chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 35 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: 204B21A and expiry: UNKNOWN) dose was not reported,1 total administered on 17-AUG-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 30-DEC-2021, the patient experienced or started symptoms was sneezing, congestion nose with phlegm (confirmed covid-19 infection). On 04-JAN-2022, the patient tested covid positive, went to see walk in clinic, doctor who confirmed covid, test showed covid positive, unsure of kind of test (confirmed clinical vaccination failure). Patient fully vaccinated with janssen brand and Patient had no symptoms at present and tested covid negative today using the JNJ supplied rapid antigen binax now test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000210495.; Sender's Comments: V0.20220109765-covid-19 vaccine ad26.cov2.s -confirmed clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
3 days post vax hospitalized w/wheezing, cough & fever,rash; RSV antigen positive; Had underlying bronchopulmonary dysplasia; No problems p/2nd HIBTITER; 4-5 days p/1st HIBTITER, wheezing, cough & pneumonia;dx otitis media, bronchitis;
2 days p/vax pt had a red discolored mark 3" long & 2" wide coming out of the area where the flus hot was given;still has mark now;
12 to 16 hrs p/vax pt t101 then a sz that lasted @ least 30-40 mins; pt had resp failure;
Pt presented in Office  complaining of upper L arm soreness, irritation, redness, itchiness, and site being swollen.  Started 3/11/23 Pt took Ibuprofen 600MG, used topical ointments like Triple antibiotic ointment, Tiger Balm ointment as well as Naproxen 1tab  Took these medication in a span of 3/11-3/14 (4 days) w/ no relieve. Hasn't helped PT at all.
Patient reported experiencing throat tightness/swelling and dyspnea (i.e. anaphylaxis).
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates these patients were vaccinated with improperly stored doses of GARDASIL 9 (lot#M027344, expiry date 30-JUN-2018, lot#M028233, expiry date 30-SEP-2018 and lot#M033212, expiry date 31-JUL-2018) for prophylaxis. No adverse effects were reported. The vaccines were exposed to the temperature of 33.8 degree Fahrenheit for 8 hours 11 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. This is one of the two reports reported from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004255.
This spontaneous report was received from a 65 year old male patient concerning himself. On 30-OCT-2013 the patient was vaccinated with ZOSTAVAX, therapy route: injection (dose, lot number and expiry unspecified). Beginning the follow day, on 31-OCT-2013, the patient began to experience an injection-site reaction which included hardness, redness, sensitivity and injection site discomfort. The patient reports that as of Monday, 04-NOV-2013, the outcome of injection site discomfort, injection site sensitivity, injection site hardness and injection site redness was reported as not resolved. Causality assessment was not provided. Additional information has been requested.
Information has been received from a woman working in a physician's office concerning a 10 year old female who was vaccinated with a dose of Varivax. Subsequently, the patient experienced an adverse event. It was reported that the patient had recovered. Additional information has been requested.
During 3 1/2 months subsequent to the 2nd Moderna vaccination (i.e. thru present date) I have experienced joint pain in my back, hips, shoulders, and knees; additionally, I have experienced muscle pain in my legs, back, neck, and left foot.
Mother called 2 days after vaccine given. States arm is swollen the size of a soft ball.
Large hives all over abdomen and on Left thigh. Face flushed. Gave him 25 mg of Benadryl and monitored him closely.
Next day post vax, the pt developed redness and warmth at injection site. Pt was seen by a physician and a dx of possible cellulitis was made. He was treated with Cefzil. On 3/1/00, the area was described as bluish gray and non blanching.
Developed a dry cough and tightness in lower lungs around 4.75 hours after vaccine (10/3 around 4:15 PM). Cough stopped around 5:30.  Developed muscle aches and chills around 7:00. Developed shaking with chills at 8:00. Developed fever of 102.7 at 9:30. Shaking with chills, muscle aches, fever, & tightness in lower lungs continued until I fell asleep around midnight. Awoke at 9:00 AM the next morning and all symptoms were gone & have not returned to date: 10/6 (only fatigue). At advice of online PA at Kaiser I isolated beginning on 10/4 and went in for a covid-19 test Monday morning 10/5 at 8:45 AM. Results came back today (10/6) as negative.
No adverse event; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Hyperthyroidism, Adrenal insufficiency and Blindness. Concurrent medical conditions included Melanoma (Melanoma of the eye), Hypertension and Asthma.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No relevant concomitant medications were reported. No treatment medication reported.
feel side effects so long; still not feeling completely well; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (still not feeling completely well) and VACCINATION COMPLICATION (feel side effects so long) 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 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced VACCINATION COMPLICATION (still not feeling completely well). On an unknown date, the patient experienced VACCINATION COMPLICATION (feel side effects so long). At the time of the report, VACCINATION COMPLICATION (still not feeling completely well) and VACCINATION COMPLICATION (feel side effects so long) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       NO CONCOMITANT AND TREATMENT MEDICATION WERE USED   Reporter did not allow further contact
Within one-half hour of flu injection in left upper arm, severe aching pain occurred in the entire left arm . This pain lessened and pain in the left shoulder with movment developed. Over time, aching, burning, or throbbing pain occurred in various areas pf the left arm throughout the day, eventually causing an inability to sleep. MD (primary physican, internist) was seen  on 12/11/2018 and ice therpy was recommended. With no improvment in one month, Dr. recommended seeing an orthopedic surgeon. Dr. was seen on 3/22/2019. An Xray of the left shoulder was taken showing no abnormalities of the bony stuctures. Prednisone taper was prescibed and physical therapy 2-3 times per week for 6-8 weeks. I am currently in the fifth week of PT. Pain in left arm has lessened and left shoulder pain with movement has lessened.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies reported. On an unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (lot# L043213, expiration date 28-AUG-2017, dose, anatomical location and route of administration were not reported). No adverse event reported. There was no temperature excursion and the time frame was 11.7 Celsius degree for 1 hour, 30 minutes; -1 Celsius degree for 2 hours, 50 minutes; 11.6 Celsius degree for 4 hours, 20 minutes and -2.3 Celsius degree for 63 hours, 10 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
ACUTE RESPIRATORY FAILURE 7/30/2021 ACUTE ON CHRONIC RESPIRATORY FAILURE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/12/2021 ACUTE ON CHRONIC RESPIRATORY FAILURE  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/24/2021 ACUTE ON CHRONIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE 7/19/2021 ACUTE ON CHRONIC RESPIRATORY FAILURE  HYPOXIA 5/5/2021 ACUTE ON CHRONIC RESPIRATORY FAILURE
Very sore arm 6 hours after shot until two days later.  Chills, shivering, teeth chattering 9 hours after shot. Body aches 10 hours after shot. Fainted 14 hours after shot. Fever of 99.8 F entire day after shot Throbbing headache for three days. Loss of appetite for four days. Tired, low energy, slept more for six days.
The first infection was on 02/26/2023. I tested at home because I had a sore throat, coughing, and a headache. I took the test and it was negative. I started feeling progressively worse and I went to bed and I said I would wait and take another test the next day on 02/27/2023. Overnight I spiked a fever of 102 and had chills, unproductive cough, and extreme headache. I had an upset stomach and no appetite, but I did not have a problem with my taste. That lasted all day on Monday 02/27. I took another test at 06:00PM that evening and it came up positive. I was taking Tylenol for the fever and headache and also had Mucinex DM. I had no cold medicine to take, so I just took Tylenol and had some honey for my throat. I called my doctor and they ordered Paxlovid for me to pick up on Tuesday 02/28. I took my first dose around noon. I took that for 5 days. Everything tasted like cigarettes butts from the Paxlovid. I had an upset stomach, so I took Zofran for that. The first time I started feeling better around 05:00PM that day. I progressively felt better and better and did not go backwards as the days progressed. I had my appetite back and everything did taste like cigarette butts until the last day of the last dose. I still had cough, but no more fever. On 03/05 I felt perfectly fine and felt like nothing happened to me. I had walked 6 miles that day. On Monday 03/06 I took a COVID-19 test at home and it was negative that morning around 07:00AM. I felt fine Monday through Thursday. Then 03/10/2023, I started getting a scratchy throat which was the same from the first infection in February. I took another home test that morning on 03/10/2023 and it was positive. I took a PCR COVID-19 test as well on the same day and I got the results back on 03/11/2023 in the afternoon and that came back positive as well. I got in touch with my doctor on 03/11 for a telehealth visit. She ordered more Paxlovid for pickup on 03/12. I started taking that again on the morning of 03/12. I started feeling better on the 03/12 actually. I took Paxlovid from 03/12 through 03/16 again. I was isolating again and taking the medication through that time. My symptoms were very mild this time for the 5 days. I did not have to take Mucinex for this infection. The taste with the Paxlovid this time tasted like rusty metal. Thursday 03/16 was my last Paxlovid dose, and I still had that taste in my mouth until Friday morning 03/17/2023. I've been fine since.
. Parent reported the right hip to the knee to be swollen with mild redness,  symptoms starting on the evening of 5/30/2023. Denied leg or joint pain, skin oozing, or bleeding. Denied fever, chills, malaise/fatigue, dyspnea, vomiting, diarrhea, insect bites, or h/o leg trauma. Influenza and MMR were given on the right thigh where the reaction occurred. Kinrix and Varicella were given on the left side with no reaction.
25JUL94 recvd vax about 3PM about 4PM started crying unconsoled to 7PM-fell asleep a few mins-immed awakened  cont crying till 11PM; refused breast or cup-vomited APAP x 3; fever 101 R; also mac papular rash
I was having a brain tumor; vision goes blurry; head hurts; brain fog; very scary symptom; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 02Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Patient reported that, she was experiencing side effects after receiving the Pfizer Covid 19 vaccine. She received the second dose on 02Apr2021 and had no side effects immediately after the vaccine. She reported that, the effects began two weeks later on an unspecified date in Apr2021, she thought at first, she was having a brain tumor. her vision goes blurry, her head hurts, the brain fog its horrible. She had to make herself think about what she needed to do, like getting a glass of water. It was very scary symptom. She was concerned about "How can she be helped before she goes crazy". The reporter assessed the events as non serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Information has been received from a physician concerning approximately 5 adult patients who were indicated for ZOSTAVAX(Merck) in 2008 and were vaccinated with 2 doses of VARIVAX (Merck)(lot number not reported) mistakenly by the provider. The physician confirmed that he administered VARIVAX (Merck) according to the prescribing information interval. There were no adverse effects reported. Unspecified medical attention was sought. At the time of the report, the outcomes of the patients were not reported. Follow-up information has been received from an office administrator who reported that there were a total of 2 patients who received the wrong vaccine. She reported that she did not have the lot number. The health care professional contacted during telephone follow-up could not supply the following information: patient's name, dates of birth, dates of vaccination/therapy, dose numbers or dates of event. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Have tooth pulled three days ago, extraction of tooth; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A male patient received BNT162B2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOOTH EXTRACTION (non-serious) with onset Mar2021, outcome "unknown", described as "Have tooth pulled three days ago, extraction of tooth". Therapeutic measures were taken as a result of tooth extraction.  Additional Information: The patient received the first vaccination of Pfizer three weeks ago and was scheduled tomorrow (from the time of report) to take second Pfizer vaccination. He had tooth pulled three days ago (from the time of report) and extraction of tooth. He was put on an antibiotic for one week and had been taken it for four days. He had three more days of antibiotic which was amoxicillin 500 mg (Treatment). The patient wanted to know if he should stop amoxicillin and if it would interfere with his Pfizer shot or if it was okay to take it with the Pfizer shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderate pain at injection site; Fatigue; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and fatigue. The patient was treated with naproxen. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix within the last 3 years. Post vaccination the patient experienced moderate pain at injection site and fatigue which required naproxen. No further information was available. For tolerance after 2nd dose refer case US2020AMR189293.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR189293:same patient, 2nd dose
3 hours post headache, fatigue lasted 32 hours.  12 hours post sore throat, sinus drainage, lasted 48 hours. 36 hours post chest tightness, stuffy nose congestion and dry cough.
Patient received the 1st dose of the Pfizer Covid vaccine this morning, within 30 min started to experience stridor, wheezing and tongue numbness. EMS called and pt was given  Solumedrol, Benadryl, and IM Epinephrine in route to the hospital. Pt was subsequently intubated in the ED and transferred to the ICU.
20 year old male with shingle type rash on the left arm. patient stated that rash started a day after immunization was given. Patient received two vaccine on 10/25/2023 Patient received TDAP right deltoid and MCV4 on Left deltoid.  Patient continue with Vesicular rash at todays visit 10/30/2023 Patient is being treated with medication for shingles.
Soreness at vaccination site soon after vaccination.Soreness continued to develop over next 30 hours. Evening of 09/05/2022 soreness became ache and after bedtime (around 08.30) ache became more pronounced.Overnight sleep was interrupted on turning on to left arm and interruptions became more frequent as the night progressed. Next morning upper arm felt hot and as well as the ache there was now dull throbbing all of which continued to get worse along with restricted movement and after a few weeks as it was not improving I made an appointment with my PCP. I attended on 09/30/2022 when X-rays were taken and I was referred to a sports injury specialist who I saw on 11/09/2022. Pains and aches had continued to get worse
This spontaneous report as received from a registered nurse refers to a 15 month old patient. On 07-SEP-2013 the patient was vaccinated with a dose GARDASIL (lot #, expiration, dose and route unspecified) instead of PEDVAXHIB. No adverse effects reported. Additional information has been requested.
Flushed, high BP, neck pain, headache, chest pain, general malaise. No fever. Slowly getting better (almost 24 hours later).
c/o dizziness, nausea, chills upon awakening;hx of inc BP;BP 130/92 which pt states it good;pt states feels much better but con to have some dizziness;
This case was reported by a physician who was also the subject and described the occurrence of shoulder pain in an adult female subject who was vaccinated with Fluarix (GlaxoSmithKline) for prophylaxis.  There were no concurrent medications.  At the time of reporting, the subject was lactating.  On an unspecified date in the past, prior to 1 December 2006, the subject received an unspecified flu shot (unknown manufacturer) and experienced lack of effect (she developed the flu).  At the time of reporting, the outcome was unspecified.  On 1 December 2006, the subject received an unspecified dose of Fluarix (.5 ml, intraarticular).  The same day, after vaccination with Fluarix, the subject experienced shoulder pain and drug administered via inappropriate route.  The subject believed she received the Fluarix injection in her right shoulder (intraarticular), but was not certain.  She reported that she has had pain in her shoulder since receiving Fluarix on 1 December 2006, and that the pain has worsened over the last week.  At the time of reporting, she had not consulted another physician regarding the pain.  The physician considered the pain in her shoulder was possibly related to vaccination with Fluarix.  According to the Fluarix prescribing information, injections of Fluarix should be administered intramuscularly, preferably in the region of the deltoid muscle.  Follow-up information was received on 02 March 2007 via the subject, who is also a physician.  The subject was 45-years-old at the time of the event.  The subject had been receiving influenza injections (manufacturer unknown) on an annual basis since 1990, and reported that she had developed influenza on two occasions despite vaccination (lack of effect).  She had no prior history of shoulder pain or rotator cuff injury.  On 01 December 2006, the subject received Fluarix which was injected into the posterolateral right shoulder.  The reporter noted that the "needle mark was at or only very slightly below joint line - not over the mid-deltoid as it should have been".  Immediately following injection, the subject developed shoulder pain which occurred daily but was "not constant".  The pain worsened in the two weeks following vaccination.  She noted that the pain occurred especially with external rotation, abduction, and some internal rotation of the shoulder, or with the use of the rotator cuff muscles.  The subject did not treat pain with medication due to continuing lactation.  At the time of this report, the event was unresolved.  The physician noted that the event did not involve severe disability, but that it was unknown whether the event resulted in permanent disability.  In the physician's opinion, the events were related to administration of Fluarix.  The physician specifically noted that the events were due to erroneous administration, and stated "The problem is not the product, but rather its incorrect administration."
Cough, fever (up to 103 degrees F) and seizure activity at around 8 p.m 11/21/15. Was transport to ER by EMS given TYLENOL. Mother was told that patient have (L) OM and pneumonia, given AMOXIL.