chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe headache, between the eyes, worsened; very bad cough, she woke up with it, its hard to breathe with the cough, worsened; very bad cough, she woke up with it, its hard to breathe with the cough, worsened; yesterday she was tired when she got her shot, yesterday morning she slept all day; she was not really hungry; yesterday she was tired when she got her shot, yesterday morning she slept all day; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 at 11:00 hours, as single dose (at the age of 63-years-old) for covid-19 immunisation. Patient had no medical history. Patient stated that she had no problems, no medications, no heart problems, no diabetes, she was free and clear of medication. Patient had no family medical history relevant to events. Patient stated that a couple family member been vaccinated, and they did not had a problem. The patient's concomitant medications were not reported. Patient had no prior vaccinations (within 4 weeks). On 07Apr2021, patient got her shot at 11:00 hours and patient were tired when she got her shot and in morning patient slept all day, she did not eat because she was not really hungry, she had a headache between the eyes and it was odd for her to not be hungry. Patient stated that it happened after the first shot. Patient had severe headache and cough happened in the middle of the night, and can't breathe (on 07Apr2021). Patient had a bad cough, she woke up with it and it was hard to breathe with the cough (on 07Apr2021). Patient asked if she could take ibuprofen for headache and she was wondering if the cough was normal and can she take cough syrup. She stated that she needs something, she was coughing and hacking. Patient stated that every time she coughs her head was pounding. She could not eat and she was an eater. Patient said that she tried to get coffee down this morning and forget it, she was not really feeling hungry (on 07Apr2021) which was unusual for her, normally she would eat whatever you put in front of her. She didn't eat anything right now. As far as tiredness she was ok, not tired right now. Patient stated that she did feel tired (on 07Apr2021) yesterday but feels uncomfortable with headache and cough. Patient had no emergency room and physician office visit.  Event severe headache, between the eyes and very bad cough, she woke up with it, it was hard to breathe with the cough was worsened. The outcome was recovered for yesterday she was tired when she got her shot, yesterday morning she slept all day (tired) on 08Apr2021, not recovered for (very bad cough, she woke up with it, it was hard to breathe with the cough, worsened), (severe headache, between the eyes, worsened) and unknown for rest of the events.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Mom states that she dressed child the morning following vaccine administration (7/19/17) and child stated that his right arm was hurting but mom did not look at it. Later that same day as she was undressing child, she looked at arm and noticed that it was red, warm to touch and swollen. Child had temp of 100 F. Mom gave child BENADRYL and TYLENOL. Mom brought child to clinic today, 7/20/17, with complaints of continued redness, whelps and pain to upper right arm. Child was given topical BENADRYL and liquid CLARITIN to take at home. Mom instructed to follow up at ER or clinic if child has any breathing issues or reaction worsens/increases in size.
Patient came into the medical office 02/17/2021 at 4:00pm to get second dose of Moderna COVID-19 vaccine. (Patient had received 1st dose at this same clinic.) Patient completed COVID-19 checklist and answered "No" to all questions on checklist, except "Have you received a previous dose", which was marked "Yes". Second dose was given in left deltoid (Lot#010M20A).  Patient's son came to office morning of 02/18/2021 and informed manager that patient had received second dose twice  on 02/17/2021, with the first, second dose being given at the Health Department in the morning (Lot#013M20A).
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 60.68   Concomitant products were not provided  On 03-Apr-2021 Excursion time was reported at 09.00 am with  temperature as 34 degrees Fahrenheit, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021 , vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  Vial was stored on cooler 1, on 03-Apr-2021, Excursion duration At 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM : 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Extreme Fatigue.  Lethargic reaction. Extreme Weakness in joints and muscles.  Almost non responsive.  Emergency room visit resulting in IV, antibiotic injections and short stay in hospital.
Approximately two weeks post vax, pt experienced myalgia and fever. The pt developed a large area of erythema around injection site and right forearm about 2-3 diameter with induration. It was noted that the pt had tuberculin skin test at that location a month before vaccination. 4 days later the pt developed 20 generalized skin lesions, on the scalp, torso and extremities. Pt was treated with Tylenol and recovered from the myalgia and fever within 3 days. The pts rash subsided approximately a week and a half later.
Cough. Fatigue. Body Aches. Sore Throat. Red, burning eyes with discharge. 102 degree fever for 12 hours. 99.5 degree mild fever for one week. Headache. Pain at injection site. Nasal Drainage.
Patient was admitted for confusion and difficulty getting words out. Imaging studies showed a lesion in the left frontal lobe and neurosurgery was consulted. Neurosurgery believed lesion was possible an acute/subacute infarct however morphology was unusual. Patient's symptoms resolved and he was discharged, instructed to follow up with neurology and PCP. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
Covered with plaque psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Covered with plaque psoriasis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Covered with plaque psoriasis). At the time of the report, PSORIASIS (Covered with plaque psoriasis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Two days after rash to medial right wrist and then on 10/20/2021 facial swelling diffuse itching adn rash all over body and very dry consistency. Went to ER given oral steroids and oral antihistamine.
Started feeling flu like symptoms around 10:30 pm about 12 hours after injection. Symptoms continued through next day. Extremely tired, body aches, nausea, groggy, low grade fever, arm sore and tender at injection site. Symptoms still continued as of 9:30pm next day
I developed a "humming " noise in my ears. As of today, it has not subsided.
A 42-year-old female patient had received a left deltoid intramuscular injection of ADACEL, lot number C2965AA and one day later, she developed a fever of 102 degrees Fahrenheit and right sided neck swelling, with spasm and pain.  She also developed edema which radiated to the left elbow, severe redness and pain.  She was seen by her treating physician and received corrective treatment with KEFLEX.  The patient had no concurrent illnesses and no known allergies.  Her past history included asthma and hypertension.  Concomitant therapies included FLONASE, ATENOL, "ADAVER", and "CINGULAR".  At the time of the report, the patient was recovered from the event.  Follow-up information received from a health care professional on 31 July 2008.  The reporter indicated that the patient's right sided neck pain and right sided neck muscle spasms started in early May, prior to the ADACEL injection.  The injection site reaction started on 16 May 2008 and ended on 20 May 2008.  The patient's temperature was 100.3 degrees Fahrenheit on 16 May 2008 and 98.4 degrees Fahrenheit on 20 May 2008.  Concomitant therapies, previously reported as "ADAVER" and "CINGULAR" were confirmed to be ADVAIR and SINGULAIR, respectively.  Follow-up information received from a health care professional on 08 September 2008.  The reporter stated that there was no additional information at that time.
PATIENT PASSED AT REGISTER IN THE FRONT OF STORE ABOUT 15 MINUTES AFTER RECEIVING VACCINE. I HEARD SOMEONE YELLING FOR AN AMBULANCE, I HAD TECHNICIAN CALL 911 AND I RAN TO FRONT OF STORE. PATIENT WAS PASSED OUT ON HER BACK ON THE FLOOR. I CHECKED AND COULD SEE THAT SHE WAS BREATHING, AND TAPPED HER SHOULDER AND ASKED HER IF SHE COULD HEAR ME WHILE I CHECK FOR PULSE. SHE CAME TO QUICKLY JUST AS I CONFIRMED SHE HAD PULSE. I WAS TOLD AMBULANCE WAS ON THE WAY AND HAD HER REMAIN LYING DOWN. AMBULANCE ARRIVED WITHIN 2 TO 3 MINUTES. THEY TOOK OVER.
SCRATCH LIKE RASH NOTED TO BODY. Patient given Benadryl 50 mg IV x1,Pepcid 20 mg IV x1, and Solu-medrol 125 mg IV X1 in ER.  Discharged on Diphenhydramine HCl [Benadryl 25 MG Caplet] 25 mg PO Q6HPRN PRN ;Famotidine [Pepcid] 20 mg PO BID for 10 Days ;  Prednisone 20 mg PO BID  for 10 days.
Information has been received from a 30 year old male consumer who at the age of 19 years, received a dose of Typhoid vaccine, USP, Heat Phenol Inactivated, subcutaneously in the "spring" of 1991. Thirty minutes after receiving the vaccine he experienced respiratory problems with tongue swelling and developed hives. He was taken to the ER where he received intravenous treatment of an unspecified nature. These symptoms resolved. Shortly after returning to his dormitory he experienced "no feeling in his left arm." A few months later he experienced digestive and mental problems and also "multiple endocrine problems." He reports having low thyroid and low testosterone levels. He was diagnosed with "Lymphositic Hypothositis." These symptoms persist.
swelling of deltoid and facial swelling.  Arm very painful and unable to use it according to patient.  Treated with ibuprofen.  Improving as of 24 hours later.
Vaccine was expired at time of administration.  It was past bud of 10 weeks in the fridge.  It expired on 3/30/22.  Called patient to discuss cdc recommendation for re-vaccination.  Patient did not want to re-vax
patient had first dose of GARDASIL 9 at the age of 8 years old and administered with second dose of GARDASIL 9 on 08/05/2019; No adverse effects reported; On 06-JUL-2015, patient had first dose of GARDASIL 9 at the age of 8 years old and administered with second dose of GARDASIL 9 on 05-AUG-2019; This spontaneous report was received from an other reporter referring to a 8- year-old child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/allergies were not reported.  On 06-JUL-2015, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, unit, route, anatomical location, lot # and expiration date were not reported) (product administered to patient of inappropriate age). On 05-AUG-2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, unit, route, anatomical location, lot # and expiration date were not reported) (inappropriate schedule of product administration). No adverse effects were reported. The outcome of product administered to patient of inappropriate age and inappropriate schedule of product administration was unknown. No product quality complaint (PQC) was involved.
arm soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 24-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm soreness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event and No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE PAIN (arm soreness). At the time of the report, INJECTION SITE PAIN (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant information was not provided.
Sunday, 2 days after vaccination, pt had vasovagal episode and was taken to the ER via ambulance.
Patient was given 0.5 mL of Moderna vaccine instead of 0.25 mL dose for their booster dose. Patient states he is feeling well and has no side effects, checked in with patient 24 hours post administration.
Day after vaccine developed fever, chills, body aches temp 100.2 F lasted for 4-5 hours.
Initial information received from a Health Care Professional on 11 July 2012 and follow-up information received on 12 July 2012. A 21 year old female patient; whose no relevant medical history and concomitant medications were not reported; had received second dose of IMOVAX intramuscular in the left deltoid area (Lot number: G1377-1) on an10 July 2012. Within one hour of vaccination, patient felt she had flu like symptoms. The injection site became red, hard and the area affected was 3.5 inch circle. The area was also warm to touch. The patient did apply ice pack to the arm. No other corrective medication or laboratory investigations were reported. The outcome was not recovered at the time of report. Documents held by the sender: Picture of affected area. Follow-up information received from Healthcare professional on 04 December 2012: It was reported that, the patient had 5 days of redness and soreness and treated with ice and Ibuprofen. The patient was fully recovered on an unspecified date of "October 2012".
Patient stated irritated and redness around the site and burning throughout her body and itching x 3 weeks.   Rash on chest torso and thighs and on down her legs.  Patient took benadryl and stated it did not help.  She received 2nd dose also and same reaction.   Resolving now.
developed painful outbreak of shingles; Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about November 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequent to the zoster vaccine live (ZOSTAVAX) vaccine being administered (date not reported), the patient developed a painful outbreak of shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of painful outbreak of shingles was considered not recovered. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
The pt developed flu-like symptoms approximately 48 hours after administration of flu-vaccine. The pt complained of malaise, fatigue, fever lasting from 10/10/99 - 10/15/99.
Would also like to note that she received a TB Skin Test of 0.1 ML of Tubersol  as well on the left forearm. Patient started losing color in the face and closing eyes a lot. Patient did not end up fainting due to nurse interventions of juice and crackers, however, patient vomited after drinking some of the juice. Patient laid back in a chair recumbent and ate more crackers and drank more juice and color returned and child was totally fine. So, fainting did not end up occurring but she did vomit.
My arm was very sore, I had very bad chills-I was actually shaking, I had difficulty breathing (I have supplemental oxygen @3% 24/7 but couldn't seem to get enough), and I had a total loss of energy/strength.  All this took place from the following morning about 10 a.m.  and lasted about 24 hours.
Started shaking at 6AM day after the vaccination. Very Tired. Barely made it back to the bed. Fell asleep. Doing fine now.
Daughter had a Hep A first dose at 3/18/2014. Then on 6/05/2014, was given another shot of it which was less than the 6 month interval. They were given the daughter's shot record (hand carried by father) at the start of the appointment which listed the prior vaccine on 3/18/2014.
Patient already received Pfizer COVID vaccine primary series on 4/21/21 and 5/12/21. On 12/28/22, patient was supposed to receive Moderna bivalent COVID vaccine booster, but was inadvertently given the Moderna monovalent COVID vaccine. This is reported as an administration error, no adverse event occurred. Patient is coming back in 2 months to receive the bivalent COVID vaccine booster.
This spontaneous report was received from a Registered nurse concerning to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 05-FEB-2015, the patient was vaccinated with GARDASIL intramuscularly (lot number K006960, dose and expiration date were not reported), and on 23-JAN-2016, the patient was vaccinated with GARDASIL 9 (lot number L027282, dose, route and expiration date were not reported) (inappropriate schedule of vaccine administered). No adverse effects reported. A product quality complaint was not involved. Additional information has been requested.
I had a family member that contract COVID-19 and so I took a home test and, I was positive. I took additional COVID-19 PCR at the pharmacy, and it was positive. The doctor prescribed PAXLOVID on November 21, 2022. I still had not developed any symptoms. I was just extremely tired with some shortness of breath. By the end of November, I was feeling completely better but I still remained stayed home a full 7 days. I still have a cough and some shortness of breath, but it did get better. 2 weeks ago on December 14, 2022, I ended up going to my physician and he prescribed a codeine based cough medicine. I was also prescribed azithromycin for a bacterial and upper respiratory infection that had developed. I completed both course of medication. I started to feel better but then the cough is getting worse. I am planning to schedule a follow up appointment for this.
606 doses were given after expiration date / Expired Vaccine Used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date / Expired Vaccine Used) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date / Expired Vaccine Used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date / Expired Vaccine Used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial placed in refrigerator - 11/27/2021  No Concomitant Medications were provided by the Reporter      No Treatment Medications were provided by the Reporter
Had sore left arm starting 1 day after injection and lasting 2 days.   Then 2 weeks later had pain in left arm again similar to the pain I had 1 day after the injection  in the exact same are of injection, that is ongoing.