chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous non valid report was received from a nurse and refers to a unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in October 2017 (reported that from 10-OCT-2017 to 12-OCT-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018, lot # M046133, expiration date: 26-SEP-2019), PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) and GARDASIL 9 (lot # L036301 expiration date: 20-DEC-2017, lot # M028323, expiration date: 26-SEP-2018 and lot # N017686, expiration date: 2-FEB-2020) (for all vaccines doses and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius (C) to 25C (11.4C) for 1 hours. Data logger was involved. Follow-up information has been received from the nurse on 11-JUN-2018. She provided that the temperature excursion took place on 10-OCT-2017. The patient identification information was not readily available. Follow-up information has been received from the nurse on 11-JUN-2018 concerning a patient of unknown age and gender. The patient was vaccinated with PEDVAXHIB (lot # M046133, expiration date: 26-SEP-2019) of temperature excursion which took place on 10-OCT-2017 from 16:32 until 19:02 (maximum temperature 11.4C). No adverse effects were reported. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is valid because the patient's identifier was received. Sender's Comments: US-009507513-1806USA008455: US-009507513-1806USA008456: US-009507513-1806USA008457: US-009507513-1806USA008458: US-009507513-1806USA008459: US-009507513-1806USA008460: US-009507513-1806USA008461: US-009507513-1806USA008462: US-009507513-1806USA008463: US-009507513-1806USA008464: US-009507513-1806USA008465: US-009507513-1806USA008466: US-009507513-1806USA008467: US-009507513-1806USA008468: US-009507513-1806USA008469: US-009507513-1806USA008470: US-009507513-1806USA008471: US-009507513-1806USA008472: US-009507513-1806USA008473: US-009507513-1806USA008474: US-009507513-1806USA008475: US-009507513-1806USA008476: US-009507513-1806USA008477: US-009507513-1806USA008478: US-009507513-1806USA008479: US-009507513-1806USA008480: US-009507513-1806USA008481: US-009507513-1806USA008482: US-009507513-1806USA008483: US-009507513-1806USA008484: US-009507513-1806USA008485: US-009507513-1806USA008486: US-009507513-1806USA008487: US-009507513-1806USA008488: US-009507513-1806USA008489: US-009507513-1806USA008490: US-009507513-1806USA008491.
Patient fainted and colapsed to the ground from a seated position.  After coming to, he was pale and lightheaded, but after waiting 20 minutes he was able to leave without issue.
Persistent chest pain, progressing to headaches and nausea (day 4/5) then plugged ears and sore throat (day 6/7), continuing  Negative covid tests 9/29 & 10/2 Previous adverse events - pain at injection site immediately after for 2 days.
Patient tested positive for COVID-19 after vaccination. He presented to the ED with dizziness, loss of taste, chills, anorexia, and productive cough.  The patient received casirivimab/imdevimab on 8/3. He did not require oxygen and was discharged from the ED.
R09.02 HYPOXIA 3/23/2023 SHORTNESS OF BREATH
noticed slight redness below the injection site; Tachycardia; arm was painful at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included atrial fibrillation and vestibular disorder. Concurrent medical conditions included anxiety. Concomitant products included fexofenadine hydrochloride (Allegra) and lorazepam.   On 16-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). On 16-AUG-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: arm was painful at the injection site). On 17-AUG-2023, the patient experienced injection site erythema (Verbatim: noticed slight redness below the injection site) and tachycardia (Verbatim: Tachycardia).  The outcome of the injection site pain, injection site erythema and tachycardia were resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and tachycardia to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site erythema and tachycardia to be related to Shingrix.   Additional Information: Receipt Date: 21-AUG-2023 The reporter was the patient. The patient received 1st Shingrix dose and his arm was painful at the injection site. The next morning the patient noticed slight redness below the injection site. Late afternoon on 17th August 2023 his heart rate was 126 so the patient went to the emergency room. The emergency room doctor said the tachycardia might be due to anxiety or a reaction to the vaccine. The patient was not admitted. The patient's normal resting heart rate was upper 70s to low 80s. The patient experienced one more episode of increased heart rate (120s) on 19th August 2023, he relaxed and his heart rate returned to normal. Nothing else was reported. The reporter did not consent to follow-up. Emergency room Visit Required. The patient declined to provide last name, address or date of birth.
Started feeling unwell the evening of the day of the shot. Continued to get worse with congestation, cough and very tired.  At first the cough was dry and couldn't cough up congestation. After a day it loosened up.
anaphylaxis; required epi; DPH; steroids; diff breathing, drooling, swelling, hives; transported to ER via EMS; d/c that night;
redness at the injection site; warm to touch at the injection site; itching at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE WARMTH (warm to touch at the injection site) and VACCINATION SITE PRURITUS (itching at the injection site) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE WARMTH (warm to touch at the injection site) and VACCINATION SITE PRURITUS (itching at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE WARMTH (warm to touch at the injection site) and VACCINATION SITE PRURITUS (itching at the injection site) outcome was unknown.        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 product use was not provided by the reporter. No treatment information was provided.
Vaccine was expired by 2 days, waiting on patient response, spoke with Pfizer and verified there was not imminent danger to their health. We scheduled an appointment to receive another vaccine
Patient c/o itchy eyes, itchy and swollen throat and general body red, swollen, burning rash that began on 4/12/18. States she took a BENADRYL with some help. Dermatologist diagnosed as an allergic reaction to SHINGRIX.
This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: Not reported), dose 2 via an unspecified route of administration, administered in left arm on 28Jan2021 as dose 2, single for COVID-19 immunization. The patient previously received first dose of bnt162b2 (Lot number: Not reported) in left arm on unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced some kind of tingling in left arm and on the side of left breast and that the sensation is sensitive, tender, and tingly on an unknown date after second dose of vaccine. It was reported patient wanted to know if this is a commonly reported AE, and how long it would last since it's been ongoing for 5 weeks since her 2nd dose. Also, the patient read about abnormal mammograms and swollen lymph nodes that have been a result of vaccination, and her symptoms seem to be where her lymph nodes are, but she does not report any swelling in the area. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
For over two weeks after my last shot, I was extremely fatigued and bedridden. After 2.5 months, I started developing painful canker sores inside my mouth and had to take acyclovir for months. The last time I needed to take acyclovir was 10/4/2021. In August of 2021, I developed sharp chest pains and extreme shortness of breath, and additional fatigue. My doctor advised me to take 81mg aspirin on a daily basis and these chest pains gradually improved. I only have slight chest pains occasionally, however I?m still battling fatigue and need 12 hours of sleep before I can function properly.
Developed esophageal spasm 5 days after vaccination. Although I have acid reflux, I?ve never had an esophageal spasm or anything close to resembling it. Recovered same day. Day 7 left arm developed Covid Arm: lump and swelling, painful to move/touch, hot to touch. Day 9 developed rash on left arm. Day 12 (today) symptoms still present for Covid Arm with reduced pain/lump size.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient).  A 70-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246), via an unspecified route of administration in right shoulder on 15Jan2021 08:40 at single dose for covid-19 immunisation.  Medical history included ongoing hypertension, family history of hypertension, blood cholesterol, drug intolerance (can't take statins for cholesterol), sleep disorder, back pain. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), zolpidem (unknown manufacturer), hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN). The patient had the first symptoms of congestion in the chest on 21Jan2021, fever of 101.2 degrees fahrenheit on 22Jan2021, has a little sinus issue and did not want to get up in Jan2021. He was tested positive for covid-19 on 23Jan2021. The outcome of the event was recovering. The patient was taking Tylenol due to the event. The event did not require visit to emergency room nor to physician office
light headed and heat rush from head down, history of feeling dizzy with needles. no breakfast/ lunch today. refused transport.
24 hours, post vax, pt had redness, warmth, induration and tenderness, approximately 10cm in diameter, at injection site. Also, with swollen and red lymph nodes in inguinal area, on side of vaccine and red streaks from vaccine site along venous pathway,  resolving with PO antibiotics.
Also he described his male part is "like a snake", referring to the skin.; After the second dose, he has rashes and aching.; After the second dose, he has rashes and aching.; itching all over; 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 male patient received bnt162b2 (BNT162B2) (Lot number: FJ8757) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid 19 immunization. The following information was reported: SKIN DISORDER (non-serious), outcome "unknown", described as "Also he described his male part is "like a snake", referring to the skin."; RASH (non-serious), PAIN (non-serious), outcome "unknown" and all described as "After the second dose, he has rashes and aching."; PRURITUS (non-serious), outcome "unknown", described as "itching all over".  Additional Information: The caller was calling about the two Pfizer shots. The caller clarified that it was the Pfizer covid vaccine and provides FJ8757 from his vaccination card. The caller had and a rash ever since he has had the second shot and has been itching all over. The caller's male part is like a snake, the whole skin fell off of it. Something was wrong, the caller wanted to know what he should do about it? The caller needs to know what to do about this. Is Pfizer covid vaccine a Pfizer product: Yes. Pfizer covid vaccine manufacturer: Unspecified. Dates for Pfizer covid vaccine: (Start: Unspecified Stop: Unspecified). NDC number of Pfizer covid vaccine: Not Provided. Expiry Date of Pfizer covid vaccine: Not Provided. Other Products: Not Provided. Patient History: Not Provided Investigation Assessment: Not Provided.  Follow-up attempts are completed. No further information is expected.
2 hrs post injection - sore throat increasing through out the day to elevated temp 101 degrees. Difficulty swallowing and SOB. Edema to eye lids. Called doctor - to take MOTRIN for fever, increase fluid intake and rest. Call if symptoms become worse x 2 days.
74-year-old female with a glomus jugulare tumor and no prior history of thromboembolic disease who presented to the emergency department with acute onset dyspnea with exertion and substernal chest pressure was found to have acute hypoxic respiratory failure secondary to acute pulmonary embolism with large clot burden.  Upon admission she received a CT a of the chest with PE protocol that showed a saddle pulmonary embolism with extensive lobar, segmental, and subsegmental pulmonary emboli in both lungs. Troponin elevated.   The pt reports she received a J&J vaccination in Nov 2021. Hospital DID NOT ADMINISTER THAT VACCINE
Mild rash starts in the upper thigh region ten days after initial dose (4/14/2021). Mild rash has not increased in intensity but has since spread to both forearms, left bicep, back of the neck and jawline. Individual bumps are no more than 2mm in diameter, but form in small clusters of about 10. Cortisone ointment is being used as treatment. When scratched and healed, surrounding area appears to be bruised (dark, splotchy red-purple patches)
Fatigue on 2nd day and 9 days later still have Covid arm (dull pain) in right upper arm and deltoids
Persistent PVCs that began within days of vaccine but didn't make immediate connection so not sure of exact start date.  Ongoing daily symptoms (palpitations)  which I have never had before.  Documented by EKG. Further cardiac evaluation is in progress.
Normal prep and counseling for shot. At injection patient flinched and said it felt as needle inbed into arm. Immediately said feeling faint, with 5 seconds passes out in sitting position and head back and actually did not appear to be breathing as we began calling 911 and attempted to get pt to prone position. As we began to try to move her she came to and began to respond. In about 10 minutes paramedics came and she did not want to go to the hospital. They worked with her and in about 50 she was able to go home with a friend.
3" red area and swelling around site of injection-sxs lasted 3 days.
11/26/2021- Resident passed away on Hospice services with comfort measures in place
Pt recvd vax 11SEP92 130PM in about 15 mins c/o h/a, pain in arms & legs, screaming due to pain-taken to peds inc; became mottled, cool & clammy had projectile vomiting x 2; very lethargic; has hx of asthma;  t102, inc HR, irregular breath;
pt recv vax 2OCT98 & on 4OCT98 pt exp swelling of epiglottis & tongue;adm to hosp & administered epi & dph;sx went away;
red at the injection site; puffed out a little bit; itchy; back red at the injection site; like a rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red at the injection site), VACCINATION SITE RASH (like a rash), VACCINATION SITE SWELLING (puffed out a little bit) and VACCINATION SITE ERYTHEMA (back red at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ATORVASTATIN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE RASH (like a rash) and VACCINATION SITE ERYTHEMA (back red at the injection site). On 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red at the injection site) and VACCINATION SITE SWELLING (puffed out a little bit). At the time of the report, VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red at the injection site), VACCINATION SITE RASH (like a rash) and VACCINATION SITE SWELLING (puffed out a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient reported, it was red for a few days after the shot, but then it went away. On 14-Mar-2021, it was back, red at the injection site. It is like a rash, it is puffed out a little bit. On 15-Mar-2021, it was a little bit bigger, and then it started to get itchy, It was also bigger since then.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Error: Wrong Dose of Vaccine - Too Low-
pain in the arm; 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 18 year-old female patient received bnt162b2 (BNT162B2), administration date 10May2021 (Lot number: EW0183) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (FIRST DOSE), administration date: 17Apr2021, when the patient was 17 years old, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10May2021, outcome "unknown", described as "pain in the arm". Therapeutic measures were taken as a result of pain in extremity.  Additional Information: Patient took Ibuprofen 15 minutes after the second vaccine. Patient took it to reduce the pain in the arm. After she came home, she took the pamphlet and read the paper and it said to wait 2 hours after the vaccine before taking anything. She wanted to know if this will cause her to have to retake the vaccine. Dates for took Ibuprofen and did not wait 2 hours was unspecified. Reporter seriousness for took Ibuprofen and did not wait 2 hours was unspecified. She just got home after receiving the Pfizer Covid-19 Vaccine. Caller was a consumer that went home after receiving the Pfizer Covid-19 Vaccine and she took Ibuprofen and did not wait 2 hours. Patient looked at her paperwork and it stated to wait 2 hours before taking any over the counter products. Patient wanted to know if there is a problem with taking that.  No follow-up attempts are possible. No further information is expected.
No adverse event; Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered) and NO ADVERSE EVENT (No adverse event) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered).    No concomitant product reported by reporter.  Seven patient received Moderna COVID-19 vaccine with Blue Capped Purple-Bordered (Ages 6-11 years Monovalent) instead of receiving Moderna COVID-19 Vaccine Bivalent.  No treatment medication reported by reporter.
Patient was given the vaccine and was sitting in the observation area. After around 5 minutes patient passed out while sitting on the chair. The two pharmacists ran out to the observation area with an epi pen and had the tech call 911. Patient had a pulse and before administering the epi pen the patient woke up.
About 6 hours (9pm) after receiving vaccine started to experience sharp pain when breathing around right rib cage later radiating into right shoulder/neck area. Extreme pain while trying to sleep. Went to urgent care 11am 11-18-2023.  X-ray taken, slight scarring in lung. Prescribed Ibuprofen for pain and antibiotic Azithromycin 250 MG.
Mom reports swelling & redness in right shoulder within an hour.  HEP A given there.  Had low grade fever, next day 102, went to school, come in 2 days later.  No fever, 6 X 7 1/2 cm erythema around shot site.
Patient said she had a sudden fever that lasted approximately 24 hours. She also experienced whole body aches and soreness. She said she took 2 TYLENOLS with no relief but later on took some ALEVE which helped. She said all the symptoms disappeared the following day.
Large lump under skin at vaccine site, exhaustion, metallic taste in my mouth that isn't going away. Increased heart palpitations
pt recv vax 27OCT97 & c/o rt arm pain w/movement, tender to touch, swollen, warm, no redness;febrile overnoc to 101.7, pain & erythema devel @ inj site w/swelling & fluid in rt bursa;dx cellulitis per infect disease specialist
after dinner , fever, took Tylenol. went home overnight vomited and went back to sleep. woke up in the morning still feeling fatigued. did not eat , did not take temperature again and did not take any more tylenol