chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious report of expired dose administered has been received from a nurse concerning a child of unknown age. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 11-Jan-2008. The FluMist that was administered on 11-Jan-2008, had expired the day prior to administration on 10-Jan-2008. No adverse events were reported at the time of the report. No adverse events were reported when the office was contacted on 08-Feb-2008. The Office Manager stated that the expired FluMist was given because the nurse did not check the expiration date prior to administration. The event is considered resolved. The patient did not experience a rechallenge while receiving the suspect product. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to MEDI-0006413, the other case submitted by the same reporter.
Within 24 hrs I got the chills and headache. By 2 am 6/14/2021, I was woken up with cold sweats and abdominal pain with some vomiting. 6/15/2021 I have mild headache.
Loss of taste; depression from the miscarriage; I had a miscarriage of 6 weeks old; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient was 6 weeks pregnant at the event onset. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: Bnt162b2 (Pfizer COVID Vaccine with my daughter's dad, we got the number 2 series), for Covid-19 immunization. The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 17Jul2021, outcome "unknown", described as "I had a miscarriage of 6 weeks old"; AGEUSIA (non-serious), outcome "unknown", described as "Loss of taste"; DEPRESSION (non-serious), outcome "unknown", described as "depression from the miscarriage". The pregnancy resulted in spontaneous abortion (17Jul2021). The patient underwent the following laboratory tests and procedures: antibody test: (13Nov2021) unknown result; blood test: (13Nov2021) unknown result.  Additional information: Consumer stated, she doesn't had a lot number. She got 2 vaccinations from (Name). That was in a 2 series, she threw away that card, they have it on (Name) on computer. Reason for no lot number was unspecified for Flu Vaccine, Consumer stated, "No, it was just the pharmacy." Additional Context: This was the first case out of the 2 cases. When confirmed the name of the vaccine as Pfizer COVID-19 vaccine, consumer stated, "Yeah, she got the vaccination, Pfizer COVID Vaccine with my daughter's dad, we got the number 2 series and then she had a miscarriage of 6 weeks old on 17Jul2021 and then she and her daughter's dad had been losing out taste. Question asked if they are going to get that back. She had all paperwork and stuff. They are off eventually the vaccination so we can taste again. They are losing our taste from the Pfizer vaccination. Question asked when will the taste come back to our mouth, she and her daughter's dad. In response to further probing, consumer stated, "if you going to send me a package on the mail. So, consumer can send the information on the miscarriage that we I had from it" Other medical conditions: Consumer stated, "No, just a loss of taste. I just want to get it back, loss of taste and the depression from the miscarriage." Prior vaccination (4 Weeks): Consumer stated, "Flu vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt was given flu shot - stated that he was fine - got up and went and sat down on the pharmacy bench in the waiting area - then about 3 minutes later started to pass out and patient's mom caught him before he fell off of the bench after passing out and slumping over. 911 was contacted and paramedics took him on to the hospital. Pt was awake and alert when he left to go to the hospital and said he was feeling better.
1st dose 27Aug2019, is late for the 2nd; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27th August 2019, batch number T2472, expiry date 23rd January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the pharmacy intern. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No symptoms reported. The reporter consented to follow up.
Soreness of the arm initially which wore off after a couple of days. Sort of like the flu shot. Itching, redness, and slight swelling at the site ten days after the shot. Not especially alarming but the red spot is about 2 1/4 x 1 inch. There is soreness when I touch the site. I've had on long sleeves every day since the shot. I applied some cortisone cream 10 to relieve the itching and slight swelling.  I have not yet recovered, however, it's not really that serious so it's not been a big deal. I just thought all side effects should be reported.
Vaccine given at pharmacy clinic on 12/18/13. Seem at clinic on 12/20/13, c/o swelling/redness at injection site. MD noticed localized itching with 12 cm x 13 cm area of redness warmth and mild induration on (R) thigh. Treated with 10 day course of KEFLEX and cool compresses.
The pt developed fever (101 deg. F. at ER), redness, swelling, hot to touch at the injection site(leg) on 02/12/2002. Also developed a knot under skin on 02/13/2002. The pt was treated with Tylenol.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 16-year-old female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 15-Dec-2010. On 20-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Severe aches and pain; chills; Fatigue; Full body rash; first dose on 04Mar2021 at 08:00 AM/second dose on 17Mar2021 at 08:30 AM; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Not known) as a single dose via unspecified route in right arm on 17Mar2021 at 08:30 AM (at the age of 60-year-old) for COVID-19 immunisation. The patient medical history included known allergies to penicillin and non-steroidal anti-Inflammatory drugs (NSAIDS). Patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Not known) as a single dose via unspecified route on 04Mar2021 at 08:00 AM (at the age of 60-year-old) for COVID-19 immunisation of event rash, swollen lips, tingle lips. Concomitant medications included biotin and multi vitamin (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021 at 17:00, the patient experienced severe aches and pain, chills, fatigue and full body rash. The treatment was taking Benadryl and Tylenol received for the events. The clinical outcome of severe aches and pain, chills, fatigue and full body rash was not recovered at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vaccine was given in left deltoid and upon completion patient stated he started feeling like he was going to pass out.  At about 0925 patient began closing his eyes and becoming incoherent.  At that time we called the medical director for assistance and got a set of vitals.  Member was drifting in and out on consciousness at that time.  Member was laid down on the exam table. Another set of vitals was taken and member became more coherent as well.  At 0938 members was alert and oriented x3 and was sat up and another set of vitals was taken.  At 0943 member was stood up, member was able to stand without any issues.
numbness and tingling in both arms n hands, entire arms fall asleep; numbness and tingling in both arms n hands, entire arms fall asleep; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Nov2021 17:30 (Lot number: FH8020) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ulcerative Colitis" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: LIADIA; VYVANSE. The following information was reported: HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 05Nov2021, outcome "unknown" and all described as "numbness and tingling in both arms n hands, entire arms fall asleep".  Additional information: The patient received second dose of BNT162B2 (lot number: 33025BD) via unspecified route on 04Jan2022 18:30 on arm right for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. On 02Nov received 1st of Pfizer, 3 days following patient had numbness and tingling in both arms and hands, entire arms fell asleep and currently waiting to see a neurologist. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Just received 2nd dose of Pfizer on 04Jan2022 and day 6 she was having chest tightness, shortness of breath, rapid heartbeat. Waiting to see a doctor today 11Jan2022. Currently waiting for treatment. Since the vaccination, the patient had not been tested for COVID-19. Known allergies: Not that patient was aware of.  No follow-up attempts are possible. No further information is expected.
Began Monday 9/25/23 @2am The worst symptom was the weakness. I was too weak to walk. I thought I would fall. My legs would not hold me up much. I used a bedside portable toilet I had from my total knee replacement. There was pain in my lower back. It felt like my kidneys. It radiated down my legs and up my spine. If we use 0-10 as the pain scale it would have been a 10. I had blurry vision. When I was able to walk again on Tuesday I was incontinent of urine.  I suppose the headache was to be expected (I've never had one this bad from a vaccine), fever (101), chills, vomiting, nausea, etc.  Event resolved Tuesday evening @7pm I broke into a sweat and began to feel better.
3/7:  No adverse reactions observed 3/8:  12:30 a.m.  Awoke vomiting and with fever of 99.8 F               2:30 a.m.  Fever of 102 F                Multiple measurements prior to 10 a.m. fever of 101.6-102 F               10:00 a.m.  Full adult dose Vick NyQuil Severe Cold & Flu.  Additional doses as directed.                Scheduled rapid Covid-19 test at pharmacy                2:00 p.m. fever of 99.5 F                4:50 p.m.  COVID-19 test, no fever                6:00 p.m.  Negative test result Remaining evening of 3/8 and until early morning, 3/12, heavy night sweats, clamminess, extreme fatigue
When I got home from the hospital I was fine.  I had some dinner and fell asleep on my recliner. When I woke up my left leg felt diffrent. I remember I wiggled my left foot around and I knew something was wrong.Getting off the chair I felt some cramping in my left calf and a numb thick feeling on the bottom and left side of my foot. As time went on the cramping got worse and tingeling in my hands started. By the time I went In for my fourth vaccination shot of RabAvert my right foot was 1/4% numb and the left foot 1/2% numb and very painful and time frame August 27, 2007. Medication given were: Tramadol HCL 50 mg - Diazepan 2 mg - Ibuprofen 800 mg - Amitriptyline HCL 25 mg.  At the end of November my health was getting worse and my worker's comp doctor took me off work on December 3rd 2007. These are the first symptoms in 2007. My workers' comp doctor released me from his care on March 11th 2008 saying that these side effect have nothing to do with the rabies vaccinations (RabAvert). My health continues to worsen my own private doctor says that it looks like Perrpneral Neuropathy and Cephalgra (shooting pain in the head). The medications I'm on now are Gabapentin 300 mg for nerve pain and Carbamazepine 200 mg to prevent and control seizures. Please feel free to contact me anytime.  Thank You 11/18/08-records received for DOS 08/1/07-Presented with bite by feral cat. Immediately after vaccine developed pain in left calf and numbness in lateral aspect of foot 3 days prior to 8/17/07-DX: possible adverse reaction to rabies vaccine. Second vaccine given 8/17/07. 8/31/07-worsening complaints of paresthesia in lower extremities radiating all way to hip. Under stress at home and work. Received next dose of rabies vaccine.  9/10/07-increasing pain in left lower extremity now in heel burning radicular fashion, paresthesias in first 3 fingers of left hand. Received last rabies vaccine. 9/21/07-increasing problems with worsening pain in left heel and spasms in right shoulder, episodic disorientation while driving and headaches. 9/24/07-increasing paresthesias with some improvement in tingling. Possible conversion reaction.
Employee noticed redness, warmth, swelling at site. Approx. measurements 6inchesx4inches. She is currently afebrile 96.4, and no other symptoms. She self-administered Motrin. Icepack given by Employee Health, area marked, encouraged to monitor vital signs and report any additional adverse effects. She wants to see a doctor today, will set up with urgent care. She states she doesn't have pain but feels "burning" today.
Site: Pain at Injection Site-Mild, Systemic: Generalized Body Aches -Medium, Systemic: Headache-Severe, Systemic: Other- shortness of breath that resolved after 15 minutes
Post COVID Vaccine SVT; This is a spontaneous report from a contactable nurse. This nurse reported similar events for three patients. This is 2nd of three reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced post COVID vaccine supraventricular tachycardia (SVT) (showed from an EKG) on an unspecified date. The patient had no known cardiac history at all. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : same reporter, same drug and event, different patient.; same reporter, same drug and event, different patient.
Painful red swelling from right shoulder down to elbow, helped by Motrin and warm compress, but persisted.
Exhausted; Heart was racing so bad, it was ridiculous; heart was racing terrible; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself.  A 63-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW01770, Expiration date: unknown), via intramuscular, administered in left arm on 24Apr2021 (at the age of 63-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered in left arm on as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history includes thyroid disorder and concomitant medications include levothyroxine.  On 27Apr2021, 3 days after the vaccination, the patient experienced heart racing so bad, it was ridiculous, and she knew it does like afterwards that heart could be raising but she had no idea that is the only thing that she could attribute. She was there in the bed and her heart was racing terrible. In the next morning she woke up she was exhausted. Consumer said she wanted to report because there was no other reason for heart would be racing like that, so she just thought it had to be a side effect from Pfizer and she never had this before. The events assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Tdap (Boostrix) was given to a 19 year old high school student.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperature and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 03-OCT-2013 (lot # H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
patient began having symptoms the day she went to hospital and was diagnosed (per patient), of Bells Palsy of the right side of face.
feet weak 2 days p/flu shot; also generalized weakness for 2 wks; sl numbness rt foot;
soreness at injection site; Back ache; administered an undiluted 0.3 ml Pfizer-BioNTech COVID-19 Vaccine to a 66 year old female patient; administered an undiluted 0.3 ml Pfizer-BioNTech COVID-19 Vaccine to a 66 year old female patient; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 28Sep2021 10:00 (Lot number: FC3184) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 28Sep2021 10:00, outcome "unknown" and all described as "administered an undiluted 0.3 ml Pfizer-BioNTech COVID-19 Vaccine to a 66 year old female patient"; VACCINATION SITE PAIN (non-serious) with onset 29Sep2021, outcome "unknown", described as "soreness at injection site"; BACK PAIN (non-serious) with onset 29Sep2021, outcome "unknown", described as "Back ache". Therapeutic measures were taken as a result of vaccination site pain, back pain.  Additional information: She was calling because one of their pharmacist administered an undiluted 0.3 ml Pfizer-BioNTech COVID-19 Vaccine to a 66 year old female patient. She was asking if there would be any side effects.  No follow-up attempts are possible. No further information is expected.
Dull pain in her jaw; Sore arm; Stiffness in her neck and face; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Dull pain in her jaw), PAIN IN EXTREMITY (Sore arm) and MUSCULOSKELETAL STIFFNESS (Stiffness in her neck and face) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN JAW (Dull pain in her jaw), PAIN IN EXTREMITY (Sore arm) and MUSCULOSKELETAL STIFFNESS (Stiffness in her neck and face). At the time of the report, PAIN IN JAW (Dull pain in her jaw) and MUSCULOSKELETAL STIFFNESS (Stiffness in her neck and face) had resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
This is a 84y.o. male with a PMHx of hypertension on Norvasc and dyslipidemia who presents to the ED from care facility via EMS for shortness of breath onset this morning.  He states he woke this morning and approximately 30 minutes later he began to experience productive cough with green sputum, followed by shortness of breath.  He called the nurse for assistance who applied supplemental oxygen and removed his mask with minimal improvement of symptoms, prompting the care facility to call EMS.  Patient reportedly presented on 15 L nonrebreather via EMS.  Patient and EMS reports he recently tested positive for Covid at this facility, however, upon review of chart no notes or prior admissions at this facility.  He denies any fevers, chills, chest pain, abdominal pain, nausea, vomiting, diarrhea, constipation.   In the ED: BP 152/78, HR 82, RR 23, SPO2 95% on 3LNC, T 98.7F.  Labs remarkable for K5.9, bicarbonate 33, troponin 0 0.09, hemoglobin 9.3, platelet 119.  CXR significant for near complete opacification of left hemithorax, small right pleural effusion and associated scattered reticular and groundglass of airspace disease.  CTA PE shows no evidence of PE; left upper lobe collapse with possible evidence of mucous plugging VS obstructive mass lesions; diffuse groundglass consolidation of left upper lobe and patchy groundglass consolidation of right upper and lower lobes; bilateral renal cysts.  Patient is started on IV Decadron.  He is admitted to internal medicine with consult to cardiology and pulmonology.
Swollen lymph node under the arm that received the shot plus minor muscular discomfort in upper torso beginning the morning of the second day after receiving the shot and lasting for 2 days.
PT REQUIRED TO RECEIVE BOTH VACCINES IN RIGHT ARM D/T PREVIOUS MEDICAL CONDITION. PT PRESENTED TO PHARMACY WITH SWELLING FROM BELOW INJECTION SITE TO ELBOW ON INNERSIDE OF RIGHT ARM. PT TOOK BENADRYL AND THE SWELLING DECREASED.
Localized redness, warmth, tenderness, and itching immediately following  vaccine. Symptoms lessening eventually until 1/26 when large hot, hard, itchy circle appeared covering the size of my deltoid muscle.