chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12hr after second dose: increased pain at injection site, but no swelling or redness; headache; Discomfort is a 6/10; gradual onset of soreness raidiating from lymphnodes in neck; gradual onset of soreness in chest/ soreness in bronchi; gradual onset of soreness in back; gradual onset of soreness in hips; gradual onset of soreness in legs; gradual onset of soreness in glutes; soreness in upper lungs; soreness in upper respiratory system; This is a spontaneous report from a non-contactable consumer. A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247), via an unspecified route of administration on the left arm from 18Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included major depression, anxiety; increased airway sensitivity due to being former smoker from an unknown date and unknown if ongoing. Concomitant medication included vilazodone hydrochloride (VIIBRYD), loratadine (LORATADINE), theanine (THEANINE).  The patient previously received the first dose on 28Dec2020 (Lot number=EK3730). There were no noticable effects after the first dose but 12hrs after second dose (19Jan2021), the patient experienced increased pain at injection site, but no swelling or redness. There was gradual onset of soreness raidiating from lymphnodes in neck, chest, back, hips/glutes, and legs; headache; soreness in upper lungs/bronchii (they are hypersensitive and usually sometimes get sore in reaction to irritants in the air), as well as upper respiratory system, but no difficulty breathing. Discomfort was at 6/10 on 19Jan2021. The outcome of the events was not recovered.
Child became lethargic 12/12/13 in afternoon - had seizure - was unable to arouse baby - went to ER - transferred to another hospital by ambulance. Remained unable to arouse baby for total of 13 hours. Discharged 12/14/13.
This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 72.68 degrees Fahrenheit for 84 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as no consent was given for further contact.
She got her vaccine, didn't have any reaction at the beginning.  Then about 8:00 is when she started getting the reaction.  It felt like a car was on top of her body, she could not move, could not walk was taking baby steps.  She was very anxious, her heart was palpitating, and just felt weird like something wasn't right, and was very nervous.  Was also sweating a lot too.  She called the Advice nurse and was told to go to the ER.  She went to the ER, and they told her that sometimes people have really bad reactions to the shingles vaccine, and they gave her something to take.  She took the medicine orally and then they gave her some Ativan for her anxiety.  This did not help really much, and was discharged from the ER.  They did blood work and everything came back on  her and that it was probably just a reaction to the vaccine.  Everyday it is getting better, and today she says that she feels good.  She is not having any symptoms at all right now.    She states that she will never get any type of vaccine as long as she lives as she felt like she was dying.
PM on the day after vaccination(2/19/20) patient was lethargic, no fever or chills & injection sites wnl, early evening he was nauseated and vomited x1, did not seek medical attention and did not give any medication for symptoms. Today 2/26/20 Mom called in to report this, stating patient appears a little better but still lethargic according to Mom. Advised her to take patient to PCP and I will follow up with her tomorrow to see how he is doing.
This is an 82-year-old female with history of cerebellar degeneration, who had her first COVID vaccine today around 11  a.m. she was in her usual state of health prior to that time. About two  and half hours afterwards she became nauseated.  She had several bouts of  emesis and then had a fall.  She was found to be hypotensive and  bradycardic.  The ambulance crew actually gave her atropine at the same  because she had a pulse in the 30s, improved her quickly and she presented to the ER.  She is to remain very orthostatic, received several liters of  IV fluid as now symptomatically better.  She remains a little nauseated.   She denies any headache, diarrhea, fatigue, or myalgias.  She does not  feel quite right.  She is still dizzy with sitting up.
Breathing difficulty, phlegm production, and headache. Patient took excedrin for headache and upon supine position breathing difficulty worsened. Advised patient to take diphenhydramine to stop any allergic reaction from worsening and would follow up with him hourly to check status.
Information has been received from a registered nurse concerning a 32 month old male with no known allergies or past medical history, who on 22-NOV-2004 was vaccinated in the left thigh with a first dose of Varivax (lot#647528/1242N). There was no illness at the time of vaccination. The patient's Grandmother, who lives with the patient's family "recently" had shingles and on 18-JUL-2006 the patient developed a rash of pimples, tiny red dots that increased in size during the day. On 25-JUL-2006 the patient presented to the Physician's office with hot, 0.5 centimeter red non vesicular papules on his arms and legs. The patient was afebrile. There was no treatment. On 28-JUL-2006 the patient recovered. There was no product quality complaint involved. Additional information is not expected.
had a sore arm for 1 day after vaccination; This is a spontaneous report from a contactable Physician communicated to a Pfizer Sales Representative. This Physician reported for an elderly male patient. A 9-decade-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced had a sore arm for 1 day after vaccination. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Itchy Rash at injection site, about 2-3 inches in diameter. Lasted 6 days.
Muscle aches, fatigue, chills, felt like I was burning up but to sick to take temp.  Next morning about 11:00 am, felt a little better but temp of 101, chills went away, less muscle aches, but experienced exhaustion, still some fatigue that slowly faded over days.   Temp reduced to about 98 after about two days after shot. Currently, still have some low level fatigue at various times of the day.
Information has been received from a physician concerning a 6 year old male who on 08-JAN-2004 was vaccinated with varicella virus vaccine live (Oka/Merck). On 22-FEB-2007, two days prior to being seen by his physician, the patient developed a rash on his chest and face. He had about 12 lesions in various stages of eruption, with tiny vesicles in addition to bigger scabbed over lesions. He had a few lesions on his body, his forehead, and one on his scalp. Subsequently, the patient was diagnosed with post vaccine chickenpox. The patient was recovered at the time of this report. Additional information is not expected.
High fever, severe muscle and body as a whole aches, night sweats, chills.  Full scale flu-like symptoms excepting respiratory.
About 6 hours after receiving dose, experienced aching in both arms that extended down into both hands - hands was resolved by next morning. Achiness in both arms remained x 48 hours
Admitted 7/27/2021 to the hospital with cough and fever, no hypoxia or respiratory distress. Determined to be pneumonia with sepsis. Returned to home at CBRF facility 7/29/2021. Contact with DON of CBRF facility on 8/10 - report was client was doing well on a modified diet. They had thought the pneumonia was from aspiration and after swallow study, they started him on a dysphagia diet. Submitter does not have access to further medical records for this client. Please contact the hospital indicated for any follow up information.
20DEC 8AM-eyes rolled back, turned white, formed tight fists;LOC for 1-1/2min;13JAN96 9AM up for a while father rocking drew up feet, head fell back, turned white, eyes rolled back, unresponsive-called amb-to hosp
Inappropriate 5/8" needle was attached to syringe due to consecutive flu shots of an elderly patient and then a small child.  Patient was given the vaccine using 5/8" needle, providing a subcutaneous injection of an intramusclar vaccine.  Patient was informed of route of administration error and instructed to return to pharmacy for proper vaccination administration.
vaccinated from expired vial (about 50 days refrigerated); received the vaccine from a vial that was refrigerated, that was about 20 days past the 30 day mark; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated from expired vial (about 50 days refrigerated)) in a patient of an unknown age and gender 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 EXPIRED PRODUCT ADMINISTERED (vaccinated from expired vial (about 50 days refrigerated)).        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.  Concomitant medication was not reported. Treatment information was not reported.
Red rash around where the injection site; Red rash around where the injection site; A little painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red rash around where the injection site), VACCINATION SITE ERYTHEMA (Red rash around where the injection site) and VACCINATION SITE PAIN (A little painful) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (The patient takes nasal spray for allergy). Concomitant products included GABAPENTIN, LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN D3 and KALLIDINOGENASE (SOMAX) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE RASH (Red rash around where the injection site), VACCINATION SITE ERYTHEMA (Red rash around where the injection site) and VACCINATION SITE PAIN (A little painful). At the time of the report, VACCINATION SITE RASH (Red rash around where the injection site), VACCINATION SITE ERYTHEMA (Red rash around where the injection site) and VACCINATION SITE PAIN (A little painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication also included antidepressants, nasal spray for allergy.   Treatment medications were not provided.   This case was linked to MOD-2021-082190 (E2B Linked Report).; Sender's Comments:  MOD-2021-082190:Same patient (2nd dose)
Left facial swelling involving left side of her mouth, impacting her ability to speak clearly. Sx developed and progressed approximately 20 min. after receiving the Flu shot. Went to emergency Department.
Local injection site reaction: Red raised area, hot about 3x6. Resolved in 3-4 days. Systemic Rxn: On Wednesday 4/10/13 patient developed rash, fever, flu-like symptoms, bad body aches, listless, no energy, nausea. No itching or pain with rash.
Admission diagnosis: COVID pneumonia with hypoxic respiratory failure Patient presented to her local emergency department, reportedly as she felt dehydrated.  She states that over the last day, she had poor appetite, felt vaguely nauseated, and wasn't eating or drinking as a result. She also endorsed generalized weakness and fatigue, along with mild nonproductive cough.  Otherwise, no shortness of breath, chest pain, pleuritic pain, change in taste or smell. She tells me that she started to have diarrhea after she was started on IVF. No recent antibiotic exposure.  No identifiable sick contacts.  She lives with her husband only and does not work outside the home.  They spend their time hurting livestock including sheep.  Her only possible recent exposure was grocery store trip.  However, she was masked at that time.  She also reports receiving both Pfizer doses April 2021.  ED Course: Hypoxic to 80% on RA, 90s on 2L. Received ceftriaxone 1 g, azithromycin 500 mg, and was started on normal saline at 100 mL an hour.
her head started itching; lip was swollen; rash all over the place; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 02Feb2021 (at the age of 67-years-old) (Lot Number: EL3302) as dose 1, single for COVID-19 immunisation; oxycodone hydrochloride, paracetamol (OXYCODONE/APAP [OXYCODONE HYDROCHLORIDE;PARACETAMOL], tablet strength: 5mg/325mg), via an unspecified route of administration from 15Feb2021 (Batch/Lot number was not reported) to an unspecified date, at 3 DF (5-325mg, caller only took three total tablets) for an unspecified indication.  Medical history included reactions to adhesives used in surgery and gallbladder operation on 15Feb2021. It was reported by the patient that her gallbladder surgery was not an emergency and knew she needed the surgery prior to getting the COVID vaccine. There were no concomitant medications.  On 16Feb2021, the patient experienced lip was swollen, rash all over the place, and her head started itching. The patient does not know if the reaction was due to the vaccine or the medication she got from her surgery. The patient informed that she was due for the second dose of the product and was wondering if she should still get it. The outcome of the events lip swelling, and rash all over was recovering/resolving whereas outcome of the event itching was recovered/resolved on an unspecified date.    No follow-up attempts are possible. No further information is expected.
5 minutes post first covid shot, patient complained of dizziness, feeling hot, and visual disturbances (seeing stars). He was pale/yellow and eyes hard to keep open. Pulse was 75. BP 114/77. Patient indicated on var and when questioned prior to administration that he had no allergies and no problem with any shots in the past. Questioned him again and wife told me that he did have a history of passing out with blood draws. Applied ice packs on head and wrists and got patient flat on floor with feet elevated. Family requested that EMS be called.  Nurse standing in line assisted in monitoring patient until EMS arrived. Blood sugar was 108 and pulse 117/77 taken by EMS. Patient was able to stand for them and refused transport. He remained seated for 20 minutes longer after they left. He was able to stand without symptoms and said he felt fine.
High fever; chills; shakes; vertigo a few times; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever), CHILLS (chills), TREMOR (shakes) and VERTIGO (vertigo a few times) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PYREXIA (High fever), CHILLS (chills), TREMOR (shakes) and VERTIGO (vertigo a few times). At the time of the report, PYREXIA (High fever), CHILLS (chills), TREMOR (shakes) and VERTIGO (vertigo a few times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported.  Treatment medication not reported.
Tested positive for COVID-19 on 06/11/2022. I received my 4th dose on 04/16/22 and my COVID-19 symptoms started in the morning severe congestions; headache; cough and extremely low energy. My wife called through tele health and they prescribed me PAXLOVID for 5 days. My severe symptoms lasted for 3 and a half days.
Redness at the injection site the same day,  followed by a rash and hot to the touch on 4/22/21.  Also reports fatigue.
Patient received monovalent pfizer vaccine as booster dose instead of bivalent pfizer vaccine. No adverse events.
Flu shot 12-21-16-Temp to 100.6. No other sx.
p/vax began breaking out with rash & mom called had & stated pt had numerous lesions on face which were draining;
Onset of abdominal pain and arm pain that night; on 12/12/09 she woke up with "black" vision that resolved when she laid down, worsened abdominal pain, vomiting, and multiple episodes of syncope. She was seen in the ED at about 12:00 and found to have HR 58, normal BP, treated for presumed UTI and discharged. Her pain worsened over the next few hours and she had perioral cyanosis when she vomited. She went back to the ED around 20:00 and was found to have HR in the 20s-30s with worsening hemodynamic instability.  EKG showed complete heart block. Echo showed dilated cardiomyopathy. Intubated, started on epinephrine drip and transcutaneous pacing and transferred to PICU.
RASH  one week after that itches at the spot on the arm where they inserted the needle.
Mouth bump, with pain, on inside of right upper lip. Swollen in right upper lip area. NOT an open sore but a painful bump lasting 3 days. Bump smaller and lip no longer swollen, with little to no pain by day 4.
Fever of 101.0, lasted 12 hours.  Sore arm and under arm for 24 hours.  Headache 12 hours.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hyperlipemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid from 07Aug2022 to 11Aug2022 treatment of COVID-19.
Red warm area at injection site. Ice, Ibuprofen, hydrocortisone cream. Site appears low and posterior, possibly in SQ area. On 10/23/17 redness and swelling resolved.
Pt arrives to the observation area following her vaccination with complaints of headache and dizziness.  She is with her mother.  She arrives at 1555 with a headache and dizziness and being flushed.  BP 161/120 HR 99 Oxygen 100% room air she is Aox3 1605 BP 169/123 HR 100 oxygen 100% room air remains flushed apple juice given patient tolerated well 1610 manual BP done 148/120 1620 BP 172/120 HR 104 Pt is reluctant to go to the ED by ambulance but with mother she has agreed to go and EMS notified 1625 pt complaints of nausea bp 170/109 hr 104 oxygen 98% room air 1630 pt remains flushed still complaining of a headache and arms being cold, pt covered with a jacket 1640 report given to  a Crew Member and pt transported to Hospital mom to follow ambulance
Numbness in the left side of my face as well as both of my lips; Muscle pain all over body; Joint pain all over body; Headache; Elevated temperature of around 99 degrees; Chills; This is a spontaneous report from a contactable consumer. A 39-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) in left arm on 19Mar2021 at 10.45 am as a single dose (at the age of 39 years) for COVID-19 immunisation. Medical history included hypertension and obesity. Concomitant medication included blood pressure medication (not mentioned name of the medication). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 19Mar2021 at 19:45,the patient experienced numbness in the left side of my face as well as both of my lips, muscle pain all over body, joint pain all over body, headache, elevated temperature of around 99 degrees and chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received any treatment for the event. The clinical outcome of the events numbness, muscle pain, joint pain, headache, elevated temperature and chills was still recovering at the time of the reporting. No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 16-DEC-2015, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, lot number K004541, expiration date 04-DEC-2016 (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 02-FEB-2016, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.