chrisvoncsefalvay/vaers-outcomes huggingface dataset:
states this should have been the 4th dose of Infanrix; received Boostrix instead of Infanrix; pediatric patient (3 years old) received Boostrix; patient (3 years old) received Boostrix instead of Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number M4E4A, expiry date 05-OCT-2025) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   On 16-AUG-2023, the patient received Boostrix. On an unknown date, the patient did not receive the 4th dose of Infanrix. On 16-AUG-2023, an unknown time after receiving Boostrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: received Boostrix instead of Infanrix), inappropriate age at vaccine administration (Verbatim: pediatric patient (3 years old) received Boostrix) and underdose (Verbatim: patient (3 years old) received Boostrix instead of Infanrix). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: states this should have been the 4th dose of Infanrix ).  The outcome of the wrong vaccine administered, inappropriate age at vaccine administration, underdose and incomplete course of vaccination 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: 06-OCT-2023 The reporter reported that patient received Boostrix instead of Infanrix. The reporter stated that this should had been the 4th dose of Infanrix (which appears that it would be a late dose if going by recommended schedule). The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The reporter reported that patient received Boostrix instead of Infanrix, which led to wrong vaccine administration. The reporter reported that 3 year old patient received Boostrix, which led to inappropriate age at vaccine administration and under dose. The reporter reported that till the time of reporting the patient had not received the 4th dose of Infanrix vaccine, which lead to incomplete course of vaccination.
20-30 minutes post vaccine, some prickling/tingling around nose and mouth, with some facial flushing.  Did not progress, waxed and waned.  Had more flushing later, took benedryl.  Went to Urgent care, advised benedryl to continue, but did not feel there was any cause for concern.    Day after injection, mild flushing at times, and diffuse mild itching  including scalp, face, particularly borders, and general arms, legs, torso.  No rash, hives, and itching not aggressive, just mild.  Persisted for about a week. Feel anxiety may have played role.  Continued with benedryl.  Had telehealth visits with PCP and with allergist.  Resumed taking zyrtec daily with additional dose in pm- symptoms resolved.  Not felt to be "serious" reaction by either MD, feel it is ok to have 2nd dose.
This spontaneous report as received from a medical assistant to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 22-AUG-2016, the patient received first dose of GARDASIL 9 (lot#, expiry date, dose, route and site of administration were unspecified). On 22-SEP-2016, the patient inadvertently received as second dose GARDASIL lot# K011562, expiry date 08-APR-2017 (dose, site and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
PATIENT DID NOT HAVE AN ADVERSE EVENT, BUT SHE HAD ALREADY RECEIVED ONE DOSE OF PREVNAR 13 ON 4/25/2015.
Low grade fever ?day of shot Overall not feeling great  CONCERN ?hard knot developed at site of injection by afternoon of day AFTER 2nd Vaccine? redness, swelling ? NO itch yet.
Presents w/redness and increased warmth over (L) upper thigh 2 days after receiving routine vaccination. No fevers, systemic symptoms. Diagnosed cellulitis, treated with IM ceftriaxone at mom's request for IM vs PO meds. F/U 2-3 day if not improved.
This case was reported by a healthcare professional and described the occurrence of fainting in a 13-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), MENACTRA (non-gsk) (Sanofi Pasteur), GARDASIL (non-gsk) (Merck) and VARIVAX (non-gsk) (Merck). On 12 May 2009 at 15:30 the subject received 1st dose of HAVRIX (unknown route, left arm). On 12 May 2009 the subject also received 1st dose of MENACTRA (Non-GSK) (details unknown), 1st dose of GARDASIL (Non-GSK) (details unknown), and 2nd dose of VARIVAX (Non-GSK) (details unknown). On 12 May 2009, 52 minutes after vaccination with HAVRIX, and less than one day after vaccination with GARDASIL (Non-GSK), MENACTRA (Non-GSK) and VARIVAX (Non-GSK), the subject experienced fainting, became pale and shaky, and fell. She had to sit for 10 minutes with her head between her legs and was given an energy bar and an unspecified drink. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved.
This is in follow-up to report(s) previously submitted on 7/15/2008. Information has been received from a physician concerning a 6 month old male who was vaccinated po with the third 2.0 ml dose of ROTATEQ (lot #657986/1205U) on 04-JAN-2008. It was reported that the patient was positive for the rotavirus after receiving the third dose of ROTATEQ. The patient received the first and second dose on 06-SER02007 and 05-NOV-2007. Unspecified medical attention was sought. The outcome is reported as recovered (date unspecified). A product quality complaint was not involved. Additional information has been requested. Follow-up information was received from a registered nurse. The reporter states that the patient (12 kg, 11 inches in height), with no illness at the time of vaccination or pertinent medical history, was seen on 05-JUN-2008 and presented with fever and diarrhea. A stool analysis revealed positive rotavirus antigen by EIA. The patient was only sick overnight and was completely better on 09-JUN-2008. The patient had no adverse events following prior vaccinations. No additional information expected.
fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 01-Jun-2021, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.            Reporter did not allow further contact
Blood in vomit and stools; Blood in vomit and stools; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 03Apr2021 08:30 as single dose for covid-19 immunisation. Medical history included the patient had covid prior vaccination. Concomitant medications included birth control, celecoxib (CELEXA) and trazodone. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in left arm on 13Mar2021 08:30 for COVID-19 Immunization. The patient experienced blood in vomit and stools on 04Apr2021 01:30. The patient did not receive treatment for events, she had covid prior vaccination, she did not test covid post vaccination. There is no known allergies, there is no other medical history. The outcome of the events was unknown.  No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
sugar level was 81 and then came back 552 after getting the vaccine.; This is a spontaneous report from a contactable consumer. An 86-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), (Lot number: EL9269 & Expiry date not reported) via unspecified route of administration in right arm on 04Feb2021 (age at the time of 86-year-old) as dose 1, single for COVID-19 Immunization. The patient's medical history include pacemaker, does not have both legs, he has had cankers and they had to cut them off, diabetes, heart surgery, he was in the house all the time, in a wheelchair. The patient's concomitant medications were not reported. On the 04Feb2021, the patient  got his first covid vaccine he was diabetic, controlled, when he went and had the breakfast, he had coffee and milk, and checked his sugar and it was 81, so he went to his house to get lunch, when he came back, his sugar was 552, really high, and he had to spend his whole day until 2AM checking his blood sugar every hour, and injected 42 units, then he was 152, at that hour, he injected 48 units and had 516, then he injected 28 of insulin, he was checking every hour, then he had 486, 477, and he injected again, he had 500, at 500, he got another 36 units at 14:00 it got lowered to 311, so normally he is between 108-120, 125, 130, and usually, this exaggeration could cause sugar attack. On 5Feb2021 (one day after vaccination) his sugar was normal, he thinks it was caused because of the vaccine, he never had this. More than 500, you must go to the hospital, to avoid attack, he has 30 years with diabetes. On 06Feb2021 (two days after vaccination) he went to have breakfast he was only 75. Patient took vaccine he was scared because all of complications he had, does not want to get infected. Other sicknesses are under control, all this time, he had surgery of his heart, they replaced his aorta with pork aorta, in the past 12 years ago, and since then he has had no problems with his heart. He was sure this was because of the injection, it was 2 hours after that he got the shot, his sugar went up 500 points, he did not eat anything, this was before the lunch. Treatment received by patient with novalog, lot/expiry unknown; they are syringes he has, once empty, they are thrown out, this one injection lasts one day, they usually last 10-12 days, he threw it away. When he feels his eyelids hot, he knows his sugar was high, but he does not feel any pain. His normal sugar level was 108-130.Caller was unsure if he will go to his second dose of the vaccine that is scheduled 25Feb2021. Patient underwent lab test and procedure include blood glucose level on 04Feb2021 as 81,552,152,516,486,477,500,311 and it was normal on 5Feb2021, on 06Feb2021 blood glucose level was 75. The outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.
Severe swollen glands and lymph nodes in my neck under my ears and back of my head. They can be seen without touching my skin and they were very painful
Superficial pink raised itchy rash over entire lateral surface of right arm, where injection was given.
Patient received vaccine at approximately 3;25 PM.  Mom states that patient began having a rash/hives and itching approximately 1 hour later.  Mom gave patient Benadryl and brought up to clinic.  Patient did not require any further medical intervention and hives had begun to diminish shortly after arrival.
Dizziness. Light-headed. Given water & mint candy. Took blood pressure. Reading normal. Offered opportunity to lie down. Refused.  Sat in chair until about 11:00 AM when felt better to drive.
This spontaneous report as received from a consumer refers to herself, a 67-year-old female patient. The patient's drug reactions/allergies included allergy to penicillin. The patient's historical condition included rash when taking penicillin. On 14-MAR-2018, the patient was vaccinated with ZOSTAVAX, 0.65 ml, once (lot # and expiry date was unknown by reporter) for prevention of Shingles. Concomitant therapies included levothyroxine sodium, LIPITOR and FOSAMAX. On 15-MAR-2018 the patient experienced redness and soreness at the injection site (injection site erythema)(injection site pain). On 17-MAR-2018, the patient felt unwell (malaise). On 18-MAR-2018, the patient experienced a burning sensation on right side from the middle of lower back around to umbilicus. The pain was not excruciating but it was annoying. The patient stated that there was no rash, but her skin was sensitive at the site of the adverse event and she feels pain whenever she leans against something or her clothes rub against that part of her body (hyperaesthesia). The patient sought medical attention (spoke with provider). The outcome of injection site erythema, chills, pain, hyperaesthesia, burning sensation, malaise and injection site pain was reported as not recovered. Causality assessment was not provided by reporter. No product quality complaint was involved.
Pt presented to EC and admitted on 09/15/2021 with c/o SOB worsening in last 2 weeks, cough, leg swelling, orthopnea, dyspnea on exertion. EKG changes. ST elevation, elevated DDimer. DX: new onset CHF with EF 10-15% no previous cardiac hx, no previous MI, no diabetes, no obesity. Hx of HTN. Pt of normal ht/wt. Heart cath show EF 14%. Reduced LV function. Placed on ENTRESTO. Referred for ICD placement.
Patient c/o panic attack;  Admin Benadry 25 PO.   Ambulated to bathroom without assistance;  VS Stable at discharge
Flu like symptoms, tide chest pain, which makes it difficult to breathe. As of today, 2 month later, I still have a tide chest and the muscles around it on the side and in the back.
a few weeks ago we both contracted the virus; a few weeks ago we both contracted the virus; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single and via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 2, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that both him and his wife received Pfizer covid vaccines. The second dose was administered this past Mar2021. A few weeks ago "we both contracted the virus" in 2021. It was not much fun, to say the least. Sometimes he wonder if they really received a true vaccine or just a placebo. He have heard the spin that that taking the vaccine saved them from a more severe case that might have required hospitalization. He suspected that they will never know. He was not aware he had the virus and infected his friend. He could of infected other people. Luckily, he got out the alarm and they were all self isolated. He doesn't remember ever hearing the virus could be disseminated by a vaccinated person. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101426770 same reporter, drug and event, different patient
Pt received Janssen vaccine at 1404, pt felt lightheaded, sweating, and had syncope episode. 2 LVNS and 1 RN assisted pt until pt regained consciousness. Assisted pt to lie down in recumbent position. Ice pack, water and apple juice given. V/S done and WNL. Pt back to baseline with no complaints. Pt left at 1440.
Pt had redness, erythema on rt arm 6 inches long 3 inches wide.
Her arm was red and still is, swollen, and hot to the touch, on Friday and Saturday. Today the symptoms have gotten worse and it is very painful. She is wearing a loose shirt and noticed that it is sore to the touch. Pharmacist, counseled her to take two naproxen tablets 220mg every 12 hours.  She went ahead and took two tablets and the pharmacist will follow up later in the day. Also advised to take diphenhydramine 25mg in a few hours if the symptoms have not resolved.
Patient was given Pneumococcal-23 IM and Flu vaccine IM in left deltoid. Patient left arm was swollen and red rash below injection sites. Patient developed, body aches and fever (low-grade). Patient advised to use TYLENOL, Ibuprofen and cold compress.
Immediately upon receiving the shot I started to have a headache and pain in my eyes. My eyes became light sensitive and I have a heightened ability to smell for the rest of the day. I awoke in the middle of the night with a fever, severe muscle and joint pain, splitting headache, tinnitus, skin sensitivity, neuralgia and a VERY sore vaccine site. My fever persisted for 60 hours and did not exceed 101.99. This morning my nerve pained flared in my jaw, tongue, mouth, throat and rib cage. I felt a very painful burning sensation similar to heartburn. I had a very similar reaction with the first shot except I did not have a fever and the symptoms did not last as long as with the second shot.
Narrative: PRURITIS STARTED 10 DAYS AFTER INJECTION.NO OTHER SYMPTOMS AT SITE
She received the second Pfizer-BioNTech vaccine in the right shoulder on 3/6/21. That afternoon she develops severe itching all over her body. The itching is still occurring as of 3/9/21. Treatments thus far have been topical otc steroids and benadryl cream, and today she received 4mg IM decadron. Outcome is still to be determined.
Vaccination site movement impairment; Vaccination site pain; Expired vaccine used; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Vaccination site movement impairment), VACCINATION SITE PAIN (Vaccination site pain) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Vaccination site movement impairment), VACCINATION SITE PAIN (Vaccination site pain) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 1 dosage form. On 05-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Vaccination site movement impairment) outcome was unknown and VACCINATION SITE PAIN (Vaccination site pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was taking Cholesterol Medications , Blood Pressure medication as concomitant medication. Patient stated that vaccine was drawn on 3 March 2021 and she received that same vaccine on 5 March 2021.
I have pain internally at the injection site that isn't subsiding and it has been over two months. The pain affects my range of motion and ability to perform tasks as simple as reaching for my seatbelt, washing my body, and doing a push-up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DEXTROMETHORPHAN, start date: 14Sep2022, stop date: 21Sep2022. Past drug history included: Known allergies: amoxicillin, reaction(s): "Known allergies: Amoxicillin".  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Prolonged tightness in chest, occasionally shortness of breath, prolonged resting heart rate of 76-88 bpm
Several hours after vaccines given developed high fever (Right 103.2). Body very limp and child very fussy.
pt recv vax 1997 & approx 2 to 3 wk p/vax pt exp ITP w/petechiae & bruising;pt was dx w/ITP & hosp;reporter was uncertain as to whether or not pt exp were r/t vax w/varicella vax;
Have developed constant plugged up ears, with non stop tinnitis and vertigo episodes since 6/7/2021 and symptoms are constant and ongoing
Pain had pain at injection site (right deltoid) that progressed to right shoulder blade, right upper back and left upper back/left shoulder blade.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Significant information received. The patient demographics were updated. The patients birthdate was added. The Race information was updated.
On 04/19/01 in the PM, this patient's mother called reporting the patient had a 103 temp, no other sicknesses; although pulling at her ears. The patient was seen in the office on 04/20/01 at 10:30 and no otitis media was evident.
flare of myasthenia gravis requiring hospitalization for IVIG patient also has a UTI (culture not available) which may be responsible for flare
Last injection of vaccine was 7/28/21.  Extreme Itching and Shingles appeared 8/5/2021 in mid afternoon.
Information has been received from a 65 year old female nurse practitioner concerning herself with lupus, multiple mini strokes, rheumatoid arthritis, basel cell carcinoma, rectal polyp, CLARITIN reaction (hives from head to foot) and a history of fatty tumor removed from left arm, migraines, compartment syndrome, and shingles prior to 2008 who in 2008, was vaccinated with a dose of ZOSTAVAX (Merck) (dose reported as 0.65). Concomitant therapy included gabapentin, PLAVIX, labetalol HCl, quinapril HCl, amlodipine and zolpidem tartrate. On 07-APR-2009, the patient experienced shingles. It reported that the patient experienced shingles 3 or 4 times since receiving the vaccine, and the last two times being in December 2009 and March 2010. Each outbreak was the same. Cultures on the sore from the actual breakout were performed (result not provided). At the time of reporting, the patient was recovering. The patient sought unspecified medical attention. The patient also reported that when taking gabapentin, she got very tired. The medications (unspecified) she had used for rheumatoid arthritis had not helped her. Additional information has been requested.