chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; bilateral burning of ears; spinal pain from mid back to neck; numbness and tingling in the injection arm; numbness and tingling in the injection arm; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Feb2021 (Lot number: EM9810) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: latex" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: seasonal allergies" (unspecified if ongoing); "Known allergies: bee venom" (unspecified if ongoing); "Known allergies: almonds" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: FLUCONAZOLE; ZYRTEC ALLERGY; LO LOESTRIN FE. Past drug history included: Cefazolin, reaction(s): "Known allergies"; Midrin, reaction(s): "Known allergies". Vaccination history included: Bnt162b2 (Dose 1, Lot number EL3249), administration date: 22Jan2021, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; EAR DISCOMFORT (non-serious), outcome "unknown", described as "bilateral burning of ears"; SPINAL PAIN (non-serious), outcome "unknown", described as "spinal pain from mid back to neck"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious), outcome "unknown" and all described as "numbness and tingling in the injection arm". It was unknown if therapeutic measures were taken as a result of headache, ear discomfort, spinal pain, hypoaesthesia, paraesthesia.  Additional information:The patient did not received any other vaccine in last 4 month and received multivitamin. The patient did not tested for covid post vaccination and it was unknown if the patient had covid prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Swelling of entire (Rt) leg. Dx in ER as cellulitis - IV antibiotic; fever mgmt.
Pt. was calm before, during, and after his injection. He was talking for approximately 30 seconds after his 2nd injection, when his shoulders tensed, his neck outstretched backwards, and his eyes rolled back. This rigidity lasted about 30 seconds. When he started responding the first thing he said was ?it?s hard to breathe? and ?my head hurts?. BP was taken at this point and it was 139/97, sp02 98%, HR 54. He continued to have a glossy look, was tearful, and unlike himself. After another 15 minutes of the change in personality, he was moved to a bed. He put his legs up and 1 minute later he was noticeably different in speech patterns ?back to normal?. Sunday night he awoke to diarrhea, nausea, vomiting without fever, cough or other symptoms. Before bed on Monday evening he vomited again
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was administered with a dose of ZOSTAVAX post supported temperature excursion (0.65 ml, subcutaneously, lot # L000450, expiration date: 09-MAR-2016). No adverse effects were reported. Follow up information has been received on 14-MAY-2015 and on 15-MAY-2015, from a pharmacist who was able to provide the patient's initials and dates of vaccination for the ZOSTAVAX that experienced a temperature excursion; it was stated that the patient of unknown age and gender was vaccinated on 21-APR-2015. The pharmacist had no additional information to provide at the time of the call. This is one of several reports from the same reporter. Additional information has been requested.
Within 10 hours of flu shot and pneumococcal shot pt. began to feel feverish, headache, body ache, nausea and could not sleep due to symptoms. Next AM blotchy rash around injection site, spreading both distally and medially with lymphedema. Pt. took aspirin for fever and TYLENOL PM with positive results. Symptoms lasted around 3 days.
The day following my shot, my arm was sore, then I began to run fever around 2pm that went up to 102 by 8pm also had a headache.  This lasted for about 8 hours and when I woke up following day all the symptoms were gone and I was fine.
RN administered Tdap vaccination Boostrix with Lot#: 7535X and Expiration date of 2/15/2015.  RN administered vaccine after vaccine expiration date.  RN notified patient and revaccinated on 3/16/15 with Tdap vaccine Lot #: U5030AA and Expiration date: 05/01/2017 by RN.
pt recv vax 1994 & pt exp a seizure like episode w/blank staring & loss of muscle control; the reporter noted that pt was not their pt;
WOKE UP WITH HEADACHE ND GENERALIZED JOINT PAIN & MILD SWELLING TO HANDS. TOOK ALEVE FOR RELIEF.
tired, dizzy. horrendous headache. chills/hot. fever. very weird need to be touched/have my back, head and shoulders rubbed. it was the only thing that kept me from losing it. nausea. arm felt like it was being sawed off.
First night (Sunday) fever, chills, fatigue (normal symptoms) On Monday, I was fatigued but nothing else.  On Tuesday, I noticed that I was dizzy but I explained it away as being unrelated. On Wednesday, I noticed heart palpitations and increased dizziness. I was having chest pains.  On Thursday, I went to the ER after I noticed that my heart was pounding whilst doing normal household chores. They discharged me with no diagnosis and did not catch the palpitations on the monitor.  Friday-Saturday, I noticed extreme fatigue and chest irritation. Increased palpitations.  Sunday morning (a week after the shot) I decided to go back to the ER because I had woken up early that morning with extreme chest pain. They caught a PVC on the monitor but nothing else.  I visited a cardiologist on Monday (day 8) and I believe he mistakenly diagnosed me with benign PVCs.  I have been dealing with chest pain, heart palpitations,  fatigue, and dizziness ever since. It's slightly better than it was, but I am not even close to recovered.
PT'S MOTHER CALLED AT AROUND 8:35 AM TO REPORT THAT THE PT HAD BEEN VOMITING UNABLE TO "HOLD ANYTHING DOWN". SHE READ ON HER VIS THAT DTAP MIGHT CAUSE VOMITING AND THE DTAP WAS SUPPOSED TO BE GIVEN AT 15-18 MONTHS NOT 12 MONTHS WHICH IS WHEN IT WAS GIVEN. I EXPLAINED TO THE MOTHER THAT DTAP CAN BE GIVEN AT 12 MONTHS AS LONG AS THERE IS AT LEAST 6 MONTHS BETWEEN DOSE 3 AND 4. PARENT ALSO STATED THAT PT HAD NOT HAD VOMITING WITH ANY OF THE PREVIOUS VACCINES SHE HAD HAD INCLUDING DTAP IN A COMBINED VACCINE (PENTACEL). THE PARENT EXPLAINED THAT PATIENT DID NOT HAVE ANY FEVER. I RECOMMENDED THAT SHE SHOULD KEEP THE PT HYDRATED, IF VOMITING CONTINUOUS TAKE HER TO HER PROVIDER/HOSPITAL, ALSO IF A FEVER/OTHER S/S DEVELOP SHE SHOULD GO TO THE DR/HOSPITAL. PT VOICED UNDERSTANDING.
This spontaneous report as received from a registered nurse via a company representative refers to a female patient of unknown age. It was reported that the patient was late getting her second dose of GARDASIL (reported as inj, dose, route of administration, lot number, expiration date were not reported). No adverse symptom was reported. Additional information has been requested.
Deep bone and muscle aches, severe headache, no appetite, dizzy and disoriented when standing, extremely tired, all began about 12 hours after injection.  Adverse reactions started to subside about 12 hours after onset, and were completely gone after about 36 hours.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 15 October 2014. A 20-year-old male patient, with a past medical history of abnormal ECG, received an injection of ACAM2000 (lot number not reported) on 21 April 2014. He was diagnosed with unspecified disease of the pericardium on 01 May 2014, i.e. 10 days post-vaccination. Troponin I on 08 May 2014 and ECG and echocardiogram on 01 May 2014 were all normal. Outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
severe headache and muscle aches, runny nose, watery eyes and signifigant swelling in lips.   headache, runny nose, and body aches 24 hours, swollen lips 48 hours and counting.  Benedryl helped.
Fever with chills and body aches started 4 hours after vaccine and lasted for 10 hours.  Followed by high fever and body aches for another 4-5 hours.  Extreme fatigue and weakness.  Feeling better but still weak 36 hours later.
Aching injection site (expected) Sweating Generalized picky & itchy sensation on skin of arms, legs, trunk, head, face. Itchy eyes Drop in blood pressure Heart pounding Headache Malaise
It started earlier in day I started to have pain in upper abdomen, I felt feverish, got worse. Felt swollen pain unbearable to the point where I had to go to emergency room. They checked to make sure not gallbladder, appendicitis, pregnancy realized I had sepsis and admitted me to ICU. Found I had pancreatitis, and did a bunch of test to find that I had acute pancreatitis that caused sepsis. There for a week until cleared up and they released me. They still don't know what happened. I went for a follow up at local hospital, CT scan and bloodwork. They said it's mostly resolved nothing they can see. The cyst has shrunk.
Pt reports headache daily x9 days following the second dose of COVID vaccine.  Headaches occurred every day, lasting most of the day.  Headaches resolved with Tylenol 1-2 doses.   Headaches started the day after the second dose of the vaccine.  Today is day 11 following vaccination, he did not have a headache yesterday or today.
Initial medication error report received on 09 October 2013 from a nurse. A 64 years old unknown patients whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE HD (route, lot number and site of vaccination was not reported) on an unspecified date. Nurse reported that gave to older than 65 years old. Patient did not have any adverse events. List of documents held by sender: none
sore arm; maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 13-Oct-2020 and the estimated date of delivery was 20-Jul-2021. On 16-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 16-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Internal review on 19JUL2021 resulted in updates to pregnancy details. On 10-May-2021: Due date of pregnancy was added, second dose date added.
No additional AE reported; M-M-R II was administered by the intramuscular route instead of subcutaneous; This spontaneous report was received from a physician regarding to a patient of unknown age and gender. Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On 27-OCT-2020, the patient was vaccinated  by the intramuscular route instead of subcutaneous with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant Human albumin) (M-M-R II), 0.5 milliliter, lot # S037499, expiration date 20-NOV-2021 .    No additional AE reported.
Patient felt tingling around mouth, lips, tongue and "gum tightening." Given 10mg Zyrtec and after 15 minutes symptoms began to subside more. Tingling is now minimal. Will  discharge home.
Headache, severe body aches, legs hurt, stomach ache, nausea, chills, loss of hair, light headed, exhaustion, shortness of breathe.  Lasted for 2 weeks, strong. Week 3 and 4 slightly better with some days feeling an ease of reactions.  However, find that even today at about 5 weeks out, the symptoms still are sometime there.  Feel like I never fully recovered.  Some days are good and some days are not.
Patient had Moderna covid vaccine #1 on 3/21/21.  Patient presented to the emergency dept on 3/23/21 complaining of a discolored right arm (turning purplish) and swollen. Patient had a blood clot in Sept 2020 and was on anticoagulation until Jan 2021. Ultrasound of the RUE found an occlusive thrombus, R subclavian and right axillary vein as well as a nonocclusvie thrombus within the inferior R internal jugular. Patient was initiated on apixaban anticoagulation. Patient was seen back in the office and had a repeat ultrasound due to lack of improvement on 3/26, thrombus was unchanged. Patient continued on apixaban. Patient called the office on 3/29 with no improvement in his arm. Patient to be re-evaluated
New acute onset of atrial fibrillation. Hospitalized with cardioversion performed. Now on Eliquis and Metoprolol.
Chills, severe body aches, coughing, spitting up phlegm, feeling cold, couldn?t get in my inhalers, couldn?t breathe good, call my doctor office ( lung & disease) was advise to go the hospital,  lasting 2 weeks, took back to back nebulizer treatments, cough medication.
Patient awoke early day after Tdap (Adacel) Injection, with L arm Pain, Headache, nausea, then fatigue. No rash noted, but can see bruising, and a lump further down L arm, below injection site. No fever, rash or difficulty breathing. DX 287: Purpura and Other Hemorrhagic Conditions. Dr. Suspects some bleeding into muscle, causing a painful lump, swelling, and visible bruising. Patient will treat with Ice, switching to heat after 24 hrs, and gentle progressive ROM.
I am having a throbbing pain where my shot was injected. I am also having tingling in my fingers. The pain also wakes me up out of my sleep at night. And I received my final shot in March.
pt recvd vax;approx 14 hrs later,devel hive like rash covering arms,legs,trunk & buttoks assoc w/ intense itching;3jan95 sought med hlth,evaluated by MD;c/o no fever or respiratory problems;fully recovered;tx w/ suldane POBID; recovered
Mother telephoned and described dime sized red and hard knot under shot site of left thigh.
COVID-19; COVID-19; Nasal congestion; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PAD" (unspecified if ongoing), notes: other medical history: PAD; "fibriods" (unspecified if ongoing); "hx of iron deficiency anemia" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "not recovered" and all described as "COVID-19"; NASAL CONGESTION (medically significant) with onset 01Jun2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (01Jun2022) Positive, notes: positive Covid 19 test on 01Jun2022. Therapeutic measures were not taken as a result of drug ineffective, covid-19, nasal congestion; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
LEG CRAMPING; RIGHT AND LEFT FOOT DROP; DIFFICULTY WALKING; DIFFICULTY WITH FACIAL EXPRESSIONS/MOVEMENTS; BACK PAIN; PINCHED NERVE/NERVE PROBLEMS; DOUBLE VISION; DISC OUT; TINGLING SENSATIONS; WEAKNESS; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was on thyroid medicine (not specified). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204321A, expiry: UNKNOWN) dose was not reported, administered on SEP-2021 for prophylactic vaccination. Age at time of vaccination 69 years old. No concomitant medications were reported. On NOV-2021, the patient experienced leg cramping, right and left foot drop, difficulty walking, difficulty with facial expressions/movements, back pain, pinched nerve/nerve problems, double vision, disc out, tingling sensations, and weakness. Laboratory data included: MRI (NR: not provided) Abnormal (showed pinched nerve and disc out). Laboratory data (dates unspecified) included: Nerve stimulation test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg cramping, right and left foot drop, weakness, tingling sensations, difficulty walking, difficulty with facial expressions/movements, back pain, pinched nerve/nerve problems, double vision, and disc out. This report was non-serious.
administrated indivertibly with bexsero instead of Boostrix; 65 years old/ was administrated indivertibly with bexsero; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 65-year-old female patient who received Men B NVS (Bexsero) (batch number abxa87az, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that, the 65 years old patient was administrated indivertibly with Bexsero vaccine instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. No adverse event was reported .  The reporter consented to follow up.  The vaccination date was not provided.
This spontaneous report was received from a healthcare student regarding two adult patients of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. Yesterday, on 19-MAR-2015, the patients were vaccinated with PNEUMOVAX 23, .5 milliliter (ml), intramuscularly (site unspecified) (product lot# not available) which expired on 08-MAR-2015. There was no information on concomitant medications. No adverse events were reported. There was no product quality complaint involved. The outcome of the events were unknown. Additional information has been requested.
- Pain, swelling, redness on right upper arm following VARIVAX vaccination.  - Treated with oral antibiotic & close follow up.
Developed a fever, then had a seizure and was taken by ambulence to the emergency room. When I evaluated her again on 2/8/12, she had complaints of 1 week of a productive cough and evidence of acute otitis media on exam.
After being administered the vaccine at 7:12 am, when the nurse stood me up and started to walk me to the holding area, I became dizzy, my legs got weak, and there was a loud ringing in my ears. I nearly collapsed as I reached the seat in the holding area they were taking me to. I placed one 0.5MG tablet of my prescription Alprazolam in my mouth and waited for the nurse to bring water. They took me via wheelchair from the holding area to a secluded spot behind a curtain. There, I laid on a cot, received cold water, and a nurse talked to me while I recovered. It felt like I was having an anxiety attack, which has never happened to me after getting a shot before. Fitbit heart rate data shows my heart rate at 105 BPM at 7:00 am (going through the admission process, walking around the facility), 83 BPM at 7:10 am, 79 BPM at 7:15 am, 74 BPM at 7:20 am. Between 8:15 am and 1:25 pm, my heart rate remained between 63 and 89 BPM. My arm was sore and my skin hurt (an issue that I have when I feel very stressed). Additional symptoms arose around 1:35 pm. I began going through cycles of chills, sweating and overheating. My heart rate ranged from 127 BPM and 93 BPM for the remainder of the night. I took Tylenol at 7:07 PM to help with my fever.
shortness of breathe, fever, chills, muscle spams, headache and diarrhea.
Information has been received from the mother of a male pt with no allergies and no medical history who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast)(manufacturer unknown)(thimerosal containing per mother). Subsequently , the pt was diagnosed with Tourettes's Syndrome. Unspecified medical attention was sought. The mother reported that no direct causality has been associated with the pt's condition and the administration of any vaccine. The reporter noted that the doctor may not be contacted. No product quality complaint was noted. Upon internal review, Tourette's Syndrome was determined to be an other important medical event (OMIC).  Additional information has been requested.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 01-OCT-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L018499; expiry 25-FEB-2017 (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.