chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant (C.M.A.) referring to multiple patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. Since 10-DEC-2015, the patients were vaccinated with improperly stored doses of GARDASIL  (lot # K010215, expiration date 05-MAY-2017; route not reported). No adverse effects were reported. It was reported that the vaccines had been exhausted and there was no previous temperature excursion. The reporter called because of the data logger. The doses and vaccination dates were listed below: 10-DEC-2015, 2 doses; 11-DEC-2015, 3 doses; 12-DEC-2015, 2 doses; 14-DEC-2015, 2 doses; 16-DEC-2015, 1 doses; 17-DEC-2015, 1 dose; 21-DEC-2015, 2 doses; 22-DEC-2015, 9 doses; 23-DEC-2014, 3 doses; 28-DEC-2015, 2 doses; 04-JAN-2017. 2 doses; 06-JAN-2016, 4 doses; 07-JAN-2016, 1 doses, 14-JAN-2016, 1 doses; 15-JAN-2016, 2 doses'; 18-JAN-2016, 3 doses; 23-JAN-2016 (reported as 23-JAN-2015), 1 dose. Temperature/time frame was reported as : 10-DEC-2015: 25.7 (unit not provided), 9 hours, 37 minutes; 15-DEC_2015: 30.0 (unit not provided), 2 hours , 52 minutes. This is one of two reports received from the same reporter. Additional information has been requested.
Information has been received from a Medical Assistant concerning a 16 year old female patient who in approximately April 2007, was vaccinated with her first dose of Gardasil. Concomitant therapy included ALLEGRA. The reporter indicated that the patient "has not had regular menstrual cycles since receiving her first dose of GARDASIL". The patient was not pregnant. Medical attention was sought. At the time of reporting the event was ongoing. Additional information has been requested.
Got the two shots last year, now I came down with shingles/ suspected vaccination failure; I came down with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received the two shots last year but now he/she came down with shingles. The patient asked what should he/she do now. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact, details were available.
feel crappy; her arm hurt pretty bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 (Lot number: EP7533) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered" (2021), described as "feel crappy"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "recovered" (2021), described as "her arm hurt pretty bad".  Additional information: She did feel crappy after the first vaccine and her arm hurt pretty bad.That was only after the first one. It only lasted like a day. She has recovered completely. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Respiratory distress, sent resident to Emergency room ; CT scan done showed a small Pulmonary EMbolism.
Within 5 minutes of injection of ZOSTAVAX pt experienced dizziness and tingling of her lips/bad taste in mouth.
Approximately six canker sores inside mouth developed at roughly 16 hours post vaccination. Very large and painful.
felt really tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt really tired) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE (felt really tired). At the time of the report, FATIGUE (felt really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-064570 (E2B Linked Report).; Sender's Comments:  MOD21-064570:
Severe weakness for 5 days  Severe itching for 5 days no visible rashes Extreme fatigue just stayed in bed , no energy to even get up , had to take off at work  a week  Pain/ swelling injection site for 15 days and a knot  on site for a month , scab formation w/ itching , had to scratch and slight bleeding  Similar adverse effects on my sister w/ J&J vaccine .  For me measures I put ice pack over injection site for 24 hours this I do even for flu shots as I always develop severe pain and swelling on injection site. Just stayed in bed and pushed fluids  Took Advil for generalized aches  and muscle pains. For the itching so terrible I used calamine lotion  mostly on my back areas  One month to fully regain my strength.
Fatigue; This case was reported by a consumer and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient asked how long the fatigue typically last after receiving the second dose of Shingrix.
approx 1 1/2 hr p/shot pt hands & lips turned blue in color; body was shaking w/both arms jerking, reddish blotches on skin; episode lasted approx 15mins; t100.9-102.8; tx @ ER APAP & Motrin given;
DAPTACEL was  used post excursion with no reported adverse event; exposed to highest temperature of 25.26 degrees C for 3 hours due to unknown reason with no reported adverse event; Initial information received on 16-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA513749.  This case involves a 6 years old male patient and it was reported Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] exposed to highest temperature of 25.26 degrees c for 3 hours due to unknown reason and product was  used post excursion with no reported adverse event..  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Polio Vaccine Inact 3v (Vero) (Ipol [Polio Vaccine Inact 3v (Vero)]); Measles Vaccine, Mumps Vaccine, Rubella Vaccine (Mmr) ; Varicella Zoster Vaccine (Varicella Vaccine) For Prophylactic Vaccination; And Hepatitis B Vaccine (Hepatitis B [Hepatitis B Vaccine]) For Prophylactic Vaccination.  On 29-Nov-2022, Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine exposed to highest temperature of 25.26 degrees c for 3 hours due to unknown reason with no reported AE (product storage error).  On 08-Dec-2022, the patient received  dose 4  once Strength: Standard of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine post excursion with no reported ae (poor quality product administered) Suspension for injection (lot number: C5816AA) (Expiry date: Unknown) via intramuscular route in the left deltoid for prophylactic vaccination.  Action taken: not applicable.  Outcome: Unknown for all the events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Generalized itching and hives. Patient also had redness, tenderness and swelling at vaccination site.
sick; Initial information received on 08-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves a patient (with unknown demographics) who was sick (illness), after he/she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that patient got sick every time he/she had a flu shot.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome for illness was unknown.  There will be no information on the batch number for this case.
Information has been received from a pharmacist concerning a 66 year old female with a penicillin and cephalosporin allergy who on approximately 09-NOV-2007 was vaccinated intramuscularly with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot #"0991U"). Concomitant vaccination on the same day included influenza virus vaccine (unspecified) (manufacturer unknown) into the other arm. On 09-NOV-2007, the patient developed swelling in both arms. On 20-NOV-2007, the patient was seen by the physician. She was treated with BENADRYL and heat pads. The patient contacted the pharmacist. On 12-NOV-2007, the patient recovered. Additional information has been requested.
Same day and next day after receiving shot: nausea, sleepiness and upset stomach, with occasional dizziness. She did not feel well felt better after a few days.
Patient received vaccine, and reported no reaction at that time. Then later that day patient called complaining of arm pain. Next day the patient's son called the pharmacy to report that his father/patient was in the hospital with an infection.
A legal complaint was received from an attorney concerning a child who reportedly received Hib-Titer, Tri-Immunol, Engerix B, and DPT vaccines during the time frame of approximately 1992 through approximately 1997. The legal complaint states that the child subsequently developed toxic neurological effects of mercury poisoning (namely autism) as a result of receiving vaccinations containing thimerosal. Mercury poisoning and autism were considered medically important (OMIC).
I experienced 6 strong migraines in 4 days, all having the pain focused in the same area, right side front of head.  I've never experienced more than 2 migraine days in a row and have never had those 2 have the pain in the exact same spot.
Information has been received from an advanced registered nurse practitioner concerning a patient who was vaccinated with GARDASIL. Subsequently, the patient experienced swelling at the injection that lasted for at lest one month after the vaccination with GARDASIL. This was one of 3 reports from the same resource. This is for a multiple patient report. Additional information has been requested. Additional information was received from an advanced registered nurse practioner who stated that all information had been sent. The nurse did not recall which patient had a sore, swelling or fever. Additional information was received from the advanced registered nurse practitioner reported that she operated at a transient clinic where young girls came and went quite often and she just did not remember who the patient was. No furhter information is available.
Today is day #9 after receiving the 1st dose of Moderna vaccine and I have a red 2 inch patch on my left arm at the site of the injection. It?s hot and feels like a sunburn - my skin feels tight in the area.
feverish; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (feverish). At the time of the report, PYREXIA (feverish) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were provided. No treatment details were provided   This case was linked to MOD-2021-275750 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received:  Reporter's additional Contact information updated.
Severe abd pain during menstrual cycle, passing blood clots, low H&H, severe dizziness and chst pains
p/vax pt taken to ER for rash on face & behind ears;denies diff breathing;states eyes were puffy;c/o discomfort on rt deltoid area w/hard area under the skin;taking pred & DPH;redness below lt eye & on lt arm dime size;
Events: Fever 100.4-102.2 even with antipyretic use, headache, body aches, chills for 3 days after injection.  Treatment: Fluids, rest, antipyretic medication. Recovered at home without doctor visit.
This spontaneous report received from a patient concerned a male of unspecified age. 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) dose was not reported, administered on 18-MAR-2021 15:00 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 19-MAR-2021, the subject experienced feeling faint. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling faint was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case was assessed as non serious.
I had the first shot did ok had a headache and tired.  2nd short not so well had to go to walk in and Doctors, walk-in (2) Had prescription and then Went to family Doctor and Perscriptions and Breathing treatment this is just, I had full details and was to long and had to start over, need more details to give me more time before it starts over or asks me.
Initial and follow up information has been received from a physician concerning a 47 year old female x ray technician who on 09?-SEP-2008 was vaccinated with a second dose of PNEUMOVAX lot # 658074/0803U. Post vaccination the patient told the physician that she had PNEUMOVAX a few weeks ago. In follow information from the doctor's office it was reported that patient received two different injection and post vaccinations she had extensive rash and red skin. The patient reported as recovered. Additional information is not expected.
Woke up out of a dead sleep at 0401am and was sweating head to toe, was super dizzy, couldn?t not breathe, and very lightheaded. I was pale and have no underlying health issues! Blood pressure was normal, o2 was reading 98% but this lasted for 15 minutes. Called physicans office in the morning and nurse suggested to report symptoms
Twitch in the left side of face, just above lip. Twitching continued daily for 5 months and then nearly on the dot stopped and I have yet to have it return.
Full body hives; This is a spontaneous report from a contactable consumer, the patient. A 63-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 left arm on 08Apr2021 at 07:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and sulfa allergy. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and dulaglutide (TRULICITY), both taken from unknown dates. 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 left arm on 25Mar2021 at 09:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 07:00, 24 hours after the vaccination, the patient experienced full body hives. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with antihistamine. The clinical outcome of the event full body hives was resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Inflammation; General aches and pains around my body; This case was reported by a consumer and described the occurrence of inflammation in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced inflammation and general body pain. On an unknown date, the outcome of the inflammation and general body pain were unknown.   It was unknown if the reporter considered the inflammation and general body pain to be related to Shingrix.  Additional case details were reported as follows: The patient received second installment of vaccine the day before reporting. The patient had general aches and pains around body which he assumed that it was due to inflammation. The patient experienced some of the typical side effects and was wondering if an anti-inflmmatory would reduce the effectiveness of the vaccination. The patient would like to avoid damaging inflammation if possible. The reporter enquired whether the patient can take an anit-inflammatory such as diclofenac (75 mg) after vaccination. The reporter gave permission to follow up.
She got her vaccine and had a headache which she still continues to have.  It is not severe but is persistent.  Normally she does not have any headaches.  She does take Ibuprofen for the headaches.
Patient claims 103 degrees, hives at injection site, dizziness, eyes red and swollen, delirium, muscle aches and pain. Patient claims reaction started Thursday about 5 PM and ran thru weekend. Patient did not call her doctor or visit an ER. Called this Pharmacy about 3 PM on 11/6/17 to report the above that she believes were caused by FLUZONE.
This is in follow up to report(s) previously submitted on 5/14/2004. Information has been received from a RN concerning a 9 year old male with no known allergies who on 19Feb2003 at 13:00 was vaccinated SC in the deltoid with a first dose of varicella virus vaccine live.(#642994/0566M). There was no concomitant medication.  The pt's three siblings were vaccinated the same day. Subsequently in 2003, he developed breakthrough chickenpox. It was reported that two of his siblings (WAES#0401USA00638 and 0401USA00639) also developed chickenpox. The reporter expressed concern with the lot. Unspecified medical attention was sought. There was no product quality complaint involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Follow-up information indicated that on 23-Oct-2003 the patient had an acute clinic visit with the onset of pruritic papule on the left temple which started on 22-Oct-2003 and progressed to his face and torso. His sister (0401USA00619) had chickenpox which lasted for two weeks. The patient was seen for a doctor's visit and his skin revealed a typical vasicular rash with erythema on his face, back, arms and torso consistent with varicella. The patient was given dophenhydramine hydrochloride (Bendaryl) (12.5 mg/5ml) 1 teaspoon every 6 hours prn, calamine lotion and oatmeal baths. Subsequently the patient recovered. Ths patient recevied additional vaccinations on 22-Jan-2003 at 13:17 which included a first dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (+) rubella virus vaccine live which was given SC in the thigh, a first dose of diphtheria toxoid (+) tetanus toxoid given IM in the thigh, a first dose of poliovirus vaccine inactivated (unspecified) which was given SC in the deltoid and a first dose of hepatitis virus vaccine (unspecifried given IM in the thigh.  Additional information has been requested.
4 days after vaccination - developed large area of itchy and painful rash, red swollen, hot. Approx 4 inch long 3 inch wide used BENADRYL 25 mg PO q4-6 hours and cortisone cream. Seen by PMD 10/5/15 for recheck.
Patient was given her first Shingrix injection. She experienced redness and swelling around the injection site along with mild fever and general body ache about 1 to 2 days later. Patient was advised to use OTC care and contact her physician if symptoms do not resolve in 1 to 2 days.
Client states began having watery eyes on 11/28/2003. Began having numbness of her mouth on 11/29 and progressed to numbness in the top of her mouth on 11/30. Reported to the clinic on 12/01/2003 with these symtoms. Was sent to the Emrgency room for evaluation. Was admitted to the hospital with a Dx of Guillian-Barre Syndrome on 12/01/2003. Discharge summary states facial paralysis, speech disorder, neuropathy. DC Summary Bell's palsy. Motor neuron disease
"Janssen COVID-19 Vaccine EUA About 7 minutes after the patient received Janssen covid-19 vaccine, he started complaining about his throat feeling tight and difficulty breathing. I quickly give him one dose of epinephrine 0.3mg on the right thigh and about five minutes later he recovered. I requested to call 911 but the patient declined. I asked him to wait longer but he left .
pt devel a papular rash on the arm covering an area of about 3in in diameter around the site of the inject;
Started feeling a little discomfort the day before. Serious effects started at the time given above. These include fever, throwing up, chills, severe cramps throughout body, sweating, difficulty breathing, confusion/dizziness, spreading infection and swelling at site of injection.