chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blacked out twice in the morning; felt like they got a concussion; scraped their shoulder in the process; felt weaker than normal and weakness; fever; Chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out twice in the morning) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) 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 medical history).    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out twice in the morning) (seriousness criterion medically significant), CONCUSSION (felt like they got a concussion), LIMB INJURY (scraped their shoulder in the process), ASTHENIA (felt weaker than normal and weakness), PYREXIA (fever), CHILLS (Chills) and NAUSEA (Nauseous). The patient was treated with Bed rest (Hydration) for Limb injury. At the time of the report, LOSS OF CONSCIOUSNESS (blacked out twice in the morning), CONCUSSION (felt like they got a concussion), LIMB INJURY (scraped their shoulder in the process), ASTHENIA (felt weaker than normal and weakness), PYREXIA (fever), CHILLS (Chills) and NAUSEA (Nauseous) 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.   no concomitant medication given patient got hydration and taken rest.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Fever, chills, malaise, nausea, diarrhea, dizziness.
A MD reported that a pt received the 1st dose of Hep B (Recombinant); exp a rash, sore throat, weight loss & a "raw area" on the back of tongue; pt recvd 2nd dose of Hep B (Recomb) & the sx recurred;
Blisters on elbow that has spread to her legs, ankles and feet; Elbow pain; it looks like she has some red things maybe on her face; This is a spontaneous report from a contactable consumer or other non hcp. A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0180), dose 1 via an unspecified route of administration on 27Jun2021 11:00 (at the age of 16-year-old) as dose 1, single for covid-19 immunisation. Medical history included   none. Family medical history relevant to AE included none. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within four weeks prior to vaccination. On 27jun2021, patient experienced elbow pain. Patient woke up with the blisters on her elbow 28Jun2021. Reporter clarified they were covered on both elbows with blistery things. Patient this morning blisters covered new areas and spreading on her arms legs ankles and feet. Reporter said it has worsened because it is now in other places. Reporter said that the actual elbow pain has persisted about the same but the worsened is the blisters in other areas. On an unknown date in 2021, reporter stated that "it looks like she has some red things maybe on her face". Reporter stated that "She had called paediatrician and trying to find recommendations and she can not find anything other than to take Benadryl and Advil, she is trying to find what to do for it, does Pfizer have any recommendations for when the reaction is blisters". The events did not result in emergency room/physician office visit. patient's father and the patient's brother and sister all had the vaccine as well and no one had this reaction. The outcome of the events were not recovered.
Worried about the second vaccine side effects; Chills; Fever 100.3 F; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever 100.3 F), MYALGIA (Body Aches) and ANXIETY (Worried about the second vaccine side effects) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Medical history was not provided.     On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever 100.3 F) and MYALGIA (Body Aches). On 28-Jun-2021, the patient experienced ANXIETY (Worried about the second vaccine side effects). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 23-Jun-2021, CHILLS (Chills), PYREXIA (Fever 100.3 F) and MYALGIA (Body Aches) had resolved. At the time of the report, ANXIETY (Worried about the second vaccine side effects) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.3f (High) Increased 100.3F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant medication information was not provided.
Pain in left leg - outside 2/7/21 went to clinic 2/8/21 Given an ultrasound Diagnosis: Blood Clot (Dvt) Given immediate shot in  belly And prescription for Eliquis Followed up with  Dr.  (internist) 2/11/21
Information has been received from a nurse concerning 2 patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose and route were not reported, lot # was reported as K021881, expiry date: 30-JUL-2016). The temperature excursion for PNEUMOVAX 23 was supported with in-horse stability data. No adverse symptoms were reported. Additional information has been requested.
diluent portion of Pentacel has been administered without being mixed with the powder (HIB) / no AE; Initial information received on 08-Jul-2021 regarding an unsolicited valid non-serious case received from a pharmacist via call center via Global Medical Information (reference number- 00674315).  This case involves a patient of (unknown demographics) who inadvertently received dtap ipv from Pentacel without reconstituting with HIB (product preparation issue) when received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique (latency: same day).  ''It was reported that while doing his inventory, he noticed that a diluent was missing. They are in the process of verifying which patient was immunized last week with only the DTAP-IPV portion.''  At the time of reporting, no adverse event was reported.  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.  There will be no information available on the batch number for this case.
Day after vax vomiting continue 10 weeks one day per week; through course of treatment endoscopy; 12-14 weeks after vax subsided. Endoscopy showed no problems.
Approx 24 hrs post tetanus vaccine, donor had flu like symptoms and fatigue.
approximately 6 days after vaccine administration, this patient began experiencing recurrent rashes diffusely that she reported to me at an office visit May 14, 2021. The rashes are itchy but not overwhelmingly bothersome.  evaluating the rash present on her arms was difficult due to her tattoos, but it did appear erythematous, maculopapular and not consistent with Hives/urticaria (no Wheals). The rash lasts longer than 24 hours when it appears.  typically, rash lasts 4-5 days then resolves and can appear elsewhere on the body.  She states they can crop up and last a few days and then subside.
patient recieved J& J vaaccine on saturday at 2 pm   following am patient woke up walked to bathroom told mom she wasnt feeling well, mom noticed she was going to pass out and assisted patient to ground, syncope lasted < 30 sec. Patient drank water/ginger ale, patient returned to sleep and woke up and reported feeling normal  Patient took an adderrall 15 mg  saturday night around 6 pm after vaccine to do school work Patient ate and drank normally saturday night  patient has period currently- normal bleeding normal cramping patient on tri lo marzia BC and on spirnolactone for acne   Of note patient does report hx of syncope in the am 1 year ago- never seeked treatment it was non recurrant Patient also states that a couple times a week she wakes up feeling dizzy- last about < 1 min and goes away.
She got her vaccine, they were both put within 1/2" of each other, and it was right in the main muscle of the upper arm.  It stung like any shot does, then she left and went home.  It was OK at first other than the area stinging a little.  Later that night she just figured it was the normal reaction from the vaccine.  The next morning when she got up she noticed that her arm seemed a little bit bigger.  It hurt a lot but she still took it as being normal for COVID shot and went about her things.  She went through that day, had a bit of a headache off and on but nothing really bad and was able to get rid of it with Ibuprofen.  It did seem to help with some of the sorness in her arm too.  On Wednesday morning early she had terrible chills, using of blankets to get warm.  She was shivering.  She went back to sleep, woke up later to take her medications around 7:30 and noticed that her arm was hurting more, was still having a headache and also noticed that her arm was a little bigger than it was the day before.  She wasn't too sure at first whether she should call the doctor or just wait and see.  She decided to wait and see what happened.  During that day she fell asleep as she was tired all the time. When she woke up about an hour later she had chills again, in the middle of the day and it was 80+ degrees without the air on, she should have been sweating but wasn't.  Then she noticed that there was a small red area that appeared where the two shots were given.  Her head was still bothering her and said that if she still had problems the next day she would see what was going on.  On Thursday morning her head was still hurting, her neck was stiff and was concerned about this, her arm was huge, the muscle just blew up in her arm like a balloon.  It is probably at least 1/2" higher than what it should be.  Instead of just being in the direct area of the two shots it had spread out some too and was starting to go across her arm, and one big line from main swelling and going around the arm now to the inside of her upper arm.  Then the redness started following it.  When she woke up this morning, the swelling had not only been going on the inside of her arm and now on the underside of the arm which is swollen and bight red.  She got her Allegra refilled and started taking that yesterday and took one today.  It started itching on Wednesday and since then has been unbearable.  She was going nuts as it hurt to scratch but she wanted to, but had taken the medication for that.  This morning it was not itching as bad, but the swelling and the redness is still there, and still just as big as it was Wednesday or Thursday.    She has not called her doctor, but did let the pharmacist know about the situation.    Did not have any reactions like this with the other vaccines, had a sore arm for a couple of days and a headache which disappeared after a few days.
Starting around 3pm day of injection patient experienced uncontrollable shakiness, muscle aches, nausea and vomiting and patient seems disoriented and confused. This continued throughout the night into the following day. At point of last contact (morning of 10/10/2020) the patients daughter was reaching out to patients physician for further guidance.
Patient came in to receive vaccinations for Immigration Status Change (ISC). Patient was given several vaccines including an MMR that had expired the day before. The day of expiration was on a Sunday and vaccines had not been removed from inventory. RN that gave vaccines did not check expiration date until after vaccine had been administered and was being charted. Event was reported to supervisor. Dose was repeated with non-expired vaccine and afterwards supervisor found guidance from IAC stating that repeat dose should wait for 28 days to be given. Agency incident report was filled out and system to flag vaccines expiring in next month was devised to prevent these errors in the future. Nurses also instructed to chart vaccines as they are being drawn up so that CIIS drop down menu will not show the lot number if it has expired. This would alert the nurse to recheck the vaccine.
pt had a heart attack + a blood clot  found in her heart in the weeks following her vaccine
THE PATIENT BRUISED AT THE SITE OF INJECTION.  I ALSO SAW A BRUISE AT THE WAIST.  HE COMPLAINED OF BEING DIZZY AND BODY ACHES STARTED 4 DAYS AFTER THE INJECTION
Information has been received from a nurse concerning an 18 week old patient (gender not reported) with a history of gas who on 07-DEC-2007 was vaccinated (route and site not reported) with a 0.5 ml dose of PedvaxHIB (lot#656520/0435U). Dose of the series of PedvaxHIB vaccine which was given was unknown. Concomitant therapy included INFANTS MYLICON DROPS. On 13-DEC-2007, the patient developed stuffiness, nasal congestion and gas. The patient's mother was convinced that the patient had these experiences because of the "recall of the vaccine". The patient did receive unspecified medical attention but at the time of this report it is unknown if the patient recovered. Additional information has been requested.
numbness in the upper lip; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (numbness in the upper lip) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.  On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (numbness in the upper lip). At the time of the report, HYPOAESTHESIA ORAL (numbness in the upper lip) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   No relevant concomitant medications were reported.  Treatment details not provided.
One week after receiving my 2nd dose, I developed small, red, dry patches of skin on my torso and chest area. They have been spreading and increasing daily. I received a steroid shot just today and Clotrimazole-Betamethasone cream to apply. Am awaiting results of this treatment.
Left arm started hurting 3 days after HPV #2 administration. Continued with pain in arm 1 month after administration of shot
pt recvd vax  11SEP92 & 15SEp92 devel dizziness, confusion & lightheadedness; 16SEp92 sx were resolving;
Information has been received from a physician and from Pfizer under case # 11655355, concerning a 23 year old female with a history of pneumonia and no spleen who in March 2010, was vaccinated with PNEUMOVAX 23 while she was hospitalized for unrelated health problem of pneumonia. Eight weeks later, approximately May 2010, titer was drawn and client had failed to seroconvert. Unspecified medical attention was sought. It was also reported that the patient was not amounting an immune response. At the time of this report, the patient's outcome was not reported. This was originally reported by a physician. This is a consolidation of two reports concerning the same patient. No further information is available.
Patient vaccinated x3 (Moderna: 4/22/21, 5/20/21, 1/21/22). Patient admitted to hospital after testing positive for COVID19 on 6/24/22
The patient called on 9/10/22 at 9:33am. She stated she had pain with the injection and that is continued and has decreased her range of motion. She has pain when moving the arm and sleeping. Patient was advised to go to urgent care. Multiple attempts to contact the patient have failed to determine if she did get medical care.
16:35-Clients mother reported that client was having a reaction. As nurse turned to look over at client, Clients body was having an involuntary body contractions arms were stiff and straight outward with hands sticking outward; legs were pointing out at the same time with feet pointing out straight forward. Clients body relaxed and would contract straight forward and outward 2 more times, during these events Client did not respond to verbal or physical stimuli. Client was a/o to name only between events. pupils were dilated, and she became clamy, skin was cool to touch, and pale in color, and experienced an episode of emesis in between 1st and second event of body contractions. v/s assessed at 16:37B/p 60/48 O2:97% HR: 95 unable to obtain Respirations. Client became responsive and a/o x 3 immediatley. Nurse gave client water and 2 lollipops, and elevated her legs on a chair. Clients color started to return to normal skin tone. Client stated that she has only had a sandwich to eat all day. re-assessed v/s at 16:45- B/p 82/52 O2:95% HR:62 R: 15. Pt a/o x3. Not clamy anymore, skin warm to touch, and normal in color. Client states she is feeling better, drinking water and eating her lollipop.-16:57 assessed v/s B/p: 100/60 O2: 100% HR67 R:15. a/o x3. -17:10: B/P110/70 O2%98% HR:64 R: 17. Client is a/o x3, and states that she feels better. Nurse did teaching with client and clients mom on reporting todays reaction with PCP and regarding second dose vaccination, as well as eating appropriately and staying hydrated. Both verbalized understanding.
Information has been received from a mother concerning her 23 year old daughter with no pertinent medical history who on 03-OCT-2007 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL. Concomitant therapy included "birth control pills" (manufacturer unknown). On 04-OCT-2007 the patient woke up in the morning with a severe headache. There were no laboratory or diagnostic test performed. The patient did not seek medical attention. At the time of the report the patient had not recovered. Additional information is not expected.
pt recv vax 6SEP90 & 7SEP90 pt devel a fever of 101 p/1st MMR vax;no further details were provided;
approx at 1120 am, pt returned to mvu5 ne2 after being administered Janssen 1808980. C/C dizziness, nausea and anxiety. Denied cp and sob. No rash, swelling and diaphoretic noted at this time. Pt is aox4, able to make needs known. Prior to receiving vaccine pt stated that she was nervous about the injection, after returning to mvu5 this was addressed and pt confirmed she was feeling anxiety due to tensions in her home environment get and only have light breakfast (smoothie) and began to cry. Pt stated that her grandmother recommended her coming back to be checked out, then apologized because she was feeling better and stated she wanted to comply with her grandmother request. Pt instructed to take a couple deep breaths and to get food and drink water. at approx 1135 am, pt agreed she was feeling better and able to go to her own accord. vs wnl. Pt and grandmother were instructed to seek treatment at urgent care or emergency room if symptoms worsen.
Numbness under tongue Numbness in jaw Discomfort I jaw and neck EMT checked Vitals. All Vs WNLs Patient refused transport to hospital. 30 minutes in observation
Information has been received from a pharmacist concerning adult female who on 04-OCT-2005 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 651524/0605R).  It was noted that the patient received her first dose prior to age 65.  On 04-OCT-2005, immediately after vaccination, the patient's entire upper arm was red and warm to touch.  It covered the entire upper arm with no defined border.  Unspecified medical attention was sought and the patient was instructed to use ice packs for comport.  The patient was recovering.  A product quality compliant was not involved.  Additional information has been requested.
Chills ,headache , sore arm at injection site. Took acetaminophen lots of water. Cold compress on injection site. Dissipated after 24 hours.
I had COVID-19 and tested positive on December 23rd, 2020. I had a loss of taste and smell. It was not a complete loss.  More like an 80% loss. I received my first COVID vaccine dose on 01/08/2021. By about mid January, however, I had almost all, if not all, of my taste/smell back. But after my second Moderna COVID-19 Vaccine dose, I lost my sense of taste and smell again. When I was at about 90-100% recovered, as of the 2 or 3 days following my 2md vaccine dose, I had lost almost all taste and smell again. As of today, 4 days after the vaccine, I'm back to around 80% again. I have not had any other congestion, etc. that might explain my loss of taste and smell.
c/o fever, pain, inability to raised lt arm, arm warm to touch, swollen in deltoid area;s/s started on 10/10/99;took APAP w/o relief;c/o neck pain;
I had a fever last night; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (I had a fever last night) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015MM20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PYREXIA (I had a fever last night). At the time of the report, PYREXIA (I had a fever last night) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
About an hour or so after the shot, I had a tingling sensation in my left leg (middle of the thigh area). The feeling felt like I had just put Icy Hot on my leg. This feeling continued on and off  for the entire week and went away by Friday. However, on Tuesday (the day after my shot), I had the same feeling in my left leg appear in the left side of my face. That feeling remained in my face for only one day and went away by Wednesday.