chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 21 year old female with a history of foot infection and no known allergies who on 08-NOV-2007 was vaccinated with her first dose of GARDASIL intramuscularly. On 11-JAN-2008 the patient was vaccinated with her second dose of GARDASIL. Concomitant therapy included SEPTRA and oxaprozin. On 12-JAN-2008, 24 hours vaccination, the patient did not feel well and developed hives al over her body. The symptoms have continued since time of reporting. The patient started taking over the counter BENADRYL. No other information was available. Additional information has been requested. 07/08/08 Initial and follow-up information has been received from a certified medical assistant and a registered nurse concerning a 21 year old female student with a recent foot infection and no known allergies, who on 08-NOV-2007 was vaccinated IM with her first dose of GARDASil. On 07-JAN-2008 the patient had taken SEPTRA for a foot infection. On 11-JAN-2008 the patient was vaccinated with her second dose of GARDASIL. Concomitant therapy included SEPTRA and oxaprozin. On 12-JAN-2008, 24 hours post vaccination, the patient did not feel well and developed hives on her back and her abdomen (previously reported as all over her body). It was reported by the nurse that the patient was also being treated for the foot infection at the time of the complaint of hives. It was also reported that the patient had eaten crab and shrimp on 12-JAN-2008. On 13-JAN-2008 the patient called the office and SEPTRA was discontinued. The patient started taking over the counter BENADRYL. The patient sought unspecified medical attention. No laboratory diagnostics were performed. The patient recovered from the hives on her back and abdomen on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Pt received vaccine at approx. 1:00 p.m. Pt received KINRIX, MMR, Varicella. Mother/father brought child in approx. 3:00 p.m. Child skin reddish color with welts approx. 1-2 cm throughout body. Child c/o itching throughout body. Child was not having breathing difficulties.
Rash around neck and front chest area developed 4 days after the injection on 2/27. Injection site swelling developed 10 days after the injection.  Patient got treated with triamcinolone cream. Rash and swelling got better after the treatment.
Pt recvd 3 doses of Engerix-B vax & 01OCT91 it was determined that the pt did not respond to the vax series;
3 vials only have 8 doses; A spontaneous report was received from a pharmacist concerning 24 patients who received Moderna's COVID-19 (mRNA-1273) vaccine from 3 vials that only had 8 doses in them.   The patients' medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   On an unknown date, the patient received a dose of mRNA-1273 (Batch number: 015M20A)intramuscularly for prophylaxis of COVID-19 infection.   The reporter stated that she thought there were 3 vials that only had 8 doses in them. She thought it was Lot number: 015M20A, but she could not be sure. She stated that all 8 doses from 3 vials were administered to patients. She did not have information on which patients those were. Upon further questioning, caller stated it was a possibility that the vials had all 10 doses and because multiple were drawn up out of a single vial they may have lost count. Caller stated the vials were disposed of.  Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event was unknown/not reported.; Reporter's Comments: This report refers to a case of Product packaging quantity issue for mRNA-1273 with lot # 015M20A with no associated AEs.
RIGHT EYE STARTED ACTING UP; ANXIETY; NUMB FACE/JAW/CHEEK/FOREHEAD; HEADACHE; This spontaneous report received from a patient concerned a 74 year old female. 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: 1808982, and expiry: 07-AUG-2021) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced headache. On 13-MAY-2021, the subject experienced numb face/jaw/cheek/forehead.  On an unspecified date, the subject experienced right eye started acting up, and anxiety. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 13-MAY-2021, had not recovered from numb face/jaw/cheek/forehead, and the outcome of right eye started acting up and anxiety was not reported. This report was non-serious.
you had the new shots,2, and still got it./suspected vaccination failure; still got it.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 11-May-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media.  The patient had the 2 new shingles shots, and still got shingles. That was why the patient was afraid to get more.  Additional Supportive Information: The case was considered as suspected vaccination failure since the details regarding completion of time to onset and laboratory confirmation of shingles was not reported. The follow up would not possible since no contact details provided.
Infant had 9 apneic/bradycardic episodes with desats and most requiring stimulation and bagging. Infant was on high flow nasal cannula and had to be intubated at 0215 on 6/21/2011. Labs drawn, antibiotics started.
Shingles outbreak (rash) on upper left chest wrapping around to upper left back. Rash is still present, however, in the last stages of healing. Patient also reported localized pain and heat during first week of outbreak.
Swelling, redness, tenderness, to left upper arm, measures -approx, - 50x22 cms. Symptoms appeared 9/5/09. Redness - measured approx - 50x42cms (remained active - playful).
No appetite; chills; joint aches; fatigue; possible fever; This is a spontaneous report from a non-contactable consumer. An adult female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included COVID-19 on unknown date. Concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient experienced no appetite. On an unknown date the patient experienced no appetite, chills, joint aches, fatigue and possible fever. The clinical outcome of the events no appetite, chills, joint aches, fatigue and possible fever was recovered at this time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: added patient country and Vaccination Facility Country.  No follow-up attempts are needed. No further information is expected.
Patient fainted after administration while waiting within the store. 911 was called. When EMS arrived Patient BP was very low. Patient was brought to the ER for observation and recovered completely
Experienced a self limited delayed hypersensitivity reaction, likely ?arthrus? reaction, at injection site on 1/24 (13 days following my first vaccine dose). Itchy, red, hives localized to injection site on my Right arm. Resolved within two days.
10 minutes after this dose became dizzy - (Had similar reaction with 1st dose Pfizer), laid on cot - vital signs ok x2 checks - after 21 minutes left site with mom.
I had my second shot on 1/26 at 1010. By 1800 I started feeling lousy. I had a few hours of fever overnight along with chills and body aches. The body aches continued all day on 1/27. I stuck it out and didn't take ibuprofen or Tylenol to be sure the vaccine had a good take. After a 1500 nap I started to feel better and was fine for a few days.   Around 1800 on 2/1 I started feeling bad again and have ever since. I don't think I have had fever, but I have been chilled a couple of times. The body aches are the worst. For a couple of days I has localized pain in my left lower shin, ankle, and knee, but that's better and now it just general muscles aches. Sometimes individual muscles are mildly tender but that's very intermittent.   I am taking ibuprofen or Tylenol tid. It's bad enough that it wakes me in the night to take meds. I'm also really tired. Still functional--I went running once my ibuprofen was working yesterday, went to work, etc--but tired.
pt recv vax 10JAN96 & 24JAN96 pt exp erythema nodosum on both shins & a fever of 101;
A fever of up to 103 for 4 days now and a chicken pox like rash all over her body
A patient (age and sex not reported) received on an unknown date an injection (route and site not reported) of FLUZONE HIGH-DOSE, lot number not reported. On an unknown date the patient experienced a rash. No further information provided. The outcome was not reported. Follow-up information was received 24 March 2011 from a health care professional who reported that the patient was recovered. No additional information was provided at the time of the report. Documents held by sender: None.
Redness at injection site, down left arm, left axilla and partial chest wall. Pt. stated redness improving. Pt reported slight shortness of breath.
Localized reaction, red, edema, hot to the touch, size 5 1/2 inches in length 4 1/2 inches width.
Patient noticed a sore arm the first night of 2nds dose of vaccine. Patient noticed central chest pain on the second night after the vaccine as well as vague flu like symptoms, bone pain, fatigue and stomach ache. Symptoms all resolved shortly after 2am and have not returned today. Patient recently had covid back in March. Suspect over-reaction to vaccination due to remaining antibodies from recent covid infection. Chest pain likely pleurisy due to location indicated and stable vital signs and no cardiac risk.
I was in a very intense training phase for a martial arts promotion and it was very hot weather. After a practice session and the AC was unable to keep up, I started feeling kind of weak and had mild chills. I rested for a couple days, and went again and had a similar feeling. First was Monday, second was Wednesday. Some time Thursday, I checked my temperature and I had a fever. I had dark urine and I was weak. I took off Thursday from work, and I couldn't work properly on Friday. My training the next week, I could not train properly. I took a quick COVID test Friday 7/23 and COVID PCR test 7/24 and they were both negative. I went to go see my doctor 7/26 and she prescribed lab work and we talked about them a few days later. She concluded diverticulitis. I had no appetite, I had to go to the bathroom a lot. Diarrhea. The most important thing was that I had abdominal discomfort. Timeline: 7/19 started, 7/21 ? knew I didn't feel right. 7/22 sinus pain and fever. Headaches. 7/26 ? started to feel better, but weakness and intestinal discomfort. Dark urine cleared by then. Rhabdomyolysis possibly & diverticulitis. Gave me antibiotics and took it easy.  Weakness lasted for 6 weeks, and gradually became better within those weeks. Weakness is still there but hard to measure. Didn't think that it may have anything to do with the vaccine, but unsure. Urgent care visit - due to COVID tests.
Rapid pulse; Blood in urine; Night sweat; Cough; Swollen lymph node; Chills; Fever; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Rapid pulse), BLOOD URINE PRESENT (Blood in urine), NIGHT SWEATS (Night sweat), COUGH (Cough), LYMPHADENOPATHY (Swollen lymph node), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jul-2021, the patient experienced PALPITATIONS (Rapid pulse) (seriousness criterion medically significant), BLOOD URINE PRESENT (Blood in urine) (seriousness criterion medically significant), NIGHT SWEATS (Night sweat) (seriousness criterion medically significant), COUGH (Cough) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen lymph node) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). The patient was treated with AZITHROMYCIN (ZITHROMYCIN) for Adverse event, at an unspecified dose and frequency; DOXYCYCLINE (DOXYCYCLIN [DOXYCYCLINE]) for Adverse event, at an unspecified dose and frequency and LEVOFLOXACIN (LEVAQUIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Rapid pulse), BLOOD URINE PRESENT (Blood in urine), NIGHT SWEATS (Night sweat), COUGH (Cough), LYMPHADENOPATHY (Swollen lymph node), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jul-2021, Blood pressure measurement: high blood pressure (High) High blood pressure.         The  concomitant medications on use were not provided.  Patient was on three different antibiotics for the adverse events, he was not getting rather getting worse. His doctor was checking for tuberculosis and lymphoma.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-284085 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 68-year-old male patient who received SHINGRIX (batch number 9349T, expiry date 7th March 2021) for prophylaxis. On 22nd August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced fever, pain and headache. On an unknown date, the outcome of the fever, pain and headache were unknown. It was unknown if the reporter considered the fever, pain and headache to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX yesterday (the day before reporting) and on the date of reporting reported adverse events as headache, fever, and general aches.
PATIENT GOT FLU SHOT HERE WITH NO ADVERSE EFFECTS, BUT WE RECEIVED A NOTICE FROM THE PRIMARY DOCTOR THAT THEY HAD ALREADY ADMINISTERED A FLU SHOT IN SEPTEMBER, IT WAS NOT IN STATE REGISTRY; PT ACTUALLY EXPERIENCED NO ADVERSE EFFECTS.
Allergic reaction after immunization (skin), multiple reddened whelps and some fluid filled vesicles all over body. Approximately 15 min after immunization Dr. notified. Instructed to give diphenhydramine. Administered diphenhydramine 0.3ml IM per protocol.
3/12/2021 vaccination  3/13 I started having increase pain R abd side. Knew something wasnt right.  3/14 ER determined I had a 'very angry appendix'.
BREAK OUT and FUZZY; Skin breakout; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (BREAK OUT and FUZZY) and RASH (Skin breakout) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis.    Concurrent medical conditions included Psoriasis (Moderate To Severe Chronic Plaque Psoriasis).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FEELING ABNORMAL (BREAK OUT and FUZZY) and RASH (Skin breakout). At the time of the report, FEELING ABNORMAL (BREAK OUT and FUZZY) had resolved and RASH (Skin breakout) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event of Skin breakout and Fuzzy was reported as no reasonable possibility for Humira.  No treatment medication were 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.
Chest pains, starting 12 hours after second shot, continuing off and on for more than one month. Still occur on occasion. No hisotry of chest pains prior to vaccination.
Patient reported feeling lightheaded and racing heart immediately after administration of vaccine. She described pain as feeling like "someone punched her in chest".  We had the patient lay down on floor with feet elevated on chair due to suspected vasovagal response.  5 minutes later, patient sat upright on floor but still felt lightheaded and laid back down on floor. 5-10 minutes later we retried transferring patient back to chair to take blood pressure. Reading was 156/105 pulse 92.  Patient still felt lightheaded and had racing heart where symptoms were not resolving which is when paramedics were called.
mom reported pt had inconsolable crying for 3 1/2hr p/vax;APAP w/o relief called MD & was instructed to given advil @ 830PM & pt settled down & slept entire noc;
BILATERAL LYMPH NODE SWELLING BEHIND THE EARS/ LYMPH NODE SWELLING ON THE COLLARBONE TO THE RIGHT SIDE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 48 year old female. 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 not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced bilateral lymph node swelling behind the ears/ lymph node swelling on the collarbone to the right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever, and had not recovered from bilateral lymph node swelling behind the ears/ lymph node swelling on the collarbone to the right side. This report was non-serious.
Fatigue; flu-like symptoms the day after; 4 days after (which is today) considerable dizziness experienced; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Oct2021 10:45 (Lot number: Pf25813) at the age of 78 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: QVAR. Vaccination history included: Bnt162b2 (Dose Number: 2, prev dose lot number: EP6955, prev dose vaccine location: Left Arm , prev dose administration time: 09:30 AM), administration date: 24May2021, when the patient was 77 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, prev dose lot number: EN6204, prev dose vaccine location: Left Arm , prev dose administration time: 11:00 AM), administration date: 03May2021, when the patient was 77 years old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 20Oct2021 07:00, outcome "not recovered", described as "Fatigue"; INFLUENZA LIKE ILLNESS (non-serious) with onset 20Oct2021 07:00, outcome "not recovered", described as "flu-like symptoms the day after"; DIZZINESS (non-serious) with onset 20Oct2021 07:00, outcome "not recovered", described as "4 days after (which is today) considerable dizziness experienced". Therapeutic measures were not taken as a result of fatigue, influenza like illness, dizziness.  No follow-up attempts are possible. No further information is expected.
Patient received booster dose varicella on 7/22/08.  He presented to the office on 7/28/08 with a substantial case of zoster to the entire length of his forearm.  ZOVIRAX 3/4 tsp tid was prescribed.
Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  nausea, sweats   Assessment : Time of assessment 0835   Actions taken:  Patient lay down on the floor with her feet up in the chair. She reports this happens each time she receives a shot and she has to put her feet up. Her BP 137/89, P 74. She was assisted up to a stretcher and went out to the triage area by EMS who observed her another 15 minutes. Last BP 131/79, P 71. She ambulated and felt fine prior to being released to go home.
Patient presented to pharmacy for 2nd covid dose informed me that when she received 1st dose her arm has red and bruised and it lasted for 5 days
nose was clogged; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nose was clogged) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (nose was clogged). At the time of the report, NASAL CONGESTION (nose was clogged) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact