chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chief Complaint  Pt via EMS found by wife in car after being in there for uknown length of time with windows fogged over and patient unconscious. Febrile en route and in triage. BG 215 en route. Diaphoretic . GCS 14. 500 ml fluids en route.  History of Present Illness  65-year-old fully COVID-vaccinated (Pfizer in June) male who has presented to the ER this evening via EMS for altered mental status, fever, sepsis and COVID-19 illness.  History is somewhat limited.  Most of the history is obtained from EMS and the patient's wife over the phone by the ER provider this evening.  Patient has not been home very much over the last 4 to 5 days.  Apparently the husband has been trying to avoid her due to her illness whi
Arm soreness onset few hours after vaccine, worsening over the day. Vomited the following morning. Also the following morning started to develop leg and chest soreness and headache, slight chills. Disrupted sleep and ability to work
This spontaneous report was received from a registered nurse referring to an 11 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 05-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
right ear swollen inside; can't hear good with that ear; swollen index finger in right arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen index finger in right arm), EAR SWELLING (right ear swollen inside) and HYPOACUSIS (can't hear good with that ear) in a 47-year-old female patient 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 09-Jun-2021, the patient experienced PERIPHERAL SWELLING (swollen index finger in right arm). On 16-Jun-2021, the patient experienced EAR SWELLING (right ear swollen inside) and HYPOACUSIS (can't hear good with that ear). At the time of the report, PERIPHERAL SWELLING (swollen index finger in right arm), EAR SWELLING (right ear swollen inside) and HYPOACUSIS (can't hear good with that ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment information not provided. Concomitant medications were not provided.
Information has been received from a health care worker and a nurse and refers to a 13-years-old female patient. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On 13-JUL-2015 (also reported as "today"), the patient was vaccinated with an expired dose of GARDASIL, lot # H020901, expiration date: 05-JUL-2015 (dose, route of administration and indication were not reported). It was the patient's first dose in the series. The patient had not reported an adverse experience. This is one of several reports received from the same reporter. Additional information has been requested.
Irregular periods since injection. Cycles used to be almost always 27-30 days since age 12. Cycles are now 20-35 days in an unpredictable fashion. This is unprecedented for me.
Redness/pain at sight, muscle aches, flushing, scratchy throat, joint aches.
Shortness of breath; palpitations/increased heart rate; palpitations/increased heart rate; Immediate left arm/chest pain; Immediate left arm/chest pain; fatigue; body aches; This is a spontaneous report from a contactable physician.   A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246), via intramuscular, on 18Jan2021 at single dose on the left arm for COVID-19 immunisation, administered at Hospital. The patient did not have a relevant medical history. No known allergies. No relevant concomitant medications were provided. No other vaccine was received in four weeks. The patient developed immediate left arm/chest pain, and fatigue/body aches. On 23Jan2021 (5 days later), he developed shortness of breath and palpitations/increased heart rate. Post-vaccination COVID test was not performed. The patient was not treated for the events. The patient was recovering from the events.
Pt c/o "constricted windpipe" and wheezing with inspiration symptoms lasted 3 hours and improved without medical treatment.
Redness around injection site that expanded over a few days to a 6 inch oval area that was inflammed and itchy, itchiness on hands, neck, around ears and nose. Red rash around eyes.
Patient was found down by significant other and brought to ER in private vehicle. Enroute patient stopped breathing. On arrival to ER patient was cold, mottled with no pulse. Code was called. After 30 minutes of resuscitation, time of death was called.
Chills; Woke up with a fever of 100.7; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6205, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 08Mar2021 at 17:00 (at the age of 36 years old) as dose 1, single for COVID-19 immunisation in a Pharmacy or Drug Store. Medical history included thyroid cancer from an unknown date. The patient was not pregnant at the time of vaccination and prior to vaccination was not diagnosed with COVID-19. Concomitant medications included levothyroxine; calcitriol; colecalciferol (VITAMIN D 3) and magnesium - all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Mar2021 at 23:30, the patient experienced chills and she woke up with a fever of 100.7 (as reported). No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
After 5 mins of  vaccination , fingers tingling, pins and needles, then heavy chest tightness, redness on chest skin.
Muscle twitch occurred a few hours after injection, at the site of the injection. Followed by extreme arm pain within 24 hours, egg-sized enlarged lymph node in left armpit, 101* fever, and chills that lasted 2-3 days. Lingering fatigue (extreme and debilitating) shaky hands and vomiting lasted about 10 days and required medical care.
face started drooping; numbness in toes on one foot, numbness spread to both feet then to hand; cannot speak clearly; Guillain-Barre' Syndrome; Initial information received on 28-Mar-2022 regarding an unsolicited valid serious case received from a patient.   This case involves an unknown demographic patient who experienced guillain-barre' syndrome, face started drooping, numbness in toes on one foot, numbness spread to both feet then to hand and cannot speak clearly after receiving vaccine influenza vaccine.  The patient's past medical history included Back disorder. The patient's past vaccination(s) included COVID-19 vaccination. The patient's past medical treatment(s) and family history were not provided.   On 28-Feb-2022, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, dose, lot number and expiry date not reported) via unknown route in unknown administration site for Prophylactic vaccination.  On 14-Mar-2022, latency 14 days, the patient started having numbness in his/her toes on one foot. On Tuesday and Wednesday the numbness spread to both feet then to hands (hypoaesthesia). He/She made an appointment to see the doctor having previous back issues and was prescribed prednisone on Thursday of that week. On Sunday (Mar-2022) his/her face started drooping (facial paralysis) (latency few days) so he/she was taken by ambulance to the hospital. He/she was diagnosed with Guillain-Barre' Syndrome (onset date: Mar-2022, latency: few days). He/She cannot speak clearly (speech disorder) (onset date: Mar-2022, latency: few days) thus today was the first day he/she had access to his/her laptop to report this. He/She did receive the Covid vaccine from Johnson and Johnson last spring with no ill effects.   It was  unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.  Seriousness Criteria: Medically significant for Guillain-Barre' Syndrome and facial paralysis. Hospitalization for facial paralysis; Sender's Comments: Sanofi Company Comment on 31-Mar-2022:  This case involves an unknown demographic patient who experienced guillain-barre' syndrome, face started drooping, numbness in toes on one foot, numbness spread to both feet then to hand and cannot speak clearly after receiving vaccine influenza vaccine. Further information regarding medical history, concurrent condition during vaccination, previous vaccination, and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
After the vaccines were administered to the patient, they left and in about 2 minutes were found to have fallen down on one of the aisles. The patient was conscious but dizzy. Paramedics were then called, upon assessment, he was found to have bradycardia and dizziness. he was then transported to the hospital for further evaluation
PATIENT GOT UP OFF COUCH FROM LYING DOWN...WENT TO KITCHEN...PASSED OUT ONTO FLOOR FOR 5 SECONDS. AMBULANCE CAME AND TRANSPORTED PATIENT TO HOSPITAL.
About 4 hours after receiving the flu vaccine, I experienced acute pain in my upper left arm and shoulder when trying to raise my arm. I have had ongoing pain when raising my arm, reaching back or across my chest since then. I have had 5 weeks of PT with little improvement.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with an improperly stored dose of ROTATEQ oral (dose and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
It was reported that an 76 year old male pt received a Fluzone SV 00-01 vaccination in 11/2000. Reportly sometime after the vaccination (date not specified) the pt developed headaches, diaphoresis, abdominal pain, myalgia, and mouth. No further information was provided from mailed correspondence returned on 06/29/2001.
Patient collapsed at home with cardiopulmonary arrest. He had been complaining of shortness of breath 1 week prior to the event, starting when he received his covid vaccination. The differential diganosis was pulmonary embolism, myocardial infarction or arrythmia. CPR was started immediately and patient received tPA during ACLS without return of spontaneous circulation.
Breakthrough COVID Case: Initially, fatigue and runny nose. Then, sore throat and feverish without fever. Very sore throat. I started Paxlovid on Tuesday.
pt recvd vax & devel a rash for 2 wks; The pt is no longer employeed by the reporting facility;
administration of expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed. No concomitant medications were reported. No treatment given to patients.
Swollen lLymph node to left side chest near clavicle.  Narrative:
Vomiting, diarrhea, shaking, difficulty breathing, OSat down to 90, whole body sensitive to touch, pain in left arm
Nausea, chills, fatigue for 12 hours. Treated with Advil at home, resolved.
This spontaneous report was received from a pharmacist and refers to a patient of unknown demographics. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 PFU, lot # reported as N042851 with expiration date on 18-JAN-2020 (route of administration was not reported). There was no adverse effect reported. The administered dose of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 45 minutes. Data logger was involved in recording of the temperature excursions. There was a previous excursion of 15 to 46 degrees Fahrenheit for 20 minutes reported.
swollen lymph nodes, stiff neck, redness at injection site--started 1 day after injection and continues to have these symptoms 10 days after injection
rash; This case was reported by a other health professional via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient experienced rash after vaccination.
Little soreness after vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (Little soreness after vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (Little soreness after vaccine). At the time of the report, PAIN (Little soreness after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Reporter refused to give contact info and no need to follow up anymore.
Started with out of breath, Liquid on lungs, Raspy breathing at night, could not sleep. Got worse and worse until sought Medical. Found I was in A-Fib
States that she has experienced generalized itching since receiving  first dose of COVID-19.  Also states that she has noticed her sclerea becoming yellow and skin "jaundice" in color.
Customer became faint after receiving her shot.  EMT's were called and an Epipen .3mg dose was administered.
On 12/19/03 and 02/19/04, pt received DTAP, IPV, HIB and Prevnar vaccines.  By the evening after shot received, leg with DTAP was red and swollen, including foot.  No rash up body.  No fever.  Pt did have aom on 12/19 and cold symptoms 02/?/04.  Otherwise healthy.  Shots were changed to opposite legs in February.  Reaction still in leg with DTAP
it was reported that a female patient received an Imovax vaccination on 25-Aug-2000. Reportedly that same day the patient developed difficulty breathing and red blotches on her body about 6-8 hours after receiving the vaccine. The patient was treated in the emergency room with Benadryl and steroids, symptoms resolved. Patient was evaluated by allergist.
pt recv vax 28JAN99 & exp pain from upper arm, to elbow particularly painful to forearm & numbness in hand; eg. painful twisting cap off tooth paste  & lifting anything;
Headache Chills Nausea  Joint paint Muscle pain  This all occurred in the early morning after the day of vaccination at approx 2am. Woke up freezing with body aches.
Area of warmth and erythema around injection site. Keflex 500mg QID.
At conclusion of H1N1 clinic it was observed vaccine recommended for age 4 and older was given to 3 yr child.
Patient notes knot in throat and feeling like her throat is being coated. Given Benadryl and monitored for 45 minutes. She felt better and left in stable conditions.
Aprox 30-45 min after receiving my flu shot my lip and throat became itchy and my lip were slightly swollen. Took BENADRYL 50 mg all symptoms resolved.
yawning; throat swollen; This spontaneous case was reported by a consumer and describes the occurrence of YAWNING (yawning) and PHARYNGEAL SWELLING (throat swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient has history of Anaphylaxis.     On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced YAWNING (yawning) and PHARYNGEAL SWELLING (throat swollen). At the time of the report, YAWNING (yawning) and PHARYNGEAL SWELLING (throat swollen) outcome was unknown.            No treatment and concomitant drug information was provided.
* 01/14/21 - Received first Pfizer COVID Vaccine. Felt really strange for first 10 mins after vaccine.  * 01/17/21 - Noticed my heart rate was at 120 bpm and I was extremely tired.  * 01/24/21 - I noticed that I?ve started getting headaches more frequently. I rarely got headaches before (maybe 3-4 per year) * 1/25/21 - Had one of the worst migraines I?ve ever had. Blurred vision.  * 1/26/21 - Went to the E.R. to get my heart checked because my heart rate was high and I was extremely tired. Also had a minor headache.  * 1/27/21 - I still do not feel right. My heart flutters. Come and go headache. Very sleepy, though I had good sleep the night before.
Chills; Body aches/ soreness; Tiredness/extreme tiredness; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer or other non-healthcare professional. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 (Batch/Lot number and Expiry date was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Feb2021, the patient experienced tiredness/extreme tiredness, chills and body aches/soreness. It was reported that the patient received his 2nd shot 6 days ago, 09Feb2021 mentioned right after the shot he experienced tiredness and went fine ever since. He further said that right now, since last night he experienced a feeling of extreme tiredness, chills, body aches, and soreness and asked that if that was considered okay. The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
This spontaneous report was received from a healthcare worker refers to a female patient of approximately 1 year old. No information concurrent conditions and medical history was reported. On 16-JUN-2015 the patient was vaccinated with improperly stored MMR II (unknown strength, route and dose) lot # K007107 with an expiry date of 16-MAY-2016, stored at improper temperature (46.8 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Moderna COVID?19 Vaccine EUA Rash at injection site.  There has been some redness since injection but the rash seems to be spreading and very itchy
Per patient, he has shooting pain on his right arm. Pain is mainly on his under arm, armpit, and going toward his rib cage. His arm barely showed any signs of swelling when he came in to the pharmacy today.  He stated that he will continue to take ibuprofen 800 mg every 8 hours.  If his shooting pain does not go away in a day or two, he will have to go to the emergency room.
I was tired that night and slept until 11:00 am or 12 pm and muscle aches and body aches were noticed when I woke up. Thursday night, My heart started racing very quickly and it lasted for 30 minutes - my whole chest was hurting really bad and my heart was beating hard. I had a monitor  - 207 beats per minutes. Blood pressure was normal. ER - monitored my heart. I think they gave me some medication. They gave me a heart monitor to check my heart for next 14 days. There was not another occurrence.
Two hours post the injection, I developed a fever and a headache that lasted for the next 4 days. I considered this relatively normal for a vaccine. Post vaccine, I have also been experiencing itching across my entire body, which has led to bruises and hives, due to the incessant itching. It has continued with no relief. Unsure of what to do now.
I contracted COVID-19. My symptoms include muscle weakness, sore throat, difficulty moving, chest congestion, and coughing. I've been taking DAYQUIL tablets and a course of PAXLOVID.
pt called and said he broke out in hives all over his body about 3 hours after receiving his moderna booster shot. he went to the walkin clinic and was prescribed benadryl and a topical cream.  Pt just wanted us to know so we can document.
After administering the 1st Moderna vaccine patient immediately said she felt faint. She did faint for about 5 seconds, when she became alert she said she felt nauseous. 911 was called. Patient started to look red in the face and arms like hives were starting. Firefighters arrived and gave her IV Benadryl and an ambulance took her to the nearest hospital.
This non-serious spontaneous case, initially received from other non-health professional on 19-Jan-2018, concerns a 39 and half month old (child) patient of an unspecified gender. On an unspecified age, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number, and expiry date: not reported). It was stated that, no adverse event was reported after the vaccination.
Pt  returned to clinic on 10-13-2020 for black spot, redness on right upper arm where pneumococcal vaccine was placed.  Pt states that arm had soreness, redness and swelling the same day as the injection, on 9-28-2020.  Pt states that she developed an ulcer to the area one week after the injection.    She contacted the clinic on 10-12-2020 to notify of the reaction and returned to our office on 10-13-2020; finding by provider were 25 X 10mm black eshcar over the lateral aspect of the right upper arm with surrounding erythema and tenderness.  Pt was prescribed cephalexin 500mg every 12 hours orally for 10 days and also given instructions on wet to dry dressing changes daily.  A moist dressing was applied in the clinic.  Pt scheduled to follow up in one week.