chrisvoncsefalvay/vaers-outcomes huggingface dataset:
POUNDING HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced pounding headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pounding headache. This report was non-serious.
Pt rec'd immunization 12/11/01 at 9:30am later in afternoon L upper arm began to hurt and developed swelling & redness involving whole upper arm. Pt called MD and was instructed to apply warm, moist wash cloth. Arm worsened, pt called MD back per pt MD couldn't fit her in so told her to go to ER. Pt was seen at ER and given an IV and IV antibiotics for an hr. Sent home with script for Cephalexin 500mg tid x 7 days. Pt said ER dx'd arm as a cellulitis.
Patient received Pfizer COVID-19 vaccine without any immediate complication on 1/14/21approx 1455, was then escorted to observation area for a 30 minute observation time. Pt had previously had a known reaction to contrast media.  Approximately 5 -8 minutes into observation, pt had one audible cough.  Nurse asked patient if this was a new onset cough. The patient stated she would try to "manage" cough. Pt escorted to bay for monitoring. Pt developed shortness of breath and wheezing rapidly. Rapid response team called and local 9-11 also called. Pt received albuterol nebulizer treatment, placed on O2 at 8L. O2 sat 99%, HR 115-120. Respiratory therapy assisted and Rapid Response Team monitored pt while waiting for EMS.  Physician order to give Epinephrine 0.3 mg IM in right deltoid, given as directed at approx 1515. Second epinephrine 0.3 mg IM given approx 1530-1535.  HR 144, O2 sat 99%. Patient transported to local ER, pt intubated approx 1927.
Fever (101.8), chills, joint pain, rash, general fatigue, headache once fever resolved. I called the doctor's office.  They stated that my symptoms could not have been due to the vaccine, that I must have the flu.
pt recv vax 20JUL95 & 30MAR96 pt presented to MD w/a mild case of chickenpox consisting of approx 58 lesions on body;also had cold-like sx & a low grade fever;tx w/med for discomfort;
Passed out, lost control of bladder, agitated, weak, memory loss,   Carried to hospital by ambulance
her throat felt like she had something stuck/she felt like she had a lump in her throat; This is a spontaneous report received from a contactable pharmacist. An unspecified aged female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, formulation: Solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient relevant medical history and concomitant medications were not reported. On an unspecified date it was reported that patient got the COVID vaccine and her throat felt like she had something stuck that lasted for a few minutes. Stated that it started two hours after the vaccine. Stated that she felt like she had a lump in her throat for about four days and then it went away. Stated that the nurse is worried about her mom getting the second one if this one is that bad. Wanted to know if her mom should get the second shot. Outcome of event was unknown.  Information on the lot/ batch number has been requested.
Patient reports shooting pain through arm, continual soreness, weakness, and feeling her arm is "not right"; Told patient should be seen by the doctor if symptoms do not improve/ if they get worse.
pt reported- dizziness, shaking, scratchy throat, chest tightness, 'feels unable to breathe'. admin 25mg PO Benadryl capsule, epi-pen JR.
p/vax pt devel chickenpox lesions on back, chest, underarms, groin area, head & abd;no fever noted;pt sought unspecified medical attention;
A report was received on 02/28/2002, concerning a 77 year old male pt who experienced shortness of breath 2 days after receiving Fluvirin vaccine on 10/09/1998. The event was considered medically important. The causality was stated to be possibly related. No further info was provided.
#1 Seasonal headache that progressed into migraine (2 days) nausea & body aches. # 2 H1N1 severe headache x 2 days.
Pt received her first Covid vaccination on 4/5/2021 few days following that, was diagnosed with filamentary keratitis and severe spasms of orbicularis oculi bilaterally.  The keratitis has resolved with treatment but she continues to have severe spasms of bilateral orbicularis oculi and cannot open her eyes.
Later Sunday June 13th arm was sore and was very tired. In the middle of the night of Sunday/ early Monday morning he woke up feeling horrible. Dizzy, nauseated, body hurt, sweating then the chills. No fever. All Monday he slept on and off waking up feeling nauseous, weak, dizzy, having chills to sweating. Monday evening started throwing up fluids. Has had no appetite. Tried to eat a piece of bread, threw it up.
Rash, redness, swelling localized at bilateral injection sites on 8/20 developed into intense itching on both injection sites 8/21/10. Symptoms relieved by 8/22/10.
Bite on arm; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of BITE (Bite on arm) and DIZZINESS (Dizzy) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced BITE (Bite on arm) and DIZZINESS (Dizzy). At the time of the report, BITE (Bite on arm) and DIZZINESS (Dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Syncope; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health professional and describes the occurrence of SYNCOPE (Syncope) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for an unknown indication.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Syncope) 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.   Concomitant medication not reported.  Treatment medication not reported.  Company Comment: Very limited information regarding the event has been provided at this time.  Further information is not expected.; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information is not expected.
Patient age of 15 got Moderna shot. Patient did not have any adverse reactions after the shot
Vaccine administered from vial which had been punctured for more than 6 hours; A spontaneous report was received from a nurse concerning a 38-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine administered from vial which has been punctured for more than 6 hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine administered from vial which had been punctured for more than 6 hours, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (Lot number: 026L20A). There were no reported AEs associated with this case.
I received my second Pfizer booster for COVID-19 on 4/27/2022. I traveled to an international airport on 9/6/2022 on a domestic flight. Of course, there is no way to be certain that this is when and where I came into contact with COVID-19, but I strongly suspect it. On the morning of 9/8/2022, I was experiencing symptoms that included runny nose, a mild fever, and dry cough. I went to an urgent care to get a rapid test, and the result was negative. The symptoms continued to develop and would not go away. On 9/10/2022, I took a home test, which yielded a positive result. I then did a telehealth visit with the urgent care and informed them of my test result, and they immediately prescribed me PAXLOVID. I began taking PAXLOVID on 9/10/2022. Within 24 hours of starting it, the symptoms subsided substantially. I finished the 5-day course and was completely symptom-free by the end of the course. About 2-3 days later, I took another home test and got a negative result. Since then, I have not had any residual issues, and I believe starting the PAXLOVID early helped.
Mild rash at/near site of injection a week after injection.  Seems to be getting better.
Immunization given 6-5-12. 4hrs after vaccination became very tired. Slept, woke up with stomach ache, headache, sore throat, itchy eyes and throat, developed hives on (L) arm, neck and forehead, local reaction at varicella injection site (warm red) area size 5.5 cm x 4cm. Took 2 BENADRYL next day (Wed.) for hives, also took 2 BENADRYL on Thurs am (today)- sent to MD.
Pt called Call center 4/23/2021 regarding of covid vaccine side effect. Noted c/o dizziness, abdominal cramping and fever(pt didn't check temperature, but pt feels cold sweats and lots of chills) today. Pt got 2nd covid vaccine(Moderna) 4/22/2021. Pt said she felt fine yesterday however from this morning pt feels dizziness as long as pt has to lay down, abdominal cramping, fever, lump at left arm injection site. Pt is taking ibuprofen. Noted hx of anxiety, insomnia, depression per pt and no allergies. Informed pt to go to ED or call 911 d/t pt shows 3 parts of emergency side effects of covid vaccine. Pt declined the offer to call 911 on behalf of pt but pt states she will go to ED. Pt is educated of covid side effects. Pt verbalized understanding.
pt recvd vax on 17FEB95 & devel fever of 107 on 19FEB95 seen in ER no findings on exam x/fever; nl exam;
24 hrs p/vax devel red, warm, pruritic, indurated (sl) inject site (8cm diameter) persisted x 2d;
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around 25-MAY-2016, the patient was vaccinated with the zoster vaccine live (ZOSTAVAX) (strength, lot # expiration date, dosage, injection anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a severe, painful burning rash on the right side of her back and was diagnosed with shingles. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, she sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Therefore, the outcome for herpes zoster was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the singles to be a disabling event.
Delayed reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Delayed reaction) in a patient of an unknown age and gender 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 VACCINATION COMPLICATION (Delayed reaction). At the time of the report, VACCINATION COMPLICATION (Delayed reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.
Blisters and rash both hands, chest and trunk. Required high dose of steroids and ER visits.
Neck pain started might of injection, woke up with migraine headache and fever lasted throughout the day . I did not have any side effects with first two . Only booster at half the dose 8 months later
Patient complained of pain immediately after administration of the Prevnar 20. The following day administration site was red, swollen, and hard underneath. She complained of redness under skin on both arms but not a rash. She applied cold/ice compress and alternated with Tylenol/Ibuprofen. She said pain is improving.
whelps have gone away; rash is all over her body and is not going away; rash all over her body, arms, face, legs, and bottom of her feet; broke out in whelps on her legs; itching is worse at night.; both her legs experienced intense burning and itching such that she could not sit still; went from her ankles to the top of her legs; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (both her legs experienced intense burning and itching such that she could not sit still), BURNING SENSATION (went from her ankles to the top of her legs), URTICARIA (whelps have gone away), URTICARIA (broke out in whelps on her legs) and PRURITUS (itching is worse at night.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products DIETHYLTOLUAMIDE (MOSQUITO GUARD) for an unknown indication, DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL ALLERGY/COLD) for an unknown indication and DIPHENHYDRAMINE HYDROCHLORIDE (ITCH RELIEF) for an unknown indication.    No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started DIETHYLTOLUAMIDE (MOSQUITO GUARD) (unknown route) at an unspecified dose, DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL ALLERGY/COLD) (unknown route) at an unspecified dose and DIPHENHYDRAMINE HYDROCHLORIDE (ITCH RELIEF) (unknown route) at an unspecified dose. On 06-Feb-2021, the patient experienced BURNING SENSATION (both her legs experienced intense burning and itching such that she could not sit still), BURNING SENSATION (went from her ankles to the top of her legs) and PRURITUS (itching is worse at night.). On 07-Feb-2021, the patient experienced URTICARIA (broke out in whelps on her legs) and RASH (rash all over her body, arms, face, legs, and bottom of her feet). On 09-Feb-2021, the patient experienced URTICARIA (whelps have gone away) and RASH (rash is all over her body and is not going away). At the time of the report, BURNING SENSATION (both her legs experienced intense burning and itching such that she could not sit still), BURNING SENSATION (went from her ankles to the top of her legs), URTICARIA (broke out in whelps on her legs), PRURITUS (itching is worse at night.) and RASH (rash is all over her body and is not going away) outcome was unknown, URTICARIA (whelps have gone away) had resolved and RASH (rash all over her body, arms, face, legs, and bottom of her feet) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fast heart rate that then dropped down dangerously low; Arm hurt so bad that he couldn't move it; Looked like, like he had the flu; Very high fever; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE ABNORMAL (Fast heart rate that then dropped down dangerously low), PAIN IN EXTREMITY (Arm hurt so bad that he couldn't move it), INFLUENZA LIKE ILLNESS (Looked like, like he had the flu) and PYREXIA (Very high fever) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE ABNORMAL (Fast heart rate that then dropped down dangerously low), PAIN IN EXTREMITY (Arm hurt so bad that he couldn't move it), INFLUENZA LIKE ILLNESS (Looked like, like he had the flu) and PYREXIA (Very high fever). At the time of the report, HEART RATE ABNORMAL (Fast heart rate that then dropped down dangerously low), PAIN IN EXTREMITY (Arm hurt so bad that he couldn't move it), INFLUENZA LIKE ILLNESS (Looked like, like he had the flu) and PYREXIA (Very high fever) had resolved.            No concomitant medications were provided. Treatment medications were unknown.    This case was linked to MOD-2021-028056 (Patient Link).
Case number PHEH2015US020308, is an initial spontaneous report from a nurse received on 08 Oct 2015. This report refers to a 61-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1515701) 0.5 ml intramuscular on 07 Oct 2015. It was reported that the patient received FLUVIRIN MDV that was out of temperature range at 47F before administration. No adverse event was reported.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 13-month-old patient of unknown gender and ethnicity received PREVNAR via an unknown route of administration in Mar2003. Relevant medical history, relevant sibling information, and concomitant medications were unknown. Vaccines that may have been given on the same day and/or within the last four weeks were unknown. In Mar2004, the patient experienced meningitis. Relevant therapeutic measures in response to the event meningitis included cochlear implants. Relevant lab data was unknown. The clinical outcome of the event meningitis was unknown. Subsequently, a contactable physician reported being unable to confirm the occurrence of the event meningitis and was unable to provide information. Follow-up (24Jun2013): New information reported from a contactable physician includes: No new information; physician unable to confirm event meningitis. Follow-up attempts completed. No further information expected.
Father stated that child could not walk when he awoke. He was instructed to call his physician and call us back. His physician told him to take the child to the emergency room. Father decided not to take the child because it was "prayer day". Instead he took him to prayer services and had a physician friend look at him there. He told us (health dept) that the physician friend said the child had a reaction to the vaccine. We asked if the physician friend would be willing to talk to us or write a statement, he said "no". The child has since recovered according to the father.
Extremely lightheaded/dizzy/lightheadedness; Nauseas; Chilling/ chills; Started getting headache and was tired.; Started getting headache and was tired.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 09:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history was reported that the only thing the patient could thought was she had a temporary crown dental appointment on Tuesday, 24Apr2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no any known allergies. Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 09:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, the patient had a normal routine after vaccination and started getting headache and was tired. The patient had no exertion on Saturday (24Apr2021) and worked on computer. On 25Apr2021, the patient went to work in yard (patient used to do every day) and within 30 minutes at 14:30, the patient experienced extremely lightheaded, dizzy, nauseas and started chilling. The patient slept all the night and woke up next morning (26Apr2021) with chills headache and light-headedness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, tired, extremely lightheaded/dizzy/lightheadedness, nauseas and chilling/chills was not resolved at the time of this report..  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.