chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine not disposed of during the previous night. Morning schedule was hectic with many patients early for vaccine appointments. Intern pharmacist came to administer vaccines and did not double-check if the vaccines were just opened; drew vaccine that were opened the day prior. Vaccine was 4 hours post 12 hours puncture expiration. Patient given Moderna as 2nd booster. Patient contacted. No reported adverse event from the vaccine.
received a 22 days expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 21-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB36AA, expiry date 31st July 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 22nd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 22nd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-Aug-2022:  Reporter's comments:  A pharmacist reported that a patient received a 22 days expired dose of Bexsero. The reporter consent to follow up. Additional Supportive Information: The patient was administered an expired dose of Besxero, which led to expired vaccine used.
Ringing in ears. Increased BP 178/49. Pharmacist gave me liquid BENADRYL. BP decreased throughout day. Ringing ceased.
Chills, Severe shaking and muscle spasms along with head ache and sore joints.
Humming tinnitus in left ear after every dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Oct2021 17:30 (Lot number: FH8020) at the age of 36 years as dose 3 (booster dose), single, administered in arm left, administration date 22Mar2021 (Lot number: EP7534) as dose 2, single and administered in arm left, administration date 28Feb2021 15:30 (Lot number: EN6203) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicilin"; Cefclor, reaction(s): "Known allergies: Cefclor". The following information was reported: TINNITUS (non-serious) with onset Feb2021, outcome "not recovered", described as "Humming tinnitus in left ear after every dose". The event "humming tinnitus in left ear after every dose" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of tinnitus. Additional information: No vaccine in 4 weeks. Vitamin B in 2 weeks. Humming tinnitus in left ear after every dose. Onset 1-5 days after. Continued on and off for months after first two doses. After booster dose 3 weeks ago, I am still having daily tinnitus  No follow-up attempts are possible. No further information is expected.
About one week after the second booster shot, I got an itchy rash that started on my legs, chest and back. I thought it was poison ivy but it didn't go away and is worse now. I've seen an allergist and a dermatologist. I have tried Prednisone, prescription antihistamine and a prescription topical ointment. The only thing that seemed to help was Prednisone but as soon as I stopped taking it, the rash came back, worse. It is incredibly itchy and is now on most parts of my body. I am waiting for biopsy results.
mild body aches, mild headache, mild fever 99.3 , mild insomnia , mild injection site discomfort; all started about 10 hours after the vaccine and resolved about 36 hours after the vacciine
PT presents with back and head pain with abd cramping x 1500. reports fever of 101.9 took tylenol motrin 2030. received JJ vaccine 1055.
This is a spontaneous report from a contactable consumer reported for himself. A 64-year-old male patient received PREVNAR 13 for immunization on 07Nov2016 07:00 at single dose via an unspecified route on the right arm. Medical history included laminectomy since 08Aug2016 and ongoing. On 03Oct2016 the patient got the influenza vaccine. Concomitant medication included gapapentin for spinal laminectomy at 300 mg, 3x/day orally and ongoing. On 11Nov2016 the patient experienced that the injection site was all red and hard, on his chest, neck and top of his back, he was breaking out of hives, swelling at the injection site and pain at the injection site. The outcome of the events was not recovered. The patient received treatment only for pain with Tylenol.
sickest year ever had; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be possibly related to Influenza vaccine.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment:This case was received by the consumer via interactive digital media. The reporter wanted to know if other guys received shot previously. The reporter reported that she did not care to debate any mom shammers on here, so don't bother to comment anything negative as a reply. The patient asked if you guys have gotten it before because she urge them to get it for yourself a few weeks before baby girl. The reporter stated that if it dose make you sick then you don't want the entire family down at the same time. The patient had only gotten the flu shot once and it was the sickest year she had ever.
Patient presented to emergency department on 11/13/2021 with generalized weakness, cough, and chills. She was found to be COVID-19 positive. She was admitted and treated with dexamethasone and supplemental oxygen. She was discharged home on 11/23/2021.
Patient received only liquid DTAP-IPV portion of PENTACEL with no AE; Initial information regarding an unsolicited non-valid non-serious case was received from other Health Care Professional via Global Medical Information (GMI) (Reference number- 00708617) and transmitted to Sanofi on 03-Aug-2021 in United States.  This case involves an 1 years old female patient who received liquid DTAP-IPV portion without reconstituting with powder ACTHIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue).  The patient's medical history, past medical treatment, vaccinations and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 03-Aug-2021, the patient received a 0.5 mL dose of received liquid DTAP-IPV portion without reconstituting with powder ACTHIB portion suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Oral solution, DTAP-IPV: lot UJ440AA, ACTHIB: lot UJ502AA and expiry date: 29-MAY-2022) via intramuscular route in the left vastus lateralis for prophylactic vaccination.  This was an actual medication error case due to inappropriate reconstitution technique (on same day).  It was reported that "Nurse asking how she should proceed."  It was not reported whether any patient had received the product and experienced any adverse event.  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 the 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.
I woke up the second morning with purple blood blister type of thing. There were also pinprick sort of spots too. Large spots were raised. I also had another spot with circular blister like spots. These went away quickly. However I still have the purple spots. They are no longer raised and are slowly disappearing.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 12-JUL-2012 and 13-NOV-2012 the patient was vaccinated with the first dose and the second dose of GARDASIL, injection, (lot #, expiration date, dose and route unspecified) respectively. The patient did not get the third dose yet. No adverse effect reported. Additional information has been requested.
Chest pains, hard at breathing, high blood pressure, swollen lymph nodes, swollen sinus glands, pericarditis.
Initially, I had a small bruise at the injection site (given on Wednesday afternoon). The following Wednesday I had what seems to be a delayed injection site reaction. I developed redness and itching around the area that lasted approximately 48 hours. I wanted to report in case others experience a delayed reaction.
Patient arrives with chief complaint of shortness of breath and a cough.  Patient has history of COPD.  Patient has noted confusion as he arrives with his pants on backwards.  Patient has had tachycardia as well as a low O2 sat at 84% today patient is here with his significant other who says that he has not been having any fevers.  Patient reports very minimal chest discomfort.  Patient has no history of CHF. Associated Symptoms: cough, shortness of breath
Pt experienced dizziness 5-10 minutes after vaccine administration. Pt lost consciousness and was diaphoretic and pale. Blood pressure was 73/42.  Pulse was 44. Blood glucose 66. 4-lead EKG - slightly elevated T waves (per first responders).   Pt slowly resolved to a more stable state. Color returned. BP - 107/77. Pulse 70. Patient refused transport and decided to return home about 1 hour after his vaccination.
Wheezing, Constant Cough- He has a breathing machine & has to have a treatment everyday. Its been causing his heart to work harder. 11/19/09 and 11/20/09 Medical records received for date 9/29/09. DX: Gastroenteritis, URI. Presenting SX: vomiting x2 days, runny nose, cough x3 days. Assessment: (+)congestion, (+)cough, (+)murmur.
Severe headache, low fever diarrhea, severe muscle and joint pain and weakness, chills, first insomnia,, then extreme fatigue.  Symptoms persisted until Tues. 3/30/21.
No additional AE/; HCP called to report she went to give 3rd dose  of RECOMBIVAX HB, to a 5 years old patient and he jumped. The needle came out and some of vaccine still in syringe and some of the vaccine liquid seen running down the patients arm. MIR on case 02437720; some of the vaccine liquid seen running down the patients arm; HCP called to report she went to give 3rd dose  of RECOMBIVAX HB, to a 5 years old patient and he jumped. The needle came out and some of vaccine still in syringe and some of the vaccine liquid seen running down the patients arm; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.      On 27-JUL-2023 the patient was vaccinated with third dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot # W022795 and expiration date 19-MAY-2025, 0.5 milliliter for prophylaxis (route and site of administration were not provided). During administration of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) the patient jumped, and the needle came out (product administration error) and some of vaccine was still in syringe and some of the vaccine liquid was running down the patients arm (incorrect dose administered, exposure via skin contact and no adverse event).
Info has been received from a 55 year old female registered nurse with allergies to sulfa medications, codeine and tetanus toxoid who on 10/22/2002 at 1600 was vaccinated intramuscularly in the left deltoid with a 0.5 ml 2nd dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M). There was no illness at the time of vaccination. Concomitant medication included vitamins, calcium, sertraline hydrochloride (ZOLOFT), hyoscyamine sulfate (LEVBID), and diphenhydramine hydrochloride (BENADRYL) prn. On 10/22/2002 at 1630 the pt developed a localized reaction with swelling pain, inflammation, "hot to the touch" and had blotches of red from the shoulder to the elbow on the left upper arm. On 11/26/2002, it was reported by a health care professional that the pt developed a local reaction which was diagnosed as erythema nodosum to the medial aspect of her humerus. No intervention was reported. Unspecified medical attention was sought. The pt recovered on 10/29/2002. Additional info is not expected.
Injection site pain; has knot with swelling; has knot with redness; Chills; Joint pain; Tiredness; Headache; This is a spontaneous report from a contactable consumer. An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 28Mar2021 at 04:00 (at the age of 85 years old) (Lot Number: ER8730) as dose 1, single for COVID-19 immunisation. Medical history included ongoing high blood pressure, chronic pain from 1964 and ongoing, ongoing restless legs, and ongoing pain management. Concomitant medications included aspirin [acetylsalicylic acid] taken for an unspecified indication from an unspecified start date and ongoing; morphine taken for pain management from an unspecified start date and ongoing; valsartan taken for an unspecified indication from an unspecified start date and ongoing; trazodone taken for restless legs syndrome from an unspecified start date and ongoing. The patient had no prior vaccination (within 4 weeks). On 29Mar2021 at 10:00, the patient experienced injection site pain has knot with swelling and redness. On 29Mar2021 at 05:00, the patient experienced tiredness and headache. On 29Mar2021 at 06:00, the patient experienced chills and joint pain. The outcome of the events vaccination site pain, vaccination site swelling, and vaccination site erythema was recovering whereas outcome of the events fatigue, headache, chills, and arthralgia was recovered on 30Mar2021.  No follow-up attempts are possible. No further information is expected.
pt exp sz w/fever to 102.3 on 27MAY96;11 days p/vax pt exp a subsequent prolonged sz w/fever on 19AUG96;
severe cervical lymphadenopathy followed by weeks of malaise, shortness of breath and cough
I immediately started exp symptoms asked to pull parking lot  for observation. Then my arm left arm started throbbing to fingertips, metal taste exp no nausea I left. By that afternoon my joints, body throbbing, fever,chills, headache and extreme fatigue. For about 4 days I dint feel like doing my normal activities exp stomach cramps (feels like effect if on a rollercoaster almost sinking feeling) diarrhea and night sweats (full body under my boobs, back of my hair, at his point I have to sleep naked constantly changing bed sheets).I have never had night sweats don't know if it was hormones. I went to doctor did blood work for menopause I was recommended to follow up with doctor for my Ulcerative colitis. Also my doctor told me I'm in stroke level now I'm back on blood pressure medication haven't not any issues since 2 years ago.
elevated bilirubin; This is a spontaneous report from a contactable Health care professional (pharmacist). This pharmacist reported for a patient (3rd patient in 3 other patients) via medical information team. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On unspecified date, the patient experienced elevated bilirubin. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021470248 same reporter/drug/AE, different patients (3rd of 3 patients)
Pt in MOB2 Vaccine Clinic for Pfizer dose#2 Following initial vaccination developed rash with absence of other symptoms Was evaluated by allergy specialist with approval for second dose with 30min observation period.   20 mins after receiving dose complained of subjective itching on forearms. No visible rash, erythema, complaints oral swelling, globus, diff breathing, swallowing. Given zyrtec 10mg SL Observed for 30 additional minutes with no progression of symptoms and resolution of pruritis.
Body temperature was still 96.7; 2 hours after injection had numb lips and jaw; 2 hours after injection had numb lips and jaw; Very cold arms, hands, and feet; This is a spontaneous report from a contactable consumer (the patient).A 68-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6200), via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 10:00 (at the age of 68-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to Apples, citrus, garlic, mushrooms, tea, white potatoes. Concomitant medication included pseudoephedrine hydrochloride (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]). The patient did not receive any other vaccine in four weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID. The patient has not been tested for COVID post vaccination. On 02Mar2021 at 12:00, (2 hours after injection) the patient had numb lips and jaw, very cold arms, hands, and feet and on 03Mar2021, the patient's body temperature was still 96.7. It was reported that two hours after injection had numb lips and jaw. Very cold arms, hands, and feet. 24 hours later body temperature was still 96.7. This persisted for 36 hours from the time of the shot. The adverse events did not result in emergency room visit or Physician office visit. On 03Mar2021, the patient underwent lab tests which included body temperature was still 96.7 (24 hours later). The patient did not receive any treatment for events. The patient recovered from events on unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Patient received vaccination of Tdap on 08/04/2009 and had local redness and swelling to left deltoid. Parent stated that patient had fever ranging from 102.0 - 104.0F and headache for 6 hours. Parent was giving patient Tylenol for fever and headache and brought patient into the Emergency Department this am and appointment scheduled to see provider.
head numbness; Throwing up; low grade temperature; Headache; severe weakness; dizziness; Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (severe weakness), DIZZINESS (dizziness), DIARRHOEA (Diarrhoea), HYPOAESTHESIA (head numbness) and VOMITING (Throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 15-Jan-2021 to 01-Feb-2021. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, APIXABAN (ELIQUIS), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METFORMIN, ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and MULTIVITAMIN & MINERAL for an unknown indication.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced ASTHENIA (severe weakness), DIZZINESS (dizziness), HYPOAESTHESIA (head numbness), VOMITING (Throwing up), PYREXIA (low grade temperature) and HEADACHE (Headache). In April 2021, the patient experienced DIARRHOEA (Diarrhoea). On 06-Apr-2021, ASTHENIA (severe weakness), DIZZINESS (dizziness), HYPOAESTHESIA (head numbness), VOMITING (Throwing up), PYREXIA (low grade temperature) and HEADACHE (Headache) had resolved. In April 2021, DIARRHOEA (Diarrhoea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Water pill and Blood pressure pill. Treatment medication not provided.
I had the Covid virus early in November 2020 I had a bad reaction to my 1st Covid shot and wanted to ask if I should get the second one? I was able to get an appointment for a Covid vaccination thru store/pharmacy. I had the shot about 4:00 on Friday. On Saturday about noon I started not to feel right; head ache and stomach. About 4:00 I started to get an increase in my temperature. At 5:30 I started getting uncontrollable shaking. Over a span of about 30 minutes I had 4 or 5 episodes that lasted 30 - 45 seconds. I had a temperature at one point that reached 102.3 I took 200 mg of Ibuprofen every three hours before falling asleep for the night. On Sunday morning I still had a slight temperature (99.9), but it seemed like all my body joints ached. I ended up feeling better about 4:00 on Sunday. Reply
Menstrual period came 12 days earlier than it should have. Patient has had regular periods for 7 years and this was one of the first times it was irregular.
My husband had lymphoma in 2016 and went through six cycles of chemo including rchop and even did the spinal chemo.  He was all clear as of 8 20 2019 pet scans clear and blood normal.  He received a flu shot 9 27 2019 although this date it was administered in a home of friend pharmacist who works for pharmacy here.  After 9 27 2019 my husbands health declined he seemed to have cold symptoms October and November.  He was getting worse by December and on December 30 2019 had horrible lip cold sore then mouth infection local urgent care sent him home after flu test and pneumonia normal.  On January 3 2020 we went to clinic ER we were put on antibiotics and blood work showed 20% blasts we were admitted and bone marrow biopsy and formal diagnosis of treatment related acute myeloid leukemia on Jan 5 2020 and 7 + 3 chemo started on Jan 6 2020.  We spent one month in patient and now have genetic results he has an inversion on chromosome 16 so we are now doing four cycles of cytarabine chemotherapy in patient for six days then home for three weeks in between cycles. I am convinced this is triggered by the flu shot and suspect underlying virus or retrovirus.  I also suspect the flu shot triggered the inversion on chromosome 16.  Patient's family  history of cancer - viral infection among family members passed to next generation infected with virus or latent retrovirus Dad passed away from non Hodgkin lymphoma at 64 on Feb 2 2005 Mom at 60 breast cancer at 74 diagnosed CLL living Sister at 48 diagnosis Brest cancer living