chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu like symptoms; really sick; This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (for tolerance of 1st dose refer case US2020161250) and Influenza vaccine.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and sickness. On an unknown date, the outcome of the influenza-like symptoms and sickness were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and sickness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix and she was really sick with flu like symptoms that lasted 2 to 3 days. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020161250:same reporter
Doesn't seem to know what's going on since post-vaccination; Last 2 weeks ago and began bumping into stuff; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Doesn't seem to know what's going on since post-vaccination) and INJURY (Last 2 weeks ago and began bumping into stuff) in a male 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 CONFUSIONAL STATE (Doesn't seem to know what's going on since post-vaccination) and INJURY (Last 2 weeks ago and began bumping into stuff). At the time of the report, CONFUSIONAL STATE (Doesn't seem to know what's going on since post-vaccination) and INJURY (Last 2 weeks ago and began bumping into stuff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
A medical assistant reported that a 66 year old male patient received an injection of Tetanus Toxoid in June 1999. In January, 2000, the patient developed an abscess at the injection site which was treated with antibiotics and Bactroban.
This non-serious spontaneous case, initially received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This case refers to 25th out of 84 patients. The vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). It was reported that, the patient was administered with AFLURIA (TIV) Thiomersal that underwent temperature excursion (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported) between 25-Oct-2017 to 27-Oct-2017 (as reported). The reporter stated that, no adverse effects after vaccination were reported. Temperature was not monitored on 24-Oct-17 (could have been between 2-8C, but not certain). Vaccine has since been discarded. Follow-up report received on 09-Nov-2017: It was reported that the vaccine was administered between 25-Oct-2017 to 27-Oct-2017 (as reported). The reporter stated that, no adverse effects after vaccination were reported. Temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain). Vaccine has since been discarded. Amended narrative accordingly. Case correction received with IRD 09-NOV-2017: Deleted "no adverse event" from the product tab. Added "special case with no AE" in general tab". Narrative was corrected from initial to initially in lead sentence.
mom states p/last shots that PM had t105 did not take to MD;states temp came down to 98 w/2 doses of APAP by PM;mom speaks no english @ clinic w/interpreter;pt recv DT/OPV/HIB 17OCT96 w/no adverse rxn;
Unusual symptoms; Unusual behavior; Almost like different person with mental problem; Can't complete a sentence; Muscle twitching; Cant stop shaking; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Unusual symptoms), ABNORMAL BEHAVIOUR (Unusual behavior), MENTAL DISORDER (Almost like different person with mental problem), SPEECH DISORDER (Can't complete a sentence), MUSCLE TWITCHING (Muscle twitching) and TREMOR (Cant stop shaking) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.  Concomitant products included WITHANIA SOMNIFERA ROOT (ASHWAGANDHA ROOT).   On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced FEELING ABNORMAL (Unusual symptoms) (seriousness criterion hospitalization), ABNORMAL BEHAVIOUR (Unusual behavior) (seriousness criterion hospitalization), MENTAL DISORDER (Almost like different person with mental problem) (seriousness criterion hospitalization), SPEECH DISORDER (Can't complete a sentence) (seriousness criterion hospitalization), MUSCLE TWITCHING (Muscle twitching) (seriousness criterion hospitalization) and TREMOR (Cant stop shaking) (seriousness criterion hospitalization). At the time of the report, FEELING ABNORMAL (Unusual symptoms), ABNORMAL BEHAVIOUR (Unusual behavior), MENTAL DISORDER (Almost like different person with mental problem), SPEECH DISORDER (Can't complete a sentence), MUSCLE TWITCHING (Muscle twitching) and TREMOR (Cant stop shaking) outcome was unknown.            Received a call from the patient's father who wanted to report that his daughter received the 2nd shot of Moderna Covid 19 Vaccine last Thursday evening, 20-May-2021 along with her mother. On Friday, 21-May-2021, His daughter had unusual symptoms of unusual behavior, almost like different person with mental problem, can't complete a sentence, muscle twitching and can't stop shaking.  The unusual symptoms had not resolved.  On 22-May-2021, they went to the Emergency Room where his daughter was admitted. Treatment information was not  provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recv vax & lab eval confirmed that pt had hepatitis B;pt MD felt the exp was r/t vax;
Dizziness, redness and rash around injection site, now developing a constant blinking process of the eyes. Medical Records received on 2/02/2005 states appetite poor. Information from Discharge summary states hyponatremia. msv
This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 5-year-old male patient who received FLULAVAL TETRA (batch number H9HZ7, expiry date 31st March 2017). On 13th September 2016, the patient received FLULAVAL TETRA .5 ml. In September 2016, less than a week after receiving FLULAVAL TETRA, the patient experienced extensive swelling of vaccinated limb at injection site redness. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site redness were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site redness to be related to FLULAVAL TETRA. Additional details were provided as follows: The patient experienced redness at the injection site, which continued to worsen. The patient presented to the clinic to see the doctor on reporting date morning with worsening swelling, redness from his shoulder down to his elbow on the arm where he received the FLULAVAL vaccine.
t103 seen in ER approx 12-14 hrs p/vax; lab studies neg; temp 101 in ER;
Information has been received from a nurse concerning an 18 year old female patient with "fear of needles" who on 18-MAR-2008, was vaccinated with the first dose of GARDASIL, on 19-MAY-2008, with the second dose of the vaccine, on 20-DEC-2008, with the third dose of the vaccine and on 29-JUN-2009, with a fourth dose of the vaccine. The nurse reported that the patient fainted right after receiving the first, second and third doses of GARDASIL and was fine after the 4th one. The event improved. The patient recovered the same day of vaccinations. The patient sought unspecified medical attention. Additional information has been requested.
After receiving vaccination, Pt. became light headed and briefly lost consciousness. Client was safely laid on the ground, continued breathing throughout event and regained consciousness after approximately 10 seconds. Upon regaining consciousness client followed commands. At 1904 patient was A&O x4, vitals as follows: BP 120/60 (R Arm, supine), O2 98%, HR 80. Pt declined ambulance ride to hospital. Vitals retaken at 1930 as follows: BP 122/78 (L Arm, Sitting), O2 99%, HR 70.  Patient staid for observation until 1950 and was driven home by partner.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Red swollen area around injection site from injection site to halfway down arm
Immediately following vaccine administration, patient with syncopal episode. Patient experienced tonic-clonic movements lasting less than one minute and was unresponsive. After approx. one minute, patient awake, pink in color, and slowly became oriented back to person, place, and time.
Dizziness half hour after vaccine mild, lasted through day 4p feelings of allergic reaction started tongue swelling, throat swelling. Swelling of forearms/calves. Medication Benadryl used. Next day symptoms started again by 9am. Bendryl, Prednisone Rx by Dr. on 3 days off 1 day - symptoms of tongue/throat swelling again. Restarted on Prednisone.
a site reaction; felt different; she did not receive the second dose in the series.; tired; left arm was sore for 4 days; had a reaction to the first dose; left arm swelled from her elbow to shoulder; left arm red; left arm hot; dizzy for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a reaction to the first dose), PERIPHERAL SWELLING (left arm swelled from her elbow to shoulder), ERYTHEMA (left arm red), FEELING HOT (left arm hot) and VACCINATION SITE REACTION (a site reaction) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION COMPLICATION (had a reaction to the first dose), PERIPHERAL SWELLING (left arm swelled from her elbow to shoulder), ERYTHEMA (left arm red), FEELING HOT (left arm hot) and PAIN IN EXTREMITY (left arm was sore for 4 days). On an unknown date, the patient experienced VACCINATION SITE REACTION (a site reaction), MALAISE (felt different), PRODUCT DOSE OMISSION ISSUE (she did not receive the second dose in the series.), DIZZINESS (dizzy for 4 days) and FATIGUE (tired). In April 2021, PAIN IN EXTREMITY (left arm was sore for 4 days) had resolved. At the time of the report, VACCINATION COMPLICATION (had a reaction to the first dose), PERIPHERAL SWELLING (left arm swelled from her elbow to shoulder), ERYTHEMA (left arm red), FEELING HOT (left arm hot), VACCINATION SITE REACTION (a site reaction), MALAISE (felt different) and FATIGUE (tired) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she did not receive the second dose in the series.) and DIZZINESS (dizzy for 4 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No Concomitant medication was reported.    No treatment medications were reported.  Patient stated that, she thinks she had a shift in the cellular blood cells.   This case was linked to MOD-2022-445279, MOD-2022-445950, MOD-2022-447065 (Patient Link).
Pt asked for preservative free flu vaccine w/o thimerosal.  She said she has had anaphylactic rxn in past, & has had PF flu shot last 2 yrs and ok.  She was given AFLURIA (PF) but said she was experiencing shortness of breath and some chest/throat congestion.  We gave her 50mg benadryl and watched her for 25 min.  She was ok when she left the store.
pt devel fever of 104-105 w/in 12 hrs of vax also had persistant crying & rash;
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 14-JUL-2016, the patient was vaccinated with the first dose of ZOSTAVAX (subcutaneously, lot # L046896, expiry date: 23-FEB-2017). On 01-AUG-2016, (also reported as today), the patient was inadvertently administered a second dose of ZOSTAVAX (subcutaneously. lot # L046896, expiry date: 23-FEB-2017). Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
Patient was diagnosed at urgent care.  Sign and symptoms: mild rash on left face especially the cheeks and was given antivirals to treat the rash. Rash was recovered in 3 days and patient is currently experiencing mild numbness on the left face.
Headache for three days following vaccination. We are a hospital and mandate vaccination. We are just beginning the vaccination for our facility for the 2017-2018 flu season and have seen multiple cases of extended headache from this vaccine.
felt real rotten; sweating; nausea; chills; bad headache; really tired/She's very active and lays flat; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt real rotten), HYPERHIDROSIS (sweating), NAUSEA (nausea), CHILLS (chills) and HEADACHE (bad headache) in a 39-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Sep-2023, the patient experienced FEELING ABNORMAL (felt real rotten), HYPERHIDROSIS (sweating), NAUSEA (nausea), CHILLS (chills), HEADACHE (bad headache) and FATIGUE (really tired/She's very active and lays flat). At the time of the report, FEELING ABNORMAL (felt real rotten), HYPERHIDROSIS (sweating), NAUSEA (nausea), CHILLS (chills), HEADACHE (bad headache) and FATIGUE (really tired/She's very active and lays flat) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  On 22-Sep-2023, patient received Spikevax, and had reactions on the first night. She had the same reaction on the same day of her 5 injections: she felt real rotten, sweating, nausea, chills, bad headache, really tired. She was very active and lays flat.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742747 (Linked Report). This case was linked to MOD-2023-742931 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742747:Mother case
Sudden onset of flu-like symptoms including nausea, extreme fatigue,  fever/chills, overall malaise
Fever; chills; nausea; headache; overall lethargy; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number El1284), via an unspecified route of administration on 18Jan2021 09:00 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose on 30Dec2020 06:45 AM (lot number Eh9899) at left arm for covid-19 immunization. The age of first dose was also 59 years old. Patient is not pregnant. The facility type vaccine was hospital. Medical history included Sulfa allergy from an unknown date. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, nausea, headache, overall lethargy on 18Jan2021 09:00 PM. Patient didn't receive treatment for the adverse events. The outcome of events was recovering.  Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities.
Got ?COVID arm? , very itchy and red welts;  took antihistamine and was good the next day. 2 days later I am getting red welts on both arms and chest, 2 days in a row now; spoke with doc and am taking antihistamines ; not sure if this will be ongoing
Had DTaP and IPV vaccines on 4/29/09, came in to office on 5/1/09 with R leg red, swollen, hot and painful to touch.  Diagnosed with cellulitis and treated with Keflex.
has not felt normal since first vaccine; Constipation; Vomiting; Dizziness; Diarrhea; Vertigo; tired; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), FEELING ABNORMAL (has not felt normal since first vaccine), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and CONSTIPATION (Constipation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension, High cholesterol and Prediabetes. Concomitant products included ROSUVASTATIN, METFORMIN, METOPROLOL, ESTRADIOL, SEMAGLUTIDE (OZEMPIC) and CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced FATIGUE (tired). On 28-Mar-2021, the patient experienced VERTIGO (Vertigo), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On 13-Apr-2021, the patient experienced CONSTIPATION (Constipation). On an unknown date, the patient experienced FEELING ABNORMAL (has not felt normal since first vaccine). At the time of the report, VERTIGO (Vertigo), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), CONSTIPATION (Constipation), VOMITING (Vomiting) and FATIGUE (tired) had not resolved and FEELING ABNORMAL (has not felt normal since first vaccine) outcome was unknown. Not Provided          No treatment information provided
patient started to feel faint/dizzy-placed cold pack on back of her neck and she asked for a sip of water. We stayed with her for  duration of time she was at our pharmacy to make sure she was ok. Patient was feeling good when left.
Patient indicated that approximately 3 days after receiving J&J COVID-19 vaccination that he experienced chest tightness which would not resolve.  He visited a cardiologist who explained that he has seen this side effect in patients after receiving the vaccine and explained that there was inflammation in the heart muscle causing chest tightness.
6/2/2021 abdominal pain with fever, diagnosis appendicitis.   6/3/2021 appendectomy
This case was reported by a consumer (also the subject) and described the occurrence of injection site pain in a 35-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 23 November 2009 at 13:30 the subject received 3rd dose of ENGERIX B (unknown route, left arm). On 23 November 2009, "shortly" after vaccination with ENGERIX B, the subject experienced injection site pain in her left upper arm. At the time of reporting the event was unresolved.
Fatigue, sore arm day 1 Fatigue, fever,chills,muscle aches, sore arm day2  Fatigue day 3 Fever, headache, fatigue day 4
Pt recvd vax 25APR90 & 21MAY exp urticaria & the 3rd dose of vax on 27SEP90 seen by MD had urticaria;
DIZZY;  FEVER; EXTREME WEAKNESS; ALL FLU-LIKE SYMPTOMS;  FEVER BROKE 48 HOURS LATER;  NAUSEA;   STILL WEAK DID NOT GO TO DR.   AT HOME.
Information has been received form a physician reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 03-OCT-2017, the patient received an expired dose of ZOSTAVAX lot # M027117, expiration date 26-JUL-2017 (dose, dose number, anatomical location and route of administration were not reported) reconstituted with diluent (manufacturer unknown) for prophylaxis. No adverse effects reported.
It was reported that a pt (3 of 3) received a Tripedia vaccination (date not specified). Reportedly, the pt developed a local reaction at the injection site (onset date not specified).
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 29-DEC-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016)(dose and site not reported). The vaccine was in excursion with a sum of hours of 72, 40 and 48. The lowest recorded temperatures were 28 and 34. The highest recorded temperature was 47. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Flu like symptoms (head ache, body aches, fatigue) for two days;  arm swollen, sensitive to touch, red, and hot for at least five days.
Patient and wife stated that he has had many vasovagal syncope events when he has had vaccines administered, both more recently, and in the past. The patient was seated in a chair with arms.  Within a couple of minutes of administering the vaccine, his eyes rolled back in his head, he broke out in a cold sweat, BP was 75/55, pulse 55.  He never stopped breathing (was snoring); epinephrine for an anaphylactic reaction was not indicated.  I offered to call 911 multiple times but his wife said this was the normal course of his reaction and held an icepack on his neck for the duration.  After 5-10 minutes the patient was once again responsive.  He sat for an additional 10 minutes and then said he was ready to leave.  His wife walked him out of the store.
Tachycardia/shortness of breath 160-180?s sustained 20 min
2 weeks after MMR developed erythematous blanching 2-3cm circular to red rash all over face, neck, spread to chest, arm/back/legs. Associated with itch, does not look like hives, raised papular, all lesions look the same (were not like chickenpox). No fever, no conjunctivitus. Benadyrl PM.
Hypotonic hyporesponsive episode, required blow by O2 to recover. Sent to ED for further care and was discharged later in the afternoon.
1PM inconsolable crying x 4 hrs; woke up crying in noc 7 times; c/o pain & stiffness p/sitting for extended periods & then trying to get up; swelling @ inject site; t102;