chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Health Professional concerning a 9 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 27-Jan-2014. The patient was administered expired FLUMIST on 27-Jan-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.
Information has been received from a legal firm regarding a case in litigation concerning a male who on 1/6/95 and 2/8/95 was vaccinated with hep B vaccine recombinant (lot 612504/0873A for both reported). Other immunizations included the following vaccines: Tetramune (lot 386987 given on 2/8/95) (lot 386988 given on 4/13/95) (lot 394957 given on 6/21/95), hep B vaccine, recomb (Engerix B) (lot 1513B2 given on 9/28/95), HibTITER (lot M3051F gvien on 4/4/95), Tripedia (lot 5K61015 given on 4/4/96) and diphtheria toxoid/tetanus toxoid vaccine (lot 0985990 given on 8/11/00). It is alleged that the pt developed severe neurodevelopmental disorders with associated high mercury exposure levels, mercury poisoning by the cumulative doses of mercury in the thimerosal, and toxic neurological effects of mercury poisoning which he now suffers and will continue to suffer. The pt was exposed to vaccines reportedly containing thimerosal and administered to him during the first years of his life, during the period from January 1995 through at least August 2000. Upon internal review, severe neurodevelpmental disorders, mercury poisoning, and toxic neurolgoical effects of mercury poisoning were considered to be other important medical events (OMIC). No further info is available.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 61st of 190 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Patient 56 years old presenting after adverse reaction to the COVID-19 vaccine.  Patient reports feeling very flushed and had itchy throat.  Patient reports it went away after few minutes and then came right back.  Patient denies any shortness of breath or difficulty swallowing.  Patient denies any lip, tongue swelling.  Patient did not take anything prior to arrival.  Patient has had anaphylactic reaction to chemo before but never any vaccine.
Improperly stored dose of PNEUMOVAX 23; No adverse effects; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S009945, intramuscular.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, route, lot number and expiration date were not reported). No co-suspect and concomitant therapies were reported. No adverse events reported. Additional information has been requested.
Started developing a ringing & buzzing noise in my left ear like tinnitus. Noise/buzzing is nonstop.
Nausea; Headache; Pain at injection site; Redness at injection site; Swollen arm; injection site swelling; Shaking; Chills; Fever; This case was reported by a physician via call center representative and described the occurrence of tremor in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th June 2019 15:00, the patient received the 1st dose of Shingrix (intramuscular). In June 2019, 9 hrs after receiving Shingrix, the patient experienced tremor, chills, fever, nausea, headache, injection site pain, injection site erythema, swelling arm and injection site swelling. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the tremor, chills, fever, nausea and headache were recovered/resolved and the outcome of the injection site pain, injection site erythema, swelling arm and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the tremor, chills, fever, nausea, headache, injection site pain, injection site erythema, swelling arm and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid at 3 PM. About 9 hours later at midnight, the patient experienced shaking, chills, fever above 101 degree F, nausea and headache. The patient also experienced pain, redness, and swollen arm at the deltoid region of the injection site. The fever lasted for 12 hours.  The patient had to take Zofran for her nausea.  The patient had recovered from everything, but she was still experiencing pain, redness and swollen arm, at the time of reporting.  No further details were provided.
Pt received ZOSTAVAX in upper (R) arm at 10:19am. PT tolerated well. Pt called 5/15 to report having "2 x 3" localized reddened area at vaccine site. It was slightly raised, itchy, and warm to touch. Denies any discharge or pain "It just feels a little sensitive." Taking ADVIL per dr. spoke with pt today (5-19-15) and she's doing much better. Swelling resolved.
Accidentally gave pfizer 6m-4y bivalent rather than 6m-4y original.
Clammy and faint. 2 hours later numbness on left side of face and  headaches that came and went. Lasted for about 2 hours.
Febrile seizure and temp of 101 degrees. Weird neck jerking motions began 3 days after the vaccinations.
Vaccine was administered 10/9/02 at approximately 2pm. On 10/10/02 when I got up, I had severe vertigo. The vertigo worsened. On 10/12/02 I went to the emergency room. I had rotational & horizontal nystagmus, nausea, vomiting, inability to ambulate. Positive nylonberone manuever (per neurologist). To date (10/26/02) I still have a degree of vertigo, imbalance and nystagmus.
Thrombocytopenia; This case was reported by a physician and described the occurrence of thrombocytopenia in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number 9AS39, expiry date 13th July 2020) and (batch number A4X57, expiry date 13th July 2020) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th June 2019, 2 days after receiving Shingrix, the patient experienced thrombocytopenia (serious criteria hospitalization and GSK medically significant). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the thrombocytopenia was recovering/resolving.   It was unknown if the reporter considered the thrombocytopenia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 81 or 82 years. The patient received Shingrix in left deltoid. The patient developed severe thrombocytopenia (platelets 0) after the receiving of the of Shingrix. The patient was admitted to the intensive care unit (ICU), received 2 pools of platelets, IVIG and high doses of steroids, and platelets are somewhat improved at the date of reporting. Several lab tests were performed.      Lab Comments: On 15th June 2019, poikil, ovalo and polych was 1 plus.
S:  received pneumococcal-PS injection yesterday.  No previous Pneumovax that I can find in our records and she does not get immunizations at other locations. That evening noted swelling, warmth and redness around the injection site and it has progressed markedly no dyspnea/wheezing. O:  Marked induration, warmth and mild erythema - 15x25 cm right arm. CTA; RRR; no other skin abnl.
diaphoretic  Narrative:  Pt received 1st dose of Pfizer COVID-19 vaccine on 3/12/21 at 10:15 AM. Within 12 mins, the pt c/o feeling diaphoretic, dizzy, itchy. Pt does not have HX of allergic reaction previously. On exam: SLBP is 83/53, HR=54. alert, awake, orientated. Given Epi Pen 2 dose IM, Benadryl IM injection, Famotidine IM. Called 911 to transfer pt to ED at Emergency Room. When rechecking BP before transfer was BP 106/62 P-59 - at the recheck pt states he felt better. Per the ED note: The medics find him with stable vital signs and he arrives here otherwise asymptomatic. No wheezing. No tongue swelling. No drooling. No other recent active illness. Does not routinely take other medications and is unaware of other allergic reaction history. The ED provider stated "This patient presents with a brief bout of diaphoresis and change of blood pressure approximate 30 minutes after receiving his Covid vaccination. I believe this to be less likely an acute allergic reaction more likely to be some type of vagal event. He is remain stable throughout his stay here and is currently stable for outpatient management. No evidence of anaphylaxis or other emergent allergic issue."
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Patient's mother in with client for next set of injections - states child had problem breathing after last visit. Had to go to ER treatment received. Doctor told her patient had received too many injections at one time.
Information has been received from a registered nurse concerning her 28 month old son who on 20-MAR-2006 was vaccinated in the leg with a dose of Varivax. On 24-MAR-2006 the patient developed fever and pain in his vaccinated leg. The patient was taken to his pediatrician but the physician did not think the symptoms were due to the vaccine. On 26-MAR-2006 the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Patient reports experiencing chest discomfort, shortness of breath, and congestion after vaccine dose 1 and dose 2.  Patient seen for televisit after recieving 2nd covid vaccine 4 days ago.  He has a little trouble breathing and has pain around his chest with some muscle pains.  He reports that the pain is increased in his upper chest.  He is more short of breath walking up stairs, coughs up a little bit, does use advair, has rescue inhaler. Patient was directed to seek further care at immediate care. Has hx of chest pain and tightness prior to vaccine most recently documented in 3/2020
LOTS OF NASAL CONGESTION; COUGHING WITH PHLEGM; SHORTNESS OF BREATH; PAIN IN CHEST CAVITY; BODY ACHE; DIARRHEA; SORE ARM; SWELLING AT INJECTION LOCATION; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body ache. On 14-MAR-2021, the subject experienced diarrhea. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced swelling at injection location. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced nausea. On 16-MAR-2021, the subject experienced pain in chest cavity. On 16-MAR-2021, the subject experienced lots of nasal congestion. On 16-MAR-2021, the subject experienced coughing with phlegm. On 16-MAR-2021, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body ache, headache, swelling at injection location, diarrhea, pain in chest cavity, shortness of breath, sore arm, and nausea, and the outcome of lots of nasal congestion and coughing with phlegm was not reported. This report was non-serious.
Tinnitus in left ear started the Monday after the vaccination, I have also had what I can only describe as "fuzzy brain" indicated by a difficulty concentrating on complex projects.  I have also been experience intermittent headaches and pressure in my head.  My left eye started watering and feeling irritated.
Fever; Body aches; Headache for 72 hours; Swelling and redness at injection site; Swelling and redness at injection site; A lot of swelling in underarm lymph nodes; A lot of swelling in left shoulder; Underarm extremely painful; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable other healthcare professional, the patient. A 53-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2587) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included heart disease. The patient had known allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via intramuscular route of administration in the left arm on 23Dec2020 at 07:00 (at the age of 52-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on an unknown date (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 29Oct2021 at 22:00, the patient experienced fever, body aches and headache for 72 hours, swelling and redness at injection site, a lot of swelling in underarm lymph nodes, left shoulder and underarm extremely painful. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of swelling at injection site, a lot of swelling in underarm lymph nodes, left shoulder which included treatment with ice for underarm and ibuprofen (MANUFACTURER UNKNOWN) for the swelling. The clinical outcome of the events fever, body aches and headache was resolved on 01Nov2021 at 22:00 whereas swelling and redness at injection site, a lot of swelling in underarm lymph nodes, left shoulder and underarm extremely painful were not resolved at the time of this report.
monitor for vs, NO HX OF PREVIOUS REACTIONS REPORTED, code green called, throat feels like she can't swallow/shot at 1446, to ER at 1530
expired QUADRACEL was inadvertently administered to a patient with no reported adverse event; Initial information received on 19-Jul-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves 4 years old and unknown gender patient who was inadvertently administered expired diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Jul-2023, the patient was inadvertently administered standard expired dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine Suspension for injection at a dose of 0.5 mL total (lot C5916AA, expiry date- 06-JUL-2023) via intramuscular route in the left deltoid for Immunization with no reported adverse event (expired product administered) (latency- same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
This initial spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On 02-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection (lot # L018351 with expiration date 11-AUG-2017: dose and route were not provided). The vaccine was exposed to temperature of 47.10F for 96 hours. There was no previous temperature excursion. The call was not because of a data logger. No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
some side effects and they weren't significant; waited 5 moths to take the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (some side effects and they weren't significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (waited 5 moths to take the second dose) in a female patient of an unknown age 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 VACCINATION COMPLICATION (some side effects and they weren't significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (waited 5 moths to take the second dose). At the time of the report, VACCINATION COMPLICATION (some side effects and they weren't significant) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (waited 5 moths to take the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant and treatment information were reported by the reporter   Reporter did not allow further contact
At 11pm began to feel achy  By 1am headache and body aches By 10am complete body shake for 2 hours, then fever of 101 Continued thru the 31st By 4/1 no fever, slight headache and lethargy thru 4/2 am. Then perfectly fine.
It happened around March 12 and to this date the illness persists.  The reaction is the loss of sensitivity in the thumb and later in the index finger.  It losses strength, it gets numb occasionally.  In the beginning it only lasted for 3 weeks the pain and the numbness of the fingers and loss of strength from the shoulder towards the arm.
Patient presented in the office on 8/27/09 three days post-administration of Menactra and her first Gardasil with myalgia. She was brought in after extremities experienced a color change while the patient was swimming on 8/27/09. Patient was sent for lab work on 8/27/09. Based on critically elevated CPK, total and CKMB along with symptoms the provider felt this could be a case of Guillain Barre Syndrome.  9/8/09  PCP records received. In for WCC on 8/24/09. Vax given. Pt returned to office 8/27/09 with R arm pain and swelling of the whole arm, muscle soreness and injection site tenderness as well.  While swimming, pt's arms and toes  turned purple.  PE (+) for edema, muscle fasiculations and weakness (Rarm > Left) of the arms, fingers and toes.  CPK/CKMB indicative of skeletal muscle damage. Dx: Myalgia.  Adverse Reaction. Guillain Barre.  Increased CPK. Tx with steroids.  Pt has not sought any other treatment at this time.