chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered ACT-HIB to a patient using an alternate diluent with no reported adverse event.; Initial information received on 06-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 1 years old male patient who was administered act-hib using an alternate diluent with no reported adverse event. while receiving vaccine hib (prp/t) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13v (CRM197) (Prevnar 13) for Prophylactic vaccination; hepatitis a vaccine (Hepatitis a) for Prophylactic vaccination; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Prophylactic vaccination.  On 10-Mar-2022, the patient received a 0.5 ml dose of suspect hib (prp/t) vaccine lot UJ579AAA frequency: once (dose, route, strength: unknown) in unknown administration site for Prophylactic vaccination.  On 10-MAR-2022 the patient developed a non-serious event administered act-hib to a patient using an alternate diluent with no reported adverse event. (Wrong diluent used) following the administration of hib (prp/t) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Wrong diluent used).  At time of reporting, the outcome was Unknown for the event Wrong diluent used.  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.
Patient called the pharmacy stating that she received the vaccine on 1/25/21. At that time, she experienced muscle pain for a day or two then it subsided. When she awoke today (2/2/21), she felt a lump at the injection site. Throughout the day, she said it grew larger and more painful. She said it is now swollen and red and larger than the morning. I advised her to call her doctor to get it checked out and to report and adverse events to the website (which I provided to her).
Had shingles; shingles; Itching; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pruritus (Verbatim: Itching). The outcome of the vaccination failure was unknown and the outcome of the shingles and pruritus were resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023 The patient had shingles after getting the shot, only itching and loved being in the summer heat.  MD put him/her on medicine, and they helped. The follow-up would not possible as no contact details were available.
presented with pneumonia due to COVID, respiratory failure, acute kidney injury, discharged to hospice where he died
Developed a fever, chills, severe headache and nausea 12 hours after receiving the 2nd dose of the vaccine.  Lasted from 8pm 4/1/21 until 8 am 4/3/21.
BP 140/90. HR 94. 94% o2. Pt felt burning sensation/heat in nose/throat. dizziness. felt like room was spinning a little bit. No SOB, chest tightness, nausea, difficulty swallowing. Pt was resting and husband drove her home.
I repeated MMRV on this patient that already had his second MMRV on 2/3/2015.
This spontaneous report as received from a medical assistant via a company representative refers to an unspecified number of patients. No specific (individual) patient information was provided. It was reported that an unspecified number of patients had received their second dos of GARDASIL four weeks after receiving the first dose. No lot number or dates of administration was provided. No adverse effects were reported. No further information was available. Additional information has been requested.
Sinus Infection and it was hurting; Myalgia; Sore Arm; A spontaneous report was received from a consumer concerning a 56-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sinus infection and it was hurting/sinusitis, body ache/pain, sore arm/pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Feb 2021 prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch:007M20A) intramuscularly for prophylaxis of COVID-19 infection.  On unknown date the patient experienced the events sinus infection and it was hurting, body ache and sore arm. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events sinus infection and it was hurting, body ache and sore arm was unknown.
This spontaneous report as received from a nurse refers to a patient of unknown age. In September 2011, the patient was vaccinated with GARDASIL dose 1. On 21-FEB-2013 the patient was vaccinated with GARDASIL dose 2. On 22-APR-2013 the patient was vaccinated with GARDASIL dose 3. The patient was not experiencing any known symptoms. Additional information has been requested.
Itchy rash on top of left hand; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 07May2021 at 08:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications included colecalciferol (VITAMIN D3) and menaquinone-7 (VITAMIN K2), both taken for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 09Apr2021 at 08:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10May2021, 2 or 3 days after the second shot, the patient experienced itchy rash on top of left hand only, same side as the shot. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event itchy rash was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt recvd vax; to er 22mar95 w/ sz;adm to hosp for observation, T 101.4; exp ataxia for 1st 24 hrs but resolved;tolerating diet;was w/out residual neurologic defect; 30 atypical lymphocytes;
The day after receiving the vaccine she developed cyclical vomiting, diarrhea, headache, weakness, fatigue, chills and brain fog. The vomiting ceased later in the day and her other symptoms have steadily improved. She is also experiencing palpitations at night but they have been improving. She also had an outbreak of her gential herpes.
Sensitive; Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Sensitive), ERYTHEMA (Redness) and SWELLING (Swelling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     no medical history is provided and concomitant drugs are provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), NORTRIPTYLINE and LORAZEPAM (ATIVAN) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced SENSITIVE SKIN (Sensitive), ERYTHEMA (Redness) and SWELLING (Swelling). At the time of the report, SENSITIVE SKIN (Sensitive), ERYTHEMA (Redness) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pain in her injected arm/pain at site of injection; This case was reported by a consumer and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes. Concomitant products included metformin hydrochloride (Glucophage) and glimepiride.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported. The patient received vaccine in an unknown arm. The patient had pain in her injected arm but it went away. The reporter did not consent to follow-up.
they had two patients that recieved the Diluted Maroon Pfizer Covid 19 Vaccine past the 12 hour window in the fridge after first puncture; they had two patients that recieved the Diluted Maroon Pfizer Covid 19 Vaccine past the 12 hour window in the fridge after first puncture; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 3-year-old male patient received BNT162b2 (BNT162B2), on 04Aug2022 as dose 1 (maroon cap), single (Lot number: FT9142, Expiration Date: 04Oct2022) at the age of 3 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (life threatening), PRODUCT ADMINISTRATION ERROR (life threatening) all with onset 04Aug2022 and all described as "they had two patients that recieved the Diluted Maroon Pfizer Covid 19 Vaccine past the 12 hour window in the fridge after first puncture".  Clinical course. Per caller they had two patients that received the Diluted Maroon Pfizer Covid19 Vaccine past the 12 hour window in the fridge after first puncture. The caller reports it was probably another 9 hours. Per caller the fridge was at 38.8F. Caller asking for stability guidance. No other Conditions, Investigations and other products. NDC number of maroon cap Pfizer Covid vaccine for ages 6 months to 4 years old: 59267007801. A medical assistant on the line calling about the maroon cap Pfizer Covid vaccine for ages 6 months to 4 years old and had two patients that received the vaccine after 12 hours of puncture in the refrigerator and it was probably another 9 hours after those 12 hours when they were left in the refrigerator and one patient was a female age 02-year-old and the other was a male patient age 03-year-old so he wanted to report this; agent provided the caller with the off label information for the additional 12 hours for a total of 24 hours if they choose to use that and the refrigerator temperature was 38.8 degrees Fahrenheit. Patient did not require treatment for the reported event. Last height and weight from Dec2021 and he was 35 inches in height and 27 pounds.
No known adverse effects; a 16 year old patient received a dose of PROQUAD; This spontaneous report was received from a nurse referring to a 16 years old patient of unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.     On 23-DEC-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S006829, expiration date 02-SEP-2020, dose and route were not provided) for prophylaxis (product administered to patient of inappropriate age). No known adverse effects were reported.
weakness, cough, body aches, chills and fever x1 day when came to ER
Pressure in my left eye and a little bit in the right eye and it is kind of itchy; Pressure in my left eye and a little bit in the right eye and it is kind of itchy; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as Dose 1, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, about two weeks ago received Pfizer shot (COVID Vaccine) and started having problems like pressure in left eye and a little bit in the right eye and it was kind of itchy. " Patient stated that it was not just itching but it was pressure in left eye and a little bit in right eye and little bit itching." The patient queried if that was a side effect of the shot. Limited information was provided by the patient. The outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Felt sore throat off and on 10/6 and 10/8.  10/12 COVID-19 at Rapid  Molecular/NAAT/NEAR.  Negative.  Evening of 10/13 felt slightly feverish 100.5, stuffy nose, sore throat, fatigue.  Went to AFC Urgent Care on 10/14.  Doctor there performed Rapid Flu and Strep.  Aditional Strep test and PCR COVID-19 Test also performed.  Only COVID-19 test was positive.  Doctor initially treated for sinus infection with atibioditcs while waiting test results.  Advised to stop antiboitics once test results came in.  Symptoms improved since 10/15 with just a little congestion and fatigue remaining.
Exactly two weeks after my second shot, I broke out in horrendous hives. Nothing else in my life changed. The hives have been persistent for 3 months despite multiple steroid rounds, allergy testing, and months of acupuncture. No history of hives for me and my family, though I did get a brief outbreak of hives after taking penicillin at age 2.  The hives are constant, daily, and cover all parts of my body.   I had an alopecia spot appear on my scalp at a similar time.
4 cm erythema @ site of ADACEL injection approx 36 hrs after injection.
He had no fever but was very grumpy. Wouldn't eat. Sleeping a lot.
1 of 5 pts vaxed from same lot who devel a local rxn consisting of rash surrounding site;rash appeared w/in days of vax (varying in size in all 5 pts;largest from shoulder to elbow;area sore & tender;no fever;recovered;
Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 07Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache on 07Aug2021. Patient wanted to know if patient could use Tylenol because patient had a headache. The outcome of event headache was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
soreness in his left arm at the injection site; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 28Jan2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient states that he received the first dose of the Pfizer Covid-19 vaccine on 28Jan2021 and had complaints of soreness in his left arm at the injection site on unspecified date in Jan2021 and the next day the soreness was pretty much gone. Patient received the second dose of the vaccine on 18Feb2021 and reported that he had no reactions. He was happy with the results of getting the Pfizer Covid-19 vaccine and "the first two seem to be working well". Patient was asking if it would be okay for him to get another dose of the Pfizer Covid-19 vaccine. Patient was asking if anyone has received the third dose of the Pfizer Covid-19 vaccine, are there any results for the third dose, and, if someone has received the third dose, has there been any side effects. The outcome of the event was recovering.  Information on Lot/Batch information has been requested.
Felt an immediate flush on face, face reddened across cheeks and nose. Later, after work, noted rash on arms, back was dark with lighter rash on stomach and chest
Pt had first GARDASIL injection on 6/20/08 and developed itching and redness of both lower legs - "below the knee" today. No rash or "Bumps" - No shortness of breath etc.
EARACHE; COLD; SORE ARM; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced earache. On MAR-2021, the subject experienced cold. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, sore arm, cold and earache was not reported. This report was non-serious.
Pt states she had reaction on 09/08/01 consisting of rash and edema of arms, face, legs, feet. Pt states she was tx with Benadryl. Pt states rash lasted for 2 weeks with itching. C/O still felling itchy.
This spontaneous report as received from a medical assistant, refers to a currently 4 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored VAQTA, (which had a lot # of N020686 and an expiration date of 22-OCT-2018; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA007361: US-009507513-1808USA007362: US-009507513-1808USA007363: US-009507513-1808USA007364: US-009507513-1808USA007365: US-009507513-1808USA007366: US-009507513-1808USA007367: US-009507513-1808USA007368: US-009507513-1808USA007369: US-009507513-1808USA007370: US-009507513-1808USA007371: US-009507513-1808USA007372: US-009507513-1808USA007373: US-009507513-1808USA007374: US-009507513-1808USA007375: US-009507513-1808USA007376: US-009507513-1808USA007360.
This spontaneous report was received from a a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M047661 with an expiration date 02-DEC-2018, subcutaneously for prophylaxis (dose, and anatomical location were not reported), reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot#L025375 with an expiration date 14-MAR-2018). There was no adverse effect reported. Administered doses of VARIVAX experienced the temperature excursion of - 13 degrees Celsius for 34 minutes. There was no previous temperature excursion. A digital data logger was involved. Additional information has been requested.
I had hives over much of my body from the tops of my feet up to my shoulders.  None of my face or the middle of my back.  Lots on my arms and legs.  I have never really had hives before.  They were extremely itchy and irritating.  I took some antihistamines which seemed to work well.  I tried both Allegra and Benedryl.
Hyperactive; cannot settle down - patient will come in for eval if sx last longer than 48 hours after vaccination
Sore arm at injection site, chills, fever, muscle weakness; started on Tuesday night, had trouble sleeping, muscles in arms and legs hurt; by morning, I felt too ill to go to work; progressed throughout day on Wed; went to Urgent Care late Wed afternoon; had x-rays of lung, flu test.
Caller reports that MMR II was administered on 4/10/2023 to 1 patient following not supported excursion that was reported in TE case 02367012. Consent to contact obtained. No additional AEs/PQCs reported. ?    Names of vaccines involved (including; No additional AEs; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-APR-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) subcutaneous injection, 1 dose, lot #U028162, expiration date: 09-SEP-2023, administered for prophylaxis (strength, and route of administration were not provided). Calller reported that 1 patient following not supported excursion was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II). The vaccine went under temperature excursion of 56 degree Farenhait for 6 hours with no previous temperature excursion (product storage error). No additional adverse event was reported.
This spontaneous report was received from a registered nurse referring to a 9 week old infant. Patient's medical history or concurrent conditions were not reported. On 07-OCT-2015, the patient was vaccinated in error with a dose of VAQTA (lot # L002717, expiry date 02-JUN-2017). The infant also received doses of PREVNAR and ROTATEQ, oral (manufacturer unknown). The infant had not demonstrated any adverse effects at the time of this report. Follow up information has been received from a registered nurse on 29-DEC-2015. Patient demographics updated. It was reported that VAQTA was ordered and given intramuscularly, instead of Hepatitis B vaccine. The patient also received Oral, ROTATEQ and PREVNAR concomitantly. Additional information is not expected as all correspondence was received. Reporter, patient, product information and narrative updated.
Rash injection site pain/arm pain, swelling at injection site Narrative:  Other Relevant History: