chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no adverse evevnt; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked to cases 2023SA054981(CLUSTER) and 2023SA057733(CLUSTER).   This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c (clesius) and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine, Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.; Sender's Comments:  SAD20230220001440:Identification number of the report SAD20230216001803:Identification number of the report
approx 4.5 hours post vacc pt presents with moderate sized welps (4-5) on left forearm and c/0 itching.  Pt assessed for and BP elevated to  160-180/100-120. No other adverse s/sx present, reported or visible. Pt assessed by Dr. Pt given 10 mg Zyrtec and observed 45 minutes. BP reduced to 140/100 and decrease in itching but welps remained unchanged. Dr. recc to see PCP next day for HTN eval.  Pt reports she did go to PCP for HTN eval next day. No further adverse reaction reported.
Stroke on August 13th, left cerebral cortex, right side paralysis. Unable to speak and move his entire right side.
Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Feb2021 at 14:45 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer from an unknown date in 2005 and allergy to penicillin and sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and Vitamin (MANUFACTURER UNKNOWN); all for an unspecified indication from unknown date and unknown if ongoing. On 22Feb2021 monday at 02:30, the patient woke up with vertigo which she never had before. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vertigo was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
p/vax pt had local rxn @ inj site;had 6.5 x 5 cm red to inj;seen in office;also very irritable 1 1/2 to 2 days later;afeb;
Screaming PM & night following DTP could only console 20-25 min @ a time; APAP given pt improved by next AM & no further problems;
Pain; Rash all over body (both arms and her chest)/developed a rash, which started on the arm opposite of the injection arm, it spread down that arm, across chest, under breasts and to the other arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team.  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (booster); unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown"; RASH (non-serious), outcome "unknown", described as "Rash all over her body (both arms and her chest)/developed a rash, which started on the arm opposite of the injection arm, it spread down that arm, across her chest, under her breasts and to the other arm". The events "rash all over her body (both arms and her chest)/developed a rash, which started on the arm opposite of the injection arm, it spread down that arm, across her chest, under her breasts and to the other arm" required physician office visit.  Additional information: The reporter was calling on behalf of his girlfriend (patient) and stated that they both received the second booster. Received the 2nd booster dose of the Pfizer-BioNTech Covid 19 Vaccine and has a rash all over her body (both arms and her chest) ever since she received the vaccine. He stated that her girlfriend was in pain. Within 24 hours, the patient developed a rash, which started on the arm opposite of the injection arm, it spread down that arm, across her chest, under her breasts and to the other arm. She has seen several doctors and they were only discussing this as a treatment. The doctors did have concerns about prescribing Prednisone, and that it might prevent the effectiveness of the vaccine. The reported wanted detailed information, in order to relief the pain that patient was having due to the vaccine. Reporter also wanted to know if the efficacy of the vaccine could be affected if her girlfriend takes Prednisone as a treatment for rashes. The patient has not taken Prednisone yet, has not been prescribed, or has not got a prescription for Prednisone. Other Conditions and investigation were not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient received Tenivac intravenously in error with no adverse event; Initial information received on 07-Jun-2021 regarding an unsolicited valid  non-serious case from a pharmacist and physician.  This case involves a 27 years old female patient who was vaccinated with 0.5 ml dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (once, total, lot number:C5779AA, expiration Date :02-Oct-2022) via intravenously in error  in an unknown administration site for prophylactic vaccination on 07-Jun-2021 (incorrect route of product administration).    The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided.  No concomitant medication was given to the patient.   It was an actual medication error due to inappropriate route of vaccination (same day latency).  It was reported that a Pharmacist wanting to know any information with administering Tenivac intravenously due to having a medical student pushing the vaccine through a peripheral intravenous site and the clinic was calling the manufacturer for guidance.   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.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses. Expiration date was reported as 09-Nov-2021.  Dates of administration of vaccine were reported as 10-Nov-2021 and 11-Nov-2021.  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up recieved contains non-significant information.
Scab on my skin at the vaccination sight; This is a spontaneous report from a contactable consumer, the patient (non-pregnant patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in right arm on 29Jan2021, at 12:30, as unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had sulfur allergy. The patient stated that, she experienced scab on her skin at the vaccination sight on 02Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test on an unspecified date in 2021, with unknown results. It was also stated that, prior to vaccination, the patient was not diagnosed with COVID-19. No treatment was received for the event. The seriousness criteria was reported as non-serious for the event. The outcome of the event was unknown.  Follow-up attempts have been completed and no further information is expected.
This case was reported by a healthcare professional and described the occurrence of headache in a 38-year-old female subject who was vaccinated with FLUARIX, (GlaxoSmithKline).  On an unspecified date, the subject received a dose of FLUARIX (unknown, unknown arm).  Twelve hours after vaccination with FLUARIX, the subject experienced headache and slight temperature.  The subject who in also a nurse, experienced headaches and a temperature of 101 degrees 12 hours post vaccination with FLUARIX.  The events resolved approximately 24 hours later.  The subject stated "this had occurred four or five times over the past 10 years.  She stated due to this experienced there have been years where she has skipped getting the flu shot, however, when she gets the injection again, she experienced the same events.  She is unsure if the flu vaccine she has always received is FLUARIX".  At the time of reporting the events were resolved.  The healthcare professional considered the events were probably related to vaccination with FLUARIX.
SWOLLEN TONGUE, WHEN TO EMERGENCY ROOM GIVEN MEDICATION DISCHARGE AFTER 3 HRS, SEND HOME WITH MEDICATION.
Pt recvd DTP/OPV 18JUL91 & immediately following vax leg turned very red, pt screamed & could not be calmed, sweated profusely & turned pasty white left clinic about 30min later, pt had calmed down & begun to be pink again; appeared ok;
She developed low grade fever and headache the evening after vaccination. The next day had macular red, itchy rash on medial aspect of lateral arm. Non pruritic, not elevated. Seen in office 2 days later; no swelling at injection site but rash distinct in Right upper arm; medial side.
Fever that broke Friday night / Feverish again Saturday afternoon; Swollen lymph node in armpit of the arm that got the injection (left) on Saturday; This is a spontaneous report from a contactable consumer. This consumer reported for a 44-year-old female patient that:  A 44-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in left arm on 28Oct2021 11:00 as dose 3 (booster), single for COVID-19 immunisation. Medical history included asthma. Patient known allergies was unknown. The patient's concomitant medications were not reported. If other vaccine in four weeks and other medications in two weeks reported as unknown. If covid prior vaccination and if covid tested post vaccination reported as unknown. Patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on unspecified date as dose 1, single and second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on unspecified date as dose 2, single for COVID-19 immunization. On 29Oct2021 patient experienced fever that broke Friday night. Swollen lymph node in armpit of the arm that got the injection (left) on Saturday. Feverish again Saturday afternoon. It was unknown if patient received treatment for the events. Awareness Date: 30Oct2021. Outcome of events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient had COVID infection in 12/2020. Had 1st moderna vaccine 1/31/21. developed new headaches 2/12/21. 2nd dose of moderna COVID vaccine on 2/25/21. on 3/18/21 admitted to the hospital with right sided weakness, expressive aphasia, left gaze preference and right hemineglect found to have a left posterior parietal intracranial hemorrhage with vasogenic edema and extensive venous sinus clot involving the superior sagittal sinus, bilateral transvere sinsu and sigmoid sinus to the level of the jugular veins. He stabilized and was airlifted from one place to another to have hospice care.
Extreme arm pain, including shoulder, neck, back, no use of arm, numbness of hands,  Flu-like symptoms, including fever, chills shakiness of legs, to the point that I can't walk
A few days after mederma booster, developed severe pain in L shoulder, upper back, cervical. I had done some yard work, enogh to be a little sore, but nothing like this. This is  stabbing, make you wince and stop what you're doing and grab your arm, shoulder, whatever pain. I've been doing rehab for 26 years, this is the kind of pain you know exactly what caused it, so i suspect the booster may have exacerbated / increased the severity of the symptoms. I have seen a chiropractor, spasms were enough to pull 2 ribs out, seeing him again tomorrow, 11/19/2021. I have had to cut down on my schedule at work significantly becasue of the pain. It's slowly improving, but has been stuck at current level, about a 3 to 7 depend on movement.  may see PT depending on how next adjustment goes.
I have a mass on the inner arm, about the size of a fist; It's painful and not going away; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Feb2021 12:00 (Batch/Lot number: unknown) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Hip surgery" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 20Jan2021, when the patient was 75 years old, for COVID-19 Immunization. The following information was reported: AXILLARY MASS (disability, medically significant) with onset 08Feb2021 14:00, outcome "not recovered", described as "I have a mass on the inner arm, about the size of a fist"; PAIN IN EXTREMITY (disability) with onset 08Feb2021 14:00, outcome "not recovered", described as "It's painful and not going away". The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (08Feb2021) mass on the inner arm, about the size of a fist; sars-cov-2 test: (30Apr2021) negative. Therapeutic measures were not taken as a result of axillary mass, pain in extremity. The lot number for bnt162b2 was not provided and will be requested during follow up.
Narrative: Patient reported mild lightheadedness following administration of 1st dose of Pfizer Covid vaccine. Patient was released without any intervention needed.
My resting heart rate is usually in the upper 70's/low 80's but has been in low 60's and 50's and upper 40's since the vaccine.
My sister took a flu shot, then took a Moderna shot after and she got sick.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (My sister took a flu shot, then took a Moderna shot after and she got sick.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (My sister took a flu shot, then took a Moderna shot after and she got sick.). At the time of the report, ILLNESS (My sister took a flu shot, then took a Moderna shot after and she got sick.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information provided. No treatment information provided.
vaccines were warm to touch with ice packs melted; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-OCT-2022 Reporter's comment: The pharmacist had called to inquire on how to proceed with the vaccine. The pharmacist had stated that they had received a Flulaval delivery and vaccines were warm to touch with ice packs melted. Another Pharmacist had placed the vaccines into quarantine. Afterwards, three patients were administered the vaccines by another Healthcare Professional (HCP) in their facility. One patient was administered on 21 October 2022, one patient on 22 October 2022 and last patient on 27 October 2022. The pharmacist was unable to provide any additional details. The reporter did not consent to follow-up. Additional supportive information: At the time of reporting, the Flulaval Quadrivalent vaccine was not stored as per the recommended storage condition, which had led to incorrect storage of drug. This was one of the case reported amongst the three patients.; Sender's Comments:  US-GSK-US2022157187:same reporter US-GSK-US2022157186:same reporter
Information has been received from an unspecified healthcare worker from a physician's office, via a company representative, referring to a patient of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of hepatitis  A  vaccine, inactivated (manufacturer unknown) (dosage, route and lot # not specified). It was reported that the patient was administered the vaccine, then went home and went to sleep and did not wake up. The patient was taken to the emergency room and was found to be opiate positive (it was unspecified what kind of tests were performed). The outcome of the events was unknown. Upon internal review, the event of "went to sleep and did not wake up" was considered to be medically significant. Additional information is not expected because we are not allowed to contact the physician.
Moderna vaccine was given beyond the manufacturer recommended use time of 30 days at the refrigerated temperature.
Mild headache began within five minutes of receiving vaccine, which worsened until dissipating at around 9 pm. At around 1 am spiked a fever; at 11 pm it was 97.5 (which is normal); it peaked at 7 am at 101.4. Chills until the morning of the 17th.  Fever between 100.0 - 101.0 continued until the morning of the 18th. Body aches all day on the 17th and morning of the 18th. Severe headache with migraine-like symptoms all day on the 17th and into the morning of the 18th (throbbing, sensitivity to light and sound). Nausea all day on the 17th, which culminated in vomiting (once) around 9 pm on the 17th. Nausea dissipated after vomiting.
(L)/SQ "allergy" nausea, sore at site, trash swelling with MMR/SQ "throat feels congested" fever 101.0 degrees.
Blisters on the head, mainly on the scalp area. Small areas appeared shortly after first shot, but became widespread across the scalp on the next day after the second shot .  This has continued since then with areas or individual blisters appearing on the scalp, neck and hairline of forehead. Very painful to touch and filled with puss like a large pimple.
Within hours of injection-pain at injection site, erythema, sweats, and a low grade fever. Diphenhydramine 25 mg TID, prednisone 40 mg once.
Had a horrible red rash down my left arm and felt sick for several days then I miscarried.
Next day sore arm and numb. Unable to lift arm above head. Shortness of breath. Tightness in chest. Headache.
Red, hard, itchy patch developed at injection site approximately 1.25" x 2.5".