chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 1:42 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 1:42 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 80.71 for dose administered on 07-JAN-2021.  No concomitant medications were reported.  Batch number 025L20A underwent temperature excursion on 07-JAN-2021.with temperature 34 degrees Fahrenheit at 09:00 AM to 10.00 AM. This vial was moved to fridge on 05-JAN-2021 and beyond use date for the vial was reported as 27-JAN-2021. Product moved to clinic on 07-JAN-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
pt recvd vax; 5 hrs later exp muscle soreness, redness & sl swelling at inject site; tx w/ ibuprofen & sxs resolved w/in 48 hrs;
Information has been received from a physician concerning a 12 year old female with no pertinent medical history and no allergies who in approximately August 2008, was vaccinated with the third dose of GARDASIL 0.5 ml IM. There was no concomitant medication. On 12-AUG-2008 the patient experienced fever after receiving the third dose. On 13-AUG-2008 the patient recovered from fever. The patient sought medical attention seen by the physician. Additional information has been requested.
Fever and body aches began around 0100 followed by onset of migraine around 0600.   Fever and migraine discontinued by end of day 10.23.2021.  Lack of appetite and mild nausea began 10.23.2021 and has continued with inconsistent severity.
inflammation markers were elevated/the patient reportedly developed rheumatoid arthritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004229.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2, administration date: 28Mar2021, when the patient was 54-year-old, for COVID-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Jan2022, outcome "unknown", described as "inflammation markers were elevated/the patient reportedly developed rheumatoid arthritis". The patient underwent the following laboratory tests and procedures: Inflammatory marker test: (Jan2022) elevated, notes: patient's inflammation markers were elevated.  Clinical course: In Jan2022, it was reported that the patient's inflammation markers were elevated, patient developed rheumatoid arthritis  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
admitted with difficulty breathing on 8/5/2021. Case said was at hospital for about a week and could not given exact discharge dates. She was on oxygen for only one day and is currently on room air now. She would not give any details about other symptoms  or her course of illness nor her past medical history. She did say that she still has difficulty breathing and hung up the phone.
ROBUST REACTION; LOCALIZED PAIN, SWELLING, AND ERYTHEMA (4-5 INCHES) AROUND INOCULATION SITE.  UNDER LEFT ARM PATIENT COMPLAINED OF TENDERNESS TO TOUCH.  FEVERS, CHILLS ON 04/13/2008.  SENT TO CLINIC TO SEE PHYSICIAN FOR FURTHER EVALUATION.
None Stated 03/05/07-records received from facility: seen in ED for allergic reaction to vaccines. HX of cough, wheezing and SOB few hours prior to ED visit, symptoms began 30 minutes after vaccines. Initially returned to PCP with c/o chest tightness, difficulty breathing, treated with epipen and benadryl and sent to ED. No swelling of mouth, lips or tongue. Allergies to cat (owns a cat). Uses nasonex for nasal congestion. VS P: 141, resp 20 BP 130/91. Treated with solu medol and ranitidine. Tremors, difficulty breathing. PE unremarkable. Lungs clear, no rhonchi, no wheezes. Admitted for IV steroid treatment.
Fever to 103 F, not responding to antipyretics, increase fussiness for about 24 hr.
swelling of deltoid region of rt arm, swelling of soft tissue in rt neck/shoulder, enlargement fo clavicular lymph node;
it was not IM nor Subcutaneous / was given at shoulder level in the interior part of the arm, not in the muscle; site of administration was "near the epiphyseal line of the arm" / Almost given near the bone where the humerus meets the clavicle, a little lower; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number K3YC7, expiry date 7th November 2022) for prophylaxis.   On 28th May 2021, the patient received the 1st dose of Shingrix. On 28th May 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. On an unknown date, the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown.  Additional details were provided as follows: The patient was given 1st dose of Shingrix, not intramuscular nor subcutaneous and the site of administration was near the epiphyseal line of the arm which led to intramuscular formulation administered by other route and vaccine administered at inappropriate site. The reporter stated that, it was given at shoulder level in the interior part of the arm, not in the muscle and almost given near the bone where the humerus meets the clavicle, a little lower. The reporter consented to follow up by email.
passed out; she is aching all over; her blood pressure drops low; a temperature of 98.8 where her normal temperature is 97.6; real bad chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passed out"; PAIN (non-serious), outcome "unknown", described as "she is aching all over"; HYPOTENSION (non-serious), outcome "unknown", described as "her blood pressure drops low"; PYREXIA (non-serious), outcome "unknown", described as "a temperature of 98.8 where her normal temperature is 97.6"; CHILLS (non-serious) with onset 2021, outcome "recovering", described as "real bad chills". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) low/decreased; body temperature: (unspecified date) 97.6, notes: normal temperature is 97.6; (2021) 98.8, notes: temperature of 98.8. It is hard to get a test right now and they do not do it over the phone. She just wanted to know the side effects of the new variant, she already had the first 2 doses and supposed to get the third one by the end of this month or 1st week of next month.   The lot number for bnt162b2 was not provided and will be requested during follow up.
ACUTE HYPERCAPNIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/10/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Ringing in left ear 14 days after first vaccine dose on August(Tinnitus); This is a spontaneous report from a contactable consumer (patient himself). A 54-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 06Aug2021 15:45 (Batch/Lot number was reported as FA7485 or F117485, pending clarification) as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypersensitivity. The patient's concomitant medications were not reported. The patient experienced positive covid-19 test with symptoms on 26Aug2021 and ringing in left ear 14 days after first vaccine dose on august (tinnitus) on 21Aug2021 at 12:00. The patient underwent lab tests and procedures which included sars-cov-2 antibody test positive on 26Aug2021 Nasal Swab. The outcome of the event positive covid-19 test with symptoms was unknown. Outcome of ringing in left ear 14 days after first vaccine dose on august (tinnitus) was not recovered.
Vagal reaction: immediately after injection, I felt my heart palpitating, I felt light-headed, and I heard distorted noises.  I became disoriented for a moment or two, then heard clearly again.  The nurse helped me lay down for about 5 minutes and gave me water and juice to drink.  She said I looked pale; my blood pressure was lower than my normal reading, and my heart rate was 50.  After resting for a few moments, I felt fine, and I have not felt any faintness or pain at the injection site since.  The nurse did not report this reaction, because in her judgment it was simply a vagal reaction and unrelated to the vaccine.  I shared this information with two employees of Merck; one of them asked me to report this reaction anyway, and the other may have reported it separately.
mom states awoke approx 2 hrs p/vax crying and cried for hrs; believes crying lasted for 3 hrs, falling asleep for a few minutes then crying again; had shaking all over episode which lasted for 5 mins or less;
tender, firm, reddened warm area over rt deltoid 3 days p/inj; small pustula @ site; probable cellulitis;
Vaccine was a GSK influenza vaccine, distributed by ID BioMedical. If it was a quadrivalent or trivalent, and lot number unknown by me. A 4 inch long swelling occurred on the arm below the injection site, as well as throat tightening. Swelling was red and hot to the touch.  Called the Doctor's office on 11/6/19 and was advised by doctor's office staff to  use ice, Motrin, and Benadryl until symptoms subsided. As of 11/11/19, the site is still slightly red, but swelling has decreased.
Pt recvd 3 doses of Engerix-B on 11APR90, 12MAY90, & 16OCT90 & was found to be a non-responder;
My lips became very chapped, skin would be flaking off, and remains that way to this day. I started having canker sores inside my mouth. That have backed off a little, but my lips stay chapped. They have me taking hydrocortisone ointment twice a week. There really isn't anything they could give me for the canker sores.
24 hours after vaccine given patient developed red, pinpoint , flat rash on lower legs and forearms; does not blanch; no itch; 7 days later it is still present
Indurated erythematous knots to all sites. Hydrocortisone cream twice a day to affected area (prescribed).
Expired Act-Hib was administered without any reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Medical Information (Reference number- 00732188) and transmitted to Sanofi on 19-Aug-2021.  This case was linked to case - 2021SA279788.  This case involves a two year old male patient who was administered an expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) and MEASLES VACCINE LIVE, MUMPS VACCINE LIVE, RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination.  On 09-Aug-2021, the patient received a dose 3 (0.5 ml) of suspect HIB (PRP/T) VACCINE (lot number: UJ398AA; expiry date: 06-Aug-2021) via intramuscular route in the right thigh for prophylactic vaccination.  It was case of actual medication error due to expired vaccine used (latency: same day).  It was reported, "Expired Act-Hib was administered, and she wants to know how to follow up? Expired ActHIB was given to 2 patients. Event Information o Treatment--none at this time o Dose # if series-3rd o List concomitant or "no other vaccines"- Kinrix, ProQuad o Pregnancy--NA  Last menstrual period  Due date  AE symptoms or no AE."  No adverse events were reported at the time of this report.  The outcome of the event was unknown.  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.
My experience with dose 3 was that my hives got worse. More hives and they still haven't gone away. I had more hives than what I originally already had.
Red and white bumps on face neck and chest. Painful joints (knee foot). Itchy scalp and ears.
Moderna 3/1/21, 3/29/21. Positive on 1/4/23
Primary series administered without any adverse effects. This booster dose resulted in high fever (103.5F), shivers, extreme sweating, severe headache, which persisted until the third day after the onset. Hydration maintained; acetominophen 1g administered TID for the duration of the fever and headache..
I had my vaccination on 9/21/2022. On 12/31/2022 I had a sore throat. On 01/01/2023 I woke up and I felt sick with a low-grade fever and sore throat. I tested COVID-19 positive on 01/01/2023. I contacted my doctor office on 01/01/2023 and was prescribed PAXLOVID. I presently feel better on 03/23/2023 with no residual symptoms.
This spontaneous report was received from a 38 year old non-pregnant female patient reporting on herself. She had no medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 16-AUG-2018, the patient was vaccinated with the first dose of M-M-R II intramuscularly (incorrect route of drug administration), as prophylaxis (strength, dose, lot # and expiration date were not reported). On 12-SEP-2018, the patient was vaccinated with the second dose of M-M-R II subcutaneously, lot # N023146, expiration date: 21-AUG-2019, as prophylaxis (strength and dose were not reported). On 13-SEP-2018, the patient experienced really large swelling (injection site swelling), inflammation (injection site inflammation), burning (injection site pain) and warm sensation (injection site warmth) at the injection site. An unspecified treatment was given for the events. No laboratory diagnostic studies were performed. She did not seek medical attention. The outcome of injection site warmth, injection site pain, injection site swelling and injection site inflammation was reported as not recovered/not resolved. The reporter did not provide the causality between the events and M-M-R II.
Lethargic, weak, for 5+days. Sore arm that popped each time I lifted it for 7+ days (still occurring at time of report)
Information has been received from a pharmacist, referring to an adult patient of unknown age and gender. Information about medical history, concurrent condition and concomitant therapy was unknown. On an unknown date, the patient was vaccinated with two pediatric doses of VAQTA injection 25/0.5(unit unknown) (dose, route, frequency, lot# and expiration date were unknown) for prophylaxis which was equal one adult dose(adult use of a child product). No adverse effects had been reported.
This case was reported by a healthcare professional and described the occurrence of crankiness in a 5-year-old subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On 2 November the subject received unspecicifed dose of Fluarix (unknown, left thigh). As a result of the vaccination with Fluarix, the subject experienced vaccination error, described as "adult" by the healthcare professional. On 2 November 2007, less than one day after vaccination with Fluarix, the subject experienced crankiness. Th healthcare professional reported on 7 November 2007 that the subject was unusually cranky since receiving the Fluarix on Friday (2 November 2007) and that the crankiness has improved but the subject wad still cranky.
no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 56-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    Concomitant medications were not reported.  Total 26 doses from Lot 065K21A Monovalent doses were administered after the BUD to patients. Treatment medications were not reported.
This 7-6/7 week old neonate infant is brought in by parents. She has been fussy today since having received her first set of immunizations and her AB monitor went off. Mom reports that while she has been screaming and crying her heart rate monitor will go off because it is high; however, she had an episode with a heart rate where her apnea monitor went off because she had stopped breathing. She did not have any cyanosis associated with this and with stimulation she began to breathe again. Parents report she has had screaming of greater than 3 hours duration since having received her immunizations earlier today. This infant was born to 33-0/7 weeks gestational mother with gestational diabetes who had undergone ovarian cyst surgery at 18 weeks into the pregnancy as well. The infant had a prolonged hospitalization stay. Her due date originally was 6/29/05. WNWD infant female, was noted to be tachypenic when she first checked in but apparently she was screaming at that time and I see the child and she is calmed down. Assessment: Irritability after immunizations in a premature infant who is on AB monitor. Plan: Tylenol every 4 hours at home while awake, and if AB monitor goes off again during the night, go to the hospital.
3 days after receiving the vaccine I started to experience swelling of the lymph nodes under my arm. I received a mammogram, and a biopsy that came back normal. They ran blood test and thought I could possible have cancer but all the test came back normal. I am still experiencing the swollen lymph nodes under my armpits but there is slight pain and I will have to continue to do follow ups with my PCP.
mom reported to clinic 3PM p/vax 10AM pt has been screaming since recv vax;pt heard in background crying incessantly w/high pitched steadiness;mom referred to child primary care MD for eval;MD states no further whole cell pertussis;
Swollen top lip; Swollen cheek; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swollen cheek) and LIP SWELLING (Swollen top lip) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.    Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    Concurrent medical conditions included Shellfish allergy (and monosodium glutamate), Nickel sensitivity and Allergy to vaccine.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced SWELLING FACE (Swollen cheek). On 02-Mar-2021, the patient experienced LIP SWELLING (Swollen top lip). On 07-Mar-2021, SWELLING FACE (Swollen cheek) and LIP SWELLING (Swollen top lip) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
The patient contacted the pharmacy today stating that she got her second Shingrix vaccine on friday, and Saturday night her arm became sore and red around the injection site. She also developed a headache and nausea and is unsure if that was from the vaccine or something unrelated. I told her the soreness and redness is common after a vaccine and could last a few days to a week but the headache and nausea are not. She asked if she should contact her doctor and I told her that would probably be a good idea. I told her she could take motrin or tylenol if the pain is bothersome and could ice the area as well.
On May 6, 2021, pt began experiencing topical pain on the left side of his head and forehead. Over the next several days, this pain turned into blisters and then scabs, and began to spread. On May 12, 2021, he was diagnosed with shingles at  Urgent Care clinic.