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.
muscle pain; generalized pain in left side of body mainly; doesn't allow her to walk or move; second dose on March 28th, 14 days after first dose; second dose on March 28th, 14 days after first dose; This is a spontaneous report from a non-contactable consumer (patient) reported for herself. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 28Mar2021 at single dose for COVID-19 immunisation. She previously received the first dose on 14Mar2021 for COVID-19 immunisation and experienced injection site pain. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient called in requesting information about the symptoms she experienced post second dose administration of Pfizer's COVID-19 vaccine. She received the first dose on 14Mar2021 and second dose on 28Mar2021, 14 days after first dose. She only had injection site pain after vaccine first dose. After second dose she had muscle pain and generalized pain in left side of body mainly, described as deep pain that doesn't allow her to walk or move. She hasn't been able to communicate with physician. Events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pharmaceutical product complaint; Swelling in foot; Low grade fever; Swelling in arm; arm being painful/Aching; This case was reported by a pharmacist via call center representative and described the occurrence of swelling of feet in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number K9L3M, expiry date 29th October 2021) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st August 2019, 1 days after receiving Shingrix, the patient experienced swelling of feet, low grade fever, swelling arm and pain in arm. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the swelling of feet, low grade fever, swelling arm and pain in arm were recovering/resolving and the outcome of the pharmaceutical product complaint was unknown.   It was unknown if the reporter considered the swelling of feet, low grade fever, swelling arm and pain in arm to be related to Shingrix.  Additional details were provided as follows: The pharmacist on the line reporting that the patient received Shingrix and had swelling in her foot on the same side of the body as the site of injection, low grade fever, and the arm being painful, swollen, and aching.  The events were improving when she spoke to her two days ago, but unknown if they had resolved.  The reporter consented to follow up. The reporter stated that three patients reported side effects after receiving this batch number. Product quality complaint (PQC) was filed for this reason.
Mother states client broke out into hives on 1/22/05. She still had hives on 01/31/05 so she took her to the doctor and he said it was from the FluMist. Client seen by Dr.
11/04/21 presents to ED "shortness of breath and cough. Checked her pulse ox at home and it was in the low 80s. She had some chills but did not check her temperature". PMHx "severe COPD, chronic respiratory failure" "CAD, seizure disorder, bipolar disorder, adenocarcinoma of the lung".
Emesis; Loose stools; Extended menstrual cycle; Nausea; Dizziness; Very nervous; Itching at the injection site; Redness at the injection site; This is a spontaneous report received from a contactable reporter (nurse). The reporter is the patient.  A 32-year-old female patient (unknown if pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 18Nov2021 at 20:00 (Batch/Lot number: unknown) at the age of 32 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Asthma"; "Allergic rhinitis"; "Fruit allergy", notes: Known allergies: Kiwi, olives; "Food allergy", notes: Known allergies: Coconut and "Penicillin allergy", notes: Known Allergies: Penicillin. Concomitant medications included: ZYRTEC; ALBUTEROL and MELATONIN.  The following information was reported: NAUSEA (non-serious) with onset 18Nov2021 at 20:15, outcome "recovered with sequelae" (an unknown date in Nov2021), described as "Nausea"; DIZZINESS (non-serious) with onset 18Nov2021 at 20:15, outcome "recovered with sequelae" (an unknown date in Nov2021), described as "Dizziness"; VOMITING (non-serious) with onset 19Nov2021 at 08:00, outcome "recovered with sequelae" (an unknown date in Nov2021), described as "Emesis"; DIARRHOEA (non-serious) with onset 19Nov2021 at 08:00, outcome "recovered with sequelae" (an unknown date in Nov2021), described as "Loose stools"; VACCINATION SITE PRURITUS (non-serious) with onset 18Nov2021, outcome "recovered with sequelae" (28Nov2021), described as "Itching at the injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 18Nov2021, outcome "recovered with sequelae" (28Nov2021), described as "Redness at the injection site"; OLIGOMENORRHOEA (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Extended menstrual cycle"; NERVOUSNESS (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Very nervous". The events "Nausea", "Dizziness", "Emesis", "Loose stools", "Itching at the injection site", "Redness at the injection site", "Extended menstrual cycle" and "Very nervous" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pruritus and vaccination site erythema which included PREDNISONE oral tablet x 5 days with relief noted/BENADRYL over the counter (OTC).  Additional Information: Latency of the events nausea and dizziness was 15 minutes and for the events of emesis and loose stools was 12 hours. The patient felt improvement after day 12. The event of nausea was intermitted for approximately 8 days. The events of itching and redness at the injection site (lasted 10 days) and had a bullseye like appearance. The second dose was due 12/9 hence the patient was very nervous about it. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Pt's mother called about seizure-like activity on 3/18/02. The pt was seen at ER and admitted to the hospital for further work-up. The pt was afebrile then.
PATIENT DEVELOPED A RASH ON TRUNK OF BODY AND ARMS THE NEXT DAY FOLLOWING VACCINATION
Patient experienced rash and swelling of upper arm within 2 hours of receiving flu shot. Patient stated that she gets flu vaccine yearly and always has this reaction.
polyarthralgias & myalgias starting about 6 hours after receiving Zostavax
Loud ringing in ears within 30 minutes of 2nd dose; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 19Mar2021 at 11:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 26Feb2021 at 13:00 (at the age of 67-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 19Mar2021 at 12:30, the patient experienced loud ringing in ears within 30 minutes of second dose. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event loud ringing in ears within 30 minutes of second dose was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
flared up; itchy; pain; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE INFLAMMATION (flared up), INJECTION SITE PRURITUS (itchy) and INJECTION SITE PAIN (pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 14-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itchy) and INJECTION SITE PAIN (pain). On an unknown date, the patient experienced INJECTION SITE INFLAMMATION (flared up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE INFLAMMATION (flared up), INJECTION SITE PRURITUS (itchy) and INJECTION SITE PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   The treatment information provided includes Paracetamol.
Developed Bell's palsy, was treated with prednisone and valtrex, almost completely resolved by 3/24/2021, he had previously when he was 15 or 16 years of age with complete resolution, was told at that time that it may recur, given over one month  doubt if from the vaccine but wanted to report since may be important in data collection
NO ADVERSE EVENT - ONLY VACCINE ADMINISTRATION DEVIATION. Administrator named provided what was believed to be the 1st dose of an mRNA COVID-19 (Pfizer) vaccine when it was reveled to them after the fact that the Pt received a first dose of a different mRNA COVID-19 vaccine (Moderna), months prior. The administrator named was not able to locate any information for the 1st dose in the COVID Vaccine Management System or any health records.
Patient given expired medication, manufacturer contacted, vaccine maintained the activity necessary to protect against Covid-19 virus at time of administration.
Information has been received from a registered nurse concerning an 8 year old female who on 28-FEB-2000 was vaccinated with a dose of Varivax. On 06-JUN-2006 the patient developed breakthrough chickenpox. Medical attention was sought. The patient's outcome was not reported. The patient's vaccination history included: A first, second, third fourth and fifth dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown on 20-JUL-1998, 21-OCT-1998, 12-AUG-1999, 13-NOV-1999, and 03-JUN-2003, respectively; a first, second, and third dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown) on 23-MAY-1998, 20-JUL-1998, and 18-JAN-1999, respectively; a first, second and third dose of Hib vaccine (unspecified) (manufacturer unknown) on 20-JUL-1998, 21-OCT-1998 and 28-FEB-2000, respectively; a first, second, third and fourth dose of poliovirus vaccine inactivated (unspecified) (manufacturer unknown) on 20-JUL-1998, 21-OCT-1998, 12-AUG-1999, and 03-JUN-2003, respectively; and a first and second dose of MMR on 12-AUG-1999 and 03-JUN-2003 respectively. Additional information has been requested.
Initial report received from a health care professional on 07 June 2011. An 11-year-old male patient, with an allergy to peanuts, received a left deltoid intramuscular injection of ADACEL, sanofi pasteur Ltd. lot number C3519AA and a right deltoid injection of MENACTRA, sanofi pasteur Inc. lot number U3556AA, on 02 June 2011. The patient took no concomitant medications, had no illnesses at the time of vaccination and had no other vaccines within 4 weeks. On 04 June 2011, the patient developed redness and swelling at the left injection site. He was evaluated at a clinic and prescribed BENADRYL and KEFLEX. The outcome was reported as recovered. Documents held by sender: None.
9 days after my first dose I became extremely nauseous while exercising and had to stop and rest for 30 minutes. That?s never happened before. That evening I developed a sore throat and felt very fatigued. Two days later the sore throat went away but I became extremely lightheaded and dizzy and was unable to perform my regular functions. I?m still dealing with lightheaded symptoms.
Shortly after receiving the shot, had vision issues and an odd feeling in a band around my head across my eyes and forehead, lead to headaches and continued with blurred vision.  After the first day and still continuing: bottom of feet are painful (walking or not), joint pain, body aches, times of increase heart rate, chest pains, headaches, pain in palms of hands, blurry vision which comes and goes.
@ 14 hours after my second vaccine,  I experienced chills, achiness and headache.
at 2 1/2 weeks after first injection had severe asthma attack that caused right posterior chest pain, fatigue, chills- increased use of albuterol with nebulizer 3 times per day
Headache, nausea, body aches, muscle aches, skin sensitivity, lethargic, fatigue, chills. Still hurt 2 day after vaccine.
Patient said that she got blisters with pain and itching on arm starting 8/3/19. She reported this on 8/22/19. She still had 1 blister. She used "Listerine" on affected area and said it helps. She sent picture to Dr and was told not to get 2nd shot. Dr. was contacted by pharmacy on 8/4/19 to report incident.
Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced FATIGUE (Felt tired). On 01-Sep-2021, FATIGUE (Felt tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medication includes antidepressant.  No Treatment informations were reported.   This case was linked to MOD-2021-337689 (Patient Link).
Nausea immediately with injection, injection site pain, tiredness, headache, body aches, dizziness, blurred vision, poor appetite, unable to taste food, feeling unwell.  day later rash on chest, next day heart racing, breathing shallow and fast, chest hurting.  roads were iced over, to unsafe to drive.
Patient had very swollen, red and itchy leg that was hot to the touch at the injection site.
Had VARIVAX on 7/16/08 in R arm, 2 days later presented to clinic with R upper arm swelling, redness and warm to touch. Hard swollen area measured 5cm x 5cm diameter.
Herniated disc; This spontaneous case was reported by a consumer and describes the occurrence of INTERVERTEBRAL DISC PROTRUSION (Herniated disc) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERVERTEBRAL DISC PROTRUSION (Herniated disc). At the time of the report, INTERVERTEBRAL DISC PROTRUSION (Herniated disc) outcome was unknown.            Concomitant medication was not provided. Patient reported plan on taking an oral cortisone treatment.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 05-NOV-2013, the patient was inoculated at a clinic with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 12-JUL-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Same day post vax, the pt developed a large reddened area that was very tender to the touch. Arm is very sore. Seen in a clinic and treated for reaction.
I fell the pain in my leg immediatley the next day and was limping all day fromt hat point on. Deep Vein Rhrombosis (DVT) in right leg knee.
No symptoms reported.; one (1) of 5 patients inadvertently received dose of GARDASIL 9 in error for another unspecified vaccine/Patient is between 6 to 9 monlhs old/GARDASIL 9 was selected as human error, not confusion.; one (1) of 5 patients inadvertently received dose of GARDASIL 9 in error for another unspecified vaccine/Patient is between 6 to 9 monlhs old/GARDASIL 9 was selected as human error, not confusion.; This spontaneous report has been received from a medical assistant referring to a 6 to 9 months old patient of unknown gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 17-DEC-2019, the patient was inadvertently received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: 1602284, expiration date: 26-SEP-2021; frequency, route and dose details were unknown) for prophylaxis in error for another unspecified vaccine (product administered to patient of inappropriate age and wrong product administered). The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was selected as human error, not confusion. No symptoms reported.
PT reported that the day after her 2nd shot (2/4/21) she experienced body wide joint aches that have persisted since 2/5/21. She saw her PCP who has since dx?d her with Rheumatoid Arthritis. She states she did not have RA previously (or at least had never been tested for it).  This is currently being managed by her PCP who is unknown to this hospital.
warm to touch; Redness; swelling; itching; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), SWELLING (swelling), PRURITUS (itching) and FEELING HOT (warm to touch) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced ERYTHEMA (Redness), SWELLING (swelling) and PRURITUS (itching). On an unknown date, the patient experienced FEELING HOT (warm to touch). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency; CEFRADINE (VICODINE) at an unspecified dose and frequency; VITAMIN D NOS at an unspecified dose and frequency and MULTIVITAMIN [VITAMINS NOS] at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness), SWELLING (swelling), PRURITUS (itching) and FEELING HOT (warm to touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: NNI
arm is hard; arm is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (arm is hard) and VACCINATION SITE ERYTHEMA (arm is red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (arm is hard) and VACCINATION SITE ERYTHEMA (arm is red). At the time of the report, VACCINATION SITE INDURATION (arm is hard) and VACCINATION SITE ERYTHEMA (arm is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Reporter did not allow further contact
pt recvd vax & devel stiffness, lethargy, extreme pain when touched; apap ineffective; afebrile but diaphoretic & MD suspected meningitis but ruled out; poss rxn to vax;
pt exp severe myalgia, arthralgias, h/a & swelling of scrotum approx 29APR92; pt was seen in ER;