chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Twinrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 71-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 01-JAN-2023) for prophylaxis.   On 14-MAR-2023, the patient received Twinrix. On 14-MAR-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expired Twinrix administered). 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: 14-MAR-2023 No reaction was reported. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up via email. The patient received a Twinrix vaccine which was already expired, which led to expired vaccine used.
Information has been received from a 22 year old female consumer (medical assistant), for the pregnancy registry for GARDASIL, who on 11-APR-2008 was vaccinated IM with the second 0.5 ml dose of GARDASIL.  On the same day she received her second dose she found out she was pregnant.  It was unknown whether medical attention was sought.  Patient outcome was unknown.  No product quality complaint was involved.  Follow-up information was received which reported that on 28-JUL-2008, an ultrasound was performed (second trimester) and the results were normal.  It was reported that there were no previous pregnancies, full term deliveries, pre-term deliveries, spontaneous abortions (miscarriages), elective terminations or fetal deaths (stillbirths).  Follow up information has been received from the consumer with no concurrent medical conditions, who reported that on 23-NOV-2008 she delivered a normal and healthy female baby weighing 6 lb and 7 oz and length 19 in.  There was complications or abnormalities, she reported an erratic heart rate and breathing difficulties of the baby who born at 36 weeks.  No complications during the pregnancy and labor/delivery, no congenital anomalies and no diagnostic test during the pregnancy was performed.  The patient had group B strep during her pregnancy.  Additional information is not available. 05/28/2009: Follow-up information has been received from medical records and from a medical assistant who reported on behalf of the physician. It was reported that the female baby had a small umbilical hernia ("an outie") which the physician felt was normal, not a congenital anomaly and would resolve on its own. At the time of reporting, the small umbilical hernia had not resolved and the causality was not reported. Additional information is not expected. All available medical records will be provided upon request.
About 4 days after second shot, I noticed I had bumps on by back side.   They did not itch.   I though they were from bike riding - chafing.    But they moved around.   10 days after, my lip started to swell pretty badly while I was in a meeting.   Got online with doctor was told to go to hospital.  Anaphylaxis was the diagnosis.    They gave standard care - steroids, antihistamine, pepcid, etc.    Issue went away including the bumps on behind.    Was told to go my doctor. Went to my doctor.   Said dont worry, likely will not come back again.   Just a reaction of some type.      Next night lip swelled up - other side of mouth.  Online doctor said to go emergency room.    Back to emergency same treatment - more steroids, pecid, antihistamine.   Back  to my doctor and he sends me to alergist.   I have never had an allergic reaction to anything in my life.   Allergist said the reaction is due to the covid shot and making my immune system go crazy.   He put me on regimen of pepcid and antihistamine.    Seems to work for about a week - but then the hives came back.   More swelling of the face (lips, eyes) but none bad enough to go to hospital.    Taking meds 3 to 4 times a day (pepcid and antihistamine).     Had swelling in the ankle which the doctor said basically hives gone crazy.   Then the hives got worse - and itching.   Covered most of my body.    The hives on the bottom of the feet felt like walking on air pillow packaging material.    Dr puts me back on steroids.    Go through this process twice with steroids.    Dr said we would have to go the route of Xolair.   Received first injection three weeks ago.    But after shot had bad hives again with itching this time  - more steroids.     Then things sort of leveled out - still had hives but not a large - and no itching _ thank goodness.     But then on 7-2-21 I woke up with severe swelling of the face - and into the throat.    Had difficulty swallowing.    Back to emergency room again - more shots and Epinephrine.     They prescribe more steroids and epi pen just in case because the reaction was so severe.    Second shot of Xolair is in one more week - hopefully gets things under control.
Patient had an adverse reaction to the Janssen COVID vaccination. After vaccination, patient was told to wait 15 minutes in this chair and we would observe. I prepare their COVID card and went back out to give card and ask if the patient had any other questions. Patient was scared of shots, so some anxiety was expected, however after a few minutes while I was talking to the patient, I noticed he got stiff, and started to seize. His family was near by and we immediately put him onto the floor with head on a cushion and called EMS/911 CODE WHITE. He did not hit anything while seizing/convulsing. Once he laid down, within a few seconds, He stopped jerking, became conscious, and asked what happened. He lost consciousness and only remembered me talking to him about his questions about the vaccine. He was fully aware of his surroundings afterwards and said he never had a reaction like that to a shot before. Some anxiety, but not a seizure. EMS arrived shortly there after and he was taken to the hospital after inspection from EMS just to make sure everything was okay. We had to make a report to management per Store Policy. VAERS was reported
Information has been received from a registered nurse concerning a 17 year old female with allergies to penicillin and DESOGEN and no pertinent medical history who on 08-JUN-2009 and 08-AUG-2009 was vaccinated IM with the first (lot# 661952/1129X) and the second (lot# 661046/0381X) 0.5ml doses of GARDASIL. There was no concomitant medication. The nurse reported that the patient experienced nausea within 24 hours of receiving her first dose of GARDASIL. She also experienced nausea, vomiting, and diarrhea within 24 hours of receiving her second dose of GARDASIL on 08-AUG-2009. She was still experiencing symptoms on 13-AUG-2009 and was treated with PHENERGAN and IMMODIUM. No lab diagnostics study was performed. At the time of the report, the patient's outcome was unknown. Nausea (both episodes), vomiting and diarrhea were considered to be disabling. Additional information has been requested.
COVID; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 11-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: unknown) via an unspecified route of administration (age at vaccination 11-year), administered in left arm on 07Nov2021 at 17:30 as dose 1, single for COVID-19 immunization. The patient medical history and patient's concomitant medications were not reported. Reported facility type vaccine was pharmacy or drug store. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not taken any COVID prior vaccination. Patient had not been tested for COVID-19 since the vaccination. On 07Nov2021 at 17:30, patient experienced COVID. The patient underwent lab tests and procedures on 02Nov2021 which included SARS-CoV-2 test: negative. The clinical outcome of the event was resolved on an unspecified date in 2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Redness swelling of left upper arm for 4 days. Treated with Kelfex 500mg BID for 7 days.
Massive headache, back and kidney pain, cramping of toes. This started around 10pm, and lasted until morning. I could not sleep due to the pain. By 10am most of the back and kidney pain was gone, but I had a dull headache until the following day, the 13th. I took Tylenol to help with the headache.
The patient became ill approximately 2 days prior to presentation to the ED. The patient has a new oxygen requirement of 6 L O2 by nasal cannula. The patient reports cough, shortness of breath, and fever. She is positive for COVID-19. The patient has received ceftriaxone, azithromycin, and dexamethasone. She is being admitted to the hospital.
The patient received booster too soon, she should have after 6 months, she did not give vaccine card until after given dose. This went through insurance fine, and was not seen that it was soon until vaccine card was seen.
One week after injection, mild itching and redness developed (circular, diameter of 12 cm) at injection site. Has persisted for  3 days.
Right eye, subconjunctival hemorrhage; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 09Apr2021 11:00 (Lot Number: EP7533) as single dose (at the age of 66-years-old) for covid-19 immunisation. Medical history included high cholesterol, cataract surgery. Patient had no known allergies. Concomitant medications in two weeks prior to the vaccination included atorvastatin (LIPITOR). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration, administered in Left arm (Lot number: EN6206) on 17Mar2021 02:45 PM (at the age of 66-years-old) for COVID-19 immunization. The patient experienced right eye, subconjunctival hemorrhage on 11Apr2021 at 12:00. No treatment was required. Patient was recovering from the event.
pt recvd vax & pt became very irritable;pt began to exp a swollen tongue, inc fever (106) & excessive drooling (allergic rxn); taken to ER & was given an inj of Celestone;
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 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing); "Known allergies: avocado" (unspecified if ongoing); "Known allergies: banana" (unspecified if ongoing); "Known allergies: strawberry" (unspecified if ongoing); "Known allergies: pumpkin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Covid 19 Treatment; (01Jan2023) Positive, notes: Tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
They were diagnosed with COVID-19 last 01Apr; This is a spontaneous report from a Pfizer Sponsored Program  Support via a contactable consumer (patient) reported for himself. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 31Mar2021 (age at vaccination was unknown) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he and his wife had the 1st shot of the vaccine last 31Mar2021 and they were scheduled for the 2nd shot on 23Apr2021. On 01Apr2021, the patient's SARS-CoV-2 test was positive and they were diagnosed with COVID-19. On 17Apr2021, the patient's SARS-CoV-2 test was negative and now they were negative of the virus. His main concern was to know if the vaccine was safe to take after all. The outcome of the event was recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (17Apr2021): New information received from a Pfizer-sponsored program Support via a contactable consumer (patient) included: No new information was reported.
Patient developed red, 2 inch wide welp half-way around arm and under arm into lymph node area on the side of the body the shot was administered (left). Patient experienced soreness, which was resolving within a week of the shot. He notified his doctor 3 days after the shot.
Initial and follow up information has been received from a medical assistant and the patient's mother, concerning her daughter with no known drug allergies or past medical history, who in approximately, October 2006, was vaccinated, intramuscularly with the first dose of GARDASIL. In approximately, February 2007, the patient was vaccinated, intramuscularly with the second dose GARDASIL and on 06-MAR-2007, the patient was vaccinated, intramuscularly with third dose GARDASIL. The specific dates for the first and second dose were not available. Concomitant therapy included an unspecified allergy medication. The patient's mother reported that after the first dose, the patient experienced tenderness in her arm at the injection site. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has requested.
A LOT OF NEUROLOGICAL SYMPTOMS; ARM PAIN; DIZZINESS; FOGGINESS AND FELT REALLY BAD; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported.  The patient's past medical history included covid symptoms, and concurrent conditions included fibromyalgia, and various genetic based immune diseases. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 01-MAY-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced fogginess and felt really bad. On 08-APR-2021, the subject experienced arm pain. On an unspecified date, the subject experienced a lot of neurological symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm pain, dizziness, fogginess and felt really bad, and a lot of neurological symptoms. This report was non-serious.
incorrect product storage; No additional adverse effect reported; This spontaneous report recibed from a nurse practitioner refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated(VAQTA) lot # T020109 expiration date 26-JAN-2022 for prophylaxis (strength, dose and route were not provided).  No additional adverse effect was reported.  Digital Data Logger registered a temperature excursion between 47 to 77 Fahrennheit degrees (47.7) for 20 minutes.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020109; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002701:
Onset of fever to 103.3 that lasted 2 days and was listless and lethargic. Wouldn't open his eyes. Can no longer follow any instructions, forgets immediately, speech is disjointed. He is not tracking and is inappropriate. Obsessive on topics. Articulation has decreased. Shuffle/slap with feet. Hand flapping, shrieking, stealing and food hoarding.
exhaustion; headache; nausea; vomiting; chills; Low grade fever; general feeling of unwell; soreness at injection site; This is a spontaneous report from a contactable consumer, the patient.  A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6201,), intramuscularly, on 18Feb2021 at 15:00 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was reported as "None."  She is allergic to sulfa drugs and penicillin. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9264) on 28Jan2021 at 13:30 as a single dose in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  The vaccination was administered to the patient at a Public Health Clinic. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN)  and vitamin D (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Feb2021 at 07:00, the patient experienced fatigue, chills, headache, nausea, vomiting, low grade fever, exhaustion, general feeling of unwell, soreness at injection site. The patient did not receive any treatment for the events. The clinical outcomes of the events fatigue, chills, headache, nausea, vomiting, low grade fever, exhaustion, general feeling of unwell, and vaccination site pain were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Patient called on 1/12/21 to inform us that she had the flu shot done on 12/9/20.  She had a sore arm for about a week after the shot was administered that progressed into painful shoulder and now she is hardly able to move her arm and is having difficulty dressing up.  She has scheduled a doctors appointment to figure out what's wrong. Patient is an RN and is still reporting pain in the left shoulder when I followed up and spoke with her on 1/18/21.
Patient stated he has been in bed since Saturday (10/24/2020) after injection was given. Hasn't eaten and has lost 20lbs.
My right upper eye lid kept twitching for 5 minutes then it stopped. Then after 2 hours kept twitching for ten minutes then it stopped.
Tennis elbow in my right arm. I saw the doctor a month ago for it. I have an arm band I wear now that doesn't really help. I am still experiencing of the tennis elbow. I do some stretching. It is my right arm, and I am supposed to rest it.
My arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm was sore) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Light headedness (takes Bisoprolol Fumarate at least 3 years and get light headed all the time with it.), Anxiety (Patient have had it all her life) and Stress (Patient have had it all her life). Concomitant products included CLONAZEPAM for Anxiety and Stress, BISOPROLOL FUMARATE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (My arm was sore). At the time of the report, PAIN IN EXTREMITY (My arm was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient have a Premature heartbeat.   Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-400034, MOD-2021-399963 (Patient Link).
Symptoms have progressively worsened over past 36 hours. Body aches, migraine headache, fever, chills, nausea, then vomiting.  Currently at the point I cannot keep anything down. Injection site is worsening in redness and soreness.  There is a 3 inch red, swollen, hot to touch area around injection site, with a pimple like bump in center.
Sore arm for two days after vaccination, swollen axillary lymph nodes 6 days after vaccination, lumps and redness at injection site 7 days after vaccination.
Fever, body aches, swollen joints, excessive tiredness, rash at injection site, sore arm
Initial report received from a consumer on 22 July 2011. A female patient born 03 December 1987 received as a child in 1985 an injection of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE, manufacturer and lot number unknown The patient experienced a bad fever of >101 and redness and swelling on thigh that the vaccine was administered. The outcome was reported as unknown. Follow-up information was received on 12 September 2011 from a consumer who is also the patient. The patient's birth weight was reported as 9 lb 12 oz and she has three siblings The patient has received DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE in 1988 (previously reported as 1989) According to the patient, she recently received the TDaP vaccine and did not have an adverse event "with the acellular pertussis vaccine, as she did with the whole cell pertussis vaccine in 1988 " No further information was available at the time of the report Outcome remained recovered. Documents held by sender: None.
A pharmacist reported that a female adult may have inadvertently received an ID injection of TD Adsorbed, Purogented on 8/16/00. The nurse who administered the injection is not certain whether she gave PPD or TD Toxoids, Purogenated. Following the injection, the pt developed an injection site reaction characterized by itching, redness and soreness. She recovered.
Per ER report: Patient began to have a seizure at 1:00 am, temp 105 rectal, flown out to hospital ER and was admitted.