (High fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (Sore / sore arm), URTICARIA (red welt at injection site), INJECTION SITE ERYTHEMA (red welt at injection site), PYREXIA (High fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  It was unknown if the patient experienced any additional symptoms/events.  Treatment medication use information was not provided by reporter.
Sore and stiff arm/shoulder immediately following vaccination. Chills, mild fever, and body aches started around 11pm on the night of the vaccination date. Symptoms continued until the following evening when they gradually subsided. Symptoms ended by the second day following vaccination.
fluzone qiv np was exposed to low temperature excursion earlier today (low of negative 4.6c for 45 minutes) due to the repairman converting the refrigerator to a freezer and administered post excursion with no reported adverse event; fluzone qiv np was exposed to low temperature excursion earlier today (low of negative 4.6c for 45 minutes) due to the repairman converting the refrigerator to a freezer and administered post excursion with no reported adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA318835(CLUSTER), 2023SA318839(CLUSTER), 2023SA319649(CLUSTER), 2023SA321113(CLUSTER) and 2023SA321127(CLUSTER).  This case involves a 20 years old female patient who was administered influenza quadrival A-B vaccine [Fluzone QIV] which was exposed to low temperature excursion earlier today (low of negative 4.6C for 45 minutes) due to the repairman converting the refrigerator to a freezer and administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, the patient received a dose of 0.5 ml once of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot: U8192BA; expiry date: Jun-2024; strength: standard) via intramuscular route in the right deltoid for Immunization.  On 16-Oct-2023 influenza quadrival A-B vaccine was exposed to low temperature excursion earlier today (low of negative 4.6c for 45 minutes) due to the repairman converting the refrigerator to a freezer and administered post excursion with no reported adverse event (product storage error) (unknown latency) (poor quality product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the 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.
Runny nose; Headache; Joint pain I guess kind of, small moderate pain; Really bad sore throat; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EKS730), intramuscular on 17Dec2020 at single dose for COVID-19 immunization at hospital. The patient's medical history included seasonal allergy (Seasonal allergies he guess, that's it). Concomitant medications were not reported. The patient previously took cetirizine hydrochloride (ZYRTEC) from an unspecified date to Sep2020, not currently, he had not been taken it since summer but he had not currently taken it, he have stopped taking it, three months before the vaccine. The patient was a paramedic (further not clarified) and received the vaccination at a hospital, not a pharmacy. Patient guessed that they vaccinated there whole front line staff. The patient got the vaccine on Thursday (17Dec2020), Pfizer vaccine, Covid 19 vaccine and he was just having side effects mostly sore throat, he was having a really bad sore throat and he was expecting. He knew they said fever, chills, headache, joint pain was normal and things like that they are normal. But he just wasn't sure of this sore throat part of it and was also wondering if he was able to take like, anything to help with the symptoms. He also had other symptoms, on 20Dec2020 (started yesterday by the time of reporting), he experienced runny nose, headache, "joint pain he guessed kind of, small moderate pain" and really bad sore throat.  As a treatment to the events, he took DayQuil on 20Dec2020 and was not sure what that dosage was. The events were quite persisting, which started yesterday. The patient had general lab work of Cholesterol on date that he didn't remember and did not know the result of it. The outcome of the events was not recovered.
Covid; caught covid shortly after receiving dose 2  and was unable to come in, he received his second dose on 02-May-2022; Initial information received on 09-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional via Nurse.  This case involves a 20 years old male patient who  caught covid shortly after receiving dose 2  and was unable to come in, he received his second dose on 02-May-2022 , after receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Apr-2022 , the patient received a dose 1 of suspect RABIES (HDC) VACCINE, powder and solvent for suspension for injection, 0.2 ml (lot T1E321M: expiry date 16-Sep-2022)  via intramuscular route in the left deltoid  and  On 02-May-2022 he also received 0.25ml dose 2  of the same vaccine  lot T1E321M via intramuscular route in the left deltoid for rabies prophylaxis (rabies immunization).  It was reported that the patient then he caught covid shortly after receiving dose 2  and was unable to come in, he received his second dose on 02-May-2022 (inappropriate schedule of product administration) (covid-19) (onset dat: 2022 ; latency: unknown). The  patient received dose 3  the vaccine on 14-Sep2022 (lot number: T2B23 ; expiry date: not reported) (dose: 1 ml)  via intramuscular route on left deltoid .  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events (covid).  At time of reporting, the outcome was Unknown for  both the 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 guidelines. 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.  Additional information received on 06-Jun-2022 from other health care professional.  Therapy details added. Text amended accordingly
From telephone contact received at manufacturer on 4/10/02 it was reported that a 32 year old male patient received a Yellow Fever vaccination administered on 4/8/02. Within 24 hours the patient developed flu-like symptoms, tachycardia, low grade fever and general malaise. Further information is requested.
R arm swollen 10cm x 8cm, red, indurated, and warm to touch. Large local reaction, few transient hives on abdomen.
pt had pain w/insertion & gen fatigue, dec endurance, h/a, dilated eyes, vertigo;no change w/antihistamine & steroids;
Tiredness, felt like I was coming down with something, pain in left arm (vaccination site). Happened about 4 hours post vaccine #1. Took tylenol, layed down and felt better.
Neurological events; This case was reported by a other health professional via sales rep and described the occurrence of neurological symptom in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 72RS4, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced neurological symptom (serious criteria hospitalization). On an unknown date, the outcome of the neurological symptom was recovering/resolving.   It was unknown if the reporter considered the neurological symptom to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The age at vaccination was not reported. The healthcare provider administered 10,000 vials of FluLaval vaccines to all employees. Three patients developed Neurological events, 1 of those 3 patients was currently in the intensive care unit (ICU). The healthcare professional (HCP) reached out to the local health department. This matter went up to leadership at the HCP. The reporter consented to follow up. This case is 1 of 3 cases reported.
Medi0006106 is a non-serious spontaneous case from a physician of fever concerning a two-year-old male.  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.  There was no medical history or concomitant medications for this patient.  The patient initiated Flumist on an unreported date.  Approximately 10 hours following administration of Flumist, the patient experienced fever of 102.6, that increased to 104.3 approximately 20 hours from the time of administration.  No further information was provided.  The event of fever resolved within 48 hours of onset of symptoms.  Action taken with Flumist was not provided.  The reporter did not provide a causality assessment for the adverse event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow up received 4/15/08. Patient date of birth, adverse event onset date/time, lot number for vaccine, and vaccine administration date/time are not provided, 03/07/08.
Lymph node went across the top of my chest. A spot on my back my right clavicle spot auricular lymph node. A spot on the outer aspect of both mid thighs. The spot on my abdomen where my appendix is, a sharp sudden pain happened in the first week. It happened two dozen times a day.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. The physician mentioned a patient who was at the time of the report in kindergarten, received a first doe of (Oka/Merck) VARIVAX (route, dose and lot # not reported) on an unspecified date 22 days before the patient turned 12 months of age. No adverse symptoms reported. No further information provided. Additional information has been requested.
Heart palpitations and mild chest pain developed 3-5 days after 1st shot. Palpitations
1 DAY POST VACCINATION CHILD HAD LARGE SWOLLEN AREA ON RIGHT ARM WHERE TDAP AND IPV GIVEN.  MOM CALLED POISON CONTROL TO SEE IF SHE SHOULD APPLY HEAT OR COLD.  GIVEN ADVIL, TYLENOL, BENADRYL, HEAT.
runny nose; sneezing; sore arm; low grade fever; joint pain; tiredness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in Arm Right on 23Apr2021 10:00 (at the age of 59-years-old), as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced tiredness on 23Apr2021, and she had runny nose, sneezing and sore arm on an unspecified date and also experienced low grade fever, joint pain on 24Apr2021. The caller reports that she received her first vaccine dose on 23Apr2021. That night she started having mild symptoms which lasted through the weekend. Symptoms reported were sore arm, tiredness, achy joints, runny nose and sneezing. Caller reports that she took Tylenol and her symptoms improved but she reports that her problem is the achy joints have not gone away. Her second dose is due next week and she is concerned about getting the second dose concerned that her achy joints will not improve. The caller wanted to know this something that is going to continue and should she consider holding off on getting the second dose. The seriousness criteria of the events were reported as non-serious. Therapeutic measures were taken as a result of tiredness, runny nose, sneezing, low grade fever, joint pain and sore arm. The outcome of the events low grade fever resolved on 24Apr2021, tiredness resolved on 25Apr2021, runny nose, sneezing and sore arm resolving and for joint pain not resolved.  No follow-up attempts are needed. No further information is expected.
Symptoms began 10 hours after injection. Patient c/o disorientation, cold sweats, nausea, insomnia, back pain, fever, muscle spasms. Symptoms resolved in 48 hours.
Injection was painful (first 3 were not). Nine hours post injection, awoke with R arm pain and lightheaded.  R arm is painful when attempting to move out from side and raise above shoulder level.
Patient advises that she had developed injection site soreness on the night of her injection. The next day, she started with symptoms of generally feeling unwell and headache. She also reports that several days after the vaccine, she had some shortness of breath, dizziness, and weakness but did not seek medical care. Patient states she had fatigue, muscle pain, chills, sweating, and runny nose on 1/15/2021. On 1/18/2021, patient complains of headache. COVID test was ordered and patient was advised to go to Urgent Care for exam if she felt she needed to see a doctor. COVID test resulted negative.
Flu like symptoms; Body aches; Headaches; Low fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches), HEADACHE (Headaches) and PYREXIA (Low fever) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches), HEADACHE (Headaches) and PYREXIA (Low fever). On 09-Jan-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches), HEADACHE (Headaches) and PYREXIA (Low fever) had resolved.        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 medications were provided by the reporter.