chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 15 year old female patient with no pertinent medical history and no known drug allergies who in 2003 was vaccinated with the first dose of VARIVAX (Merck) (Lot # 645048/0197N, expire date and route not reported). On 17-FEB-2011, the patient was vaccinated with the second dose of VARIVAX (Merck) (Lot #, expire date and route not reported). There was no concomitant medication. Licensed practical nurse stated that a few years after administration of one dose of VARIVAX (Merck) on 16-FEB-2010, the patient developed shingles of the right side of her face. On 16-FEB-2010 and on 27-FEB-2010, the patient was examined by physician. Licensed practical nurse mentioned that on 27-FEB-2010, patient's rash was worse. Patient was given VALTEX for 2 weeks. There were no laboratory diagnostics studies performed. On an unspecified date, the patient recovered. Additional information has been requested.
Patient stated that the individual administering the vaccine had difficulty pushing the plunger.  She developed 8/10 pain within 24 hours of the vaccination which persisted for several days.  Moderate level of pain then persisted for 2 weeks before she was seen.  On revaluation on 24 October she continued to have moderate pain, decreased ROM and pain with ROM, especially with flexion of the shoulder.   She has been treated with ibuprofen, home physical therapy exercise, ice and Medrol dose pack.
1 dose HepA in 2003, not finish series; 1 dose HepB in 2003, not finish series; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Hepatitis A vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis A vaccine (received 1st dose of Hepatitis A vaccine in 2003) and Hepatitis B vaccine (received 2nd dose of Hepatitis B vaccine in 2003).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis A vaccine and the 2nd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination and incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 22-FEB-2023 Reporter's Comment: The reporter had patient who were traveling to and wanted to finish the hepatitis B and hepatitis A series before this trip.  The patient received only one dose of Hepatitis A and Hepatitis B in 2003 but did not finish the series. The vaccines administered were the generic versions of Hepatitis A and Hepatitis B because healthcare professional could not confirm brand names. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Hepatitis A vaccine and Hepatitis B vaccine, which led to incomplete course of vaccination. The case had been linked to US2023029948, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023029948:Same reporter
Great grandmother reports that when they got home from appt and went to take patient out of carrier she had an episode of staring and shaking that lasted a couple of seconds and repeated the activity again 1 minute after. Went to ER and was evaluated. Referred to neurology for follow up. Dx: abnormal involuntary movements
Thursday evening after work , I started to have headaches starting at my lower neck ( brain stem area) getting worse over the next 4 hour to the point of seeing spots, bad pain to the point of vomiting, because of the pain, head throbbing, like zI could feel my pulse pounding in my entire head, ringing in my ears.
MIND FOG; SERIOUS BODYACHES; CHILLS; ARM TENDER & SORE WHEN RAISED IT UP ON DOMINANT SIDE; A LOT OF FATIGUE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced arm tender & sore when raised it up on dominant side, fever, chills, serious bodyaches, mind fog, and a lot of fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm tender & sore when raised it up on dominant side, fever, chills, serious bodyaches, mind fog, and a lot of fatigue. This report was non-serious.
Reddened, incapacitating pain, felt hot to touch, lasted 10 days. Patient did not see MD and did not take antibiotics. Patient took Tylenol for symptoms. Symptoms resolved by themselves after 10 days.
Redness, swelling, tenderness on left thigh at site of vaccine that was noticed 2 days after receiving vaccine.
Left upper arm from elbow to half way up shoulder, pink warm, and swollen and tender to touch. Family MD thought it was an allergic reaction and pt allergies. Talked with pt 10/25/2001 and she states it is almost better.
after you first dose to have side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (after you first dose to have side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (after you first dose to have side effects). At the time of the report, VACCINATION COMPLICATION (after you first dose to have side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Twenty minutes after having the vaccine, my right arm had limited mobility, similar to a limb ?falling asleep.? That has lasted since the date of injection, and will come and go throughout the day.  I experienced no fever, but had severe fatigue the following two days and beginning 6 days after vaccination, my lymph nodes in my right armpit began swelling so significantly that the excruciating pain kept me from completing most daily tasks and prevented me from sleeping for 5 nights. My breast area tripled in size from the inflammation.  I?ve had to take daily doses of ibuprofen in order to cope. Beginning on September 12th, the injection site has become hot to the touch, hard to the touch (area of roughly four additional inches in each direction around it) with a rash from bicep to wrist that comes and goes throughout the day. When this side affect came to be, the numbing pain has continued with an intensified pain that radiates down the radius and ulna areas of my forearm.
Information has been received from an office manager concerning a 20 year old female who was vaccinated with the first and second dose of GARDASIL and did not have any problems. In March 2008, the patient was vaccinated with the third dose of GARDASIL. Concomitant medication included birth control (unspecified). Following the third dose of GARDASIL, the patient experienced continued constant dizziness and headache. The time development of the dizziness and headache were unspecified. The patient went to her primary physician (name unspecified) for treatment of the dizziness and headaches. At the time of reporting, the patient had not yet recovered. Additional information has been requested.
Sore arm after injection; This is a spontaneous report from a non-contactable consumer. A male patient of unspecified age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm after injection. The clinical outcome of the sore arm after injection was unknown.  No follow-up attempts are possible; information about lot number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information.
Pneumonia vaccine, noteworthy reaction.  Received immunization in right leg.  About 6 hours after this, developed stiffness and swelling in leg muscle from hip to knee, so severe that I literally could not bend the leg more than a few degrees.  It took 15 minutes to bend it enough to sit in an automobile, and then another 15 minutes to unbend it upon standing up.  Skin was light pink on front and inner leg, about 10 degrees warmer to touch than opposite leg, and leg had swollen about 10-15% larger than other leg, to the point the skin was stretched.  This extreme swelling and stiffness/warmth lasted 30 hours and then slowly dissipated over the following three days, with some redness and swelling remaining between knee and 8" above knee for another 3 days.  So, a little over a week altogether.
The COVID vaccine that was administer to the patient was accidently stored in the freezer instead of refrigerator.   No adverse symptoms.
Initial misuse report received on 13-Dec-2013 from a health care professional. An unknown patient whose medical history and concomitant medications were not reported, received TUBERSOL (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that the expired TYPHIM VI vaccine was given to the patient thus, expired vaccine was used. No reaction was reported. List of documents held by sender: none.
This case was reported by a nurse via sales rep and described the occurrence of chills in a adult female patient who received SHINGRIX (batch number 27K24, expiry date unknown) for prophylaxis. On 21st June 2018, the patient received SHINGRIX .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced chills, fever, myalgia and fatigue. In June 2018, the outcome of the chills, fever, myalgia and fatigue were recovered/resolved. The reporter considered the chills, fever, myalgia and fatigue to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient reported adverse event to the office on 23rd June 2018 and on 25th June 2018, the patient was checked. The adverse events were lasted for 48 hours and subsided. The reporter did not agree for follow up from GlaxoSmithKline. This case has been linked to the case US2018GSK115511, reported by the same reporter.
LOCALIZED REDNESS AND INDURATION TO LEFT LATERAL THIGH, COMPLAINS OF ITCHING
Vasovagal reaction. Was observed by EMS and her symptoms resolved. She left under her own ambulation and was symptom free.
Patient is a 51 year old female c/o possible reaction to covid vaccine. C/o tingling of lips, left arm, hands and feet. Hives and itching. Received 1st dose of covid vaccine at 1635 today. Developed sxs 2-3 minutes after. Was given bendryl 25 mg po at 1643. Was brought by nurse. Hx of chronic urticaria, takes claritin daily with control. Hx of allergic reaction to bactrim. Has epi pen with her. Nurse brought note from Doctor, to order tryptase lab
I had the Shingrix vaccination yesterday at the Clinic, around 4:00 pm.  This morning around 3:00 a.m. I woke up shivering even though I was under a blanket, a quilt and down comforter. I was also in a lot of pain. My joints hurt so much it was painful to turn over. I was awake for a couple of hours just trying to get as comfortable as I could. When I finally did get up, I was very dizzy, tired and my stomach has been making noises.
loss of appetite; dry mouth; Severe cough; Chills; Fatigue; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), DRY MOUTH (dry mouth), COUGH (Severe cough), CHILLS (Chills) and FATIGUE (Fatigue) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced DECREASED APPETITE (loss of appetite), DRY MOUTH (dry mouth), COUGH (Severe cough), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Low grade fever). At the time of the report, DECREASED APPETITE (loss of appetite), DRY MOUTH (dry mouth), COUGH (Severe cough), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Low grade fever) outcome was unknown.            No concomitant medication was reported  No treatment medication was reported , Action taken with mRNA-1273 in response to the events was not applicable
LOWER BACK PAIN; WEAKNESS; FEVER 99-100; This spontaneous report received from a consumer concerned a 30 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021, the subject experienced lower back pain. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced fever 99-100.  Laboratory data included: Body temperature (NR: not provided) 99-100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever 99-100, and weakness, and the outcome of lower back pain was not reported. This report was non-serious.
Patient developed febrile response to vaccine, complained of feeling cold on a 104 degree day. Also was experiencing rigors x 20 minutes. Patient was given one ibuprofen 200 mg and symptoms resolved within 1 hour.
Uniformly erythemic, pruritic, round and oval plaques,lesions approximately 4 inches x 3 inches appeared on inside of upper right arm extending from below right armpit to 1 inch from right elbow.
My period has been significantly longer than before I received the vaccine.  Typically it is only 3 days.  Since being vaccinated it has been 6 days each month.
Nausea, vomiting, diarrhea & abd pain (severe) Diffuse erythema, pain at injection site (R) deltoid about 3/4 to elbow.
Moderate tingling and pin prink stabbing sensation in the soles of my feet  and burning of my feet
This case was reported by a healthcare professional and described the occurrence of allergy attack possibly due to latex (allergic reaction) in a 28-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 17 September 2010 the subject received unspecified dose of FLUARIX (.5 ml, unknown). On 17 September 2010, less than one day after vaccination with FLUARIX, the subject experienced allergy attack possibly due to latex (allergic reaction). A possibe latex allergic reaction developed following a FLUARIX vaccination; the reporting nurse stated that the subject was admitted overnight in the hospital due to the reaction. The subject was hospitalized and the healthcare professional considered the event was disabling, life threatening and clinically significant (or requiring intervention). On 17 September 2010, the allergic reaction was resolved. Follow-up information received from reporting healthcare professional on 20 October 2010: It was reported that the subject had not previously had any allergic reactions to other drugs. It was unknown if she had received FLUARIX previously. The subject received one dose of FLUARIX prior to the hypersensitivity reaction. At the time of the allergy attack possibly due to latex (allergic reaction), the subject experienced bronchospasm. She was taken to the emergency room and stayed in the hospital for two nights (17 September and 18 September 2010). The duration of the event was reported as two days, however, the reporter indicated that the subject had not made a full recovery at the time of reporting as the subject was still being seen for complications due to this incident. At the time of reporting, the outcome of the allergy attack possibly due to latex (allergic reaction) was reported as unresolved. The reporter considered it was probable that the event was caused by the FLUARIX vaccine.
This spontaneous report as received from a licensed practical nurse refers to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients received doses of improperly stored VAQTA lot # L015460 with expiration date: 20-JUL-2017 (dose and route of administration were not reported). Administered doses of VAQTA underwent temperature excursions at 35.3 Fahrenheit degrees, for 7 hours and 21 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
4x2? redness that is hot to the touch on left arm, but about 5? from the injection site. This just showed up today (4/27). Also, loss of appetite started day of second dose (4/24) and is still in effect.
Subsequent to receiving first and second dose of varicella virus vaccine live a titer was drawn due to pts pregnancy. The varicella titer was negative. The physician told the pt that even though her titers were low, that does not mean she is protected against it. The pt has never developed the varicella virus. She is inquiring as to whether she should be revaccinated. Additional information has been requested.
The night after the vaccination: fever & abdominal discomfort. The following day: nausea and vomiting. The third day: diareah, cramps, nausea.
10/27/21 Dr. note: "Sepsis 2/2 COVID-19 Pneumonia POA, Acute hypoxic resp failure, COVID acute PCR positive)". Treatment: "remdesivir: yes (started 10/24); steroids: yes(dexamethasone started 10/24)".
After recieving first round of Gardasil shot- three weeks later noted small red spoches on chest area( Sat AM), Sun day felt weak, back cramps, and nausea.  Mon AM and continuing- red spots darken and increased in number.  Doctor diagnosed as pityriasis.  Have found other forums where pityriasis is connected with the vaccine.  Within one week of three spots- the rash has spread throughout entire chest, back, neck and now starting to form on arms and legs. Doctor claims unknown cause or cure.
Rash on arms and legs, 1 day, post vax. Benadryl given.
1-2 minutes post vaccine (given in left deltoid) patient developed bilateral tinnitus. No associated headache, dizziness, nausea, chest pain, abdominal or shortness of breath.  No other focal neurological motor/sensory deficit.  No signs or symptoms of anaphylaxis (no airway compromise). Tinnitus remained consistent over next 1 1/2 hours of observation (until discharge home).    Patient reports 1-2 prior mild episodes of tinnitus, none as severe or prolonged as today.
Just 12 hours later experienced severe headache that woke me up in the middle of the night.   Fever (100), chills, all over body aches, sore throat, alteration of taste, heaviness in chest, nausea.   The headache lasted a few days .... each morning for the next 4 days I awaoke with headaches
Stored  in the fridge for 40 days so 10 days over our recommended storage; Vaccine  administered after being in the fridge for 40 days; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Stored  in the fridge for 40 days so 10 days over our recommended storage) and EXPIRED PRODUCT ADMINISTERED (Vaccine  administered after being in the fridge for 40 days) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Stored  in the fridge for 40 days so 10 days over our recommended storage) and EXPIRED PRODUCT ADMINISTERED (Vaccine  administered after being in the fridge for 40 days). On 31-Aug-2021, PRODUCT STORAGE ERROR (Stored  in the fridge for 40 days so 10 days over our recommended storage) and EXPIRED PRODUCT ADMINISTERED (Vaccine  administered after being in the fridge for 40 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: This report refers to a case of Product storage error and Expired product administered for mRNA-1273, lot # 040C21A in a immunocompromised patient (third dose)  with no associated AEs. Causality is Not applicable.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; PAIN; DONT FEEL WELL; This spontaneous report received from a patient concerned a 67 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, pain. The patient stated covid-19 (chest cold, ha (headache)), 21 days and she was never been so sick and it is the delta variant. The patient had IVs (Intravenous solutions) in the hospital and was given monoclonal antibodies. The patient said she would never be the same and still did not feeling feel well.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure, pain and don't feel well was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint (PQC).; Sender's Comments: V0: 20211108755-Covid-19 vaccine ad26.cov2.s- suspected covid-19 infection, Pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211108755-Covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS