chrisvoncsefalvay/vaers-outcomes huggingface dataset:
GBS/AIDP: Aug 15 I started feeling some numbness in my fingers and toes. By the 17th I was also getting some headaches and backaches. By the 19th I was seeking medical assistance from my general practitioner and a dial a nurse. I did get in the next day to see a NP at my regular Dr.?s office on that Saturday. She wanted to schedule an MRI the next week at the next door hospital . Unfortunately, they have no staff for that on the weekends. I was told to go to the emergency room if this got any worse. I did not get any sleep or rest that afternoon or night so I went to the emergency room around 6 AM. I was told to go to a hospital and they would let them know I was coming. I arrived around 10 AM and was finally admitted through emergency to the Neurology ward around 4 PM. I received several blood tests, motion tests, breathing tests, and finally a CT at 6 PM and an MRI at midnight. The next morning, I was given a spinal puncture and was diagnosed with GBS. At this point I could not walk or barely lift a leg or arm. I spent 7 days on the Neuro ward receiving a 5 day series if IVIG. I was then transferred to the inpatient physical therapy ward to learn how to walk and move again for the next 10 days. I was released on Sept 6th. My daughter drove me the two hours home. I went to see my GP the next day who recommended I see a local Neurologist. The local physical therapy is almost impossible to get into so I continued with exercises at home. I got in to see Dr. at hospital on November 7th for a Neuro checkup and will see her again on June 5th. She felt my progress was good considering what I had but also did notice some balance issues and numbness tingling in hands and feet.  She said if in June this was still occurring, we may try another round of IVIG. As of today I am still taking gabapentin 300mg twice a day for nerve tingling/pain. I still question my balance at times though I have not fallen down. I am also concerned about some memory loss/brain fog as remembering short term things and names is difficult.
Narrative:  Fully vaccinated COVID positive upon admission. Presented with AMS likely 2/2 to COVID PNA vs metabolic with uremia requiring dialysis. Patient with no prior hx of COVID infection.
SWOLLEN ANKLES; ICE COLD FEET; TYPICAL SIGNS AND SYMPTOM; This spontaneous report received from a parent concerned a 30 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included postural orthostatic tachycardia syndrome (POTS). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced typical signs and symptom. On 27-MAY-2021, the subject experienced swollen ankles. On 27-MAY-2021, the subject experienced ice cold feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen ankles, ice cold feet and typical signs and symptom was not reported. This report was non-serious.
Patient arrived in clinic to receive their second dose of COVID 19  vaccine. Lower than authorized dose administered.  Administered 10 mcg/0.2mL, NDC: 80777-0283-02 to 11 month  old child.  Information provided by the CDC & Facility relating to the updated COVID 19 vaccination schedules on 04/18/2023 was not clear.  Specificity of vaccine dose & injection volume in disseminated informations from these sources would have improved our understanding. This error was discovered 2 weeks following it's occurence.
Sore Arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix. On 28th June 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 1st July 2019, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The patient experienced sore arm which resolved within 3 days. For tolerance to 2nd dose, refer linked case US2019158370.
Initial report received from a health care professional on 30 March 2011. A 30-year-old female patient with no concurrent illnesses, had received an intramuscular right deltoid injection of ADACEL (lot number U3554CA, Sanofi pasteur Ltd. lot number C3661) on 28 March 2011, and 2 hours after receiving the vaccinations she reported having a headache that progressed to a migraine, and neck stiffness that required a doctor visit. Results of doctor visit were not provided. No relevant diagnostic tests/laboratory data were performed. The patient had not received any other vaccinations within 4 weeks prior to 28 March 2011; and her pre-existing medical history and use of other medications were unknown. It was also unknown if the patient had experienced any adverse events with prior vaccinations. A the time of this report, the patient had not recovered. Documents held by sender: None.
pt exp paresthesias in lower extremities & lower torso p/vax;numbness & tingling is slowly resolving in downward fashion;pt does not recall having any sx p/initial vax 24JUN96;
Patient tilted her head back and her face turned red and actually stopped breathing, then woke back up when i prepared to start cpr procedures. Patient woke back up and seemed fine and actually drank water and laid on the floor until EMS came to store.  Patient spoke with us the whole time and stated she ate a small snack this morning.  Patient is now doing okay and is shopping in our store at the moment and has been cleared by EMS. Patient  may have passed out due to excitement of the shot itself.
Approximately 15 min after vaccination began to experience tingling sensation under tongue. It was not bothersome so I proceeded to go home. At 2:04 pm, approximately 40 minutes after vaccination was driving home and began to experience an elevated HR, shortness of breath/difficulty breathing and throat tightness. Proceeded to pull over to a gas station and felt extremely weak when trying to walk and a tingling sensation all over.  Took 25 mg of Benadryl tablets and symptoms began to subside within about 10 minutes or so. Proceeded to continue driving home and had another episode at 2:49 pm, experienced significant shortness of breath and tingling sensation in mouth spread to back of tongue and it felt swollen. I bought liquid Benadryl instead and took ~20 mL. This episode resolved within 10-20 minutes as well and was okay for the rest of the evening.
This case involves a 69 years old male patient who was accidentally administered 2 doses of acthib with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB]. The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. On 04-Dec-2021, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE (strength, formulation, frequency, route, administration site, lot number not and expiry date was unknown) for prophylactic vaccination. On 06-Oct-2021 he again  received a  dose of the same vaccine (strength, formulation, frequency, route, administration site, lot number not and expiry date was unknown). On 11-Jan-2022 he also received again accidentally two 0.5 mL doses of the same vaccine (lot UJ574AAA and expiry date: 20-Sep-2022) via intramuscular route in the left deltoid. On 11-JAN-2022 the patient developed a non-serious  event "accidentally administered 2 doses of acthib with no reported adverse event" (extra dose administered) 3 months 5 days following the administration of HIB (PRP/T) VACCINE. Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable. It was not reported if the patient received a corrective treatment for the event (accidentally administered 2 doses of ACTHIB with no reported adverse event). At time of reporting, the outcome was Unknown for the event accidentally administered 2 doses of acthib with no reported adverse event. Reporter causality: related.
Information has been received from a manufacturer pregnancy registry concerning a 23 year old immigrant female with no known past medical history who no 5/22/03 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy that day included a dose of MMR, a dose of hepatitis B vaccine, a dose of tetanus toxoid and prenatal vitamins. The patient's last menstrual period was on 4/4/03. Unspecified medical attention was sought. Follow up information received indicated that it was not known if the patient was tested for varicella antibodies before vaccination. An ultrasound on 9/4/03 was normal. An amniocentesis and MSAFP were declined. The patient had no previous pregnancies. There was no local reaction at the vaccination site. There were no symptoms of varicella or herpes zoster post vaccination. The live born infant was born on 1/16/04. The infant was a normal female and weighed 10 pounds and 4 ounces. The mother was 40.6 weeks from her LMP. There were no congenital abnormalities. There were no complications during pregnancy. During labor/delivery, there was a failure to progress and prolonged ruptured membranes. A Cesarean section was performed. There were no diagnostic test during pregnancy. There were no infections or illnesses during pregnancy. There were no concurrent medical conditions. During pregnancy the mother used 5 doses of 12.5 mg of promethazine hydrochloride on 1/15/03 for nausea. Upon internal review, failure to progress/prolonged rupture of membranes was considered to be an other important medical event (OMIC).
sore arm; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (sore arm) and CHILLS (chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010NZ0A) for COVID-19 vaccination.     Concurrent medical conditions included COPD (Lungs are compromised).    On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and CHILLS (chills). At the time of the report, VACCINATION SITE PAIN (sore arm) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not reported.   Treatment information was not reported.
Client vaccinated 1st, 3 brothers vaccinated after. Client seemed fine until directly before departure. Client fainted and fell to the floor hitting right upper cheek on floor/carpet. Client had small rug burn on upper cheek. Immediately after fainting (cont'd on back) mother picked up off floor. I grabbed the smelling salts & prepared, then client woke up. Smelling salt was not needed. I provided client with a juice & a cool rag for his face. During fainting episode client urinated in his clothes. Monitored client for approx. 25 minutes. Checked pulse, within average range. Pulse was 92 bpm. Client regained some color in his face & was able to walk to restroom with mother's assistance. Client remained very lethargic after fainting episode. Referred mother to urgent care due to client bumping cheek/face on the floor and continuous lethargy. Client being vaccinated 1st then watching 3 brothers being vaccinated along with wearing heavy winter coat could have contributed to fainting episode. 8:40 am 2/14/12 Spoke with mother. Client is well & back to normal. They did go to urgent care, urgent care directed them to take client home & monitor for a couple of hours & if needed then seek care at ER if felt necessary. After leaving urgent care client vomited then felt better, family went and had ice cream. Client vomitted shortly after consuming ice cream. Mother said after that he was doing well & back to himself. They did check on him a couple of times through the night.
Left arm red and swelling  Patient instructed ice and Benadryl and if it does not help needs to be seen by a doctor.
muscles are hurting; extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscles are hurting) and FATIGUE (extremely fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscles are hurting) and FATIGUE (extremely fatigued). At the time of the report, MYALGIA (muscles are hurting) and FATIGUE (extremely fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Pt developed Cough, Congestion on Saturday, 10/9/2021 Developed SOB on Monday, 10/11/2021.   COVID + and admitted to hospital for Oxygen.
Patient received Moderna COVID vaccine on 2/9/21 and 3/9/21. Patient was found lying on the floor on 1/14/22 and was transported to our ED by EMS. On 1/14/22, patient admitted to our inpatient med/surg unit with acute encephalopathy, acute hypoxemic respiratory failure due to COVID-19, and COVID-19 pneumonia. As of today (1/18/22), patient is still admitted in the med/surg unit.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received on unknown date (refer case: US2018208921). On 6th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th November 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, fever, stomach pain, weakness, joint pain and chills. In November 2018, the patient experienced injection site erythema, injection site pain and rash. On 15th November 2018, the patient experienced feeling of warmth facial and red face. In November 2018, the outcome of the injection site erythema and injection site pain were recovered/resolved. On 16th November 2018, the outcome of the feeling of warmth facial and red face were recovered/resolved. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, stomach pain, weakness, joint pain and chills were recovered/resolved and the outcome of the rash was unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, influenza-like symptoms, general body pain, fever, stomach pain, weakness, joint pain, chills, feeling of warmth facial, red face and rash to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in right deltoid. The patient woke up that night with chills which again turned into flu-like symptoms that included body aches, fever, stomach ache, weakness and all joints hurting. These events resolved within 1.5 days. The patient was presented with injection site pain, redness and soreness that lasted approximately three days. The day before reporting, the patient woke up with her face very hot and red. She stated that her face looked like it was sunburned. The patient did not consent to follow up. The reporter did not want her physician to be contacted and indicated that she herself was a pharmacist. The patient had the SHINGRIX vaccine a week ago and had adverse effects for 2 days. At the time of reporting, the patient had rash on face. This case was linked with case US2018208921, reported by the same reporter for the same patient.
diffuse erythema, shoulder to mid arm over deltoid area on lt arm, edema @ site, warm to touch;
heart racing/her heart beat was 140 BPM; felt flush, hot; tired; soreness at the injection site; This is a spontaneous report from a contactable consumer. An adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient received the vaccine and with 10 minutes felt flush, hot, and her heart racing on 22Dec2020. At one point she looked at her watch and her heart beat was 140 BPM. She was sent immediately to the ER (emergency room). Since then she was tired and had soreness at the injection site. She would have to see an allergist before getting the 2nd shot. The outcome of the events was recovered on unspecified date in Dec2020. Information about batch/lot number has been requested.
The night after the vaccination I developed a mild fever (under 100 F) and had a severe headache.  It lasted most of the night.  When I got up in the morning, both symptoms were gone and I assumed I made it through any side affects.  That whole day I felt great.  I had delayed my daily 7 mile run, which I normally do in the morning, to make sure the symptoms were really over.  So by 4 pm, still feeling great, I decided to go for that run.  I didn't run particularly hard or fast,  It was a relaxing, enjoyable run.  No issues.  When I got back home around 5:30 pm, I went straight back to my office to keep working.  I was feeling hot, as you would expect after a run, so I turned on the ceiling fan.  after about 15 minutes I started to feel like I was shivering from the cold, so I turned off the fan.  Within less than 5 minutes, I was shacking and my muscles were spasming uncontrollably.  It was similar to the couple of times in my life where I have gone into shock from an injury.  So I dropped everything and made my way as quick as I could to a very hot shower.  I was scared enough to ask my 17 year old daughter to check on me to make sure I don't pass out.  A couple time I thought about calling 911, but I didn't have my phone and I was afraid to leave the shower.  After about 20 minutes in the near scolding shower, I stopped shaking enough to where I decided to wrap up and get under a bunch of covers laying on the bed.  The shacking  completely stopped after 5 or 10 minutes in bed, but the fever shot up and I developed a debilitating headache.  I took Tylenol and eventually Excedrin Migraine to ease the pain.  The fevered stayed over 100 F most of the night (my normal temperature is a little above 97), and the headache remained but gradually declined.  By 7 am the this morning I was fine and I've been fine all day.  The only reasons I'm reporting this is because the shaking was very severe, at times I wondered if I was heading for a seizure, and, being a runner, I want to make sure there is not a link between severe reactions and distance running shortly after the vaccination.
Diagnosed with Vitamin D deficiency and Stage 4 Chronic Kidney Disease two days ago; Diagnosed with Vitamin D deficiency and Stage 4 Chronic Kidney Disease two days ago; This is a spontaneous report from a contactable consumer (wife). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, at the age of 57-year-old, on an unspecified date as single dose for covid-19 immunisation.  The patient medical history was not reported. There were no concomitant medications.  The patient was diagnosed with vitamin d deficiency and stage 4 chronic kidney disease on 08Mar2021 with outcome of unknown.    Information on the lot/ batch number has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-MAY-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (dose, route of administration were not provided) lot # K006960, expiration date 19-FEB-2017. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
According to Dr's report, "VACCINE REACTION: Within 10 minutes of receiving vaccines, patient developed erythematous macules and patches on the face, head and torso. Rash was slightly pruritic, O2 sat 99%, no respiratory symptoms. Examination on injection sites showed erythema around DTaP injection site but not at site of HAV or Hib vaccines. Both rash and pruritis self-resolved after about 30 minutes.
swelling of face; 6 hrs later, patient experienced swelling of face, & her eyes; face pealed; This spontaneous case was reported by a pharmacist and describes the occurrence of SWELLING FACE (swelling of face), EYE SWELLING (6 hrs later, patient experienced swelling of face, & her eyes) and SKIN EXFOLIATION (face pealed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052B22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Lung disease. Concomitant products included PREDNISONE for an unknown indication.    On 18-Nov-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2022, the patient experienced SWELLING FACE (swelling of face), EYE SWELLING (6 hrs later, patient experienced swelling of face, & her eyes) and SKIN EXFOLIATION (face pealed). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (swelling of face), EYE SWELLING (6 hrs later, patient experienced swelling of face, & her eyes) and SKIN EXFOLIATION (face pealed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported patient received 1st dose of primary series. 6hours later patient experienced swelling of face and her eyes and face pealed. Patient had prednisone at home.
Within 2-3 minutes after receiving imm, infant developed hives at the sites where PEDIARIX and PREVNAR. Rt thigh - L- thigh - red and swollen, infant had intense cry, high pitched - given BENADRYL P.O. - symptoms resolved 30 min.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. On 17-JUN-2013 and 25-JUL-2013 the patient was vaccinated with the second and third doses of GARDASIL (lot # not reported, dose, route not reported) for vaccination. No adverse effects reported. Additional information has been requested.
Erythema, induration, swelling on the site of administration three inches in diameter, tender to touch. Developed nine days after vaccine administration.
Aug. 11th 2021 - pain, tightness in chest. Ambulance called. - Died, resituated after 25 minutes. - woke up in hospital, was told I had a stint put in. Aug. 17th 2021 discharged from hospital. Now on atorvastatin 80mg, clopidogrel 75mg , baby aspirin 81mg. and metoprolol 50mg.