chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given a flu shot at the pharmacy and was feeling fine right afterwards.  The patient and his family shopped a little while and came back to the pharmacy to checkout.  It was about 5-10 minutes since he received the flu shot when he suddenly collapsed to the floor and fainted.  His mom was able to catch him so he only bumped the back of his head slightly on the floor.  EMS was immediately notified.  I was also immediately notified and went around the pharmacy counter to see how I could assist.  By the time I went to the patient's side, he opened his eyes and was conscious.  He was unconscious for about 5 seconds.  The patient complained of being hot and very tired and his face was very pale.  Mom mentioned that he had slight tremors while he was unconscious also.  Patient had some cold water while he was sitting on the floor.  EMS arrived about 5 minutes later and took over.  They took the patient's vital signs.  While this occurred, the patient vomited a couple times.  Once the patient looked stable, EMS recommended transport to the hospital for monitoring and tests.  His parents agreed to this and they left the pharmacy.
electric shocks on the neck and skull and above the ear and then where the bone was below the ear; having pain shooting in her head down her right arm; having pain shooting in her head down her right arm; brain fog; hardly remember something; body aches; fatigue; rash on her arms; shingles; twitches and shooting pain from her right shoulder all the way down to the thumb of her right hand; twitches and shooting pain from her right shoulder all the way down to the thumb of her right hand; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534) at the age of 70-years, via an unspecified route of administration in arm right on 15Mar2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 infection from Nov2020 to an unspecified date; seasonal bronchitis which comes with laryngitis almost every time. Concomitant medications included methylprednisolone from 05Apr2021 and ongoing; tramadol. Patient received her first injection of the vaccine and then 10 days later, she started experiencing electric shocks on the neck and skull and above the ear and then where the bone was below the ear, was on her right side, which was the same side where she received the vaccine. On unspecified date, the patient also experienced having pain shooting in her head down her right arm; brain fog; hardly remember something; body aches; fatigue; rash on her arms; shingles; twitches and shooting pain from her right shoulder all the way down to the thumb of her right hand. The patient underwent lab tests and procedures, which included on 02Apr2021, flu test was negative, COVID-19 virus test was negative. Outcome of the event electric shocks on the neck and skull and above the ear and then where the bone was below the ear was recovering/resolving while of remain was unknown.   No follow up attempts are needed. No further information expected.
vomited small amt 6 minutes after the vaccination. She also c/o lightheadedness and stomach cramping.   is menstruating at present.  Assisted  lay on Yoga mat with legs elevated. Her VS were taken. Her BP was 100/58, P 65;R18 and O2 sat 99%.  stated she felt better after lay on yoga mat. Assisted  sit up on Yoga Mat at 1:55PM ; VS taken sitting: BP 90/56; P90: Resp 18 and O2 sat 98%.  admit she did not drink much water before she came and her menstrual period is heavy.  instructed to drink water and electrical flds provided to her while sitting on mat which she did. Her heart rate went back to 70 and her BP went up to 100/60 sitting. At that time  states she feels good and she went back to her chair. Observed  for another 10 minutes and she left the site with her mother at 2:10pm  completely recovered.
On the 8th day after receiving my vaccine, my arm at the injection site was itchy and I felt a small bump. When I looked at it in the mirror, it was swollen and red. It was also warm to the touch. No pain though besides the initial itch. It is about a 1"-2" diameter circle. Today is day 9 after receiving the vaccine and it is still red and slightly swollen but not itchy. No other symptoms present.
dizziness; her stomach feels shaky; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (her stomach feels shaky) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 29K20A) for an unknown indication.     Concurrent medical conditions included Hypothyroidism.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (her stomach feels shaky) and NAUSEA (nausea). At the time of the report, DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (her stomach feels shaky) and NAUSEA (nausea) outcome was unknown. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (her stomach feels shaky) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 29K20A) for an unknown indication.     Concurrent medical conditions included Hypothyroidism.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (her stomach feels shaky) and NAUSEA (nausea). The patient was treated with IBUPROFEN at an unspecified dose and frequency; LEVOTHYROXINE at an unspecified dose and frequency and AMLODIPINE at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (her stomach feels shaky) and NAUSEA (nausea) outcome was unknown.
temperature of 100.5, a little high; Headache; She took a nap and around 4pm, she woke up and didn't feel good; Nausea; This is a spontaneous report from a contactable consumer (patient). This 35-year-old female consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3248) on 21Jan2021 around 09:30 AM, in right upper arm, for COVID-19 immunization. No other vaccine was given on the same day or within 4 weeks prior. Medical history included gastric sleeve surgery on 05Jan2021. Concomitant medication included ondansetron hydrochloride (ZOFRAN) for nausea. The patient took a nap and around 16:00 on 22Jan2021 she woke up and didn't feel good and had nausea. On 22Jan2021 at 16:40 the patient experienced also temperature of 100.5, a little high and realized she had a headache. However, she also just had a gastric sleeve surgery on 05Jan2021 and she had been experiencing nauseas from some days, so she was not sure if what she was experiencing had anything to do with that or with the COVID-19 shot because she had not nausea every day. She did take a Zofran. The events did not require a physician office or ER visit. Relevant tests: none. Events outcome was unknown.
This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 30-MAY-2017, the patient was inadvertently vaccinated with an expired dose of VAQTA (lot # M016191, expiry date 26-MAY-2017). No adverse effects were reported. Additional information has been requested.
Patient was vaccinated on 7/24 and began to have itching, erythema, swelling and heat from injection site on the morning of 7/25. Patient seen by me in clinic at 1930 on 7/25 and patient with 4cm diameter area of erythema and induration. Mother showed picture of much larger area which now seems to be resolved after application of ice. Mother requested that I complete a VAERS report.
A spontaneous report had been received from a pharmacist concerning a 5 years old male patient. Patient had upper respiratory tract infection three weeks before he developed Guillain Barre Syndrome. On 29-Oct-2015, patient received FLUMIST QUADRIVALENT (intranasal) annually. On 12-Jan-2016 (after ten weeks), patient was diagnosed with GBS. Sign and symptoms of GBS were of leg weakness, loss of deep tendon reflexes in lower limbs, bladder dysfunction and positive Romberg. Patient had treatment of two day course of intravenous Immunoglobulin of total dose of 2g/kg. Patient had respiratory infection several weeks before GBS development after FLUMIST administration. Electromyography (EMG) and nerve conduction study showed distal latency of all motor nerves were prolonged. C-reactive protein was increased. Patient had recovered from the event of GBS with sequelae of gait instability and extremity weakness. Patient was current in rehab. Reporter considered the event of Guillain Barre Syndrome to be serious with seriousness criteria of hospitalization and important medical event.
Felt "spacey" Patient was given water and was  observed, symptoms resolved Discharged to home
Pt showed big red patch 12 x 9 cm wide spreading entire upper arm. Reported to Dr. Dr told pt to report to us: Pt got both shots in same arm: stated other arm could not be used.
administration of expire dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expire dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expire dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of expire dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.
Patient reported fever 101F, chills, fatigue, muscle pain, redness on upper arm, itching on upper arm, rash on upper arm, warmth to touch on upper arm. Patient self medicated with Tylenol and Benadryl cream. Pharmacy was not notified until 12/12/15 after fever and redness subsided.
This case was reported by a consumer (subject's mother) and described the occurrence of fussy in a 3-week-old male subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 7 February 2013 at 10:30 the subject received 1st dose of ENGERIX B adult (unknown details, unknown thigh) and experienced overdose. The subject was younger than indicated for the ENGERIX B adult dose. On 7 February 2013, 6 hours after vaccination with ENGERIX B adult (at approximately 16:00 to 17:00), the subject experienced fussy. The subject was treated with TYLNEOL after the vaccination on 7 February 2013. On 8 February 2013, the subject's mother reported that the adverse event of fussy had resolved. On 17 February 2013, the subject's mother reported that the subject experienced fever, fussiness and cold. The subject's mother stated that "fever on 17 February 2013 and fussiness due to cold." At the time of reporting, the outcome of the adverse events of fever, fussiness and cold were unknown. The subject's mother stated that the immunisation series was not discontinued or delayed. The subject's mother also reported another case. See case A1013506A for details on the other case. Follow up information was received from a nurse (subject's grandfather) on 20 February 2013. The overdose has now been medically confirmed. The nurse stated that the subject received 20 mcg, 1mL dose of ENGERIX B adult. He also stated that there were "no problems he knows of with child having this" dose of ENGERIX B adult.
Patient showed copious rash and urticaria on the right arm (arm where the vaccine was injected)
sore arm; muscle pain; Headache; Neck pain; Back pain; Cold sweat; Hot flushes; Painful arm; Tiredness; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MYALGIA (muscle pain), HEADACHE (Headache), NECK PAIN (Neck pain), BACK PAIN (Back pain), COLD SWEAT (Cold sweat), HOT FLUSH (Hot flushes), PAIN IN EXTREMITY (Painful arm) and FATIGUE (Tiredness) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lactation decreased and Headache.   On 04-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 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 04-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), NECK PAIN (Neck pain) (seriousness criterion medically significant), BACK PAIN (Back pain) (seriousness criterion medically significant), COLD SWEAT (Cold sweat) (seriousness criterion medically significant), HOT FLUSH (Hot flushes) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) (seriousness criterion medically significant) and MYALGIA (muscle pain) (seriousness criterion medically significant). On 05-Aug-2021, HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) and MYALGIA (muscle pain) had resolved and NECK PAIN (Neck pain), BACK PAIN (Back pain), COLD SWEAT (Cold sweat), HOT FLUSH (Hot flushes), PAIN IN EXTREMITY (Painful arm) and FATIGUE (Tiredness) was resolving.        The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.       Patient reported taking paracetamol, which helped.  Concomitant medications were not provided.  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. Events were classified as serious by regulatory authority (seriousness criteria: medically important condition). However, as per medical criteria none of the events was serious (not IME listed and resolved).; 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. Events were classified as serious by regulatory authority (seriousness criteria: medically important condition). However, as per medical criteria none of the events was serious (not IME listed and resolved).
Client verbalized feeling of anxiety after receiving the vaccine.  Full assessment done by Paramedics.  Client was released for home at 4:33 pm.  Per paramedics no further evaluation needed.  Symptom resolved.
First dose just sore arm for 2 days.  Second dose is what got me. Started feeling like I had the flu or something.  Headache, tired, sweating throughout the nite. Felt like I would vomit (wet mouth). Next day, not much better. Felt blah. Took 2 ibuprofen and a nap and by afternoon, felt fine again except for the sore arm. Today I feel like me again. Just a sore arm.
2 hrs after vax admin her face began to swell & itch. Also difficulty sleeping a few days. Also clear runny nose. No neuro or resp sxs. Has similar reaction to flu vax yearly; no reaction to other vax. Still itchy face 4 days later.
Call received today 8/26. Fever, swollen lymph, mass on site of injection noted 8/23. 8/26 URI symptoms, diarrhea, fever. Taking TYL./MOTRIN. Will week medical tx if continue/worsen.
Soreness at site of infection for about 5 days. The first night I had muscle aches, discomfort and couldn't sleep. The second night I had those same symptoms plus chills. Continued to feel extremely fatigued, no appetite, slightly queasy and aching for 7 days. ON THE FIRST NIGHT I EXPERIENCED THE SENSATION OF A MAJOR FEVER BLISTER OUTBREAK AND TOOK VALACYCLOVIR. DID NOT GET THE FEVER BLISTERS BUT AM CONCERNED THAT THIS MEDICATION ENHANCED MY REACTION AND REDUCED EFFECT OF VACCINE.
I95.9 HYPOTENSION 3/31/2022 ADVANCE DIRECTIVE DISCUSSED W PATIENT
7-8 days after shot, arm had a massive red spot around injection site. Area feels hot to the touch, painful to move / touch and it itches. Area is swollen as well.
Violent Chills; Violent Nausea; no energy; feels like she has laryngitis; horrible tinnitus; Heart Pain for 48 hours; slight earache; weakness; muscle ache for 48 hours; Sore arm for 48 hours; fever for 48 hours; nausea for 48 hours; Violent Chills for 48 hours; Severe muscle aches; This spontaneous case was reported by a nurse and describes the occurrence of LARYNGITIS (feels like she has laryngitis), TINNITUS (horrible tinnitus), CHEST PAIN (Heart Pain for 48 hours), EAR PAIN (slight earache) and ASTHENIA (weakness) in a 78-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.     Concurrent medical conditions included Autoimmune disorder.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LARYNGITIS (feels like she has laryngitis), TINNITUS (horrible tinnitus), CHEST PAIN (Heart Pain for 48 hours), EAR PAIN (slight earache), ASTHENIA (weakness), MYALGIA (muscle ache for 48 hours), INJECTION SITE PAIN (Sore arm for 48 hours), PYREXIA (fever for 48 hours), NAUSEA (nausea for 48 hours), CHILLS (Violent Chills for 48 hours), PYREXIA (Severe muscle aches), CHILLS (Violent Chills), NAUSEA (Violent Nausea) and FATIGUE (no energy). At the time of the report, LARYNGITIS (feels like she has laryngitis), TINNITUS (horrible tinnitus), EAR PAIN (slight earache), ASTHENIA (weakness), PYREXIA (Severe muscle aches), CHILLS (Violent Chills), NAUSEA (Violent Nausea) and FATIGUE (no energy) outcome was unknown and CHEST PAIN (Heart Pain for 48 hours), MYALGIA (muscle ache for 48 hours), INJECTION SITE PAIN (Sore arm for 48 hours), PYREXIA (fever for 48 hours), NAUSEA (nausea for 48 hours) and CHILLS (Violent Chills for 48 hours) 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.
severe pain shooting up to head/neck and down to hand. fingers tingling/numb. chest pain, radiating to back (shoulder pain); whole arm very uncomfortable
Severe constant muscle weakness impacting legs/arms/hands/speech (Autoimmune Myasthenic epsidode) Ongoing/chronic daily since 2/26  Besides increasing medication and resting, nothing has helped.
mom states that pt awoke from nap 5PM 14OCT92; felt warm, temp not taken; pt was fussy, no other sx; seizure occurred 510PM 14OCT92; seen in hosp ER t104.3 R; devel cough & runny nose; sx dx as febrile sz from a virus;
Drug eruption rash started 12/15/22 and continued to progress 1/5/23. Turned purple hue around end of December. Spreading down thigh and beginning to show on bil upper arms. Denies fevers, limping, decreased activity, decreased appetite. Second dose given 12/28/22 (due to unknown it was from the COVID vaccine) and now rash has begun on R leg (administration site) as well.
Feb 15, 2021 Monday, I started feeling pain on the right portion of my neck; Feb 16, 2021 Tuesday, I felt the pain radiating inside my right ear and had a mild headache.  Tuesday evening, my wife noticed that I am not fully blinking/closing my right eye; Feb 17, 2021 Wednesday, I didn't have the same pain but there's numbness on my right cheek extending to my right lips.  Wednesday afternoon around 2pm, I went to my dentist thinking it was due to my Invisalign which I started on Jan 25, 2021.  The dentist told me it is most likely Bell's palsy so I decided to go to Emergency.
This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient. A 57-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "type 1 diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1, single, lot number: EK9231, administered in arm left), administration date: 08Jan2021, for COVID-19 immunisation. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "12 hours of high sugars". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 3-month-old female patient who received ROTARIX (batch number 9R3ZC, expiry date 18th October 2019). On an unknown date, the patient received ROTARIX 1 ml. On an unknown date, 1 hr after receiving ROTARIX, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related ROTARIX. Additional details were provided as follows: The health care professional stated that the patient was 3 month old child vomited curdled breast milk approximately 1 hour after vaccination. The batch number does not exit in sales data sheet and corrected from 9R32C to 9R3ZC.
On 01/21/2022 at 15:46 nurse administered second dose of the Pfizer pediatric vaccine to 10 year old patient. Pfizer pediatric dose of 0.2 ml was administered prior to reconstitution of the vaccine vial.
This spontaneous case reported by a consumer, describes the occurrence of inappropriate schedule of product administration (2nd dose administered beyond 35 days) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 029K20A and 039K20K) for COVID-19 immunization. No medical history reported. On Dec 19, 2020, at 8:00 am, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 26, 2021, at 8:00 am, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 26, 2021, patient given inappropriate schedule of product (2nd dose administered beyond 35 days). At the time of the report, inappropriate schedule of product administration (2nd dose administered beyond 35 days) outcome: unknown. No concomitant medication or treatment information reported. This case linked to MOD-2022-452964 (patient link).
The patient woke up the morning after receiving her vaccine and complained of severe pain throughout her arm. Unable to lift her arm or extend her arm.
Started symptoms of a cough, sore throat, diarrhea, and upset stomach on 03/08/2021. Received monclonoal antibody therapy on 03/19/2021.