chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnicity. Initial information processed with additional information received from reporter on 05-APR-2022. 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, expiry: unknown) 1 total, dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient was in hospital at the time of reporting with Covid-19 and was doing well. The patient was hospitalized (date and days unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from Covid-19. This report was serious (Hospitalization Caused / Prolonged). "This report was associated with product quality complaint: 90000224510. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. Sender's Comments: V0: 20220405438-covid-19 vaccine ad26.cov2.s-Covid-19 . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
pt recvd 3 doses of vax on 20SEP90, 16OCT90 & 3APR91 & on 10JUN91 exp severe pain in rt shoulder which radiated up into neck & down to mild-upper arm; pain was severe ache assoc w/burning & electric-like sensation; dysesthesia; rotator cuff
4PM recvd Hep B #3 dose; 5PM vomiting episodes began & cont that evening & through the next day; pt was fine p/24 hrs;
I sat for 15 minutes after the vaccine, after that I went home, I was fine until 2 1/2 weeks ago. I started to feel pain under my chest underneath the ribs, I could not touch the area, I felt nauseous, I still have the pain, tender to the touch, but not as severe as last week. I called my doctor, and they gave an appointment, another doctor saw me, and he does not know what it is, tomorrow I will have an ultrasound and if nothing shows other tests will be done.
SHE REPORTED RASH ABOUT 2 TO 3 INSHCES BELOW THE INJECTION SITE
got the shot on Monday and it really hurt, then  arm was hot, red and sore for a week. On Tuesday  extremely tired, then  had the chills and was really achy for a couple of days. Late Wednesday  got a headache. This lasted about four days.
Initial and follow-up information has been received from a physician concerning a 27 year old female with a history of three previous pregnancies, 3 full term deliveries with no birth defects or complications, and condyloma, who on 02-MAY-2007 was vaccinated with a first dose of GARDASIL (Lot# 657006/0188U). On 05-JUL-2007, the patient was vaccinated with a second dose of GARDASIL (Lot# 657621/0387U). Subsequently, the patient became pregnant after receiving second dose of the vaccination. On 09-OCT-2007 and 06-DEC-2007 ultrasounds were performed for dating and fetal screening, the results were within normal limits. On 20-NOV-2007 a serum alpha-fetoprotein test was performed for screening, the results were within normal limits. The patient's last menstrual period was 10-JUL-2007 and her estimated delivery date was 15-APR-2008. At the time of the report, the patient's outcomes was unknown. No product quality complaint was involved. On 15-APR-2008, forty weeks from her last menstrual period the patient gave birth to a female infant that weighed 9 pounds 2 ounces. The infant was 20 3/4 inches long, her apgar score was 9/10, and her head circumference was "13 1/2." The infant was normal, with no congenital anomalies, complications, or abnormalities. Other medications used during the pregnancy were REPLIVA 21/7 from 13-MAR-2008 to 18-OCT-2008 once a day as an iron supplement, PRIMACARE ONE from 13-MAR-2008 to 18-OCT-2008 once a day, GYNAZOLE 1 started on 24-SEP-2007 once at bedtime for vaginitis, CLINDESSE started on 24-SEP-2007 once at bedtime for vaginitis, CLINDESSE started on 24-SEP-2007 once at bedtime for vaginitis, and VALTREX 500mg started on 09-OCT-2007 (reported as 09-OCT-2008; two times a day for Herpes simplex outbreak. Additional information is not expected.
Vaccinations were given at 11:16 am.  Patient started getting nauseated at 11:22 and eyes were puffy.  He vomiting once and symptoms worsened.  Physician was notified.  Oxygen probe was placed on child and read at 83% 02.   Nasal cannula was placed on child with oxygen flowing at 2L and titrated to 4L.   Child was given 5 ml of Benadryl at 11:25 and 20 ml of Prednisolone at 11:35.    02 saturation level increased to 92% .  EMS was called by clinic manager.  Child was taken by ambulance to ER.
Tdap indicated but DTaP initially administered. After error was discovered, Tdap was also administered. Patient was observed, no treatment was necessary, no adverse outcomes were noted.
Fever (100°), extreme chills, body aches, extreme headache, lightheaded, sore/tender arm, burning/stinging down the arm... all last all day on 04/29/2021 starting at 06:00 am.  Took Tylenol extra strength twice (2 pills each time) which resulted in a lesser headache, lesser body ache, and reduced fever.
Continuous tiredness that turned into exhaustion. I was sleeping every free moment but never feeling rested. Then my body started to hurt a week after the vaccine. I ignored it. I thought it was because my period was coming. My breasts felt swollen and like they were on fire and my chest felt inflamed and sore.  One week ago I started to develop itchy bumps on my back. I thought it was hives. I went to the ER today because my body was in so much pain. I thought I was tired due to stress, but my entire body had been aching for weeks and this morning it was unbearable. I have been getting ample rest, and a healthy diet before and after the vaccine. I started to get a rash on the right breast. I have had chest pain for weeks. Breast bone and sternum pain. Back pain the has been consistent for weeks. I was diagnosed with shingles today.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2004, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. In 2008, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Received DTaP left arm 09/05/2001. Indurated area/local Rxn pink and red upper arm within 12 to 21 hours of injection 50% upper forearm affected with edema. Nontender not 5x5 anaphlaxis, temp 100.4 on 09/07/2001 (already swell and red arm by 09/07/2001 vs. 09/05/2001). Cold compresses, Ibuprofen and pre cautioned cellulitis.
high blood pressure of 209/101; general "unwell" feeling; This is a spontaneous report from a contactable consumer (granddaughter). An 85-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: Unknown), via an unspecified route of administration on 24Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. According to the consumer her grandmother received the first dose of bnt162b2 on 24Jan2021 and has experienced high blood pressure of 209/101 and a general 'unwell' feeling on an unspecified date. The outcome of the event general "unwell" feeling and high blood pressure of 209/101 was unknown.   Information about lot/batch number has been requested.
headache, loss of smell, sinus congestion, nasal congestion, post nasal drainage, chest congestion, sneezing.  starting on 9/23/21
felt itchy all over 10min p/vax;then had diff breathing-felt as if throat was closing-20min later taken to ER-given DPH;dx allerg react;
Staff member started to feel fatigue and chills the evening he received the vaccine. Symptoms continued the following day and a half. Fever was as high as 101.4. He had COVID nine months ago. Symptoms have resolved.
Generalized rashes, itching, hives 15 minutes after shots given. BENADRYL 50 mg IM given "stat". Symptoms resolved 30-45 minutes later.
Myalgia Narrative:  chills, fatigue, burning eyes, insomnia, light sensitivity, involuntary contractions
first 24 hrs  - achy all over and feverish, took tylenol for sleeping.  In 48 hours, achy in all joints, no energy, continued tylenol and rested. In 72 hours pain gone from injection sites but still achy joints. Right elbow red and swollen with cellulitis. In 96 hours, energy back, swelling gone but right elbow still red and itchy.
Intense soreness at injection site for 2 days after vaccine.  The day after vaccine complaints of fatigue and weakness.  Four days after vaccine noticed red rash about 3 inches below injection site.  Site is warm to touch and tight.  No temperature at time she came to clinic.
IPV/IPOL vaccine deemed not viable during temperature excursion. Vaccine administered by staff.
Rcd vaccines 10-1-07, increased discomfort, favoring (R) leg - limping, knee swollen on Friday 10/5. Seen in office 10/8 - still favoring (R) leg, no swelling or redness noted, no muscle mass noted. No hx trauma.
Information has been received form a physician referring to unknown number of patients of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with oral ROTATEQ (lot # L035511, expiration date 25-MAY-2017, dose, dose# and route unknown). The vaccines were stored under 34F for 13 hours and the vaccines were back in range without previous excursion. No adverse reactions reported. This is one of two reports received from the same source. Additional information has been requested.
History rash (hives) on & off x 2 days after administration of vaccines (PENTACEL, HBV, ROTATEQ, PREVNAR).
Very lethargic, mild pain injection site, severe shortness of breath. Severe hoariness  , voice   Complications, aches and severe joint pain , knees ankles shoulders. Headache.. Everyday tingling in hands and feet.  So tired , trouble breathing with and without mask.  Blurred vision, depression,  severe anxiety,  changes in  mobility..
Had a cold; This case was reported by a consumer via call center representative and described the occurrence of cold in a 51-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced cold. On an unknown date, the outcome of the cold was recovered/resolved.   It was unknown if the reporter considered the cold to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced horrible cold after receiving vaccine. This case has been linked with cases US2019149365, reported by the same reporter.
The symptoms I had the initially I thought it was a sinus cold, I had a horrible runny nose, no productive cough. I felt short of breath. My lungs felt like I could not do a big depth breath. For about two weeks I was extremely tired. I had a dry cough for a week in a half. Anything that came up was clear. I also had chills. I had a 30-hour period of really bad symptoms and then everything got better. No appetite. I got prescribed PAXLOVID. By the time I started taking the medication I started to feel better. During this time, I was doing ski trials and I fell and broke a rib.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 25-JAN-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, lot# reported as N027624 with expiration date of 05-NOV-2019, for prophylaxis (dose and route of administration were not reported). No symptoms reported. The administered dose of the vaccine experienced a temperature excursion of 70 F for 23 days. There were not previous temperature excursions and it was not a call because of a data logger. No product quality complaint was involved.
severe pain in my shoulder at the injection site for 14 days. Constant level of pain when at rest, but extreme pain when I use/lift my arm at all. Difficult to drive, hold anything in my right hand, or lift arm at all.  Starting yesterday, 4/14/21, it's starting to feel better, but still far from normal. No redness or swelling at injection.  I think the shot was probably administered too high in my arm, but not sure.
Also tested positive after vaccination (believe 2 others); Also tested positive after vaccination (believe 2 others); This is a spontaneous report from a non-contactable consumer. A patient of an unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER, UNKNOWN, SINGLE for covid-19 immunization. Medical history and concomitant medications were not reported. The patient underwent sars-cov-2 test and tested positive after vaccination on an unspecified date. It was unknown whether the vaccine they had received is the Pfizer vaccine. Outcome of the event covid-19 was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
7 x 5 cm area redness (Lt) thigh; no warmth or tenderness to touch; afebrile; activity WNL.
I got my period 10 days early; This is a spontaneous report from a contactable consumer (patient, self-reported). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 16Mar2021 at 09:00 AM (age at vaccination: 43 years), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history was not reported. The patient did not have known allergies. Concomitant medication included sertraline. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization and had heart flips four days after the first shot, continued through the whole vaccinated month. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On an unspecified date in Mar2021, the patient got her period 10 days early after the second dose. This never happened before in her life. The patient did not receive any treatment for the event. Outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
(R) arm 2x3 cm induration, 9x6 cm erythema/edema/warmth/tenderness.
Nickel-sized rash, itchy, painful, redness, raised bumps on inner elbow of arm received vaccine in.
allergies became very bothersome; sinuses felt raw and were burning; sinuses felt raw and were burning; nose very stuffy, and runny; nose very stuffy, and runny; Throat became dry; voice scratchy; intermittent dry cough; upper respiratory irritation; This is a spontaneous report from a non-contactable healthcare professional (patient). A 67-year-old male patient received bnt162b2 (BNT162B2), second dose via an unspecified route of administration, administered in the right arm in Feb2021 (lot number: EN6198) as single dose for COVID-19 immunization. Medical history included pollen allergies and hay fever. Ongoing concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) and fluticasone propionate (FLONASE ALLERGY RELIEF); both taken for allergies, start and stop date were not reported. The patient took BNT162B2 first dose (lot number was not reported) in Feb2021 in the left arm (at the age of 67-years-old) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Mar2021, several days after receiving second vaccination shot, and while continuing with his allergy medications, the allergies became very bothersome, sinuses felt raw and were burning, nose very stuffy, and runny. Throat became dry, voice scratchy, intermittent dry cough, and upper respiratory irritation. It has been 4 weeks since his second Pfizer vaccination and still have symptoms, but over the last few days symptoms seemed to be lessening. The patient was hoping that the reduction in symptoms continues and to be back to normal soon. The patient did not receive any treatment for the adverse events. The patient was not diagnosed with COVID-19 prior to the vaccine and has not been tested for COVID-19 since the vaccination. The patient considered the events to be non-serious. The patient was recovering from the events.   No follow-up attempts are possible. No further information is expected.
Patient was given two doses of MMR Proquad and Dtap, one on 8-31-07 and the other on 11-1-07.
Patient with history of COVID-19 admitted to hospital with COVID-19 detected test. Per physician discharge note, "Reason for Admission:  Patient is a 70 YO male with a PMH of PAF on Eliquis (last dose 8/31), Chronic HFmrEF 45%, HTN, ESRD on hemodialysis, anemia, hx of Ischemic MCA CVA and found to be covid+ (asymptomatic) with residual aphasia who sufferred a GLF yesterday when he attempted to get out of his chair. He presented to the ER with c/o right ankle pain, xrays revealed an acute distal fibular fracture mild lateral subluxation of talus suggesting syndesmotic and/or deltoid ligament injury. COVID-19 infection 8/31/23 - asymptomatic. No cough/ SOB or hypoxia."
Tested COVID + on 12/27 which is 5 days after receiving 1st dose of the vaccine.
Itchy rash on her arm; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 18th January 2021, 7 days after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved.   The reporter considered the itchy rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and about one week later developed an itchy rash on his arm.   No lot number or expiration date was known for this vaccine.   No HCP information was provided The reporter did not consent to follow up. This case linked with US2021022952 and US2021022953, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021022952:same reporter US-GLAXOSMITHKLINE-US2021022953:same reporter
The day after the vaccine I had a little bit of a headache but it went away after four hours. My left leg - I started feeling some pressure behind my knee when I was walking. It happened two days in a row and then it happened a week later (April 22th). I  called the doctor and they sent me to get an ultrasound done.  I'm a carrier for Factor V Leiden which I knew.
Patient had 2 shots on the arm on Friday morning and, in the evening felt itchy, sore, bump as well as hot red on the vaccinated right arm. No lymph glands and he got better on Monday 3/10/2008.
Fever 7 days after immunization. Saw doctor on call then had rash lasted month after vaccination.
Within a few hours of receiving the shot, I experienced very very weak legs. I felt I could hardly walk or support myself whenever my feet would touch the ground. I would manage to walk, but with difficulty and a lack of coordination. It was one of the most petrifying experiences in my life! I hope it was temporary, but after a week I visited my doctor and she claimed she had not heard of this effect yet. She did some blood work and requested an ultrasound on my legs. My blood work was all good except for a mildly elevated d-dimer. I didn't have a chance to do the ultra sound yet as I had an urgent trip to attend to. My leg weakness and heaviness cannot be described as pain. It is primarily weakness, heaviness, and discomfort. I feel that I have some sort of neurological disorder after the shot, but I don't really know for sure. The problem, is that I am still facing these issues even a month later! It's less than before and I am not as terrified as I was initially, but I feel there is some sort of permanent damage that has happened. I have opted not to go for the second vaccine under any condition. I actually wish I would have taken my chances with covid as my health and lifestyle are definitely compromised as a result of this vaccine. Some answers and remedies would be really appreciated please!
Patient received vaccination at 2pm on 9/16/18. By 4pm on 9/16/18 patient stated that her arm started hurting. Patient went to doctor the following day and the doctor stated that the injection was given too high on the patient's arm.
Patient presented to health clinic for his 2nd dose of the COVID Moderna vaccine. While being processed for 2nd dose vaccination, the client reported that approximately 24 hours after receiving her first Moderna dose, he experienced chest pressure x3 days. Client notes aggravating factors include staying still and alleviating factors include moving around and taking "deep breaths". Client reports taking a total on 3 aleve doses, 1 dose every day  for 3 days following onset of symptoms. Co-Lead RN was advised by Vaccinator, regarding client report. Co-Lead RN responded. The client states symptoms resolved after third day. Client denies experiencing shortness of breath or any other symptoms at the time that he experienced chest pain. Client did not follow up with PCP or seek medical attention for symptoms. Client denies medical history and notes he has allergies to mold and dust. Co-Lead RN, consulted with medical team Medical. Medical team recommended that client proceed with 2nd dose Moderna COVID 19 vaccination. Co-Lead RN informed client who agreed to plan of care. Client received 2nd dose Moderna COVID 19 vaccination and was observed for 30 minutes. No symptoms reported by client. Co-Lead RN educated client on ED precautions. No additional interventions indicated at this time.