chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Additional information was received providing patient demographics, medical history, product lot number and laboratory results. Information regarding PREVNAR was received from a healthcare professional regarding a 10-month-old male patient who experienced pneumococcal bacteremia. The patient received the third dose on an unspecified date. On unspecified dates, a 10-month-old patient had received three doses of PREVNAR. On an unspecified date in Nov-2009, the patient experienced pneumococcal bacteremia. The patient was hospitalized and a blood culture confirmed Streptococcus pneumoniae, serotype 7F. The patient was administered dose 4 of PREVNAR series, and was treated with antibiotics. The patient recovered on an unspecified date. No additional information was available at the time of this report.
warm to touch; arm itchy; blotchy diffuse red rash size of orange; arm red; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (arm itchy), VACCINATION SITE RASH (blotchy diffuse red rash size of orange) and VACCINATION SITE ERYTHEMA (arm red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 102M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm red). On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (arm itchy) and VACCINATION SITE RASH (blotchy diffuse red rash size of orange). The patient was treated with HYDROCORTISONE (CORTIZONE 10) at a dose of 1% and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Itch, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (arm itchy), VACCINATION SITE RASH (blotchy diffuse red rash size of orange) and VACCINATION SITE ERYTHEMA (arm red) 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 medications were not provided. Patient's arm was red, but 3-4 days ago became blotchy diffuse red rash size of orange, warm to touch and itchy. Patient was using Cortizone cream 1% and took Benadryl and had less itching.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional information received via TCR, patient informed everything was fine and reporter information updated.
tiredness; headache; stomach upset; Feeling of chills; pharmacist gave the shingrix vaccine it was hurting and the pain; Arm is sore, painful/ leg ache; Arm is sore, painful and slightly red; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 22nd October 2020, the patient received the 1st dose of Shingrix. On 22nd October 2020, immediately after receiving Shingrix, the patient experienced injection site pain, pain in extremity and erythema of extremities. On 23rd October 2020, the patient experienced tiredness, headache, upset stomach and chilliness. On an unknown date, the outcome of the injection site pain, pain in extremity, erythema of extremities, tiredness, headache, upset stomach and chilliness were unknown.   It was unknown if the reporter considered the injection site pain, pain in extremity, erythema of extremities, tiredness, headache, upset stomach and chilliness to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. On 20th October 2020, the patient received Flu vaccine in left arm. On 22nd October 2020, the patient received the first dose of the Shingrix in her right arm. The patient stated when the pharmacist gave the Shingrix it was hurting, and the pain continued and now the right arm was sore, painful and slightly red. On the day of reporting, 1 day after receiving Shingrix, the patient woke up with feeling of chills, stomach upset, headache, leg ache and tiredness. The reporter consented to follow up.
Narrative:  Patient received two doses of Pfizer vaccine in Feb/Mar 21. The patient tested positive for COVID 19 on 6 Sep 21 and was hospitalized estimated on 15 Sep 21 at hospital with COVID pneumonia. The patient was discharged on oxygen on 29 Sep 21. Reported per EUA.
Soreness in the arm. Skin is sensitive on the left hip. Left calve area is sore.
second dose administered after 6 months; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 16th May 2018).   On 18th October 2019, the patient received the 2nd dose of Shingrix. On 18th October 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist called to ask regarding the vaccination schedule of Shingrix. The pharmacist reported that the patient was vaccinated with the 2 dose of Shingrix but the second dose was administered after the 6 month series, which led to drug dose administration interval too long. The vaccine administration facility was the same as primary reporter. No other information reported. The reporter consented to follow up.
Tingling, restlessness, heaviness of lower legs after 2nd rabies vaccine dose. Symptoms have not improved. (Patient will finish the rabies series and receive 4th dose tomorrow). Note - patient has received rabies immunoglobulin.
1/30/21 blisters developed around lips, assumed was from fever the night before. took lysine didn't work to stop the growth. 1/31/2021 still taking lysine, blisters spread to inside mouth and nose. can't blow nose, swollen, open sores, can't eat, open sores on gums and roof of mouth, gums swollen.
Pt. complained erythema, tenderness, almost half of his arm was red and tenderness, and itchy, cant tell if pt's arm was swollen. He complained no shortness of breath, no dyspnea or any other parts of the body like lips, mouth etc are swollen, and no swelling of throat or bleeding. pt didn't complain of any nausea, vomiting or diarrhea. Pt. only complained of erythema,redness,and tenderness, palpable at the injection site. On 09/07/12 at 9:30 we called and followed up on the pt., pt. said he is fine, but his arm still feels sore and itching.
four hours after vaccine. I went into a hot tub. the temperature was 105 degrees and dropped to 98 degress when i got out. the following day around 4 o'clock my back started to itch . My husband told me i had red welts on my back.  Around 9p.m. I had welts all over my body. They look like chicken pox. Sunday morning came and I called my physician and he said as long I was not having difficulty breathing to make an appointment on Monday to come see him. I called my pharmacy where I received my shot and  told her of my breakouts. after some investigating, she determined that it sounds like hot tub folliculitis. I specifically asked  prior to going in if It was  gonna be alright to go in a  hot tub. I was assured it would be not problem.  So I went.  Monday appt. with Doctor confirmed our suspicions. Antibiotic for 7days. My question is now will i be able to get the second dosage of the Moderna Covid-19 vaccine?
The same day of vaccination, 4/8/02, the pt experienced pain throughout his left arm. He was not able to sleep. He had swelling from his upper deltoid to his elbow. Painful back, fever, goose bumps and shaking.
Patient's arm became red, puffy and a little purple at sight.  She went to her provider 11/05 and the swelling was decreasing so no medical treatment was recommended by provider
Near injection site approximately 2" irregular oval shape red spot, swelling, hot, itching--began 3/2 PM and today 3/8 AM pink circular shape, not swollen, not hot, and not itching
Patient fainted approximately 30 minutes after receiving the AFLURIA vaccination. Patient felt fine leaving vaccination room.
patient started bleeding at the site of injection. During her wait time initial felt hot and was seeing spots. The patient also was sweating  and didn't feel well. Patients blood pressure did drop. We gave the patient an ice pack and water. Patient refused 911 and refused Benadryl. We took the patients blood pressure and had the patient wait for 30 /40 minutes after the vaccine. the patient felt better
SICK; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick. This report was non-serious.
Hive around injection site of PROQUAD - 48 hrs after vaccine was given, rx: BENADRYL mother observer - to return to office if worsens.
tooth ache; Teeth was loose; pain and aggravation; This is a spontaneous report from a contactable consumer (patient).  A 78-year-old female patient received first dose of bnt162b2 (BNT162B2; Lot number was not reported), via an unspecified route of administration on an unspecified date (at 78 years) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was going for her 2nd shot on 12Mar2021. 2 days had a tooth ache (Mar2021) but last night seemed to stop. She did not have any tooth ache for years. Teeth was loose and had pain and aggravation (Mar2021). On 12Mar2021 she felt better, took ibuprofen on 10Mar2021 but not on 12Mar2021. Patient asked if she can get the shot. Final outcome was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
after booster (3rd shot) my hair started falling out. The shedding hair is beyond excessive. Literally handfulls of hair lost daily.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 at 18:15 as dose 3 (booster), single (Lot number: 33026BD) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Allergy of pepper" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 2, Dose brand unknown: False, Dose lot number: EW0171, Dose administration time: 03:45PM, Dose vaccine location: Right arm), administration date: 28Apr2021, when the patient was 64-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, Dose brand unknown: False, Dose lot number: EP7533, Dose administration time: 04:00PM, Prev dose vaccine location: Right arm), administration date: 31Mar2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 10Jan2022, outcome "not recovered", described as "after booster (3rd shot) my hair started falling out. The shedding hair is beyond excessive. Literally handfulls of hair lost daily.". Therapeutic measures were not taken as a result of alopecia. Additional information: The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Beginning in the evening of 02/10/21 itching began around injection site.  On the morning of 02/11/21 the site began to swell and redness is noted in about a 2 inch diameter circle around the injection site.  The site is warm to the touch, slightly painful, and very itchy.  There is about a 1 inch lump in the center. The site has continued to itch and swell throughout the course of the day.
Administered my Spikevax at roughly 2pm on the 21st. I had a bad migraine the next day (yesterday) that required multiple doses of rescue medication. I started to have some joint pain last night. When I went to bed, I laid comfortably under my blanket and suddenly got extremely cold. I was freezing and was shaking/shivering so badly I could barely get up to get more blankets. I don't know if I had a fever.    I woke up very early in the morning (1am) and noticed my skin was very warm on my arms and I have spots on them. They are red, very slightly raised and look like they have tiny pustules in the center. They are not hives. I thought maybe it was chickenpox, but I had chickenpox as a kid and I've had two Varivax doses over the past two years. I don't have anywhere to go this weekend that's covered by my insurance to be able to be evaluated in person.
Full day on 01/09/21-extremely sore muscles to the point of it being painful to move and breath. Extremely painful joints. Felt like there was an ice pick trying to pry them apart.  Full day 01/10/21-hives and extremely itchy. Sore, not as bad as first day.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 52-year-old female patient who received FLUARIX QUADRIVALENT (batch number K4GP4, expiry date 24th June 2018). On 3rd October 2017, the patient received FLUARIX QUADRIVALENT .5 ml. In October 2017, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced injection site erythema, injection site induration, injection site tenderness and injection site swelling. In October 2017, the outcome of the injection site erythema, injection site induration, injection site tenderness and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site tenderness and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient was a GlaxoSmithKline employee.
01/05/23 presents to ED for "fatigue, SOB". PMHx of "heavy uterine bleeding requiring pRBC transfusions, recent diagnosis of DVT/PE and leukocytosis"
On the day following administration of the vaccine (5/23), the patient reported experiencing headache, dizziness, nausea, and "feeling cold". These symptoms were significant enough for her to go home at lunchtime and go to bed. The next day (5/24), the patient woke with a headache but all symptoms had resolved by that evening. The patient did not report any reappearance of symptoms after the evening of 5/24.
12 hours after injection I experienced extreme chills for an hour and a very sore arm.   Two weeks later my arm was swollen, red with a rash, sore and itched for a full week.
lethargy; fever; coughing; sore throat; respiratory distress; This is a spontaneous report from a contactable consumer.  A 13-year-old male patient received second dose of bnt162b2 (COMIRNATY; Batch/Lot Number: unknown) intramuscular into left arm on  09Oct2021 03:00 PM (at the age of 37-year-old) as single dose for covid-19 immunisation.  The patient had received the first dose of  bnt162b2 (Batch/lot number: 301308A)  on 18Sep2021 Intramuscular Arm Left. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination were none. Medical history included cold-induced asthma. Prior to vaccination, the patient was diagnosed with COVID-19. No relevant past drug history and no known allergies.The day after vaccine, patient had sore arm and was lethargic. Two days after vaccine, at 8:30am, patient received Flu shot and HPV shot and then experienced fever, coughing, respiratory distress, sore throat, lethargy. Symptoms continued for several days. The events resulted in Doctor  office/clinic visit. Rapid PCR (45 min) Nasal Swab  on 12Oct2021 was Negative. Dr prescribed one dose of decadrone (oral steroid) and daily albuterol. Day 8 patient was back to normal, no symptoms.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
blood pressure was significantly higher; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (blood pressure was significantly higher) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Blood pressure high.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced HYPERTENSION (blood pressure was significantly higher). At the time of the report, HYPERTENSION (blood pressure was significantly higher) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HYPERTENSION (blood pressure was significantly higher) to be related.    Concomitant medications were not reported.  It was reported that patient blood pressure had been well controlled for many years on a low dose ARB. After he received the covid vaccine, his blood pressure was significantly higher. This required 2 subsequent increases in his ARB medication dose in order to bring his blood pressure back into normal range. Patient convinced that adverse event was vaccine related.
Severe neck stiffness with severe pain (9-10 on 10 pt scale) and swelling on left side from base of neck to bottom of shoulder blade. Ibuprofen 800mg every 8 hrs, ice packs, bed rest without pillow. Lasting 3 days.
Patient began to experience weakness and lower extremities and hands one day after receiving H1N1 vaccination. Is now admitted to our PICU for presumed Guillain-Barre. 11/10/09 Medical records received for date 11/2/09 to 11/9/09. DX: Pt. admitted to hosp. for mild GBS secondary to H1N1 vax. Pt was seen on 11/2/09 with c/o pain on left side. Pt. received H1N1 vax in left arm. 11/4/09 pt c/o sore throat, HA, lethargic after taking abx for sinus inf. Later returned to office with worsening of sx. Assessment: parent feels pt is experiencing GBS. (+) rectal abscess. Pt. referred to ID. 11/9/09 After consult pt. admitted to hospital.    11/20/09 Hospital records received service dates 11/7/09 to 11/11/09. Assessment: Presumed GBS. Transferred from another facility. Progressive lower extremity weakness and loss of lower extremity reflexes. IVIG. Head ache. Prior to discharge patellar reflexes +2 ankle jerk reflexes +1.
dizziness, labored breathing, hyperventilation, increased pulse and blood pressure, O2 sat of 80% briefly passing out. O2 applied per nasal cannula.
intense body aches; fever; joint pain; several episodes of tachycardia; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration on 09Jan2021 10:00 at a single dose on right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 19Dec2020 at 08:45 AM on right arm (lot number: EH9899) for COVID-19 immunization and experienced sore arm, mild headache/nausea. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Jan2021 20:00, the patient experienced intense body aches, fever, joint pain; and approximately 1 week after through more than 2 weeks after (Jan2021) had several episodes of tachycardia. No treatment was received for the adverse events. The patient has not recovered from the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious.
He got his vaccine, he woke up 2 days after with no energy whatsoever, and very poor equilibrium and very poor peripheral vision in his right eye.  It stayed about the same, and did not think too much about it at the time, but went to the doctor in August.  From there he also went to an eye surgeon and had a CT scan done and the prognosis was that he had a occipital stroke that affected his equilibrium and lost 30% of the peripheral vision in the right eye.  He did not have any problems with his vision prior to the vaccine.    He went to the ER on 8/28/22 where he had a sudden complete loss of memory and was diagnosed as transient global amnesia.  This lasted for about 15 hours which cleared on it's own.  He was admitted over night to the hospital.    Since his diagnosis he has gone for another CT scan and has seen a neurologist who has scheduled an EEG which he is going to have on Thursday and had the CT yesterday.  His name is Dr. at Hospital.  He saw her for the first time on 9/6/22.  She added a baby aspirin to his regimen.
Soreness for 2 days after injection. Now one week later injection site redness, slight swelling, itchiness.
Mother called health dept. to report what she thought was a vaccine reaction. Pt developed a "red bumpy rash on left side of torso left side of neck and face." Onset of rash 24 hours post vaccine. Afebrile. No other symptoms. Mother advised to contact personal physician.
Fever, chills, body aches, headache, and very brief (1-3 seconds) sharp pains in random areas. These all started ~9 hours after the second injection and lasted ~24 hours.
pt recv vax 19OCT95 & that evening arm became swollen, hot & painful w/use;tx w/APAP & cool compresses;The pain lasted for 3 days;soreness cont for 2 to 3 wk;pt devel pneumonia;
Our daughter received IPV, DTAP, and Prevnar on March 30, 2006. These were her six month shots. The day she got the shots she ran a low grade fever and demonstrated mild discomfort. The next day she continued with those symptoms but also was not sleeping.  This was so atypical that our daughter stayed awake untill 10:00pm at night, a child whose bed time is 6:30pm.  That evening at 1:00am she began vomiting.  This went on for 1 1/2 hours with 4 sequential vomits.  She continued to run a fever.  She is not having any other flu like symptoms such as diarrhea or lethargy.  Other than her vomiting and loss of appetite she is acting normally. This leads us to suspect that the vaccinations which have casued mild gastrointestinal discomfort in that past are the reason for her sickness.
Severe headache that started the day after the shot,  developed change in taste, neck muscle pain. Symptoms progressed until 4/8/2021 and woke up with left sided facial drooping. He was seen and in the ER and diagnosed with bell's palsy. Was hypertensive 180/110
Unknown amount of the Pedvax Hib administered/injected due to spill of vaccine from syringe.
p/vax pt c/o dry mouth; low grade fever; felt weak; sl rash on face; neck; seen @ urgent care ctr; feeling tired; low grade fever at night only;
pt recv vax 14MAY96 & mom states pt was given APAP q 4hr;mom took pt to sitter 3PM & gave APAP;@ that time;between 5 & 6PM temp went up;6PM t106 & pt had sz;blood work indicated viral illness;febrile sz secondary to viral illness