chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Registered Nurse for GARDASIL, a Pregnancy Registry Product, concerning a 30 year old female patient with no pertinent medical history, or drug reactions/allergies, who on 25-JAN-2011 was vaccinated IM inadvertently with a 0.5ml dose of GARDASIL (lot#666162/0565Z) instead of an unnamed influenza vaccine. Concomitant therapy included prenatal vitamins (unspecified). A vial of the GARDASIL was misplaced in a box with the influenza vaccines. On an unspecified date, a pregnancy test ultrasound was performed. No adverse symptoms were noted. Patient's last menstrual period was 15-NOV-2010. Expected date of delivery was 22-AUG-2011. Follow up information was received from a Registered Nurse (R.N) via pregnancy questionnaire who reported that the 30 year old female patient has a history of 3 pregnancies (2 full term deliveries) and 1 spontaneous abortion of twin fetal demise at 14 weeks in 2010. There was no defect in previous pregnancies. It was reported that on 25-JAN-2011, an ultrasound was performed which was within normal limits. The patient was scheduled for the next anatomical ultrasound on 01-APR-2011. Follow-up information was received from an initial pregnancy questionnaire from the registered nurse indicating that the patient's 2 full term deliveries were at 39 weeks from last menstrual period. Additional information has been requested.
Rash at injection site beginning 14 days post vaccination and ending 17 days post injection.
Day of injection:fever over 100, body aches, fatigue Day 2-same as day 1 plus dizziness, extreme high blood pressure and a seizure Day 3&4-all symptoms continue except the seizure Day 5&6-fever broke, now just dizzy and blood pressure spikes Day 7-most symptoms subsided, but blood pressure still spikes slightly and tinnitus began and continues
Pt received both TDAP and Meningococcal vaccine in R deltoid on 23 Jul 2010. Within 24 hrs, notice local swelling and tenderness over injection site. As per pt. swelling extended from proximal area to mid area. Pt eval in clinic ? had 6 x 4 cm roughly 1.5 cm thick induration over injection site no rash, warmth, or erythema.
Prior to vaccination I had a prolonged viral infection lasting about a month. Because the infection was improving and I was afebrile, I received my annual Flu vaccine. Just over a month later I woke one night with severe (L) scapular pain - with resulting (L) deltoid pain and (L) thumb numbness the symptoms progressed to (L) arm pain and onset of (L) hand weakness. (L) hand weakness improved after 2 courses of steroids - but persists after one year now. EMG's showed severe radial nerve damage. My neurologist felt based on her research the Brachial Neuritis was caused from a virus or vaccine. My question was - Did the combination of a persistent viral illness a long with the influenza vaccine contribute to the development of the Brachial Neuritis.
This spontaneous report as received from a nurse refers to patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with VARIVAX injection, lot # N012488 with expiration date on 20-APR-2019; lot # M038857 with expiration date on 14-SEP-2018 and lot # N007930 with expiration date on 08-MAR-2019 (dose and route of administration were not reported). The doses of vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). Administered doses of VARIVAX experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 14 hours and 54 minutes. There were no previous temperature excursions. Digital data logger was involved in recording the excursion. No adverse effects were reported.
After my 2nd shot the next day I had a 102/103 temperature with body aches and pain, nauseated and with a headache. It affected my breathing a little. That lasted 2-3 days and I got alright. Then in August all this stuff started happening to me and I called my Cancer Dr. he I thought the shot and my cancer medication could be causing me problems. I told him the constipation I had and he said that it could be due to the cancer medication. I told him I was having breathing problems and feeling tired all the time and the Doctor told me to do CT Scan of my lungs and Echocardiogram for my heart. I also went to a lung doctor who said I didn't have cancer of the lung and he gave me another inhaler. I've been using the inhaler since August and the breathing problem has gotten better. I was to get the booster shot today but last Saturday I had a temperature and been feeling tired so I canceled the shot.
Might have administered some / vaccines reconstituted with sterile water; Might have administered some / vaccines reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that they might have administered some Menveo vaccines reconstituted with sterile water instead that the approved diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case had been linked with case US2021094213, as reported by the same reporter The reporter had no data at time of call. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094213:Same reporter.
light-headedness, tremulous, palpitations, cold sweat about 10min post inj;lasted about 5min;
Pain at injection site x 36 hrs.; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EK5730), via an unspecified route of administration on 16Dec2020 18:00 at single dose (right arm) for Covid-19 immunisation. Medical history included seasonal allergies, depression, elevated cholesterol and pollen and dust allergies only. The patient had no allergies to medications and food. Concomitant medications included fluoxetine, loratadine, Montelukast sodium (SINGULAIR), fluticasone and mul (as reported). On 16Dec2020 19:00, the patient experienced pain at injection site x 36 hrs. The patient was vaccinated at the hospital. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of event was recovered on an unspecified date.
Patient was diagnosed with Juvenile Idiopathic Arthritis September 2009 after the lining of her lungs became inflammed. She had been complaining about wrist pain and knee pain since a few months after receiving the shots. She does have arthritis in the joints of her knees, wrists and ankles and has been diagnosed with Raynaud's as well.
This spontaneous report was received from a wife regarding her 60 year old husband (who is the patient). The patient had no pertinent medical history or drug allergies. On 22-MAY-2013, the patient was vaccinated with a dose of RECOMBIVAX HB (lot # H015537, expiry date 09-JUL-2015). Concomitant therapies included LIPITOR, LISINOPRIL, VERAPAMIL HYDROCHLORIDE and LYRICA. On 24-MAY-2013, the patient experienced stomach irritation, swelling of feet, eyes, tongue, lips, hives and itching. The patient had taken as a two pediatric dose injection was RECOMBIVAX. No lab tests were performed. The outcome of the events were reported as not recovered. The patient sought medical attention. Additional information is not expected.
convulsing; joint pain; freezing; shaking; could not stand up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: SEIZURE (medically significant) with onset 17Nov2022 at 03:00, outcome "recovering", described as "convulsing"; DYSSTASIA (non-serious) with onset 17Nov2022 at 03:00, outcome "recovering", described as "could not stand up"; FEELING COLD (non-serious) with onset 17Nov2022 at 03:00, outcome "recovering", described as "freezing"; ARTHRALGIA (non-serious) with onset 17Nov2022 at 03:00, outcome "recovering", described as "joint pain"; TREMOR (non-serious) with onset 17Nov2022 at 03:00, outcome "recovering", described as "shaking". Yesterday (16Nov2022), patient got booster, 4th booster shot (Pfizer COVID-19 Vaccine) yesterday and patient was kind of a surprised because patient woke up at about 3 in the morning and patient was absolutely freezing and patient was convulsing, patient was shaking, patient could not stand up and the joint pain was unbearable and this was really bizarre because patient had experienced that sometime ago with the flu shot. (Medication name could not be clarified; Unspecified Flu Shot) But never with the COVID-19 shot. Patient must say that at the present time it had diminished quite a bit. Patient was just wondering why patient was experiencing that when patient never did before. Patient stated never mind, it subsided quite a bit. It was not as bad as it was. Patient was feeling a lot better.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 1/30/13 cl's mom called and reported that on 1/27/13 client developed hives on feet, knees, hands, a few on face, and her hands became "completely swollen" so that client couldn't bend her fingers, hands purple in color. Client treated at clinic with BENADRYL and CLARITIN. Mother was told rash related to client's URI which began 1/23/13.
approx 2 1/2 hrs p/vax of DTP pt started crying & could not be consoled for 1 hr; then got pale & limp & unable to arouse for 20" therefore rushed to ER; t100.2;
Patient tested positive for COVID  7 days after receiving her first COVID 19 vaccine. She developed symptoms including shortness of breath, fatigue and headache. She tested positive outpatient for COVID on 2/9
hard swollen lt thigh given Ibuprofen 1/2tsp po q 6hr;ice pack to area x 15min;
On 11/3 fever of 104 F, green nasal discharge. On 11/4 temperature reached 105 F, with seizure. Seen in ER and bathed, temperature dropped to 101. Pt was started on Zithromax.
sick; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious social media case from the consumer (patient mother) via social media.  This case involved an unknown age female patient who experienced sick (Illness), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (Illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  Final diagnosis was sick.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for sick, at the time of reporting.  There will be no information available on the batch number for this case.
After the initial 15 min wait period I was feeling fine, so i left the pharmacy. About 5-10 min later my heart rate became very fast very quickly and it became more difficult to breathe. I was driving home at the time, had to pull over and wait a few minutes until the event subsided. I debated contacting medical help, but i began recovering and was able to continue driving. Since the event i have been feeling slightly fatigued and i have a slight feverish feeling, but in general have been able to rest and have not had a repeat occurrence. I received no medical attention or treatment.
Patient received his first Pfizer COVID-19 vaccine on 2/9/21 at 2:23 pm. Patient had experienced mild respiratory symptoms the day of vaccination. Patient reported more severe respiratory distress such as tightness of chest and shortness of breath on 2/15/21. He also had a fever. Patient went to an urgent care clinic and was tested for COVID-19. He received antibiotics for possible respiratory infection. 2/17/21 patient reports improved symptoms and no fever. Client is taking antibiotics and is using supplementary oxygen with his CPAP PRN.  Checked in with patient on 1/23/21 and patient has improved. Client has a productive cough and has finished his course of antibiotics.
1ST INJECTION WAS 1/28/21 THE EVENING AFTER 1ST INJECTION (1/29/21).. FEVER 102 MUSCLE AND JOINT ACHES, HEADACHE AND SWOLLEN AXILLARY NODES IN LEFT ARM LASTING ABOUT 24-36 HOURS. 4 200ML ADVIL TAKEN   SWOLLEN NODES REMAINED SUNDAY MORNING AND I WOKE WITH LEFT SIDE OF MY FACE NUMB BUT FUNCTIONING WHICH CONTINUED FOR ABOUT 48 HOURS.  TODAY (2/2/21) IS DAY 5 POST INJECTION,  SWOLLEN NODES REMAIN AND PINS AND NEEDLES FEELING ON LEFT SIDE OF FACE
Information has been received from a registered pharmacist concerning an 83 year old female with allergy to beta blockers and macrolides and a history of pneumonia who on 01-FEB-2007 was vaccinated with Pneumovax (0.5 ml), intramuscularly. Concomitant therapy included albuterol, COREG, CEFTIN, citalopram, ANZEMET, LASIX, ROBITUSSIN, SYNTHROID, nystatin, PROTONIX, SEROQUEL, COUMADIN and meclizine. On the morning of 02-FEB-2007 the patient developed an injection site reaction. The reaction was described as a cellulitis at the injection site and was swollen, red, and warm to touch. As of 02-FEB-2007 at 6:00 PM the reaction was "now traveling down the arm." Warm compresses were applied. At the time of the report the patient was considered to be not recovered. There were no laboratory or diagnostic tests performed. Additional information has been requested.
22May90 pt vax; devel firm, sore, tender, egglike mass in triceps area.  24May90 xray revealed the mass to be soft tissue density arising from triceps muscle mass.  One week later pt was fussy & more clumsy than usual.  See worm..
right arm swollen and red - worse over night to 7/2/10 more swollen measuring about 6 x 6 cm  expected to resolve
3-4 days later had Covid-19, she was hospitalized for 30 days; caller received the 1st dose but lost the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (3-4 days later had Covid-19, she was hospitalized for 30 days) 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.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (caller received the 1st dose but lost the 2nd dose). On 05-Feb-2021, the patient experienced COVID-19 (3-4 days later had Covid-19, she was hospitalized for 30 days) (seriousness criterion hospitalization prolonged). The patient was hospitalized for 30 days due to COVID-19. On 02-Feb-2021, PRODUCT DOSE OMISSION ISSUE (caller received the 1st dose but lost the 2nd dose) had resolved. At the time of the report, COVID-19 (3-4 days later had Covid-19, she was hospitalized for 30 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.   Callers mother received first dose on 02 Feb 2021, 3-4 days later had Covid-19, she was hospitalized for 30 days.   No treatment information was provided.  Company Comment: Based on biological implausibility, a causal relationship between the reported event COVID-19  and the administration of mRNA-1273  is assessed as unlikely. Causality for the event Product dose omission issue is not applicable.; Sender's Comments: Based on biological implausibility, a causal relationship between the reported event COVID-19  and the administration of mRNA-1273  is assessed as unlikely. Causality for the event Product dose omission issue is not applicable.
reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion standards with no reported adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid non-serious case received via physician.  This case concerns a 82 years old female patient who reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion standards with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (Shingrix) for Prophylactic vaccination.  On 18-Mar-2022, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.5 ml with lot C5873AA via intramuscular route in the left deltoid for Immunization.  On 18-Mar-2022 (latency : same day) the patient developed reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion standards with no reported adverse event (product storage error) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Reportedly negative 2.1 C from 07-Mar2022 until 31-Mar-2022 Did it occur due to a human error: No. Does extended stability data cover the excursion: No and in case of negative advice: was the product used by/ administered to the patient: Yes-14   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion standards with no reported adverse event).  At time of reporting, the outcome was Unknown for the event reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion standards with no reported 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.
Patient complained of pressure/swelling of left axilla and left side of neck. BP 112/60 (repeat, 110/69), pulse 73 (repeat 72), and O2 sat 96% to 97%. Drank apple juice and water - felt well enough 40 minutes later to leave for home.
tremendous arthritis in his hands and had trouble gripping; A spontaneous report was received from a physician concerning a male patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tremendous arthritis in his hands and had trouble gripping.   The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient was tested positive for COVID-19 in the March/April or springtime.   On an unspecified date (reported as 3 weeks ago from the reporting date), the patient received mRNA-1273 (LOT# unknown) route unknown and unknown site of administration for prophylaxis of COVID-19 infection.  On an unspecified date, the patient had experienced tremendous arthritis in his hands and had trouble gripping. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the event, tremendous arthritis in his hands and had trouble gripping was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vaccine received at 11:00 AM on 04/09. No issues on Friday. Saturday evening starting at 6:00 PM, slight headache and chills. Took 2 Tylenol.  Woke up at 1:00 AM and took 2 more Tylenol.   Got up at 7:00 AM on Sunday, and noticed a red rash on arms, torso and legs. No associated pain.  Called hospital and was referred to my family physician unless I was having breathing issues.   No breathing issues.  I will be contacting the doctor on Monday for instructions.
A report has been received from a consumer concerning a 6 year old, male patient. No medical history, concurrent diseases and concomitant medications were reported. On 23-Sep-2014, the patient received FLUMIST QUADRIVALENT (intranasal). The patient experienced Toxic Synovitis which started on 23-Sep-2014. The outcome of the event of Toxic Synovitis was unknown. The report was considered to be non-serious by the reporter.
No adverse reactions, Phone call to check on client today by Clinic Manager, Client states he  has no problems
My first vaccine was in April (4/21/21) on  the last day of my menstrual period. My period has always been regular, I have never skipped a period and suddenly for over 3 months I had no period anymore. An Ob-Gyn  ultrasound examination revealed a big cyst on my left ovary. It resolved on its own after 3 months. In August I got my period back and it has been normal since then. But the more worrisome side effect I got after the second shot of Pfizer (on 5/12/21): in late June I started having pain in the front of my neck. After it did not go away for over 10 days I saw my personal care physician. Blood tests showed mild hyperthyroidism with undetectable TSH (<0.1 uIU/ml) and mildly elevated T4 (1.6 iIU/mg). First blood test was on 7/19/21. Later tests on 7/23 showed T4 at 1.8 uIU/ml and then at 2.3 uIU/ml on 8/7 and 2.2 uIU/ml on 8/13. I was prescribed 2400 mg of Ibuprofen daily, but this did not help and on 8/15 I was started on medium dosage prednisone. On 8/24 my T4 was 1.2 uIU/ml (normal) and it kept dropping to 0.6 iIU/ml on 9/6, when I was put on levothyroxine. I was diagnosed with Subacute Thyroiditis by an Endocrinologist. Apart from the neck pain, I had heart palpitations, resting pulse of 120 bpm, so they had to put me on betablockers. I have never had any issues with my health before, no thyroid disorders in my family. I do have a grandma with Lupus though. I am still on levothyroxine.