chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CoughWheeze CONTINUOUS DRY COUGH Narrative:  -PT WAS BROUGHT TO THIS WRITER AFTER RECEIVING THE COVID VACCINATION #2 7 MINS. AGO AT 7:53 AM. PT WAS COUGHING CONTINUOUSLY WHILE IN REC HALL OBSERVATION. -PT A+OX3, AMB, EXTREMITIES AND FACIAL MOVEMENTS APPEAR SYMMETRICAL. PT CONTINUES TO COUGH CONTINOUSLY, BUT IS ABLE TO SPEAK BETWEEN COUGHING SPELLS. AIRWAY NARROW BUT OPEN, NO STRIDOR OR WHEEZING NOTED. -NOTIFIED PROVIDER WITH FINDING, ADMINISTERED EPIPEN PER STANDING ORDER, PT TRANSPORT TO ED, WARM HAND-OFF TO ED NURSE AND ED HT. -PLEASE NOTE, DURING CALL WITH PROVIDER AND BEFORE EPIPEN ADMINISTRATION, PT STARTED C/O TINGLING SENSATION TO THROAT ALLOW WITH WITH CONTINUOUS COUGHING. AFTER EPIPEN ADMINISTRATION, PT SEEMED TO HAVE RESPONDED WELL. PT COUGH SUBSIDED FOR THE TRANSPORT OVER TO THE ED.
This case was reported by a healthcare professional and described the occurrence of injection site pruritus in eight to ten adult subjects of unspecified gender who were vaccinated with Flulaval (GlaxoSmithKline).  Concurrent vaccination included pneumonia vaccine, (manufacturer unspecified) given between 28 September 2007 and 04 October 2007.  Between 28 September 207 and 04 October 2007 the subjects received unspecified doses of Flulaval (0.5 mL, unknown).  "Right away" following vaccination with Flulaval, the subjects developed itching at the injection sites.  At an unspecified time after receiving Flulaval, the subjects also experienced events including hard "knots" at the injection sites, injection site redness and injection site pain.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The healthcare professional stated that eight to ten subjects of the approximately fifty who were administered Flulaval between 28 September 2007 and 04 October 2007 reported side effects.  The healthcare professional also indicated that "most symptoms have resolved but unsure exactly how many"; however, an outcome of unresolved was also reported.
Patient reported headache, nausea, joint pain, vomiting, and injection site pain 1 day after getting 3rd/booster dose of moderna, subsided on it's own after~2 days. Did not report similar reaction with initial 2 dose series.
I started my period. This was two to three weeks earlier than it should have started.; This is a spontaneous report from a contactable consumer. This is a female consumer (patient) reported for herself. A female patient of an unspecified age received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as dose 2, single for Covid-19 Immunization. The patient's medical history and concomitant medications was not reported. Historical vaccine of BNT162B2 for Covid-19 Immunization as first dose. She reported that, within less than 24hrs of receiving my second Covid 19 vaccine, I started my period. This was two to three weeks earlier than it should have started. This has never happened in my life that a cycle is this short. The outcome of the event was unknown.  No follow up attempts are needed, information about lot/batch number cannot be obtained.
Itchy, red rash at site of injection.  Itching began 2/19/21. Rash is still present at time of report.
This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.   On an unknown dates,  the patients were vaccinated with an improperly stored doses of LIQUID PEDVAXHIB for prophylaxis (doses, route of administration, anatomical location, lot# and expiration dates were not reported). Administered doses of LIQUID PEDVAXHIB experienced an unknown temperature (out of range temperatures) for an unknown time, on an unknown date. There were multiple previous temperature excursions (dates, time and of the excursions were not reported). It was unknown if the digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012038: US-009507513-1701USA012037: US-009507513-1701USA009285: US-009507513-1701USA012036:
A report has been received from a Health Professional concerning a, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. It was reported few patients received expired FLUMIST QUADRIVALENT. The outcome of the event a few patients received expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
This report describes the occurrence of twitching in a 4 month old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received from the subject's mother and has not been verified by a physician or other healthcare professional.  Reportedly, the subject had no relevant medical history or concurrent conditions and had no adverse experiences following previous immunizations. The mother reported that on 04/16/03, the subject received her third injection of Engerix-B (Lot # ENG5288A2), administered four months after the first injection rather than the recommended interval of six months.  This occurred because the first injection was not recorded by the hospital at which it was administered.  It was later determined that the hospital had administered the first injection.  On 04/16/2003, she also received injections of DTAP (manufacturer unknown), HIB (Manufacturer unknown), IPV (AP), Prevnar (Lederle).  The mother reported that on 04/17/03, the subject began to be sleepy, "jerky-twitching", cranky, was "not talking babytalk", had a "slight" fever, "pupils small-just dots", was "not three days after the immunizations.  The events reportedly resolved on 04/20/03.
This spontaneous report was received from a pharmacist regarding a male patient aged above 60 or more. Information on pertinent medical history and drug reactions/allergies were not reported. On 19-OCT-2016, the patient received a dose of ZOSTAVAX 19400 PFU (dosing details not reported). Concomitant medication included warfarin. On 19-OCT-2016 (reported as unknown time after receiving vaccine), the patient noted that his arm was bruised and had a melanoma at the injection site. The patient was treating the bruising with cold compress. The patient had sought medical attention. The reporter stated that a clinician was currently on the way to visit the patient at home and examine the arm. Bruising was still present at the time of reporting, five days later. Outcome of the event injection site hematoma was unknown. Causality of the events was not reported. No product quality complaint was involved. Additional information is not expected as there is no consent to contact the reporter.
Swelling in arm, redness, warmth, and hardness started 5 days after injection and still present on day 9
SX 2-9-22  COUGH FEVER FATIGUE, RUNNY NOSE, MYALGIAS;   TESTED + 2-10-22;  DECEASED 2-15-22
Within 30min of vaccine administration, patient felt very flushed, weak, lightheaded. Unusual cooling sensation like dripping in ear every couple minutes. Later developed headache and following morning still felt weak. No respiratory symptoms. No fever. No nausea or vomiting. Vital signs normal. Headache persisted greater than 24hrs.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 at 14:00 as dose 1, single (Lot number: EL8982), in left arm, on 18Mar2021 at 14:00 as dose 2, single (Lot number: EP7534), in left arm, on 29Sep2021 at 10:00 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 06Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Reoccurrence of Covid symptoms with positive test 4 days after all symptoms had disappeared and had a negative COVID TEST; (unspecified date) Negative, notes: Reoccurrence of Covid symptoms with positive test 4 days after all symptoms had disappeared and had a negative COVID TEST; (21Dec2022) Positive, notes: Reoccurrence of Covid symptoms with positive test 4 days after all symptoms had disappeared and had a negative COVID TEST. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Reoccurrence of Covid symptoms with positive test 4 days after all symptoms had disappeared and had a negative COVID TEST. Known allergies: No. Other medical history: None. Other medication in 2weeks: No
First dose only had a head ache; This is a spontaneous report from a non-contactable other HCP (patient).  A 36-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number EK5730) , via an unspecified route of administration on 22Dec2020 09:15 at single dose on left arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient reported first dose only had a head ache on an unspecified date. She was fine the morning before receiving second dose.  Patient was not pregnant. Patient did not have Covid prior vaccination and Covid was not tested post vaccination. Patient did not receive other vaccine in four weeks. No known allergies. The outcome of the event was resolved on an unspecified date.   No follow up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist mentioned a shipment of live ZOSTAVAX and live (Merck) VARIVAX were received with a 4 days shipping time period were given to patients (unknown date). Pharmacist stated the shipment was received and the ice packs were still frozen and the live ZOSTAVAX and live (Merck) VARIVAX were stored in the freezer. There were 9 patients who received live ZOSTAVAX. On 07-FEB-2013, one of the them was vaccinated with a dose of live ZOSTAVAX lot # H019040, Expire date: 17-JAN-2014 (route and dose not reported).No concomitant medication were reported. The patient was not experiencing any known symptoms. Patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Significant arm swelling, facial swelling, V, 104 fever, body aches.
Vaccine given at 5:19 pm. After the vaccine, mom took pt and walked around the store rather than stay in the waiting area. They returned at approximately 5:45 pm, because pt was complaining of a bad headache rating pain 6/10. He denied any other symptoms. We had him sit down in the waiting area and gave him a bottle of water. He started feeling lightheaded a few minutes later and was moved to an exam room. I had him lay down on the exam table. At approx. 5:55pm, I checked his BP while he was laying down and it was 104/62. He reported feeling a little better, so I had him sit up. Rechecked BP and it was 108/70. He reported dizziness had resolved and headache was now 5/10. At some point while I was not with the pt, mom gave him some Aleve, but I don't know what time. Mom decided to take him home at that point.
Presented to the ED via mobile health care c/o SOB. Pt is COVID positive for 11 days. Admitted for COVID-19 pna w/acute resp failure; aggressive care needed w/intubation, vasopressors, CRRT d/t acute renal failure; pt went into PEA 1/21 and unable to obtain ROSC and expired
SEVERE CONGESTION TO THE POINT WHERE BOTH NOSTRILS WERE BLOCKED WHILE SLEEPING; SWOLLEN ARM; HEADACHE; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: unknown) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-AUG-2021, the patient experienced swollen arm. On 07-AUG-2021, the patient experienced headache. On 08-AUG-2021, the patient experienced severe congestion to the point where both nostrils were blocked while sleeping. Treatment medications (dates unspecified) included: paracetamol, cetirizine hydrochloride, and oxymetazoline. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe congestion to the point where both nostrils are blocked while sleeping, and the outcome of swollen arm and headache was not reported. This report was non-serious.
Pt's arm got very red, swollen, and itchy radiating out from vaccine site. It was larger than a softball. She saw MD.
Patient arm got swollen for a few days. Patient did not go to the doctor and arm is back to normal.
One week after receiving the vaccine I noticed  a hive on my left upper arm. The next day it was much larger, looked like a welt and itchy. It responded to 25mg OTC antihistamine. Still have some of it 3 days later but has greatly improved.
Nausea/vomiting at 9 am in the morning after receiving second dose; fever between 99.3-99.7 all day, mod-severe fatigue, aches/chills all day, headache, soreness at site of injection
Pt scratching vaccine site after administration. Redness and swelling noted around vaccine site to right thigh the morning of 10/31/18. Redness and swelling have increased. Red area feels warm. Pt had a fever last night.
Information has been received from a physician concerning a 4 year old female with no allergies or medical history who at 12 months of age 4 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. There was no illness at the time of vaccination. On 5/3/04, the patient came to the physician with a breakout of 20 lesions. No treatment was required. It was noted that therapy was discontinued. A product quality complaint was not involved. Follow up information received from the physician who indicated that the patient had a break through varicella with about 70 lesions. Subsequently, the patient recovered. No further information is expected.
Shot was given in the left shoulder joint. Because most of the vaccine would not go in, a second vaccine was given in the right arm. On March 19, 2021 woke up in the middle of the night Wet with sweat.
Post vax, client began to suffer from severe muscle aches in neck and body. Describes as 'deep joint pain and severe muscle ache'. Lasted one week, severe, and one week, less severe. Onset 24-48 hours post vax. Hesitated to report but was due for 3rd vax so decided to report reaction. Since has had full recovery. Did not contact physician or seek treatment.
Appendicitis- had increased gas leading up to it, then severe stomach ache which led me to go to the ER
inc sz activity beginning 30 hrs p/vax; pt hospitalized & cont to have sz;
11-19-07 - Received MMR, Varicella, Prevnar and Influenza. 48 hours later broke out in blistery rash and facial swelling. Steroid therapy in ER. 2/25/08 - Received Dtap and Hep A 24 hours later broke out in blistery rash.
Information has been received from a registered nurse concerning a 12-year-old male who on 20-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 658198/0854U). On 23-AUG-2007 the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
immediately upon injection she had intense pain at the injection site and brisk bleeding. When the tech applied pressure to the bleeding she nearly fainted due to the pain. She had burning pain down the arm and in the intervening weeks has progressive decreased range of motion suggestive of frozen shoulder
I tested positive for COVID-19 on 5/18/22. I was having fatigue, shortness of breath, fever 100.7, congestion, cough, and wheezing. I saw multiple doctors about this through the clinic. I was prescribed Prednisone, and an Albuterol inhaler. I am still having some symptoms at this time. I went back to the walk in clinic on 5/11/22 because I was having worsening symptoms, coughing, and shortness of breath. They took me off the mediation and they found that I had a small case of Pneumonia and they put me on Paxlovid.
Pt stated he started lifting weights about 2:30PM on 01/25/21 and after lifting took a shower and notice his chest was getting white bumps. Pt applied his steroid cream to his chest. Pt states bumps look like those after you burn yourself. Pt states he called Vsafe w/ the CDC and they have been keeping track of his symptoms and came to the conclusion that he is ok to get his second dose. Pt states he called Vsafe, he did not feel the need to call facility to notify us.  Pt states that Dr. called him to make sure he was ok on 01/27/21, because his sister in law came in and told us about his reaction and called to follow up with him.
ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE
Has UTI infection; Reschedule her second Moderna COVID-29 vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Has UTI infection) and PRODUCT DOSE OMISSION ISSUE (Reschedule her second Moderna COVID-29 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medication history was provided.  Concomitant products included CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) from 12-May-2021 to an unknown date for UTI.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Reschedule her second Moderna COVID-29 vaccine). On an unknown date, the patient experienced URINARY TRACT INFECTION (Has UTI infection). At the time of the report, URINARY TRACT INFECTION (Has UTI infection) had not resolved and PRODUCT DOSE OMISSION ISSUE (Reschedule her second Moderna COVID-29 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provider by the reporter.
The vaccine expiration date was identified to expire on June 22, 2021, but the manufacturer expiration date was February 25, 2021.  Based on the information learned, Health department took the following steps: ? Contacted Moderna for guidance and based on Moderna data, the Moderna Medical Information team provided the following information:  o ?The vaccine administered on March 4, 2021 through March 10, 2021 from lot number 025J20-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.?  ? Contacted a medical director and based on this information from Moderna, no re-vaccination is needed.
Fever/Low fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever/Low fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066F21A, 011A21A and 029L20A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Trigger thumb. Concurrent medical conditions included Hypertension and High cholesterol.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever/Low fever). At the time of the report, PYREXIA (Fever/Low fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-724098 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724098:Bivalent Dose
Evening of 27AUg, pt became unresponsive w/head turned to one side; Family members noted jerking of head; pt was taken to hosp & remained overnight; Taken to another hosp & started on Phenobarb; One additional episode occurred @ hosp;
Could not move her legs; Swollen Left Arm post second vaccine; Hard to the touch Injection Site; Red Injection Site Spreading 6"; Spent 17 hours laying on the floor; Chills; A spontaneous report was received from a consumer concerning herself. She is a 77-years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Swollen Left Arm/peripheral swelling, Could not move her legs/ Monoplegia, Hard to the touch Injection Site/Vaccination site induration, Red Injection Site Spreading 6"/Vaccination site erythema, Spent 17 hours laying on the floor .  The patient's medical history was not reported. Concomitant medications were not listed.  On 25 JAN 2021, prior to the onset of events the patient received first of their two planned doses of mRNA-1273 (Batch N0: unknown)intramuscularly in the left arm for prophylaxis of covid 19 infection, and Her Arm swelled up, and she had chills for 3 days.  On 22 Feb 2021, prior to the onset of events the patient received second of their two planned doses of mRNA-1273 (Batch N0:016M20A )intramuscularly in the left arm for prophylaxis of covid 19 infection. on 22 Feb 2021, Her Arm Swelled Up again, Red, Hard, Spreading 6" and at 2AM could not move her legs. She fell on the floor when tried to get up. She was on the floor For 17 hours until help arrived. She was Hospitalized for 2 days. Discharged 24 FEB 2021, released to a Home Health Care Facility. They started physical therapy.  Action taken with mRNA-1273 in response to the events not applicable.  The outcome of events, Swollen Left Arm/peripheral swelling, Hard to the touch Injection Site/Vaccination site induration, Red Injection Site Spreading 6"/Vaccination site erythema were considered recovering/ resolving by 24 Feb 2021, Spent 17 hours laying on the floor, Could not move her legs/ Monoplegia considered recovering or resolving by 3 mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
PT REPORTED LEFT ARM UNABLE TO MOVE PAST HIS ELBOW AND STRETCHED ABOVE HIS HEAD. HE DID NOT GO TO ER BUT RATHER TOOK TYLENOL AND USED ICE FOR SWELLING.
pt recvd vax & pt's fingers felt stiff; pt taken to ER; MD felt it is arthritis; caused from immun; tx w/ meds