chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8-9 broken blood vessels in my hands/had broken blood vessels in her hands and other parts of her body; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on Jun2021 as dose 1, single for COVID-19 immunisation. The patient medical history included she was born with hole in her heart from an unknown date and unknown if ongoing and concomitant medications were not reported. On an unspecified date in Jun2021, the patient experienced 8-9 broken blood vessels in her hands and other parts of her body. This lasted a couple of weeks. When the caller went for her 2nd dose, she was turned away and told to follow up with her HCP, because of the broken blood vessels after the 1st dose. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Dose 1 Pfizer 04/23/2021 EW0172  pt has covid 19 8/18/2021
On 10/10/16 5 month old pt was given KINRIX which is for ages 4-6 years.
Pain and swelling left leg (thigh and below knee), Child won't stand per mom. Treated with IV.  Complaint: cellulitis; antibiotics and PO antihistamines.
I started with headaches and fever within hours of the shot. I received the shot at work as I am an RN at a Hospital. Symptoms continued to worsen and I was finally tested for Covid and found to have + covid on 01/08/2021.  After returning to work 14 days later just never felt right. SOB with minimal exertion and unable to exercise. Primary care at the time added Prvovental inhaler and said possible exercise induced asthma post covid. Inhaler did not help and infact made me feel worse. In April 2021- ended up in ER for tachycardia 140-148 that lasted close to 2 hours before deciding to go to ER. In ER after another few hours heart rate came down to 100's. Sent home and told to follow up with a cardiologist for ? heart failure and new onset left bundle branch block. Cardiologist subsequently did an ECHO showing "severe left ventricular dysfunction and ejection fraction of 30"  Put on Entresto and metoprolol which I am still on. (previous HCTZ and ramapril were of course stopped)  Cardiologist said "viral Cardiomyopathy" However unsure if caused by  Covid shot or the fact that I obviously was exposed and had Covid when I received the shot.
Left arm pain and tightness. Difficulty lifting arm to the side and behind without pain. Loss of strength. Treatments: Physical Therapy, Chiropractor, massage therapist, accupuncture
Freezing cold, could not warm up for hours. Very mild fever. Eyes were foggy and dazed. Very little movement could be made. Headache.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received FLUARIX QUADRIVALENT  (batch number 2RG54, expiry date 30th June 2017). On 16th September 2016, the patient received the 5th dose of FLUARIX QUADRIVALENT .5 ml. On 16th September 2016, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The health care professional reports that the patient complained of arm pain in right arm after receiving the FLUARIX. The patient said there was pain with lifting. The health care professional stated that the patient had similar symptoms in the past with non GlaxoSmithKline flu vaccines. Patient would be seeing an orthopaedic doctor.
In the middle of the night 1 week following the vaccination, my left deltoid became extremely itchy.  Over the next day a circular red rash appeared about 3-4? long and 2? wide with some mild swelling and the area remained itchy.  I only had soreness at the injection site that lasted 2-3 days before this developed.  I never developed fever, or any other side effects.  I did not take any medications for this rash because I am breastfeeding a 4 month old.  The rash is still faintly present and mildly itchy still, nearly 2 weeks after receiving the first shot and 1 week after this side effect first appeared.
after receiving vaccine, patient vomited and presented lethargic. mother discloses after vaccine paint complained of chest pain few hours earlier. vital sigh initiated, ems activated. client pointed to abdominal area and complained of pain.    transferred to hospital
Sudden onset flushness, warm, and 'not quite right'  Vital Signs: BP 118/80 HR 68 O2Sat 98 Skin Signs: Warm and dry  Vitals taken. Continued observation.  At 15:44 HR 74 O2Sat 94 Continued observation  BP 126/78 HR 71 O2Sat 96 Pt released by medical staff  Disposition: Home by Self
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L018499, expiration date 25-FEB-2017; dose and route of administration were not provided). No adverse event were reported. Follow up information has been received from the registered nurse on 06-NOV-2015. The nurse reported that on unknown dates, the doses of improperly stored VAQTA (lot # K012457, expiration date 04-JUN-2017) (dose and route were not reported) were also administered to unspecified number of patients. Follow up information has been received on  30-DEC-2015. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information was received on 07-JAN-2016 from the registered nurse. On 29-OCT-2015, the patient of unknown age and gender was vaccinated with a dose of VAQTA (lot # L018499, expiration date 25-FEB-2017; dose and route were not reported) that was involved in the temperature excursion. The nurse confirmed that no adverse events were reported. This is one of several reports received from the same source. Additional information has been requested. Patient tab, product tab, event tab and analysis were updated.
Headache and hives. I took Benadryl and the hives went away in a couple hours.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Abdominal Pain-Mild, Additional Details: Rash on upper extremeties and torso
Patient began having seizures 8 days after receiving the Varicella vaccine.  Seizures have continued to the present.  Patient has had 20 seizures from August 15, 2007 to the time of the filing of this report on May 20, 2008.  MRI and CT scans show no physical damage, and two EEGs have been performed, one showing normal, one showing abnormal electrical brain activity. 6/2/08-records received ER visit 8/24/07-altered mental status, seizure then fell and hit head, positive for urinary incontinenece. Seen in ER seizure. Transferred to another facility.  6/26/08-records received for DOS 8/23/07-ER visit. Impression 2 events consistent with unprovoked complex partail seizures. Given history patient has complex seizure disorder.
She had shingles; Red spot on her forehead; Tingling on her forehead; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 28-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling on her forehead), HERPES ZOSTER (She had shingles) and ERYTHEMA (Red spot on her forehead) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PARAESTHESIA (Tingling on her forehead). On 20-Feb-2021, the patient experienced ERYTHEMA (Red spot on her forehead). On 25-Feb-2021, the patient experienced HERPES ZOSTER (She had shingles). At the time of the report, PARAESTHESIA (Tingling on her forehead), HERPES ZOSTER (She had shingles) and ERYTHEMA (Red spot on her forehead) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Email
Patient presented to emergency room with fever/chills and increased erythema and warmth to the right arm, surrounding where the vaccine had been given. Reaction started within 1 day after vaccine administration.  Patient received both HD-fluzone and PPSV23 at the same visit in the same arm, but stated that the redness was more surrounding where the PPSV23 was administered. Patient received broad spectrum antibiotics and was discharged with a home regimen, although cultures never grew any pathogens.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 28-JAN-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L024250, expiration date 30-JUN-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
I am the patient and also the (Privacy) here at (Privacy). We have given 27 boosters to employees. We gave them ALL 0.5ml IM injections, myself included. No adverse reactions have been noted at this time. Our dates of clinic were 12/2/2021, 12/10/2021 and 12/16/2021. It was a pharmacy and administrator error on the dosing order.   I am G2P1. Due date April 19th 2022. No adverse effect has been noted to me at this time. We just wanted to make sure the administrative error was documented properly. We will be giving 0.25ml dose Moderna boosters in our clinic tomorrow. Please contact me with any more questions. Thank you.
As nurse started to give shot, patient jerked her right arm. The needle slightly went into arm. A hematoma developed at injection site. Patient reinjected with needle. All of the vaccine was given at this time. No side effects noted. The patient's mother told to put ice on site when she gets home.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients received unspecified dose in the ROTATEQ (lot # K001831, expiry date: 21-OCT-2015) immunization series that were improperly stored. Nurse stated that the dates of administration was presently unknown. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. The case is also related to 1509USA008456, 1509USA009767, 1509USA009768 and 1509USA009766 (same reporter link). Additional information has been requested.
Blurry left eye after injection. Cleared  up after a few days. Contracted COVID 2nd time August 2023 - left eye blurry again.  Cleared up somewhat in a few days.
This case was reported by a nurse via call center representative and described the occurrence of laceration of finger in a adult female patient who received FLULAVAL QUADRIVALENT (batch number AT3CC, expiry date 31st May 2016). On 22nd October 2015, the patient received FLULAVAL QUADRIVALENT. On 22nd October 2015, immediately after receiving FLULAVAL QUADRIVALENT, the patient experienced laceration of finger. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger was recovered/resolved and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the laceration of finger to be related to FLULAVAL QUADRIVALENT. Additional details provided were as follows: This case was associated to the pharmaceutical product complaint. The reporter stated that, the FLULAVAL QUADRIVALENT vaccine arrived on 9th September 2015 and was stored in a refrigerator. On 22nd October 2015, the another nurse (patient) opened the box and saw that one vial was broken on its side and the patient cut her finger due to this broken glass inside the box.
FACE FLUSHED DIZZY, SPOTS BEFORE EYES, HEADACHE, STOMACH ACHE. LAID CLIENT DOWN TO MONITOR BLOOD PRESSURE.  BP 124/86 142/88 112/74. HR 105 INITIALLY AND THEN RETURNED TO 78 AFTER 15 MINUTES. FOLLOW UP PHONE CALL TO MOM 6:58 PM 5/12/11 DOING WELL.
2nd vax dose developed pruritic axillary rash @ inject site which spread to rt arm & was painful to touch; small localized rxn & was sore for one day; 1st & 3rd dose given w/no noted problems;
Started having muscle pain; I didn't have chills. I  was very fatigued - in bed all day. I had a headache and the muscle pains went into my left side and into my left lung and every time I breathed I would get a sharp pain. It went into both of my breasts but worse on left side of breast. This lasted about three or four days. I went to the doctor on Thursday, the 15th. But now everything is cleared up and I feel good. Yesterday, the 22nd I started feeling myself again. Except, I have a tremor that won't go away - I had a slight tremor before the vaccine but now after the tremor  it is much worse.
During my 20 week ultrasound I was informed my baby has cleft lip; This spontaneous case was reported by a consumer and describes the occurrence of CLEFT LIP (During my 20 week ultrasound I was informed my baby has cleft lip) in a  foetus of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during pregnancy.    No Medical History information was reported.   On 05-Mar-2021, the mother received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the foetus was diagnosed with CLEFT LIP (During my 20 week ultrasound I was informed my baby has cleft lip) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Outcome Pending. For foetus 1, The outcome was reported as Unknown. At the time of the report, CLEFT LIP (During my 20 week ultrasound I was informed my baby has cleft lip) outcome was unknown. Not Provided          No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  Company Comment: This is a case of product exposure during pregnancy with an associated adverse event of Cleft lip in the foetus. Based on temporal association a causal relationship cannot be excluded. . Patient´s mother  will continue to be contacted for further monitoring.   This case was linked to MOD-2021-290269 (Parent-Child Link).   See case MOD-2021-290269 for details regarding the Parent case.; Sender's Comments: This is a case of product exposure during pregnancy with an associated adverse event of Cleft lip in the foetus. Based on temporal association a causal relationship cannot be excluded. . Patient´s mother  will continue to be contacted for further monitoring.
redness at the injection site today; Lump under injection arm; lymph nodes under her arm are quit swollen/lymph nodes were only swollen under the arm she received the injection in; nausea; did not feel well; arm and shoulder were quit sore; arm and shoulder were quit sore; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 03Mar2021, for COVID-19 immunization, reaction(s): "No Adverse effect"; Bnt162b2 (DOSE 2, SINGLE), administration date: 25Mar2021, for COVID-19 immunization, reaction(s): "No Adverse effect". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 29Oct2021, outcome "not recovered", described as "lymph nodes under her arm are quit swollen"; PYREXIA (non-serious) with onset 28Oct2021, outcome "recovering", described as "fever"; NAUSEA (non-serious) with onset 29Oct2021, outcome "unknown", described as "nausea"; MALAISE (non-serious) with onset 29Oct2021, outcome "unknown", described as "did not feel well"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 29Oct2021, outcome "unknown" and all described as "arm and shoulder were quit sore"; INJECTION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness at the injection site today"; MASS (non-serious), outcome "unknown", described as "Lump under injection arm". The patient underwent the following laboratory tests and procedures: body temperature: (29Oct2021) tapered off during the day, notes: Fever.  Additional information: Thursday, the patient had the booster dose. Same day, she developed fever. The patient did not feel well. Had nausea. Had fever all day Friday.  On Saturday in the morning, she had a fever, but it tapered off but she did notice her arm and shoulder were quit sore. She also noticed the lymph nodes under her arm were quit swollen and were still swollen as speak. Caller also reported redness next to the injection site that she just noticed today and had not noticed previously. Lump under her arm is just under the injection site arm. Noticed redness at the injection site today that she has not noticed previously.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a female patient who on an unspecified date, was vaccinated with her first dose of GARDASIL 0.5ml, IM. Concomitant therapy included INFANRIX received during the same visit. The patient experienced syncope after administration of her first dose. She was unconscious for 10 seconds. On unspecified date, the patient recovered from syncope. The patient sought medical attention via: office visit. She has since received her second dose of GARDASIL 0.5ml, IM and did not experienced any adverse event. Additional information has been requested.
Headache, injection site soreness, pain in left armpit 3 days after receiving vaccine. Onset of period.
Approx 4-5 cm erythema rxn @ site of injection Rt arm
Pale skin; clammy; sweating; nausea/vomiting; blood pressure normal. Patient given water. Called 911. EMTs took over and evaluated patient. Patient had COVID-19 3 months ago.
Erythema multiforme developed on Monday 12/27 and worsened significantly on the evening of 12/28. Lesions began less than an inch across and grew to 3-4 inches at present. Spots are extremely itchy and intermittently painful under pressure, and continue to grow.  Lesions are most frequent on extremities but continue to develop in new locations. Significant dermatographia is also observed. After diagnosis by an ER doctor, patient has been taking Benadryl and Tylenol, and will apply a topical steroid and take cetirizine. Treatment thus far has failed to mitigate irritation, skin sensitivity, or lesion growth.
The pt experienced a painful, warm, swollen, red spot at the injection site which was an inch in diameter and then a bruise after a week of the symptoms.
Patient was administered PREVNAR-13 in the right arm on 10/02/2018, and FLUBLOK QUADRIVALENT in the left arm on 10/02/2018. Patient said that the PREVNAR-13 injections site was sore the day of vaccination and went away on 10/04/2018. Patient said that her arm started to become red on 10/04/18 and the redness spread and itch. Patient she put alcohol and ice on the red area. Patient said her right arm was red on the upper arm only around the injection site.  Patient went to Priamary care physician on 10/09/208. Dr. told patient to start taking BENADRYL.  Patient took first dose of BENADRYL 25 mg at 12:00 pm on 10/10/2018 and second of BENADRYL 25 mg at 4:00 am on 10/10/2018 third dose of BENADRYL 25 mg was taken at 10:00 am 10/10/2018. Patient reports redness is improving no longer itching and will be following up with Dr. on 10/11/2018.
Patient received 1st dose of Pfizer vaccine.  5 minutes later, the patient was having difficulty breathing  and chest tightness.  After assessing patient the patient wanted us to call 911.  Pt was given smelling salt before paramedics came in.  Pt was feeling better but wanted to be checked out in the ER just in case.  Vitals were within normal range per the paramedics.
broke out with herpes simplex 1 on my nose.; This case was reported by a consumer via interactive digital media and described the occurrence of herpes simplex in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2021, the patient received the 1st dose of Shingrix. On 15th November 2021, 5 days after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced herpes simplex. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the herpes simplex was unknown.   It was unknown if the reporter considered the herpes simplex to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and yesterday (day before reporting) broke out with herpes simplex 1 on his/her nose. The patient took 2 tabs of valacyclovir as a treatment medication, and asked that would it interfere with. The patient asked to GlaxoSmithKline that had the GlaxoSmithKline heard of anyone experiencing this as a side effect. The follow-up would not possible as no contact details were available.
Narrative: Patient developed shortness of breath following second dose of pfizer covid vaccine. Patient went to urgent where she was diagnosed with bronchitis and given steroids and inhaler as treatment.
pt recv vax; w/in approx 6 hr post vax, pt exp a welt at inject site; sx resolved w/ in 1 1/2 - 2 wk;