chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT RECEIVED A DOSE OF PFIZER BIVALENT BOOSTER DOSE WAS PAST BUD, SPOKE TO HUSBAND AND HE STATED THAT HIS WIFE HAS NOT EXPERIENCING ANY ADVERSE EVENTS. PATIENT WILL SCHEDULE TO BE RE-VACCINATED.
Flushing, Sweating, Dizziness, and Fatigue. BP 141/88 HR82 RR 19. After monitoring in observation area, despite stable VS, patient continued to report dizziness, nausea, and headache, EMS called and patient taken to ED.
Pt did not experience any adverse events.  Pt was given vaccine that was stored at freezer temperature for 3 days greater than advised per Pfizer's storage requirements.
Suspected Vaccination Failure; Shingles; 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.   Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   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: Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023. The patient reported this case via interactive digital media. The patient got shingles which he/she did get vaccinated for right after he/she got his/her Covid booster shot.  The patient's PCP physician was very concerned about this.  The reporter did report it.  The reporter said of course no response. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Pt called & stated her (Rt) arm was red, swollen & warm to touch where she received her vaccine.
Pt recvd vax 12MAY92 & approx 3 wks later devel mumps, characterized by a rt parotitis & a mild runny nose;
patient with severe reaction/ Patient develops hives with vaccine; This non-serious case was reported by a other health professional via sales rep and described the occurrence of hives in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.  Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMO 23) for prophylaxis.  Additional patient notes included the patient was not allergic to COVID (Pfizer) vaccine.  On an unknown date, the patient received Flu vaccine and PNEUMO 23. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced hives (Verbatim: patient with severe reaction/ Patient develops hives with vaccine). The outcome of the hives was unknown.  It was unknown if the reporter considered the hives to be related to Flu vaccine.  It was unknown if the company considered the hives to be related to Flu vaccine.  Additional Information: GSK Receipt Date: 24-APR-2023 The reporter had reported that the he had a patient with severe reaction to flu and pneumo 23 and was not allergic to COVID (Pfizer). .  The patient had developed hives with vaccine. The reporter does not specified which flu vaccine.  No other information shared by field representative in agency. The reporter had consented to follow-up. It was unknown if the reporter had considered the adverse events to be related to PNEUMO 23 vaccine.
patient who started the rabies series but did not follow up, just returned and wants to follow up with the series with no adverse event; Initial information received on 06-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 21 year old male patient started the rabies series but did not follow up, just returned and wants to follow up with the series with no adverse event while receiving diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) and rabies (hdc) vaccine (Imovax Rabies).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-Feb-2022, the patient received once a day of dose 0.25 to 2 ml of suspect rabies (hdc) vaccine (strength, lot number, expiry date: unknown) via intramuscular route in the right deltoid; boostrix not produced by Sanofi Pasteur (strength, route, frequency, dose, administration site, lot number, expiry date: unknown) for immunization.  On 25-Feb-2022 the patient started the rabies series but did not follow up, just returned and wants to follow up with the series with no adverse event (inappropriate schedule of product administration) (Latency: same day).  Action taken was not applicable  Outcome 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.
Nurse states: While setting up the current station with supplies and equipment, I opened the caps of both the normal saline and Pfizer vials, wiped both tops using a different alcohol wipe and obtained a new 1mL syringe with 25g needle. 1mL of air was pulled back into the syringe and injected into the normal saline bottle. The normal saline bottle was then inverted upwards and 1mL of diluent was pulled back into the syringe and injected into the new vial of Pfizer. The same step was repeated a second time with 0.3mL of air injected into the normal saline bottle, 0.3mL of normal saline pulled back into syringe and injected into the vial of Pfizer. The vial was then inverted 10 times to ensure both the vaccine and saline was thoroughly mixed.   But nurse noticed when administering that she was short a number of doses that should have not been left over if vial was diluted correctly or the correct dosage was administered.
Mild edema with erythematous base irregular margins, warm slight tenderness no systemic manifestation i.e. no fever, no wheezs-tx'd as a cellulitis with Cephalexin and antipyretics.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was reported by the reporter.
Head pain on left side lasted 16 days after first shot; Pain in left neck to ear first shot; Pain in left neck to ear first shot; Swollen lymph nodes in neck. Swollen lymph nodes in upper right breast first shot; Upper back leg pain both legs; White pimple on tongue first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Feb2021 13:30 (Lot number: eLB8982) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 15Feb2021, outcome "recovered" (03Mar2021), described as "Head pain on left side lasted 16 days after first shot"; NECK PAIN (non-serious), EAR PAIN (non-serious) all with onset 15Feb2021, outcome "recovering" and all described as "Pain in left neck to ear first shot"; LYMPHADENOPATHY (non-serious) with onset 15Feb2021, outcome "recovering", described as "Swollen lymph nodes in neck. Swollen lymph nodes in upper right breast first shot"; PAIN IN EXTREMITY (non-serious) with onset 15Feb2021, outcome "recovering", described as "Upper back leg pain both legs"; ACNE (non-serious) with onset 15Feb2021, outcome "recovering", described as "White pimple on tongue first shot". Therapeutic measures were not taken as a result of headache, neck pain, ear pain, lymphadenopathy, pain in extremity, acne.  Additional information: The patient did not receive any other vaccines in four weeks. If Covid prior vaccination and covid tested post vaccination was reported as none.  No follow-up attempts are possible. No further information is expected.
Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. 48-hr follow up didn't identify AEs. Patient Patient received COVID vaccine on December 31
A report has been received from a health professional concerning a 43 year old, female patient. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient started receiving a treatment with nasal FLUMIST. On 10-Dec-2012, the patient reported that she got flu B after receiving the FLUMIST. The patient recovered from the event of flu B after receiving FLUMIST on an unspecified date. The report was considered to be non-serious by reporter.
1st dose Feb 2021 and 2nd dose administered on Feb 24 2021; a reaction on her legs/some problems on her leg; a reaction on her legs/some problems on her leg; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (a reaction on her legs/some problems on her leg), LIMB DISCOMFORT (a reaction on her legs/some problems on her leg) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Feb 2021 and 2nd dose administered on Feb 24 2021) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced IMMUNISATION REACTION (a reaction on her legs/some problems on her leg) and LIMB DISCOMFORT (a reaction on her legs/some problems on her leg). On 24-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Feb 2021 and 2nd dose administered on Feb 24 2021). At the time of the report, IMMUNISATION REACTION (a reaction on her legs/some problems on her leg), LIMB DISCOMFORT (a reaction on her legs/some problems on her leg) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Feb 2021 and 2nd dose administered on Feb 24 2021) outcome was unknown.            Patient's height was reported as 5'2 or 3". Patient had no history relating to adverse event and acute and chronic illnesses at the time of vaccination. Patient never had Covid test and diagnosis. Patient did not receive other vaccines within one month prior to Moderna vaccine. No concomitant medications were reported. Patient went to ER but was not hospitalized. Patient had some problems on leg last year which she thought was due to her age. Patient was told to drink plenty of water. Patient did not experience similar event in the past.   This case was linked to MOD-2022-648164 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 10:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "atopic dermatitis" (unspecified if ongoing). There were no concomitant medications in 2 weeks. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (15Jan2023) Positive, notes: tested positive on home test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Jan2023 to 11Jan2023 Clinical course: COVID-19 was back to normal and then 4 days after last Paxlovid dose developed mild runny nose and cough and tested positive on home test.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 (COMIRNATY) to the reported events drug ineffective and COVID-19 cannot be ruled out.
This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 28-DEC-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M039452 and expiration date 19-DEC-2017 (dose, frequency and route of administration were not provided) for prophylaxis. The reporter stated that the vaccine of ZOSTAVAX did not have any temperature excursions prior to administration. No adverse symptoms reported.
This infant had redness at the injection site on the day of the shot (08/16/01). Redness (9 1/2 x 9 1/2 cm) and swollen (5 1/2 x 5 1/2 cm) on 08/17/01. Told to give Tylenol, Benadryl, and Augmentin.
Her tongue was swollen and she was sticking it out for about two days then she was able to keep it in her mouth.
On friday i woke up with strong body odor this is not usual for me I thought it was strange but went along with my day. Around 4 pm i started to feel a strange sensation on top of my right foot I had walked 2 dogs and i thought maybe i injured myself. By 7:30 I started to feel full like I wasn't breathing comfortably so i propped 2 pillows to help . After that i laid to watch a movie when on top of my right food i started to feel like something was traveling on top it just didnt feel right i ignored it but then my left foot and right foot started to have like a muscle spasm very painful my i started to shake felt confused and shaky speech took Ibuphrophen  400 mg  everything started to subside fell asleep . Next day back to normal i didnt have pain in my legs no soreness.
sore arm; pink arm; vaccination site warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ERYTHEMA (pink arm) and VACCINATION SITE WARMTH (vaccination site warm) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029l20A.) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), ERYTHEMA (pink arm) and VACCINATION SITE WARMTH (vaccination site warm). At the time of the report, PAIN IN EXTREMITY (sore arm), ERYTHEMA (pink arm) and VACCINATION SITE WARMTH (vaccination site warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
This spontaneous report was received from an 82 year old female patient, reporting on herself. Patient's concurrent condition included high blood pressure. Medical history was not reported. Patient was allergic to VALTREX, penicillin and unspecified sulfa drugs. On 05-MAY-2009 the patient was vaccinated with 1 dose of ZOSTAVAX in the left arm. Concomitant therapies included SYNTHROID and unspecified blood pressure medication. On 15-AUG-2015 (also reported as years after getting the ZOSTAVAX vaccine), the patient developed shingles. Patient sought medical attention and was treated with VALTREX and acupuncture on an unspecified date. The outcome of event was unknown. Causality assessment was not provided. Additional information is not expected as the reporter did not wish further contact.
ACTHIB that was reconstituted with normal saline instead of the supplied ACTHIB diluent with no reported adverse event; Initial information received on 27-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient who was being administered Acthib that was reconstituted with normal saline instead of the supplied Acthib 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 7V (CRM197) (PREVNAR) for. Prophylactic vaccination  On 27-Jun-2022, the patient received a  0.5 ml dose of suspect HIB (PRP/T) VACCINE, (lot: UJ589AAA ; expiry date: 25-Oct-2022) once via intramuscular route on left leg  and it was reported that the patient was being administered Acthib that was reconstituted with normal saline instead of the supplied Acthib diluent with no reported adverse event (product preparation error) (latency: same day)   Action taken : not applicable.  Outcome: 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.
Child seemed to hold breath after 2nd vaccine - was picked up, then started crying - no prior rxn to any shots.
A report has been received from a Physician concerning a, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, Unknown. FLUMIST QUADRIVALENT started on an unknown date. It was reported that patient had been have receiving expired FLUMIST two weeks past the expiration date. The outcome of the event of expired FULMIST is unknown. The reporter's description of the event was as follows: none reported. The report was considered to be non-serious.
inject site rx, headache,dizziness,myalgia lasting 1 wk.No Tx given.
Fever[104.1F],Numbness, Dizziness, Nausea, incapacity to walk, stand or perform any activity for 5 days.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2022 at 12:00 as dose number unknown, single (Lot number: FL3197) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. There were no concomitant medications.The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Swelling of axillary area Left side; swelling of lymph tissue under L arm and around L breast; tenderness and pain Left axillary/ lymph area; redness, swelling, pain around injection site also.
Client stated to nurse that she felt dizzy, had a funny taste in her mouth and her heart was racing.   Blood pressure and pulse were elevated & taken 2 times.  EMS called and responded.   They took her blood pressure and pulse and both had come down.  The client stated to EMS that she was afraid of the shot after side effects had been explained to her.  She declined ER and was allowed to leave.
Pt developed urticarial rash throughout body and face approximately 12 hrs after vaccination. Treated with Benadryl. No respiratory component noted. No vomiting no fever.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates the patients, were vaccinated with unspecified number of doses of improperly stored ROTATEQ lot# reported as L035637 with expiration date: 09-JUN-2017, orally (dose was not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
About 5 or 6 that night, I was nauseous; had body aches, dizziness, horrible headache. I took Tylenol, Emer-Gen C packet; water. 02:00 am - sweating profusely and 102.7 temperature - The next morning, I called:   Providence Employee Health Dr  - my temp was hovering over 103 even with Tylenol. They called in a COVID swab - 11:00 -01:00 on the 20th I got swabbed (I had to wait until I wasn't dizzy). I was pretty sick for two or three days. I was generally exhausted for about a week. I drank Emer-Gen C packet; water and rested.
Mother noticed Friday afternoon redness, swelling, heat, & itching to (L) upper arm. Mother put ice pack to site and gave client TYLENOL and BENADRYL. Today site is 1 in x 1 in with minimal swelling and mild tenderness noted. Instructed to given warm compresses to site/TYLENOL for pain verbalizes understanding.
On or about 4 hrs after Administration, generalized flush red coloring all over body, itching and swelling in face. Administered EpiPen autoinjector and symptoms subsided. Fever remained between 101-103F as of this writing.
After receiving  the Moderna COVID-19 booster at 11:15am on 10/24/21, she felt normal until 10pm that evening.  The she was chilling slightly, headache and general body aches.  On 10/25/21, at around 10am, she became short of breath and experienced pain in her left side.  She measured her O2 and was a 94; after using some auxilary oxygen (her husband's machine) at 3 liters, she reached 97.  General malaise continued and at approximately 8pm, she suddenly collapsed and died.
After Flu shot, I have had constant pain in my upper arm. Shot appeared to have been given too high up in the arm. 24 hours a day, it's painful, unable to use my full range of motion and I wake up several times at night in pain.
pt recv vax 12AUG97 & 19AUG97 pt exp rash described as small pimples all over body;f/u info reported that pt exp was not r/t vax;