chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a nurse on 31-Jul-2018. This case is linked to 2018SA212665, 2018SA212627, 2018SA212638 and 2018SA212648 (Same reporter). This case involves a 15-month old male patient who was vaccinated with fourth dose of PENTACEL (Batch number: C5529AA, expiration date: 04-Oct-2019) via unknown route in unknown administration site on 24-Jul-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate reconstitution technique. It was reported that a lyophilized powder portion of ACT-HIB that was not given from a box of 5 single doses of PENTACEL and the reporter was unsure which one of the 5 patients who received doses from this lot didn't get the ACTHIB portion. It was reported that the patient had no reaction. 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.
APAP given post vax, pt was given 2nd dose 3 hrs later which vomited up; mom reported had been fussing w/unusual cry; pt pale, limp, grunting resp, t100.4, vomited again; MD felt poss vagal vaso response
1) Event: Palpitations, chest pain on the left side, numbness in the left arm, lack of oxygen, 2) Event: Weakness, low heart rate, numbness of the extremities, with purple fingernails very cold.
Got a flu shot  After a few hours my  tounge swollen  Throat a little closed  Hives all over body   I took a benydryal call the help line and reported it  They told me if I feel like I cant breathe to go to the emergency  I can still breath but this is very hard in me and uncomfortable and my tounge is burning
Pt treated w/ Herceptin & Navelbinc per protocol. Devel fever to 100.7, mild chill, and rhinorrhea. Admitted to hosp due to neutropenia, fever. 60 day follow-up states the "reporter" did not submit any reports to VAERS and has no information about this case. Follow-up: Please note, I do not work on any vaccine trials, and I do not recall submitting this Adverse Event Report. I contacted the 800 -number and was informed that this may be a computer error. Please contact me with any questions.
Gave 3rd dose too soon. Was given 4 weeks after 2nd dose instead of 8 weeks.
Pt presented to clinic with father. Hives visible on chest, back, arms. Father states they come and go. Denies respiratory problems. Denies prior occurrence. Denies h/o any allergies or ingesting any different type of food in past week. Pt denies discomfort. No high temp or other signs of illness. Gave parent info on medical clinics he could use for pt, prn advised Benadryl.
Information has been received from a physician concerning a 50 year old female with diabetes who on 23-JUL-2007 was vaccinated with Zostavax (Oka/Merck).  On 11-AUG-2007 the patient experienced Bell's palsy.  As of 13-AUG-2007, the patient had not recovered.  Additional information has been requested.
We were notified that pt was in the ER on 6/13/21 with a diagnosis of Bells Palsy.
I administered what I believed to be DTaP #4 , however previously a DTaP/IPV had been inappropriately given at another facility.
3 days post booster vaccination I started seeing hives on my arms, legs, & feet (red, itchy, swollen). This lasted about 3 days while taking Benadryl. A week later, on January 3, the hives returned and were popping up everywhere. Hives were red, itchy, swollen, & very hot and would last at minimum of 2 hours. They would spread from one area to another (no specific pattern). Saw an allergist on January 13 and was told to take Allegra twice daily and titrate up if necessary, hives did continue to show up.
Hives. Started with just bumps I could feel on thighs by the morning of 10/12 the bumps had turned to hives from the waist down. I took a dose of Benadryl. Hives subsided for 12 hours woke up 2:00 a.m. 10/13 with hives from the injection site on arm all the way down my legs. Took Benadryl again and subsided until 10:00 am 10/13 and then hives appeared again but less only on knees and elbows. 10/13 4:30 PM, currently, only a couple hives on knees. Itching much less. Options were limited because exclusively breastfeeding. If hand't been breastfeeding would have went to ER when hives appeared at 2:00 AM on 10/13 but afraid to take steroids. Called nurse on call 10/12 and then had mobile "doctor" appointment by phone on 10/13 at 4:00 PM. Throat got itchy and slightly swollen but airway was not constricted.  Hoping that the worst of it is gone. Advised to go to ER or Doctor.  Took pictures of the hives.
Headache and temperature elevated during the 36 hours after the vaccination.  Temperaure was as high as 105F. Used Tylenol, Ibuprofen, and cool baths to control temperature.
Covid toe on second and third toe of each foot; Blotchy patches on forehead and nose; Itching and burning when warm.; Itching and burning when warm.; This is a spontaneous report from a contactable nurse. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 15:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The medical history included hypothyroidism. The patient had no known allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for hypothyroidism from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 27Feb2021 at 15:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 02Apr2021, the patient experienced COVID toe on second and third toe of each foot, itching and burning when warm and also blotchy patches on forehead and nose. The patient reported that she understood skin issues were more common with skin exposure to cold and she walked every day in cold weather. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events COVID toe on second and third toe of each foot, itching and burning when warm and blotchy patches on forehead and nose were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Extreme nerve sensitivity approximately 10 hours after the shot and  for about 48 hours after the peak of symptoms. I could feel every hair on my body, it was like all my nerves were firing all the time and all in concert. Stronger pain/nerve sensation on my back neck head and nipples. It was awful until I could handle moving to get an NSAID, then was tolerable but painful for the next couple of days.
On July 7, 2022, I was fine when I woke up but at noon I felt like someone hit me. I realized I had a fever and I was shaking with chills. I had 103 temperature. I began to have diarrhea and cough with congestion and sore throat. The next morning when I woke I was unable to keep fluids down. I took the home COVID-19 test and it was immediately positive. I called urgent care and received script for PAXLOVID. I continued to have fever. The next day I woke up and still felt like I had a very bad cold and diarrhea continued, but I no longer had fever. Each day that I took PAXLOVID, I began to feel better except for the diarrhea. I was also so very fatigued and could not keep liquids down. I was unable to do anything but lay down for days 2, 3, and 4. Day 5 the fatigue was easing up and I was able to function. After the 5 days of PAXLOVID. The following Friday I had congestion again and just treated it as a cold and just tired. I took the entire next week off from work because I was just tired and wasn't able to think as normal. I was just unable to process. On the 22nd I felt better and was able to think again and was not as tired.
Patient reports vaccine site developed a hard lump which ulcerated after a few days. Site did not appear infected and has since healed without intervention
Exposed to covid virus; This is a spontaneous report from a Pfizer-sponsored program  via medical information team. A contactable male consumer reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller would like to know if he can get the 2nd dose of the vaccine tomorrow 28Mar2021 or should be rescheduled as he was exposed with the virus, he lives in the same house with his daughter. Also, on 26Mar2021, he was tested but he did not get the results yet so he was confused if he needs to take the 2nd dose or should push a week more. Caller added that he will get his result for his covid test today. His daughter was tested on Wednesday 24Mar2021 and the result came on 26Mar2021 positive, already got the 2 doses of the vaccine, the second dose was 11Feb2021 and the 1st dose was 3 weeks before the 2nd dose. Already spoke to his health care professional and advised him to cancel his second dose and reschedule it the next week. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recvd vax 26APR94 & 27APR94 pt devel rash on trunk, chest & abdo; by 28APR94 presented to MD rash looked like a scarlet fever rash, but pt was asymptomatic for a strep infect & had no sore throat;
Large area of edema on thigh where DTP was given; Red & painful if touched; occurred few hrs p/shot; had dec in amt of edema p/48hrs; taking APAP & tried using cool cloth applied to thigh;
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 12-JUL-2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 12-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 12-JUL-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 12-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 12-JUL-2022).    No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Jun-2022. The date of vaccine administration was from 4-Jun-2022 until 26-Jul-2022. The vial did not undergo any temperature excursions. Patient received half dose. No treatment medications were reported.
Severe rash from top of head to middle of trunk which started after the first dose and accelerated and worsened after second dose
The night of the vaccination, I had a fever and tiredness. I had a red, sore rash on the vaccination site. Then next day, my fever went up to 102, no appetite, nausea, headache with flu like symptoms. These symptoms lasted intensely for 3 days then gradually faded. I called my doctor and she prescribed medication for nausea. I had my second dose 03/14/2021, lot number 038A21A and that night I started feeling sick with fever and tiredness. My symptoms seemed worse this time with no appetite, nausea, headache with flu like symptoms. I had a red, sore rash on the vaccination site. These symptoms lasted for about 3 days and were intense. I received my third dose 9/17/2021, lot number 939902. With my third dose, I had the same symptoms as before but not as intense and lasted 2 days. I had a red, sore rash on the vaccination site. I received a fourth dose, lot number 003K21A on 02/18/2022. I had muscle and joint pains and tiredness. I had a red, sore rash on the vaccination site. The symptoms were milder than before.
Pt received NOVARTIS, 102138PTA .5 cc lm - (R) deltoid by above nurse. Pt has slight allergy to eggs. Pt eats eggs and gets a metalic taste, site is red, and swollen. (-) SOB, lung clear, pt observed 30 mins. Feels ok. Instructed to apply ice to site.
Approximately 5 minutes after receiving his first dose of the pfizer covid vaccine, the patient began feeling faint and ended up fainting while sitting down.  He laid his head on his girlfriend's shoulder and fainted.  He was alert and conscious within 2 minutes.  At that time, the patient said he does suffer from vasovagal syncope and frequently passes out when his anxiety is high.  He denied our attempts to call for 911.  After 30 minutes, the patient left under his own strength.  His girlfriend drove them both home.
The pt had nausea and abdominal cramping beginning on 1/8/02 and continuing through 1/14/02. No treatment.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: pt hypotensive after vaccination bp 52/36 hr 57-Medium, Systemic: Hypotension-Medium, Additional Details: blood pressure normal upon departure 103/77
Pain and tingling in my lower left back started 2 days after the second vaccine.  By 5 days after the second vaccine. I had a rash diagnosed on 3/29/21 as shingles.  I had never had shingles before.
Information has been received on 23-MAR-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 14-DEC-2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the patient was treated and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
pt recvd vax;pain in shoulder joint w/in 24 hrs p/ vax; could not abduct shoulder greater than 90 degrees; dx:impingement type of synd; tx w/ non-steroidal anti-inflammatory med;7 days later pt had angioneurotic edema;seen in er for tx;
Upper arm - inflammation, redness and itching. Much better today 11-10-14.
awoke day p/vax w/severe h/a, nausea, watery mouth, felt fain (no syncope); chills & hot flashes-did not check temp
I was having a minor cough last Sunday. It got worse as the night went on it got worse. Monday I was way worse and took a COVID-19 test and it was positive. I had general malaise, I had a fever by that night of a 106.1, the cough was worse and I was congested. I met with my healthcare provider virtually and they got me Paxlovid which I started taking that same day. I am at about day four or five now and have about two doses of the Paxlovid left. About two days after starting that medication I was feeling better. At this point I am just tired and have a little bit of a stomach ache.
extreme dizziness; weakness; heart was racing; had trouble walking; This is a spontaneous report from a contactable consumer. This 59-year-old female consumer (patient) reported for herself. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 16Aug2021 as dose 1, single (age at vaccination: 59 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Aug2021, she experienced extreme dizziness and weakness, my heart was racing immediately after receiving the shot. It was pretty bad for one hour, had trouble walking and with 2-3 hours it was completely gone and queried that she had a side effect after first dose and if she should get the 2nd Pfizer covid vaccine dose. The clinical outcome of the events was resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I initially became ill with fever, body aches and general malaise. This lasted two days.  On the third day, my right eye felt swollen and dry. It became weepy and then started twitching. The twitching continued and then I developed uncontrolled dystonic muscle firing in my face. It would start on the right and go across to the left side of my face. I had mouth and nose twitching and firing as well. The right side of my face and tongue were numb and tingling.  Eventually it progressed to left facial dropping. I have some sharp shooting pains in my head and symptoms similar to those I feel with migraines.  I have eye pain, seeing spots in my eye and phantom sensations in my right arm.
1/26/2021 headache,  generalized muscle aches, injection site pain 1/27/2021  generalized muscles aches, left arm pain 1/28/2021  increasing left arm pain with limited mobility, unable to lift arm past shoulder height 1/29/2021 left arm pain, unable to lift arm more than 45 degrees, pain level 10/10 1/30/2021 left arm pain continues, unable to lift arm more than 10 degrees
4 Abnormal ECG readings, Atrial Fibriliation readings, chest tightness
Enlarged heart; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CARDIOMEGALY (Enlarged heart) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIOMEGALY (Enlarged heart). At the time of the report, CARDIOMEGALY (Enlarged heart) had not resolved.            No concomitant medications were provided by reporter. No treatment medications were reported.
Missed my period the month following the vaccine. About a month and a half after getting the vaccine I have had at least 2 cycles a month each no less than 4/5 days with continuous spotting between cycles
SHINGRIX: arm became red, mild swelling at injection site MODERNA: injection site, very red, moderate to severe swelling, pus filled blisters
Patient was diagnosed with myocarditis on 6/24/2021 after 4 days of fever, malaise, fatigue, and an episode of chest discomfort.  His evaluation revealed elevated inflammatory markers,  CRP and ESR, and elevated troponin levels.  His EKG and echocardiogram were normal.  He has been started on colchicine.
30mins after receiving the Flu Mist, my heart started beating really fast and I could not even walk to the bathroom and back I would get exhausted and dizzy I slept most of the days following.
Fatigue: began 3 hours after and lasted for 2 hours Body aches: began 3 hours later and lasted for 2-3 days Hives on face and chest: 9 hours later and lasted for an hour Fever: began the next morning and lasted for 5 hours
Patient was at facility with 1 week of watery diarrhea and extertional dyspnea found to have covid 19 and AKI. Patient was transferred to another facility on 9/17/21 for higher level of care. Patient completed 5 doses of rermdesvir from 9/19-23.  chest x ray showed worsening reticulonodular opacities in the bilateral lung fields with increased work of breathing and hypoxia consistent with covid ARDS requiring transfer to MICU.  Patient completed courses of micafungin and peromenam for PAN while in the MICU and was transferred to ICU for further workup and closer nursing monitoring.  Patient was discharged on 12/1 to rehab.
2/25/2021 Started Peeing blood and went to ER and they were not sure what to do after test urinalyses and blood panels, showed normal. On 2/27/2021 went to Urgent Care and same test were done with same results. Sent home, no treatment. 3/1/2021 Later went to Urologist and with a review of the blood test a Cystoscopy was ordered and was referred to another urologist for the procedure. 3/2/2021 The Cystoscopy was done to find the source of the bleeding and was given no treatment because it was healing.  Issue was resolved.
Information has been received from a physician concerning an 18 year old female patient with asthma who on an unspecified date was vaccinated IM with a dose of VARIVAX (Merck). Concomitant therapy included steroids for asthma control. Subsequently the patient had chicken pox multiple times within the last 5 years. The outbreaks had occurred within the last 1-2 years. The patient sought unspecified medical attention. At the
Patient was given her vaccine and seemed fine. She  left the pharmacy area with both of her parents. I followed them to let them know that for the school we may need to print a form for her to show proof of the vaccine. When I turned to go print the form, her mom yelled for help that patient is passing out. We all lowered patient to the floor. I told her dad to call 911. I checked for breathing and she was breathing. I rubbed by her collar bone and said her name for her to wake up(while always having my face by her face checking her breathing)  and after maybe 20 seconds, she woke up. We kept her on the floor for a while. She said that she had nothing to eat all day. He mother then told me that patient passed out when she got her last tatoo. Management brought her an orange juice and 911 checked her out. She said she was fine and they let her go on her with her patents.
patient appeared pale immediately after shot, then 24 hours later mom felt he was pale and a bit limp