chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Accidental Overdose; Kinrix was inadvertently ordered and administered; Infant was administered Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th July 2022, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 14th July 2022, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced accidental overdose, wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental overdose, 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 Information: GSK Receipt Date: 14-Jul-2022. Reporter's Comments: The practice manager stated that an infant was administered with second dose of Pediarix and Kinrix at the same visit. The patient was supposed to get Prevnar-13, Rotateq, Hiberix, and Pediarix, but the Kinrix was inadvertently ordered and administered. The reporter consent to follow up via mail. Additional Supportive Information: The patient was given Kinrix instead of Prevnar-13, Rotateq, Hiberix, which led to wrong vaccine administered and inappropriate age at vaccine administration. On the same day, the patient received Pediarix, which led to accidental overdose.
By evening of the same day I read the vaccine my right side got numb my cheek and eye hurt to the touch, my eye socket was very sore, like if I was getting Bells Palsy. I took Vitamin B12 sublingual and went to bed and the next day it was still sore but I took the vitamins again and later on it subsided. By the first of the month those symptoms  were a lot less and now I am fine.
Injection site is red; Injection site is/swollen; This case was reported by a consumer via (Shingrix GSK and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th May 2021, the patient received Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient got the Shingrix shot on the arm. After vaccination, the patient's arm around the injection site was red and swollen. The patient asked what he/she should do.
Chills; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient . A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 22Apr2021 at 00:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 31Mar2021 at 13:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 00:00, the patient experienced 5 hours of chills, another 8 hours of fever and headaches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills was resolved on 22Apr2021 at 06:00; while that of fever and headache was resolved on 22Apr2021 at 09:00.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling, redness, soreness of left arm below vaccination site. Diagnosed as cellulitis by primary care doctor. Treating with cephalexin and prednisone.
Pain in left armpit.; Swollen lymph nodes; This is a spontaneous report from a contactable consumer. An adult female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 20Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown if the patient diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. On 20Apr2021, post second dose of the Pfizer vaccination, the patient experienced pain in left armpit, probably from swollen lymph nodes. Since the vaccination, unknown if the patient had been tested for COVID-19. It was unknown if the patient received any treatment for the reported events. The clinical outcome of the events pain in left armpit and swollen lymph nodes was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Vaccination and observation period successfully completed without adverse event.  The patient's significant other reported neither of them were feeling well on 2/21/2021.  Approximately 28 hours after vaccination, the patient was found unresponsive in the bathtub.  EMS arrived within 5 minutes, resuscitation attempt was unsuccessful, CPR terminated at 1503 and the patient pronounced dead.  The Medical examiner refused the case on the basis of lack of jurisdiction, and the remains were moved to a local funeral home.  No autopsy was performed.  This event is not thought to be related to the vaccination event or the vaccine, the death is thought to be from natural causes.
Moderna COVID-19 Vaccine EUA. Itchy rash on back of right lower arm. Administered 50mg of Benadryl. Had patient wait 30 minutes for rash to stop itching and resolve.
A severe reaction of a fever in the following afternoon, so cold-teeth chattered, every cell in the body ached, temperature of 103.9, vomiting, after 6 days blood pressure was so low 77/55 she was blacking out, urged to go to emergency, severe brain fog, now every afternoon around 3pm her temperature is elevated and has been consistent since she had the booster shot.  The fever is the same as when she was diagnosed with Latent Tuberculosis in 2011. Brain fog is so severe she cannot drive, fix a meal or handle bills or take a shower for fear of fainting. She has no appetite.
weak, weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak, weakness) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K204 or 038L204) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced ASTHENIA (weak, weakness). At the time of the report, ASTHENIA (weak, weakness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Headache, fever, large red and very swollen and sore area at injection spot, itchy at injection spot, weak and extremely tired. Today is day 3 and my arm is still super swollen, red and painful.
About 12 hours after shot (2:30 am), I woke up with a fever (100.5-101.0), chills and shaking, a racing heart, and pain in my neck and left shoulder (though I got the shot in my right arm). These symptoms continued throughout the night. The next day I had a low-grade fever that responded to Tylenol, and generally felt fatigued and achy. The next night I had some chills and shaking (though not as bad). The following day I had a headache and fatigue but no fever.
pt recvd vax & exp sz @ home a/being taken to hosp by ambulance; had been treated 15MAR94, same day, in MD's office for URI;
Vaccine pharmacy 10/13 6pm. Soreness from 7pm to 1200 am. Then numbness in r wrist/thumb, elbow pain. Aching and tingling in r wrist and thumb. Ice applied from 12-2, 20 mins on, 20 mins off. Unable to lift arm horizontal to body. Aching in shoulder joint continues. 3:20am still attempting to sleep, can only lay on back or L side. R arm tingling and aching through r thumb, outer aspect of elbow, and injection site. Next day 10/14, unable to lift R arm or move shoulder. Ice applied to r thumb/wrist. Unable to move wrist/hand without intense pain. Took two ibuprofen. Called out of work (work as a nurse and cannot work if one of my arms doesn't work). Over course of day, able to move thumb a little more, but still with pain. Soreness with movement of R arm 10/15, 10/16 arm feels fine but r thumb still in pain with movement. 10/17 symptoms resolved.
Patient reported history of syncope episode with another  vaccine in the past. Patient has history of seizure disorder. At 10:10am, patient was sitting  with her mother when she started to convulse sitting up right in a chair. She also vomited while convulsing for about 15seconds. Full consciousness regained.
General lethargy; Random muscle/joint aches; Generally feeling unwell; Random muscle/joint aches; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old adult male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7533), via an unspecified route of administration in left arm on 26Mar2021 at 16:15 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. No medical history was reported. The patient had no known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and bupropion hydrochloride (WELLBUTRIN) used for unknown indication from unspecified date. The patient also took unspecified vitamin once a day. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 07:30, the patient experienced general lethargy, random muscle pain, joint aches and generally felt unwell. The patient did not receive any treatment for these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of general lethargy, random muscle pain, joint aches and generally felt unwell was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient starts having arm and shoulder pain about 15 minutes after injection. Patient experienced chills, exhaustions, body aches, and fever about 7 hours after.
Right arm/hand numbness/weakness, right arm redness at the site of injection x 7 days enlarging, right shoulder pain and difficulty with full range of motion/mobility.  Have to be very careful moving my shoulder.
Right side of upper and lower lip felt tingly. This persisted during the day, kind of spreading across to the left side. No trouble talking, eating, swallowing, breathing and smile is symmetrical.
Patient reported loss of sensation in arm 4 days following vaccine administration. Reported to pharmacy 2 days following symptom onset. Patient reported feeling has improved since onset.
This spontaneous report as received from a Licensed Practical Nurse refers to a 77 year old male patient with benign prostatic hyperplasia, bradycardia, memory loss, peripheral neuropathy, obstructive sleep apnea, chronic peripheral edema, rheumatoid arthritis, sinus node dysfunction, atherosclerotic cardiovascular disease, diastolic dysfunction, esophagus hiatal hernia, metabolic bone disease, chronic COUMADIN anticoagulation, erectile dysfunction, chronic kidney disease stage 3 and type 2 diabetes mellitus. The patient's medical history included coronary artery bypass grafting (4 times) and history of shingles. On 24-APR-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (Lot number was reported as 8022062, expiry date was 28-FEB-2014, route and dose was not reported). Concomitant therapies included PLAVIX, PRILOSEC, aspirin, COLACE, AVODART, FISH OIL, LASIX, gabapentin, glipizide, ARAVA, SYNTHROID, minerals (unspecified), CENTRUM, potassium chloride, LYRICA and ULTRAM. On 24-APR-2013, the patient presented to the Emergency Department with a fever (medically significant, disability and life threatening), an unresponsive episode (medically significant, disability and life threatening) and encephalopathy (medically significant, disability and life threatening) after receiving PNEUMOVAX23. The patient also had unspecified "pneumonia symptoms" (medically significant, disability and life threatening) upon arrival to the Emergency Room. The patient sought medical attention. The patient was admitted to the hospital on 24-APR-2013 and was treated with unspecified steroids, and ROCEPHIN and Azithromycin. Diagnostic test performed included blood work: CBC (Complete blood count), CMP (Comprehensive Metabolic Panel), CRP (C-reactive protein), PT/INR (prothrombin time), fasting lipid profile and cardiac enzymes. The test results were not provided. The outcome of encephalopathy, fever, unspecified pneumonia symptoms and an unresponsive episode was reported as recovering/resolving. Additional information has been requested.
first dose / on 8/5/2020 / not reminded for my second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 5th August 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 case was reported by the consumer. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix , which led to incomplete course of vaccination. The patient also reported that he/she was not reminded for his/her second dose. The patient was also asked was it too late for second dose. No further information was reported. Reporter consent to follow up was unknown.
pt recv vax 22APR98 & w/in min of vax pt felt lightheaded;pt collapsed, hit head & had a poss sz;pt unconscious & jerked arms & legs & eyes rolled back;while falling hit lt occipital area & devel a hematoma;vasovagal rxn;neck discomfort;
Pt received vaccine 10/12/10 approx 10AM. At approx 12N pt had redness, swelling, heat. About quarter size area (L) deltoid at about 2pm area of about 1 1/2 around injection site. Still redness, swelling and heat. No c/o pain. Was itchy. Cold packs utilized. On day On dx for BENADRYL and MOTRIN. 10/13/10 Better. Less redness, slight swelling. Still warm c/o pain at injection site. Afebrile. No SOB 10/15 slight pain otherwise ok.
Diaphoretic, flushed, tachycardia. monitored  for 30 minutes, cleared with no symptoms.
Tingling tongue and numbness and tingling on R cheek and jaw; R jaw line pain and R sided teeth pain--pain rated 8/10 initially; Provided 50 mg of Benadryl orally; tingling tongue symptom resolved; after 45 minutes pain 2/10 with "mild" jaw and teeth pain and R-cheek numbness and tingling
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patient were vaccinated with VAQTA (dose, frequency, route, lot # and expiration date were not provided), PEDVAXHIB (dose, frequency, route, lot # and expiration date were not provided) and GARDASIL (dose, frequency, route, lot # and expiration date were not provided). The licensed practical nurse reported that on an unknown date, the patients might been administered VAQTA, PEDVAXHIB and GARDASIL that were not supported in a temperature excursion. It was unknown if the patients sought medical attention. No adverse effects were reported. At the time of the report, the patient's status was unknown. Additional information has been requested.
Vaccine expired on 06 October 2016. ZOSTAVAX Lot L025001. Vaccine was given to the patient on 17 October 2016.
chest pain; feeling occasional pain and tightness to my heart; feeling occasional pain and tightness to my heart; She also had tenderness in muscle where site of vaccine was; headache; Left arm pain; This is a spontaneous report from a contactable consumer reporting for herself.  A 74-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 27Jan2021 (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation (Age at vaccination 74 years) .  Medical history included atrial fibrillation from 2019  (AFib was diagnosed a couple of months before Dec2019) , chronic obstructive pulmonary disease from Dec2019  , medical device implantation  (Watchman device inserted), anaemia  , oesophagogastroduodenoscopy  , oesophageal stenosis, obesity. Concomitant medication(s) included clopidogrel bisulfate (PLAVIX) from Jul2019 to an unspecified stop date; metoprolol (METOPROLOL) taken for heart rate irregular from Nov2019 to an unspecified stop date.  The patient previously took bnt162b2 for covid-19 immunisation on 06Jan2021. The patient also took aspirin (E.C.) and experienced haemorrhage.  The patient experienced feeling occasional pain and tightness to my heart  on 30Jan2021 with outcome of not recovered , chest pain  on an unspecified date with outcome of not recovered , she also had tenderness in muscle where site of vaccine was  on 28Jan2021 with outcome of recovering , headache  on 28Jan2021 with outcome of recovering , left arm pain  on 28Jan2021 with outcome of recovered.    No follow-up attempts are possible. No further information is expected.
Myalgia, Fever, NauseaVomiting, EXTREME FATIGUE Narrative:
Adminstered inadequate dose from a leaked syringe/ fluid in vaccine cap less than 1/2 0.5cc vaccine dose was administered; Adminstered inadequate dose from a leaked syringe; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Adminstered inadequate dose from a leaked syringe/ fluid in vaccine cap less than 1/2 0.5cc vaccine dose was administered) and DEVICE CONNECTION ISSUE (Adminstered inadequate dose from a leaked syringe) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced UNDERDOSE (Adminstered inadequate dose from a leaked syringe/ fluid in vaccine cap less than 1/2 0.5cc vaccine dose was administered) and DEVICE CONNECTION ISSUE (Adminstered inadequate dose from a leaked syringe). At the time of the report, UNDERDOSE (Adminstered inadequate dose from a leaked syringe/ fluid in vaccine cap less than 1/2 0.5cc vaccine dose was administered) and DEVICE CONNECTION ISSUE (Adminstered inadequate dose from a leaked syringe) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown. The patient did not report any adverse event during the one hour observation period.   This case was linked to MOD21-050051 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received on 21-Jun-2021 contains No newinformation; Sender's Comments:  MOD21-050051:
none.  HiB was duplicated for 2nd dose in series. one as part of Pentacel and one as pedavax.  pedavax was given in place of Hep B vaccine. no adverse event (pain/reaction at site/ any systemic issues) at the time/ later noted. infants vaccine will be continued in future as normal series.
Vaccine that was administered was diluted 23 hours prior to vaccination (instead of within the 12 hours as directed by manufacturer). Clinical staff called Pfizer and verified that since the dose had been in a consistently monitored refrigerated setting since dilution, that it was considered viable through 24 hours and that the dose counts as a valid dose.
Headaches every day and I never get headaches. I have to take something every day. Fatigue. I have to go to bed by 9:00 every night. Chest congestion. Always feel like I?m on the verge of getting sick.  I have to take Mucinex often.
Woke up  small area of inflamation burning on right  index finger. Seems to have developed into a small area of shingles. I had chicken pox as a small child. Affected area has calmed down and skin is peeling mildly and I seem to be recovering.
Tinnitus in left ear for most of the day. Resolved around 6 PM.
My wife & I are unsure if what we both are experiencing is just coincidental or actually the cause as a result of the 2nd dose shots we both received but we are both experiencing similar events approximately a week+ after the 2nd dose of the Pfizer vaccine. Her information is as follows: Pt age 64, same address & contact information as listed for myself, 1st Pfizer dose 2/6/21 EL9264, 2nd dose 3/1/21 EN6202. We had no immediate event after both shots except for soreness in upper arms at injection sight and this ceased after approximately a day. But as mentioned at a week+ of 2nd dose we both started having a severe aching pain. Her pain is in her right knee. My aching pain is in my right hip down my leg to my knee & chin/calf area. It was very difficult to put weight on the leg to walk. We have been icing the areas and taking pain over the counter medication Aleve which has helped somewhat but we are still experiencing as of the date of this submission.  It seems strange we both are experiencing similar issue at approximately the same time.  Coincidence?  Due to reaction to the vaccine?  We are submitting this report to see if it might be and if others have experienced this issue. We are unaware of any physical activity  we may have done during this time to have caused this pain to start occurring. Thank you for any response.
Information was received from a physician concerning a "healthy" 15 month old male with asthma who in Feb 2002 was vaccinated with a dose of MMR.  Shortly after vaccination the child developed facial swelling and was taken to the ER.  The child was diagnosed with mild mumps.  The child was treated with medication but the child's father could not recall what it was.  It was reported after 4-5 days that condition was resolved.  No product quality complaint was involved.