chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever/elevated temperature; This is a spontaneous report from a contactable physician (on behalf of a nurse) and a nurse. A female patient of an unspecified age (reported as 18 unit unknown) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 06Jan2021 at single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got her first Pfizer Covid 19 vaccine and a couple of days later she developed symptoms of Covid and tested positive. The patient recovered and had no symptoms. The physician informed that the patient received the second shot and experienced fever. The physician wanted to know if it was okey to give the second shot. The patient got her second injection yesterday (06Jan2020) and had an elevated temperature which was an immune response (Jan2021). The outcome of the event fever/elevated temperature was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA274333 (same reporter). This case involves a 16 years old female patient who received vaccine FLUBLOK QIV instead of FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. No concomitant medication was taken. On 01-Oct-2018, the patient received a first single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1802 and expiry date: 30-May-2019) (dose, dose in series and route was not reported) in the right deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration and Product appearance confusion and wrong vaccine administered. It was reported that wrong vaccine was given to the wrong age group and the box for the Flublok Quadrivalent looked like Fluzone Quadrivalent, both boxes were navy on a white box and they were close enough in appearance. It was unknown whether any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Information has been received from a health professional concerning a female who in February 2007, was vaccinated with Gardasil. Following vaccination, the patient experienced pain and lump at the injection site and fever. The patient's pain and a lump at the injection site and fever persisted. Additional information has been requested.
Pt verbalized feeling flush on the face (red cheeks), she was evaluated by paramedics and released home at 1:20 pm feeling better.
15 hours after the 2nd dose I experienced moderately severe body aches and fatigue. 26 hours after 2nd dose I developed a severe rash on left arm, then bilateral knees, then 30 hours later hives on bilateral thighs. 37 hours hives again on bilateral calves. 55 hours later hives again on bilateral legs and throughout mid and low back.
Patient requested Moderna Bivalent vaccine and was administered Moderna 6m-5y. Staff monitored Patient for 30 minutes and did not report adverse side affects. Staff contacted the Moderna manufacturer and was directed to call CDC to determine if patient could be given the Bivalent vaccine. Staff was told that patient would have to wait two months before being eligible for the vaccine.
Receiving doses from vials affected by a temperature excursion; Receiving doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Receiving doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Receiving doses from vials affected by a temperature excursion) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2022 at 1:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2022 at 1:09 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Receiving doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Receiving doses from vials affected by a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Receiving doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Receiving doses from vials affected by a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Number of vails was reported as 6. 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range. Patient received half dose. It was reported that no adverse event occurred at time of administration or were reported thereafter. Treatment medications were not reported.
About 30 minutes after getting vaccine, when I was told I could go...I experienced extreme faintness. I made it to my and home, but could not get out of car after arriving. Eventually I did, but could barely move and dropped everything at my door. Could not undress because I let so faint. Then I started feeling cold. Made it to a chair and slept there about 5 hours before everything went away.  I had rad all possible side-effects, but did not see feeling lightheaded and almost fainting or fainting  on the list.
Pt fatigued & with weakness.  Blood work taken and platelet count > 1,000,000.  No other sig abnormalities identified.  Referred to a hematologist
received booster half shot past 12 hour post puncture; This spontaneous case was reported by an other health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received booster half shot past 12 hour post puncture) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received booster half shot past 12 hour post puncture). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received booster half shot past 12 hour post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-372131 (Patient Link).
No energy; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy) and FATIGUE (Exhaustion) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced ASTHENIA (No energy) and FATIGUE (Exhaustion). At the time of the report, ASTHENIA (No energy) and FATIGUE (Exhaustion) had not resolved.            No concomitant medications were given  No treatment information was provided  Action taken with mRNA-1273 in response to the events was not applicable.       Reporter did not allow further contact
I was 5 months pregnant when I received my first Moderna vaccine. At the time I received the vaccine, my only reaction was a sore arm. However, when I gave birth to this baby (my third child, a daughter) on Sept 2nd, 2021, the baby had a ridge down the middle of her head  and was malformed in the back. We later learned that this defect is called Sagittal Craniosynostosis at the baby's 7 week checkup (Oct 21, 2021) when it did not go away. The baby was born 8 lbs 8 oz, and 21 inches long. We are now seeking surgery for our baby to treat this and prevent brain damaged from this condition.
Dizzy, near syncopal. BP 108/71 (pulse 110), O2 sat 99%. First day of menstrual cycle with painful cramps.
not feeling well; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series of immunization was completed, Unknown manufacturer.), for Covid-19 immunization; Covid-19 vaccine (first booster dose, manufacturer unknown), for Covid-19 immunization. The following information was reported: MALAISE (non-serious) with onset 25Sep2022, outcome "unknown", described as "not feeling well". It was unknown if therapeutic measures were taken as a result of malaise. Additional Information: The patient received the booster vaccine 24Sep2022 and reported "not feeling well" the following day 25Sep2022. It was unknown if the patient received other vaccine in four weeks. It was also unknown if the patient had covid prior vaccinated and if the patient had tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 01-APR-2016, the patient was vaccinated with improperly stored dose of VARIVAX 9dose and route of administration were not reported, lot # K006133 with expiration date:29-APR-2016). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chills/hard time sleeping due to the chills; tired/sleepy; achy all over; joints hurt; muscles ached; fever; slight headache; I felt like I was getting the flu; wobbly on feet after getting up from trying to sleep; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Right arm on 26Feb2021 09:30 (at age of 74 year old) as dose 2, single for COVID-19 immunisation. The patient medical history was reported as none. Concomitant medications included lansoprazole (PREVACID); levocetirizine dihydrochloride (XYZAL); paracetamol, phenyltoloxamine citrate (TENSION HEADACHE RELIEVERS) and daily vitamins, all taken for an unspecified indication.  Patient has known allergies to Darvon/Darvocet. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9810), via an unspecified route of administration, in right arm, on 05Feb2021 09:45, as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior vaccination, patient was not diagnosed with COVID-19 and did not receive other vaccines in four weeks. On 26Feb2021 16:30, patient experienced chills, was tired/sleepy, but she had hard time sleeping due to the chills, was wobbly on feet after getting up from  trying to sleep, also reported, achy all over, along with joints hurt, muscles ached, fever and slight headache. She felt like as she was getting the flu. Since vaccination, patient had not been tested for COVID-19. No treatment was given in response to the events. The outcome of the events was recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
Employee reported hives all over body, facial swelling, and shortness of breath that started Saturday midday after receiving the Hep B vaccine on Friday afternoon. Employee took oral BENADRYL around the clock until symptoms resolved late Sunday.
Administer expired vaccine to 450 patients after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Health care professional (HCP) administered expired vaccine to 450 patients, after the manufacture date of expiration. Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses. Dates of administration of vaccine were reported as 10-Nov-2021 and 11-Nov-2021. The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Non-significant follow-up received contains: Reporter details updated.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
5/14/09 - Vaccination (itch, no fever); 5/16/09 - 1 spot (arm); 5/18/09 - 5 spots (arm, hip, leg); 5/19/09 = 10-20 (arm, hip, leg, back); 5/20/09 - 30-40 spots; 5/21/09 - 40-50 spots; 5/2209 to 5/30/09 begin to dry up. Spots were red with 1 or more clear blisters.
STARTING A FEW HOURS AFTER THE VACCINE, PATIENT EXPERIENCED VOMITING, LEADING TO VOMITING OF BLOOD. SHE STARTED EXPERIENCING MUSCLE TREMORS, EXTREME PAIN ALL OVER HER BODY AND HAS HYPERSENSITIVITY TO HER SKIN. SHE HAS TRIED USING EXCEDRIN FOR THE HEADACHES AND PAIN BUT NOTHING HAS HELPED.
Previously frozen Flublok Quad 22-23 PFS  vaccine was inadvertently administered to the patient.   No reaction has been reported
Approximately 24 hours after 2md shot Fever was greater than 105, chills, nausea and upset stomach. Highest fever was after taking tylenol, 2 hours later taking advil and 2 hours later tylenol. After 4 doses of fever reducer and cool compresses it started to come down. Then went back up 30 hours later. Stomach upset for appr. 2 weeks.
12/11/06 reported onset of 25 disseminated pruritic Maculo papular lesions associated with malaise, achiness.
she got full blown pneumonia after received pneumonia vaccine; Her doctor gave her a 3rd of a test dose of a pneumonia vaccine; This spontaneous report was received from a 54 years old female patient referring to herself via Pfizer, Inc. On an unspecified date in 1976, she got German measles from head to toe (also reported as rubella) after delivering her daughter and receiving with the German measles vaccine. The patient's concomitant medications and drug allergies were not reported.   On an unknown date in 2005, the patient was vaccinated with the 3rd (extra dose administered) of a test dose of pneumonia vaccine (manufacturer unknown) (dose, strength, route, lot # and expiration date were not reported) for prophylaxis.   On an unknown date in May 2005 (also reported as after the shot), she had ended up in the hospital with 103 + Fahrenheit fever with full blown pneumonia. She had a 100.3 (unit not provided) fever for 8 days. She was in the hospital for 2 days and as soon as she was taken off intravenous (IV) therapy and switched to pills, she begged to go home. She promised she would take the pills. She was allowed to go home in May 2005. That Friday morning, her temperature finally broke to 99 (unit not provided). She researched the components of the pneumonia vaccine and saw there was several strains of pneumonia in the vaccine. Her body for some reason, took any bit of it. Ever since then, she has stayed away from vaccine. It could have been deadly if she received the full dose of the pneumonia vaccine considering the way her body reacted to a 3rd of a dose. The outcome of pneumonia was not reported.  The causality between pneumonia and pneumonia vaccine (manufacturer unknown) was not reported.   Upon internal review, pneumonia was determined to be medically significant.
About 5 minutes post-vaccination, patient fainted. He came to within seconds, but reported memory loss between the time that he sat and the time that he fainted. He was sweaty, pale, and shaking. He reported feeling nauseated which he contributed to not eating breakfast yet. About 3 minutes later, he reported tingling in his hands. A few minutes after that, he reported the same tingling in his feet. EMS was called when he fainted. They assessed him and decided to take him to the hospital due to him still feeling poorly. The patient stopped by about 2.5 hours later to report he was ok. I left him a message the next day to check on him, but never heard back.
Within an hour of getting the DTaP shot, she started throwing up and having diarrhea. Lasted 5 days. Reflux then became strong and painful. Thought it was teething, and treated it as such, but the reflux continued to get worse for several weeks. Finally on April 19th took her back in because she was crying uncontrollably, and was not teething but the reflux had gotten significantly worse. Still struggling with reflux symptoms.
Received vaccination in the afternoon.  By 11pm patient had chills, vomiting, and felt very weak.  Chills and vomiting had ceased by the next morning but she continued to feel weak the next day.  Patient states she feels better today (2 days after vaccination).
Patient received 12 month vaccination series at his Pediatrician's office 3 days ago. Mother is unsure of which vaccinations he received. Had 4 inoculations. Presents to my clinic with varicella rash. No other complaints. No signs of cerebral or pulmonary involvement.  Pt's mother was told to treat the symptoms. No antiviral medications administered. Instructed to watch for complications.
pt recv vax 1997 & JUN97 pt exp a rash w/in 7 days following vax;
She received the vaccine on 12/30/2020 at approximately 4:35 PM. At 7 PM she experienced immediate exhaustion, very hot, and body aches. Her temp when she got home was 102.7. She experienced an all over rash and her temp fluctuated for 65 hours. She went to Urgent Care both on Saturday and Sunday due to the ?burning? of the rash. She received Steroid treatment both days. She is back to work today, however, continues to have burning rash. She was advised by the Urgent Care provider not to receive the second injection, and not to ever receive vaccines with the mRNA component.
Feeling Heavy; Feeling very drowsy; Experiencing tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling Heavy), SOMNOLENCE (Feeling very drowsy) and FATIGUE (Experiencing tiredness) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced FEELING ABNORMAL (Feeling Heavy), SOMNOLENCE (Feeling very drowsy) and FATIGUE (Experiencing tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feeling Heavy), SOMNOLENCE (Feeling very drowsy) and FATIGUE (Experiencing tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Client awoke 11/6/05 with red raised small bumps clustered on tops of her hands.  Client stated rash started on right hand first then spread to left hand.  Client states her face felt puffy and was reddened in blotchy patches.  She applied cortisone cream to her hands.  Client states her symptoms began to subside by Sunday evening and by Monday it was mostly gone.  11/14/05-Client states all rash symptoms were gone.  Instructed client to follow directions from her primary physician if she is to receive HAV #2 due 5/4/06.  Client stated she would call primary physician.  12/15/05-no response from client.
devel fever of 101 & lethargy 16hr p/vax;ran fever of 101-102 for another 23hr even w/APAP q 3-4hr;on other illness or sx;hx of febrile sz but tolerated ped DT p/sz;
Around 45 minutes to an hour after my vaccine my lupus malar rash appeared on my face, bright red and burning hot, then spreading to my cheeks, chin, nose and forehead. A couple hours later a chain of events started. The back of my head and neck felt like they were covered in hot, prickly heat. There was no redness or rash at site. My arm that received the shot hurt from my neck down to my fingers. I then started to get heart palpitations almost constantly. I was extremely tired so I layed down. The entire left side of my body hurt including my leg. I got tmj pain in my right jaw and lost feeling in my right hand. I took my temperature and it was only 99.5 F. I slept for hours. Woke up with no heart palpitations but everything else stayed the same. The next morning my heart palpitations came back. I still had loss of feeling in right hand and extreme fatigue, face redness and pain down my left side. Everything else had dissipated. I called my doctors office and spoke to a nurse in triage who recommended I go the the ER. At this time I had started to have shortness of breathe and cramping in the center of my chest. I went to hospital where they took my blood and did and ECG. I was then sent home.
patient received 1st dose Pfizer on 3/29/23 and received her second dose of Pfizer bivalent on 4/19/2023 three weeks  later.  Vaccine was given to early.
Patient receive first dose of Moderna on 3/29 and received second dose of Moderna on 4/19, 7 days too early.
Hives, which were first discovered at the back of the left calf, then spread to near underarm of both forearms and chest.  Went to health clinic on 10/17/2010 and was prescribed Methylprednisolone 4MG Dospak 21's and Hydrocortisone 2.5% cream 30GM.  Still in treatment.
Information has been received from a physician concerning a female who was vaccinated with Varivax. Subsequently, "in the past couple of weeks", in approximately March 2006, the patient experienced zoster with pain and itchiness and was hospitalized. It was reported that the patient recovered. No product quality complaint was involved. Additional information has been requested.