chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered pharmacist concerning a 6 year old patient who was vaccinated with a dose of ZOSTAVAX (Merck) instead of VARIVAX (Merck). This happened within the past 24 hours at a hospital physician unknown. No adverse effects known. The pharmacist was not aware it was product confusion. The grandmother indicated human error. Unspecified medical attention was sought. No product quality complaint was involved. This is one of several reports received from the same source. No further information is available.
TIRED; This spontaneous report received from a parent concerned a 25 year old. 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) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 31-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210424198.
Pt recvd vax on 11JUN92 & on 12JUN92 pt devel a vaginal yeast infect & fever blisters on lips given 2nd dose of vax & exp small blister on lip;
redness, warmth, swelling, & induration of anterior thigh; lt thigh (site of DTP) 6cm diameter erythema; rt thigh site of HIB 3 cm diameter erythema;
Headache, Myalgia & UrticariaPruritus Narrative:  headache migraine, both legs aches and right arm radiating/shooting pain persisting since 2/15/22, was seen by PCP and been to urgent care x2. h/o migraine
Mom contacted clinic by telephone and stated patient c/o itching all over and she noticed rash to body. Mom was instructed to take patient to ER and voiced understanding. This clinic follow up with mom and she stated she called 911 and EMT(s) came to home and administered BENADRYL. Mom stated itching stopped and rash was better. Patient was scheduled an appointment with Dr. on 5/9/2018 for rash to body and to rule / rule out adverse reaction.
I had pain and inflammation in my arm at the injection site. It was red and swollen. I had joint pain that is still ongoing for a year now. I have been to my doctor about this. They have done x-rays and blood work on me.
Information has been received from a nurse referring to a patient of unknown age and gender. No relevant medical or historical conditions were reported. On 12-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), 0.5 ml, subcutaneously (lot# L010143, expiration date 24-SEP-2016), which was exposed to -10 Degree Celsius for 14 hours. No adverse effects were reported. Additional information has been requested.
Tingling from left knee down to leg; Didn't feel well; Taste was off; Didn't feel like eating; Feet and toes turned black and blue; Lemonade smelled like gas; Lemonade tested like it sat for a month; Blueberries tasted like mold; acute iron deficiency; Had fever of 104 F that back down to 99 F; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling from left knee down to leg), MALAISE (Didn't feel well), AGEUSIA (Taste was off), DECREASED APPETITE (Didn't feel like eating) and SKIN DISCOLOURATION (Feet and toes turned black and blue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart valve disorders.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling from left knee down to leg), MALAISE (Didn't feel well), AGEUSIA (Taste was off), DECREASED APPETITE (Didn't feel like eating), SKIN DISCOLOURATION (Feet and toes turned black and blue), PAROSMIA (Lemonade smelled like gas), TASTE DISORDER (Lemonade tested like it sat for a month), TASTE DISORDER (Blueberries tasted like mold), IRON DEFICIENCY (acute iron deficiency) and PYREXIA (Had fever of 104 F that back down to 99 F). At the time of the report, PARAESTHESIA (Tingling from left knee down to leg), MALAISE (Didn't feel well), AGEUSIA (Taste was off), DECREASED APPETITE (Didn't feel like eating), SKIN DISCOLOURATION (Feet and toes turned black and blue), PAROSMIA (Lemonade smelled like gas), TASTE DISORDER (Lemonade tested like it sat for a month), TASTE DISORDER (Blueberries tasted like mold), IRON DEFICIENCY (acute iron deficiency) and PYREXIA (Had fever of 104 F that back down to 99 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 104 (High) Had fever of 104 F that back down to 99 F.         No treatment medication were provided. No concomitant medication information was provided. Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient visited to the ER on 30-MAR-2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-065283 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Significant Follow up Appended - New event added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065283:1st dose case
Noticed the injection site became very red, warm to the touch, swollen with pain described burning and aching. Had hot flashes. Symptoms started approximately 3 hours after vaccination and continued through night. Feelings of warmth have subsided at time of report 0930 following day, but all other symptoms continue.
felt faint; fever; sick; This case was reported by a consumer via call center representative and described the occurrence of felt faint in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced felt faint, fever and sickness. On an unknown date, the outcome of the felt faint, fever and sickness were unknown.   It was unknown if the reporter considered the felt faint, fever and sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix recently and experienced fever, felt faint and was sick. The reporter did not had any further details.  The reporter did not consent to follow up. This case has been linked with case US2019104323, reported by the same reporter.
Fever of over 100 F all day. As high as 102.5 F responded to Tylenol  Vomiting
Fatigue; Bodyaches; This is a spontaneous report from a contactable nurse (patient himself).  A 24-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL0142; Expiration Date: Mar2021), dose 2 intramuscular, administered in Deltoid Left on 11Jan2021 18:50 (age at vaccination:24-Year-old) as DOSE 2, 0.3 ML SINGLE for covid-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date: Mar2021), intramuscular in the left arm on 21Dec2020 18:45 at 0.3 ml, single, for COVID-19 immunization and then he experienced Left arm soreness on 22Dec2020 12:00 and Left supraclavicular lymphadenopathy on 25Dec2020. Left arm soreness was Recovered on 27Dec2020 and Left supraclavicular lymphadenopathy was ongoing. Patient's family medical history included grandparents of vaccine recipient both suffered from lymphoma later in life (more than 60-year-old). Concomitant medications were not reported. No Vaccination administered at military facility. Vaccination facility Type was Hospital. On 12Jan2021 08:00, The patient experienced non serious fatigue body aches. He underwent lab tests and procedures which included CBC, CMP, DIFF which result was negative abnormalities on an unknown date in 2019. No treatment was received for the adverse event fatigue body aches. Outcome of event fatigue and body aches was recovered on 13Jan2021.  The casual relationship ((Covid-19 virus vaccine, EL0142 Mar2021) was reported as yes. Information on the lot/batch number is requested. Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Soreness at site of injection; headache; This is a spontaneous report from a non-contactable consumer. A 29-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration on 27Mar2021 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported.  On an unspecified date in Mar2021, the patient experienced soreness at site of injection and headache. The patient did not receive any treatment for the reported events. The clinical outcome of the soreness at site of injection and headache were recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Injection was in right arm.  Rash on right temple.  Itching on right arm, right trunk, right thigh.  Bleeding on right thigh and in right groin.   Red spots on right arm.   Smeared sites of itching with Mometasone Furoate cream, which stopped with itching.  Some bleeding in the groin still occurs
mom states fever over 105, seen by PMD in the ped office late noc clinic 4NOV98;
Donor reported pain in her right arm related to her 2nd Rabies immunization given on 02/16/19.  Pain began off-site about 4 hours post vaccination at the injection site and slowly radiated up and down the right arm and into the right side of the donor's neck. Donor took a one-time dose of 800 mg Ibuprofen.  Donor reported that 3-4 hours later the pain had decreased.  As of 2/25/19, donor had mild tenderness in the upper right arm upon palpation.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. Medical history and concurrent were not provided. On an unknown date, the patient was vaccinated with a stored improperly dose of VARIVAX (Merck) (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one o several reports received from the same reporter. Additional information has been requested.
devel bumpy red rash on abd 3SEP96 c/o itching @ rash site;no fever or other sx;advised to check w/PMD;5SEP96 TC to f/u rash remains;no other sx;no PMD contact;
Patient reported soreness in the arm continuing for over 3 weeks after receiving Afluria immunization.  He has noticed significant weakening in the right arm, and pain when lifted laterally.
Pt reports having vivid nightmares, which had disrupted her sleep.  This is not a normal occurance.
Patient developed a seizure without fever consisting of one sided arm and leg shaking with staring and head turning to same side for 1-2 minutes.  This was followed by 10 minutes of poor balance on sitting/weakness on that side.  This occurred the night after the patient received DTaP, HiB, PCV, IPV, HepB vaccines.
Initial report received from healthcare professional on 26 Jan 2010: This patients with unknown medical history was vaccinated with FLUVIRIN (batch no. 103136P1), IM on 25 Jan 2010 and then inadvertent received one 0.25ml dose of sanofi H1N1 (batch no. UP066AA) on the same day. The reporter was reported no adverse reaction had occurred.
Received Varicella Vaccine on 7-1-2002. Adverse reaction ? grand mal sz on 7-15-2002. Taken to ER in hospital where I worked. 9-11-2002 apparently "less severe" sz ? at home - unwitneesed - undetermined if seizure activity. Taken to ER for follow-up.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included allergic reaction. Previously administered products included shingles vaccine. On 10th August 2018, the patient received the 1st dose of Shingrix 50 mcg/mg. In August 2018, less than a week after receiving Shingrix, the patient experienced headache, pain, varicella-like rash, swelling arm, sickness, pruritus and injected limb mobility decreased. On an unknown date, the outcome of the headache, pain, varicella-like rash, swelling arm, sickness, pruritus and injected limb mobility decreased were unknown. It was unknown if the reporter considered the headache, pain, varicella-like rash, swelling arm, sickness, pruritus and injected limb mobility decreased to be related to Shingrix. Additional details were provided as follows: The caller noted she had the previous shingles vaccine on the market a few years back. The caller reported she had a history of allergic reactions and that was expressed to the pharmacist, but the pharmacist insisted and gave her the first shingrix shot last Friday from the reporting date. She calls the day of reporting the events noted above, feeling like she could have died from them. She noted the bumps were fine and located on her arm and appeared like chicken pox. She stated she was taking a medication for the headache but she continued to experience all the events. The description section of the prescribing information was reviewed with the caller and it was also being mailed to her. The healthcare professional note asked as caller hung-up abruptly. The caller was upset GlaxoSmithKline could not provide any recommendation on treatment. The caller was referred to her physician and medical advice statement given.
a low grade fever; Headache; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 22Feb2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus and covid-19.  The patient's concomitant medications were not reported.  After receiving the vaccine, he got a low-grade fever and a headache on 23Feb2021. No treatment was received. Patient was recovered from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1.  Tingling in left ring finger immediately 2. Left arm burning and soreness starting at injection site and traveling down arm worse within 48 hours with continued pain left arm with on and off altered sensation left ring finger currently (3 weeks post injection) 3. Early fatigue left arm 4. Significant body/bone aches for 6 days
Tingling in ears and extremities, heart was racing, tickle in throat, dizzy, short of breath, nauseous
Pt had dt booster left deltoid - experienced slight fever, malaise, localized reaction with erythema and cellulitis. Had chest pain with negative EKG. Pt had had (she thinks) 3 dt's in about 5 years? No SOB or anaphlactic reaction.
I contracted COVID-19 on 06/07/2022 with symptoms of congestion, sore throat, cough, loss of smell, vomiting, headache, fatigue, myalgia, and chills. I was not prescribed any medications or offered monoclonal antibodies. I was ill for 9 days before my symptoms began to resolve. I have fully recovered with no lingering symptoms.
vaccines that are administered but have been deemed not suitable for use. the vaccines were on the truck on Thursday but didn't arrive to them until around 11 AM / No AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.   This case is linked to cases 2019SA267341, 2019SA267342, 2019SA267344, 2019SA267336 and 2019SA267346 same reporter.  This case involves 60 years male patient who received 0.5mL dose of vaccines INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot UJ223AA, expiry-30-06-2020) via intramuscular route in the left deltoid but have been deemed not suitable for use.  It was a case of actual medication error due to incorrect product storage. Caller is saying the vaccines were on the truck on Thursday but didn't arrive to them until around 11 AM but they did not hear until late in the day not to use them stating they received a message around 4:20 PM. Caller states as soon as they arrived she started giving injections and feels they should have been told earlier in the day that the vaccines shouldn't have been given.  At the time of report no adverse event was reported.  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 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.  Documents held by sender: none.
This spontaneous report was received from a certified medical assistant (CMA) and refers to an unspecified number of unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients may have received doses of improperly stored doses of PEDVAXHIB lot # M001814, expiry date: 15-OCT-2018 (route of administration was not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
12MAY94 pt to MD skin test read; mom states pts leg is red from the inject; rt post thigh w/central area pallor & induration surrounded by warm/red flare; prob sterile abscess;
Pt should have received second dose pfizer covid vaccine but instead recieved  moderna second dose.   Pt was notified of  event and was observed for 15 mins without adverse reaction  noted.
Pt cried unconsolaby for 4 hrs beginning 1 1/2 hrs after DPT. It was not particularly high pitched but not your normal fussy cry, (per Mom).
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and drug reactions or allergies was provided. On 24-APR-2017, the patient was vaccinated with improperly stored dose of PROQUAD injection, lot # M042498 with expiration date 17-APR-2018, therapy type: human recombinant albumin (RHA) (dose and route of administration were not reported) reconstituted with properly stored sterile diluent (manufacturer unknown). Temperature excursion ranged from minus 14 to minus 10 degrees Celsius for 15 minutes and to 27 degrees Celsius for 30 minutes. There was no previous excursion. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA013407: US-009507513-1710USA013408: US-009507513-1710USA007631.
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317376 (same reporter).  This case involves a 61 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
My Lumbar spine (right L-2 and L-3) has bulging disk and (left L-4, L5, and S1) problems, as well.; I could not walk, stand, nor sleep.; I could not walk, stand, nor sleep.; I could not walk, stand, nor sleep.; BOOSTER; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Oct2021 16:00 (Lot number: FH8020) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm, administration date 15Oct2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "degenerative disc - discectomy in 2018" (unspecified if ongoing); "degenerative disc - discectomy in 2018", start date: 2018 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Asprin, reaction(s): "allergies". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11Mar2021, when the patient was 58 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 01Apr2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: On 23Oct2021 12:00, her Lumbar spine (right L-2 and L-3) has bulging disk and (left L-4, L5, and S1) problems, as well. She could not walk, stand, nor sleep. The patient was Hospitalized for the events (hospitalization duration: 7 days) (Hospitalized for 2 weeks was also reported, pending clarify). The events were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of events included Steroid injections into all L discs involved. Outcome of events was Recovered with Sequel.   Follow-up attempts are completed. No further information is expected.
A bit sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 14-Feb-2023 Reporter's comment: The case was received form the patient via interactive digital media. The patient got his/her first shot Friday and experienced a bit sore but better then if he/she had shingles. Additional supportive information: The follow-up could not be possible as no contact details were available.
The first and second day I had pain in the arm, muscle aches. This morning, which is the third day I had red urine.