chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated he usually feels lightheaded, sweaty after anything involving needles. A few minutes after receiving the vaccine, the patient stated he felt those feelings and it is usually resolved by having a candy bar. I gave him a chocolate granola bar and some chocolate candy. Patient stated that just seeing the food I brought had him feel better. He was back up to 100% a few minutes after. After full observation patient was fine to leave.
Moderna COVID-19 Vaccine EUA Soreness and warm at shot site but not hard. Extreme fatigue
extremely sore arm, long lasting pain, soreness, throbbing, pins and needles, numbness . Treated with Ibuprofen then Prednisone then back to Ibuprofen. 5 weeks out and off all meds but still painful and uncomfortable
Pain at injection site and limited ROM. As of 2/02/2010 the patient is still experiencing symptoms and has not seen a doctor.
minor arm pain; 7 days after the vaccine, I developed a red welt about 3inches in diameter.  w; It was raised off of the skin, was a defined red circle,; caused my upper arm to swell,; as hot to the touch,; was itchy.; This is a spontaneous report from a contactable consumer, the patient. A 23-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in left arm on 20Mar2021 at 16:30 (at the age of 23-years-old) as single for COVID-19 immunisation. Medical history included asthma, environmental allergy to trees, molds, animals and attention deficit hyperactivity disorder. Concomitant medications included vyvanse (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN), breo ellipta (MANUFACTURER UNKNOWN) and birth control pill. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient experienced pain in arm after two days of vaccination and on 27Mar2021 at 12:00, red welt for about 3 inches in diameter after 7 days of vaccination, which was raised off from the skin around a defined red circle which caused the upper arm to swell, was hot to touch and itchy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The adverse events resulted in doctor or other health care professional or clinic visit. The patient did not receive any treatments for the adverse events. The clinical outcome of welts, skin red, swelling arm, hot dry skin, itchy were recovering at the time of the report. The clinical outcome of the pain in arm was recovered at the time of this report.   No follow-up attempts needed. No further information expected.
Information has been received from a physician concerning a 64 year old male with a history of chickenpox and no known allergies who on 02 JUL 2007 (also reported on 03 JUL 2007) was vaccinated on right deltoid muscle with a 0.65 ml dose of zoster vaccine live (Oka/Merck) (lot # 657765/0585U).  On 06-JUL-2007 the patient experienced bad rash.  There was no recent exposure to chickenpox.  It was reported that the rash developed 3 days after vaccination.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Tested positive for COVID / she got COVID on an unspecified date; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. While reporting for herself, the reporter mentioned that she had a friend who was a pharmacist and she got the COVID vaccine and five days later, she got COVID on an unspecified date and she posted it on a social media. She said she must have been exposed before that. She did not have any additional details to report. Outcome of event was unknown.  Information on the Batch/Lot number has been requested.
Developed bilateral ankle pain on 4/28 which progressed to significant ankle pain (difficulty bearing weight) and rashes to both ankles, now spreading up both legs on 4/30.
Patient received second dose of vaccination and fainted a couple of minutes after receiving the vaccination. Patient sat down and rested for about fifteen to twenty minutes and felt fine.
10 x 10cm urticaria left deltoid - swelling, tender to touch - started on ZYRTEC qd.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Mar2021 13:15 (Lot number: ER8733) at the age of 31 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Moderate Obesity" (unspecified if ongoing), notes: verbatim: Moderate Obesity; "Metabolic Syndrome" (unspecified if ongoing), notes: verbatim: Metabolic Syndrome. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 29Mar2021 13:15, outcome "recovered" and all described as "Moderately sore arm. Was difficult to lift hand above eye level for about first 2 to 18 hours after inoculation. Driving with both hands on the steering wheel the morning after was challenging". Therapeutic measures were not taken as a result of pain in extremity, loss of personal independence in daily activities. Additional information: It was reported that, Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He had not received other medications within 2 weeks of vaccination. Since the vaccination, he was not tested for COVID-19. Prior to vaccination, he was not diagnosed with COVID-19. Allergies to medications, food, or other products reported as none. No follow-up attempts are possible. No further information is expected.
Client passed out of chair face first on ground while sitting in observation right after receiving injection. Client convulsed for 15 seconds. Vital signs taken - BP 70/50, pulse ox 98% on room air, pulse 60. Client then became alert and oriented. EMS called and arrived on scene. Client refused EMS transport. Vital signs stable. Mom and boyfriend called via client phone. Boyfriend took client in his car. ER follow-up recommended by APRN on scene. Client has history of 1 other seizure. No other pertinent medical history. No injury from fall.
Significant injection site discomfort in addition to a sore type of catching pain that starts at the deltoid and radiates along the inner upper arm.  The injection site pain went away however she continues to have that discomfort which catches with any functional lifting or flexion of the left upper arm.
pt recvd vax while sitting down; immed appeared to faint & began shaking; both arms & legs shook for about 25 seconds; pt came out of it by self & was dazed for a minute then became more alert;
Patient states of soreness x 4 days, then began to swell (size of grapefruit) and red and warm to touch and hard. Recommendation ice and hydrocortisone cream. Will call in AM to check on.
Headache, Myalgia, NauseaVomiting, malaise Narrative:   Other Relevant History:
15 MINUTES AFTER SHOT- DIZZINESS, BLURRY VISION, SHORTNESS OF BREATH, SOME CHEST PAIN, INTENSE ANXIETY
Headache, Myalgia, c/o injection site pain,reddness,and swelling. having chills. Told to follow up with primary care physician if problems persist Narrative:
pt reported feeling heavy, unsure and staff noticed poss swelling of her eyes.  escorted pt to first aid area. took pt vital signs, medical history, assessed pt , encouraged pt to stay 30 minutes for further monitoring; encouraged pt to call her dr when she goes home if she does not feel well.  pt denied symptoms of anaphylaxis-no sob, itching, nausea, hives
Fever, UrticariaPruritus, Redness and swelling at injection site Narrative:  Other Relevant History:
Information has been received from a consumer concerning a male who, on an unknown date, was vaccinated with MMR II (lot # not reported). There was no concomitant medication. It was reported by the child's mother she "would never give her child MMR II because it caused my son to develop autistic symptoms." A product quality complaint was not involved. Upon internal review, autism was determined to be an other important medical event. No further information was available.
I had a very sore throat and next day runny nose and the 3rd day extreme fatigue, I couldn't get out of bed and couldn't function. Did not test for Covid. Spoke to insurance company on 5 or 6 Aug2021 and they they concluded that it was Covid. The extreme fatigue was the same feeling as I had on my 2nd dose.
Tongue numbess, burned sensation -- immediate onset after 2nd injection. Symptoms remain the same after 9 days post vaccination
left side of face tight; Bone pain around eye and cheek bone; headache; left eye watering; Face tightness; Ear ache; This spontaneous case was reported by a consumer and describes the occurrence of REDUCED FACIAL EXPRESSION (left side of face tight), BONE PAIN (Bone pain around eye and cheek bone), HEADACHE (headache), LACRIMATION INCREASED (left eye watering) and REDUCED FACIAL EXPRESSION (Face tightness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced REDUCED FACIAL EXPRESSION (left side of face tight), BONE PAIN (Bone pain around eye and cheek bone), HEADACHE (headache), LACRIMATION INCREASED (left eye watering), REDUCED FACIAL EXPRESSION (Face tightness) and EAR PAIN (Ear ache). On 26-Feb-2021, HEADACHE (headache) had resolved. On 27-Feb-2021, LACRIMATION INCREASED (left eye watering) had resolved. On 03-Mar-2021, BONE PAIN (Bone pain around eye and cheek bone) had resolved. At the time of the report, REDUCED FACIAL EXPRESSION (left side of face tight), REDUCED FACIAL EXPRESSION (Face tightness) and EAR PAIN (Ear ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Severe swelling in limbs that severely limits my range of motion even causing me to walk with a walker, developed love handles on my sides
FEVER; BODY ACHES; CHILLS; HEADACHE; This case was reported by a consumer and described the occurrence of fever 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, 5 hrs after receiving Shingrix, the patient experienced fever, general body pain, chills and headache. On an unknown date, the outcome of the fever, general body pain, chills and headache were not recovered/not resolved.   It was unknown if the reporter considered the fever, general body pain, chills and headache to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient experienced fever, body aches, chills and headache about five hours after receiving second dose of Shingrix. The reporter asked how long would these side effects last. The follow-up would not possible as no contact details were available.
3-4 inch induration on right arm.  1-2 days following vaccination shot.
10 minutes after vaccine administration, patient reported feeling lightheaded and had a syncopal episode, fell off chair and hit head on the ground.  EMS was present.  BP was low and patient was mildly hypotensive.  Patient started feeling better after some water, juice, and pretzels.  BP stabilized.  He was able to leave the vaccine area after 30 minutes.  Follow up phone call that afternoon, he reported feeling better.  Follow up phone call on 4/13, reports he is feeling fine.  No complaints.
Tingling in extremities, slight nausea, dizziness upon standing. Symptoms progressed to mid-grade fever, aches and joint pain, vomiting.
12 weeks and 2 days pregnant when administed the vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (12 weeks and 2 days pregnant when administed the vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 22-Jul-2021. On 09-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (12 weeks and 2 days pregnant when administed the vaccine). On 09-Jan-2021, EXPOSURE DURING PREGNANCY (12 weeks and 2 days pregnant when administed the vaccine) had resolved. Not Provided      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 medications were not provided. Treatment details were not provided; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 42-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Pt claims she had a bad reaction to a flu vaccine received 12/18/2014. Pt received flu shot on left arm but pt is complaining she is having issue with her right arm. Pt complained on 7/22/2016 to pharmacy staff.
pt devel papulovesicular crusted lesions rt side of forehead & face;lesion started on 10/19/99 seen in office 10/20/99;pt seen by MD pt condition worse by evening;pt irritable, listless & looked sick;adm to hosp;  60 day follow-up received on 10/5/00 states that the pt has recovered.
This spontaneous report as received from a physician refers to a patient of unknown demographics. The patient has received a dose of ZOSTAVAX 19400 PFU (dose, site of administration unknown) at an unspecified date in the past and inadvertently was vaccinated with ZOSTAVAX on 28-OCT-2014. No concomitant medications were reported. No adverse effects were reported. Product quality complaint was not reported. The outcome of patient received a dose of ZOSTAVAX at an unspecified date in the past and inadvertently received a second dose was unknown. Additional information has been requested.
Paramedic assessed patient.  Pt stated dizzy, lightheaded, blurry vision, flushing-felt hot.  BP 135/78, HR 75bpm, respiratory 24.  Hx of ABX allergy rocephin.   Pt. monitored and was stable to leave upon expired observation time.
Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 17 year old daughter who experienced chills, nasal congestion, nasal drainage, and sleeping longer.  At 17 years of age, the pt received a dose on 12/13/03.  The pt's concurrent illness includes seasonal allergy.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/13/03.  Dose regimen was 1 dose 1 (IN).  Concomitant therapy included Claritin.  The pt experienced chills, nasal congestion, nasal drainage, and sleeping longer on 12/15/03.  The mother reported that her daughter slept twelve hours on the night on 12/15/03 and had to stay home from school on 12/16/03.  The mother indicated that Sudafed and Claritin have not helped with the congestion and drainage.  No additional information was available at the date of this report. Follow-up information received from the patient's mother provided additional event details and physician information. On 15-Dec-2003, the patient developed a "flu like cold" (influenza like illness), chills (rigors), nasal congestion (nasal congestion), nasal drainage (nasal sinus drainage) and sleeping longer (somnolence). The mother reported that her daughter slept twelve hours on the night of 15-Dec-2003 and had to stay home from school on 16-Dec-2003. The mother indicated that Sudafed (psudoephedrine) and Claritin have not helped with the congestion and drainage. The mother reported that the symptoms lasted for three days, and the patient did not see a physician. No additional information was available at the date of this report.  The physician reported taht the patient recovered.
Reaction included hives and swelling 10 cm circumference of injection site, fever and extreme tenderness at site. Was seen in Medical Center ER at 10:00PM on 8-20-14. Treated with BENADRYL PO and CELESTONE IM. Patient kept out of school on 8-21-14 per parent.
Approximately 24 hours after vaccination patient noticed the area was red, hot, inflamed, itchy and painful.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 6:47 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 6:47 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. Patients were given doses from vials that were stored in an ultracold freezer which is colder than they should have been. The vial undergone temperature excursions for one month. The vial was in frozen state at the time of the excursion. The vials moved from freezer to refrigerator on  19-Nov-2021. The maximum and minimum reached temperatures was negative 82 degrees Fahrenheit. The vials were returned to the freezer or refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.   This case was linked to MOD-2021-402935 (Patient Link).
Breakthrough case of varicella. Seen 04/30/02 with 2 days of vesicular rash dx with chicken pox seen by docotr. Samples of aveeno/Exerin given.
diagnosed with Covid-19 infection 8 days after receiving initial dose of vaccine. Not hospitalized but did go to ED for evaluation Narrative: Went to ED on 12/30 for evaluation of symptoms that began on 12/25. Vaccine given on 12/22, Diagnosed with Covid 19 with left sided pneumonia. Discharged home from ED
expired ActHib vaccine was administered to a patient in error, no adverse event; Initial information was received on 04-May-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves an adult patient who was administered an expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] (Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Apr-2020, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot number not reported, expiry date: 13-Mar-2020) via unknown route in unknown administration site for prophylactic vaccination  It was a case of an actual medication error due to Expired product administered.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on lot number
No additional AE; PROQUAD was accidently given to a 13 year old patient on 17AUG2022.; This spontaneous report was received from an other health professional who is an educator and refers to a 13-year-old patient of unknown gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 17-AUG-2022, the patient was accidently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age). No additional adverse events details or product quality complaints were reported (no adverse event).
Red mark at injection site; Oval redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red mark at injection site) and ERYTHEMA (Oval redness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included MIRABEGRON (MYRBETRIQ) and CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red mark at injection site) and ERYTHEMA (Oval redness). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Red mark at injection site) and ERYTHEMA (Oval redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.