chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling unwell; Fatigue; Headache; Nausea; first dose of the Moderna COVID-19 vaccine on 06Jul2021 and the second on 17Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 06Jul2021 and the second on 17Aug2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039C21A and 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Nerve pain and Rheumatoid arthritis. Concomitant products included GABAPENTIN for Nerve pain, SALICYLIC ACID (SALVAX) for Rheumatoid arthritis.   On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 06Jul2021 and the second on 17Aug2021). On an unknown date, the patient experienced MALAISE (Feeling unwell), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 17-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 06Jul2021 and the second on 17Aug2021) had resolved. At the time of the report, MALAISE (Feeling unwell), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            Patient didn't feel well, was fatigued, had a headache, all around didn't  feel good at all, had nausea, was tired. Side effects started that afternoon.
Significant shoulder pain starting next day and persisting to present. Temporary improvement when taking unrelated course of oral steroids for asthma (prednisone tapered dose). Primary care doctor referred to orthopedics due to persistent and significant pain levels. Orthopedic doctor said showed tendinitis and rotator cuff impingement and referred to physical therapy along with anti-inflammatory ibuprofen.
26 weeks pregnant I was told TDaP was mandatory for mother?s  at NMCP. Developed headache and nausea within the ?15 min? time frame they keep you for after administration et approx 1100. They asked if I wanted to talk to someone I said no went home. Nausea persisted headache progressed to migraine. Vomiting, cough, diarrhea, and sore throat.
Patient did not qualify for this vaccine, they were 64 years and 10 months, not 65. No adverse reaction, just incorrect administration.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 2nd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In October 2018, less than a day after receiving SHINGRIX, the patient experienced shingles, pruritus and skin lesion. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the shingles and skin lesion were recovering/resolving and the outcome of the pruritus was recovered/resolved. It was unknown if the reporter considered the shingles, pruritus and skin lesion to be related to SHINGRIX. Additional details were reported as follows: Less than 20 hours after vaccination, the patient experienced shingles and itching. The patient was treated with antiviral for itching. The contact details of the physician was provided.
soreness in arm; achiness; Covid testing was positive/diagnosed with Covid-19; pulse ox 92 (lowest level); tightness in chest (no productive cough); This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at the left arm on 10Jan2021 09:00 (lot number EJ1686 and expiry date unknown) at single dose for Covid-19 immunization in a hospital and not in a military facility. Medical history included asthma. Concomitant medications included albuterol [salbutamol] from unspecified date for unspecified indication. Historical vaccine included flu shot in Oct2020 for immunization and experienced some soreness in arm and achy. The patient was not given other vaccines given the same day or 4 weeks prior. In Jan2021, the patient had some soreness in arm and achiness (Jan2021) after the Pfizer BioNTech Covid-19 vaccine it didn't last long and she went to work afterwards. The patient was scheduled for work the next day and could tell something was not right. The patient was flushed and thought it was from the Albuterol since it can cause a racing heart beat and checked for a fever and didn't' have one. The patient checked temperature before bed and it was 100.5 degrees and she went straight to (redacted). The patient informed that she went for Covid testing; she went to physician office for Covid testing. The patient was praying for the flu so she could take Tamiflu and the flu test was negative (21Jan2021) and the Covid testing was positive (21Jan2021). The patient was tested positive after first Covid vaccine and ran fever 8 to 9 days and highest temperature was 101 degrees, had a little bit of asthma and kept a close watch, congestion, pulse ox 92 (lowest level), tightness in chest (no productive cough), felt beat up, fatigued and tiredness. The patient was diagnosed with Covid-19. She was told as well not to take pain relievers (ibuprofen, Advil and Aleve) and was advised to take Tylenol instead. The patient informed that she was to get her second dose tomorrow. The patient wanted to know if she can get the second dose if she was tested positive. The patient was supposedly scheduled to have the second dose on 27Jan2021 however it was moved to 04Feb2021 due to tested positive of Covid and was put on quarantined. The outcome of the events was recovering. The patient was unable to provide seriousness criteria when queried and said that this was her luck of the draw. The patient thought the shot actually helped.
Severe neck pain radiating to head.  Treated with steroid injection,  oral prednisone, and a muscle relaxant.  After 3 days, symptoms improved, but not entirely resolved as of this dat.
This spontaneous report was received from a nurse and refers to an unknown number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. Since an unknown date in January 2017, the patients were administered improperly stored doses of ROTATEQ orally (doses, lot # and expiration date were not reported). The administered doses of vaccine underwent a temperature excursion between 32 degrees Fahrenheit (F) to 35 degrees F, and between 47 degrees F to 77 degrees F, a time frame was not yet determined. There was no previous temperature excursion reported and a digital data logger was not involved. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA009189:
Fever, shivers, nausea fatigue. Treatment: Tylenol outcome: complete resolution of symptoms.
This case was reported by a healthcare professional and described the occurrence of extra dose administered in a 26-year-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline), ADACEL.  Concurrent medical conditions included elevated cholesterol.  Previous vaccination included booster 2nd dose of HAVRIX, (GlaxoSmithKline) given 1 year ago in 2008.  Concurrent vaccination included GARDASIL, (non-GSK manufacturer; unknown) given on 28 July 2009.  Concurrent medications included Oral contraceptive.  On 28 July 2009 the subject inadvertently received 3rd dose of HAVRIX (1440 iu, unknown route, left arm) and an extra dose of ADACEL (left arm).  On 29 July 2009, 1 day after vaccination with ADACEL and HAVRIX, the subject experienced localized reaction on the left arm of injection site redness and injection site pain.  There was no fever or shortness of breath.  It was reported that the subject also received extra dose of GARDASIL (administration site unknown).  At the time of reporting the outcome of the events was unspecified.  Follow-up information received on 21 August 2009 indicated that the resolved by 31 July 2009.  The reported felt that the events were probably related to treatment with HAVRIX.
Rash/erythema on left breast, left shoulder, left deltoid, and at front of neck at base
Sore arm, nausea, headache, fever, chills. For 5 days now
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles twice. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
On  02-08-2023 during day, tickle on my throat happening during the daytime while at work. I experienced had body aches, and sweating. On 02-08-2023 I went to a walk-in clinic and got a PCR test and also received a COVID-19 test. I received results of PCR test on 02-10-2023 which was negative. I received results of the COVID-19 test on 02/10/2023 which was positive.  I also had mild congestion that came and went and had a dry cough. By 02-10-2023, I felt really better and my symptoms went away fast. I also received a Pneumonia test on 02-08-2023 which was negative.
Pt recvd series of Engerix-B vax 13OCT90, 12DEC90 & 3MAY91; 10JUN91 AntiHBS testing indicated "non-reactive"; recvd 4th Engerix-B dose 13JUN91; 31JUL91 Anti HBS testing indicated non-reactive; recvd 5th Engerix-B dose on 6AUG91;
Information has been received from a pharmacist via field representative refers to a 61 year old female patient. No concurrent or historical conditions were reported. On 18-DEC-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K010646, expiration date and route unspecified), 1 injection, in left arm. Concomitant therapies included levothyroxine sodium. On 19-DEC-2014, the patient experienced redness and swelling around the injection site after being administered ZOSTAVAX in left arm. The events outcome was unknown. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Pt recvd Engerix-B &/or Recombivax & exp Anaphylaxis & passed out;
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021 at 4:43 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Jan-2021 at 4:43 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 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 35.29. Concomitant products were not provided. On 06-Jan-2021, Excursion time was 03 PM, temperature was 35, total doses given for the day was 32, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 06-Jan-2021. 3 vials were sent to clinic. Vaccine BUD date was 27-Jan-2021. 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 Fisher brand 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 in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Patient was receiving covid Pfizer booster when near the end of injection of vaccine, fluid (vaccine noted to be going down patient's arm. Pt received some vaccine but provider unsure of exact amount. Offered to provide another booster at time of incident. Mother wishes to not have another vaccine given at this time due to being unsure of received amount
EXTREME fatigue and nausea.  I'm still feeling tired and it's been a week since I received my first shot.
Beginning the next morning after the injection :   Moderate Stiff neck, limited neck range of motion,  achy neck and upper back muscles on the left side for one week following injection.  Those symptoms retreated to mild.  Same symptoms appeared on right side of neck, upper back, and rhomboid  area., moderate discomfort.  Three weeks  now after injection the right side symptoms persist, reduced from moderate to mild\ moderate with  limited  but improving neck range of motion.   Left side symptoms persist with mild , and decreasing discomfort.
Wednesday March 11 that morning I felt very tired, fatigued  I felt like I needed to sleep more to get this medicine out my system.  Later that day around 1:30 I could have fallen asleep where I was...I went home and took a nap.  Around 5:00 p.m. I felt chills, I took 2 Tylenols and laid down.  No fever. About 6:00 or 6:30 chills were gone.  Later that night at  8:00 I felt like myself.  I was able to eat and go back to bed.  Friday morning March 19,  just a little tired when I woke up around 6:00 a.m.
About 4/3/10 parent noted eruption over torso eventually crusted, spread over course about 2 weeks.
70 y/o client experienced H/A, bad taste in mouth, maliaise, fatigue, and wheezing 24 hours after 2nd Pfizer COVID Vaccination dose.  Client stated it seemed as if she had "glaze" over eyes.  Client stated she had no adverse reactoins from first dose but dos have hx of COPD.  Client described it as "feeling like she had COVID" AND IS GETTING TESTED FOR covid-19 WITH pcp ON 2/24/2021
I woke up from a dead sleep in the middle of the night itching the palms of my hands vigorously.  Rash present over my whole body.  My hands hurt and itch.
p/vax pt exp an inj site rxn characterized by redness, swelling & pain;the site of vax & inj rxn were not specified;
On 4/15/21, I experienced extreme fatigue, insomnia, body aches, headache, nausea, chills, and extreme skin sensitivity.  On 4/16/21, the flu-like symptoms had passed, but I discovered what looked like a red rash at the injection site. The area is swollen, occasionally itchy, and hot to touch. Throughout the day, it has grown larger. I also feel unusually hot, though I am not running a fever.
I received my second Moderna dose at about 16:25 in the afternoon. Within a minute or two, I then felt a strange flushing sensation in my left shoulder, neck and left side of the head (the same side where the shot was injected) . This made me very uneasy but I went outside to wait while my husband got his shot. Within five minutes, I felt my heart begin to race and pound extremely hard, like a hammer against my chest. My whole body began to feel hot and I felt weak and shaky. I put my fist on my breastbone and tried to breathe slowly. I wasn't sure if this was anaphylaxis because I've never experienced that before, but this did not feel normal. I texted to my sisters what I was feeling in case something bad happened. I almost got up to tell the pharmacist that I needed help but felt too shaky and didn't want to make a scene. When my husband came out to join me, I told him I wasn't feeling right and my heart was pounding. But I was breathing okay. My tongue started to feel "fuzzy" and thick, so I kept breathing slowly and talking as a way to check if I was going to be okay or get worse. After about ten minutes this strange reaction started to pass. By 16:50, I texted my sisters that I was feeling well enough to get up and complete my shopping. The strangest part was that my heart was beating extremely fast and very hard, like a fist beating against my chest. And that my whole body felt weak and shaky while that was happening.
On 8/23/2021 at 8am  different from a ischemic stroke. She has expressive aphasia and became altered and forgetful.
Woke up this am and the site was itchy and red about the size of a quarter. He scratched it during the day. At 1545 he presents with 80mm diameter red/itchy area at site of injection. Artuse reaction. Edematous and tender to touch.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042266, expiration date was not reported) (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
The second dose was very painful, compared to no pain when the first dose was given one month ago. My arm was immediately hot and tender after administration. The area around the injection site had less feeling than the rest of my arm - it felt almost numb. My arm was very sore and warm the rest of the evening. I began having fatigue, muscle aches, and joint pain last night as well. I woke up around 6 this morning and the room was spinning. I was also nauseous. I tried to roll over in bed but was unable to feel my arms and legs. I was also temporarily unable to see. Right after, I passed out and lost urinary continence. I regained consciousness a minute later and had normal functioning again. I have not had any more dizziness today but am still sore and fatigued.
During a review of the local Health clinic internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
arm is now itchy; felt fatigued and tired; naseous; severe headache; chills; I think I had a fever; swollen lymph nodes; I did vomit once; soreness in arm right away; felt hot and sweaty; felt hot and sweaty; diarrhea; sometimes difficulty breathing; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (soreness in arm right away), FEELING HOT (felt hot and sweaty), HYPERHIDROSIS (felt hot and sweaty), DIARRHOEA (diarrhea) and DYSPNOEA (sometimes difficulty breathing) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no adverse event reported.). Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), CITALOPRAM and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm right away), FEELING HOT (felt hot and sweaty), HYPERHIDROSIS (felt hot and sweaty), DIARRHOEA (diarrhea), DYSPNOEA (sometimes difficulty breathing), FATIGUE (felt fatigued and tired), NAUSEA (naseous), HEADACHE (severe headache), CHILLS (chills), PYREXIA (I think I had a fever), LYMPHADENOPATHY (swollen lymph nodes) and VOMITING (I did vomit once). On 23-Feb-2021, the patient experienced PRURITUS (arm is now itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in arm right away) and PRURITUS (arm is now itchy) had not resolved and FEELING HOT (felt hot and sweaty), HYPERHIDROSIS (felt hot and sweaty), DIARRHOEA (diarrhea), DYSPNOEA (sometimes difficulty breathing), FATIGUE (felt fatigued and tired), NAUSEA (naseous), HEADACHE (severe headache), CHILLS (chills), PYREXIA (I think I had a fever), LYMPHADENOPATHY (swollen lymph nodes) and VOMITING (I did vomit once) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product included birth control pills.