chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant and a physician assistant concerning a 13 year old female with no pertinent medical history, known drug allergies or routine medication use who on 09-AUG-2007 was vaccinated (site and route not reported) with the 1st 0.5 ml dose of Gardasil (lot # not reported) and had no adverse reaction.  On 08-NOV-2007, the patient was vaccinated (site and route not reported) with the 2nd 0.5 ml dose of Gardasil (lot # not reported) and experienced dizziness, blurred vision, fever, visual aura, and bilateral peripheral scotoma a few minutes post vaccination.  The bilateral peripheral scotoma resolved after 30 minutes and was followed by the onset of a bilateral frontal headache and lightheadedness.  The patient's vital signs were stable.  Additional information has been requested.
Syncopal event.  Witnessed loss of consciousness while standing and fell forward.  Did not strike head.  Pt breathing rapidly & upper extremities shaking.  VSS except RR 26 A&Ox4.  911 Called given LOC for further evaluation.  Transported to ED.
Minimal left upper extremity swelling and minimal erythema in the medial biceps and forearm area for 4 days.
Shoulder joint became very sore with limited range of motion within several days after receiving vaccine.  Joint pain is still present  = 3 months later.
Fainted as the vaccine went into her body.  Headache, dizziness, nausea, muscle pain, stomach ache 12 hours later still.
Cellulitis of his right upper extremity. Mom noticed swelling on right thigh the day after vaccination; rapidly progressed over the day. Admitted to hospital 2 days after vaccination with 8cmx5cm area of erythema and mild color, with central area of induration. This is second episode of vaccine associated cellulitis. Given Ancef/Keflex 250mg for 10 days.
Breakthrough case after three vaccines Pfizer 1/22/21 Lot# EL3246 Pfizer 2/12/21 Lot# EL9265 Pfizer 10/18/21 Lot# Ew0150
Pt received VARICELLA vaccine 10/4/16 - mom called on 10/14/16 - child developed chickenpox on face. Spoke with mom - taking child to MD today - advised her to call MD for FMD visit - T.C. to Dr re: vaccines, child received on 10/4/16 TC tomm 10/17/16 -  Child saw MD - dx with VARICELLA - Ok to got to school once they clear up 0n face. Child doing well.
Patient is 22-year-old male who received the smallpox vaccine on 17 Dec 2004 who presents with complaints of distal lesions from the vaccination site.  Patient reports having an itchy area on his elbow and when he looked at his elbow he saw that he had a rash.  He reports two or three new little papules at the site.  He reports feeling lightheaded yesterday.  He was reportedly pale.  No fevers but he did complain of being chilled.  No nausea or vomiting.  He does say that his "stomach felt weird".  He reports it was a sharp pain but it went away on its own.  No headaches.  No chest pain.  Due to deploy on the 12th of this next month.   No history of skin problems or history of psoriasis.   MEDICATIONS: 1. None  PMH: 1. None  MED ALLERGIES: 1. NKDA  Family History: No allergies or problems with medications  Social History: Non-smoker  Infectious History:  no history of recurrent infections or bad infections a/ generalized vaccinia
Information was received from a registered nurse concerning a 35 year old female patient, who received 2 doses of MMR II (each doses on a separate unspecified date in 2009) (albumin status, dosage, and route of administration not provided). On 04-JUN-2015, the patient had MMR titers drawn and the titers showed that the patient was negative rubella. The patient received a dose of MMR II (lot #K011188, expiration date 12-AUG-2016) on 16-JUN-2015, and an additional dose of MMR II (lot #L003856, expiration date 05-FEB-2017) (albumin status, dosages and route of administration not provided) on 15-SEP-2015, because of the negative rubella titer. The outcome of the negative rubella titer and the causality was not reported. No further information was provided. Additional information has been requested.
patient had dizziness, lightly syncope but patient was still conscious (knowing her name, date of birth, where she was at..) 10 minutes after getting the vaccine. Paramedics came and checked on patient. Paramedics let patient  go home after that
THE NEXPLANON BIRTH CONTROL STOPPED MY PERIOD UNTIL I GOT VAXED AND NOW I HAVE IT AWFULLY LIKE IM NOT EVEN ON BIRTH CONTROL
Can barely move left arm; reaction on Left arm that is painful; . This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Shingrix.  Additional  details provided as follow: Age at vaccination was not provided. The patient experienced reaction on left arm that was painful and could barely move that arm.  Pharmacist mentioned patient still has some lingering effects of it. The patient was wondering about the second dose. Pharmacist unable to provide vaccine details. This case is linked to the case US2021056501, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021056501:same reporter
Facial numbness/paralysis started 10 minutes after injection. Paralysis of tongue and jaw muscles followed an hour later. Paralysis of eyelids followed. Medical staff on-site were not informed on how to proceed and recommend to take a benadryl and sleep it off. Muscle function returned 12 hours later.
5-29-2018 client called HD to report onset of right shoulder blade pain starting 2/16/2018, day after Flu injection received. Reports had slight pain at injection site. States no injury to area at that time. Reports she thought it would get better and waited one month before seeing her physician. Reports pain under shoulder blade was getting worse and more frequent. 4-10-18 physical therapy started to present. Stated Physical Therapist told her she has SIRVA. Client reports right shoulder aches when sitting or standing with arm unsupported, has difficulty sleeping due to pain waking her up. Heat helps relieve pain. Denies decrease range of motion. Flu injection was administered in left deltoid per record, not in right arm.
Liquid stool Abdominal pain Chills Loss of Appetite Started 12/22 in the morning
Swelling next day, then increased to elbow pain 1 week started to resolved. Some itching, took BENADRYL.
One of nine expired cases: An event of Expired Drug Administered occurred in a six-year-old female. The report was received from a registered nurse . No medical or drug history was reported for the child. The child received a one-time dose of FluMist intranasally on 15-Jan-2008. On 15-Jan-2008, the child received FluMist which had an expiration date of 19-Dec-2007. The reporter stated this is one of nine children that was vaccinated on the same date. In discussing the error with two reporters from the site, they both indicated that the front of the FluMist box states "For the 2007/2008 Season", there is an expiration date on the side of the box. The reporter indicated they also administer a competitor's product, which is good for that entire season and does not expire until May/June timeframe. One reporter also stated many of the vaccines they give do not have an expiration date. She also indicated they do look for expiration dates but it was confusing to have the front of the box indicate the vaccine was "For the 2007/2008 Season". The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than three weeks. Outcome: the child had no ill effects, the site has not had any contact from the child's family. Further dosing with FluMist is not indicated. Causality assessment is not applicable for this vaccination error. This reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
pt devel fever, poor feeding, sleepy 4DEC96;6DEC96 raised red rash devel on neck, spread to chest, back, face, extremities;fever 102, cough, runny nose;
Feeling very sensitive skin on right hip area of body. By Tuesday went to the doctor as pain was internal off and on sharp shooting. By Saturday rash broke out, confirming shingles.
Patient found unresponsive and unarousable in chair. Doctor on site alerted EMS. Smelling salts were used. Patient returned to consciousness. Unresponsive for less that a minute. Oriented to surroundings. Vital signs taken by EMS and doctor. Blood pressure was undetectable. Patient transported to ER via ambulance
My daughter woke up pale.  Her stomach has been hurting her since Sunday.  She had a dizzy spell and almost blacked out in school
First two days after shot- arm was very sore with slight headache and fatigue. On 3rd day- burning sensation with pain. On 4th day-  large red rash - with continued pain. Arm was ?hot? to touch and itchy. This continued on the 5th day. On 6th day - went to Emergency room. This continued
rash on face, scalp for four days rash behind knees and on inner elbow continues 11 days
Hives began around bed time and patient took one Benadryl. The hives persisted and she took another Benadryl (total for both doses was 50mg). Hives dissipated after second dose of Benadryl.
Caller reported temperature excursion/Temperature -13.3C; This spontaneous report was received from a registered nurse, referring to a 1-year-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 11-DEC-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (ml), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T017688, which has been verified to be valid, expiration date reported and validated as 21-MAY-2022). The vaccine administered experienced a temperature excursion of -13.3 degrees Celsius (C), for a time frame of 4 hours and 15 minutes, as recorded by a data logger (product storage error). There was no previous temperature excursion reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA013501:
The same day, I started to experience tongue tingling and movement. 5 days later, the tongue experience got worse and I started to experience tremors in my arms, legs. It is almost external tremors. I've experienced heart palpitations, etc since then. I have been to neurologist, cardiologist, etc. All my test shows that I'm not experiencing certain neurological or heart disorders but I have never experience any of these symptoms until I took the vaccine. My concern is to know when will it completely stop.
About 5 minutes after injection (Pfizer dose #2), patient felt tingling in tongue, then swelling sensation in tongue, then cough.  Took Epipen, Benadryl 50 mg po, albuterol inhaler... exam showed clear lungs, tachycardia, "geographic tongue".  Via ambulance to ED.
High level of fatigue and general body soreness which lasted about 2 days. Extremely sore and swollen throat as well as general congestion which has worsened over the course of 1 week
Information has been received from a 34 yr old female with no known medical history or allergies who on 02Nov05 was vaccinated IM with a dose of hep B virus vaccine rHBsAg (yeast) (manf unk) (lot AHBVB135AA). There was no concomitant medication. Immediately after vaccination the pt fainted. Once revived, she stated that she had low blood pressure and tinnitus but had since recovered. Unspecified medical attention was sought. No laboratory diagnostic tests were performed. It was unk if the pt was hospitalized. The pt's status was recovered, date not specified. There was no product quality complaint involved. No further information is available.
This spontaneous report as received from a medical assistant refers to a 8 week old patient of unknown gender. On 28-JUL-2013 the patient was vaccinated with a first dose of RECOMBIVAX HB 10 mcg/ml (dose and route unknown). On 25-SEP-1997 the patient was vaccinated with a second dose of RECOMBIVAX HB 10 mcg/ml (dose and route unknown), as reported more than a month later after the first dose. On 09-DEC-1997 the patient was vaccinated with a third dose of RECOMBIVAX HB 10 mcg/ml (dose and route unknown), as reported less than 6 months after the first dose. No adverse effects were reported. Additional information has been requested.
No adverse event; 1 patient received monovalent vaccine past the 30 day use by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient received monovalent vaccine past the 30 day use by date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient received monovalent vaccine past the 30 day use by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient received monovalent vaccine past the 30 day use by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 patient received monovalent vaccine past the 30 day use by date.).    Concomitant medication was not provided.   Treatment information was not provided.  This case contains information for the 1st out of 3 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712108 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712108:Same reporter(2 patient invalid case)
Information has been received from a physician concerning a female (age not reported) who was "positive for one strain of papilloma viral infection". On an unspecified date, the patient was vaccinated intramuscularly with the first "single dose vial" of Gardasil vaccine (yeast). Subsequently, the patient developed an "allergic reaction". The patient was sought unspecified medical attention. The patient was treated with a "steroid dose pack". At the time of this report, the outcome of the event was unknown. Additional information has been requested.
This spontaneous report was received from the office manager and refers to a 13 month old male patient. The patient's medical history, drug reactions and allergies were not provided. On 29-JAN-2018, the patient was vaccinated with an expired dose of properly stored M-M-R II 0.5 ml once, lot# M004305, expiration date on 25-JAN-2018, for prophylaxis, (route was not provided); reconstituted with properly store sterile diluent lot #M045717, expiration date: 31-MAY-2019. No adverse effects were reported.
dry coughing; hot to cold flashes; joint pain; fatigued and tiredness; Headaches; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hot to cold flashes, dry coughing, fatigued, joint pain, tiredness and headaches.  The patient's medical history was not provided. Concomitant medications reported were Wellurine -  an anti depressant for drug use for unknown indication.  On unknown date, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 8 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 004M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced Arthralgia (joint pain), Cough, Fatigue, Headache and Hot flush (hot and cold flash)  Treatment details included nothing.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
tinnitus in left ear; heat at the injection site; rash at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (tinnitus in left ear), VACCINATION SITE WARMTH (heat at the injection site) and VACCINATION SITE RASH (rash at the injection site) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059ELIA and 011520) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus (Diabetes type 1) since 01-Jan-1985 and Hypertension (Has become erratic since 02-Apr-2021) since 01-Jan-2002. Concomitant products included INSULIN, ROSUVASTATIN CALCIUM (CRESTOR), EZETIMIBE (ZETIA), OMEPRAZOLE and VALSARTAN for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced TINNITUS (tinnitus in left ear), VACCINATION SITE WARMTH (heat at the injection site) and VACCINATION SITE RASH (rash at the injection site). At the time of the report, TINNITUS (tinnitus in left ear), VACCINATION SITE WARMTH (heat at the injection site) and VACCINATION SITE RASH (rash at the injection site) outcome was unknown. Not Provided          The patient connected with primary care provider and the primary care provider recommended the patient to take ice and antihisthimine/Tylenol   This case was linked to MOD-2021-066013 (Patient Link).
Adverse reaction; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The age group was not reported but was selected as adult as per the vaccine indication. The reporter stated that one of the patient was on a similar medication to Creon. The patient had a bad reaction to the Shingrix vaccine. The reporter did not describe what bad reaction meant. No further details were provided. The reporter consented to follow up.
Information has been received from a pharmacist concerning a 15 year old male patient with AMOXICILLIN allergy who on 08-SEP-2008 was vaccinated with VARIVAX (Oka/Merck) (lot number 659603/1903U, site and route not reported) at a clinic associated with the hospital.  Subsequently, two days after the vaccination, the patient's parent called to report the injection site reaction which was described as swelling and warmth at the injection site that involved the whole upper arm.  The area was warm to touch, but the patient did not have a fever.  There was no other information.  The patient sought medical attention.  The patient sought medical attention.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the Center for Biologics Evaluation and Research and was released.  Further information has been requested.
None. Pt had received FLUMIST 10-19-12, then on 10-23-12 received FLUZONE IM 0.5 ml. No reaction.
I had a fever for a couple of days, followed with congestion high in my chest. I had some fatigue, the fever lasted for three days. I took a home COVID-19 test that came back positive, it was on the weekend, and I called the on-call group. I did not get a call back until Monday so I was not able to get a prescription for PAXLOVID. I was advised to use over the counter medication. It has been three weeks and I still have a lingering cough.
Received Shingrix subcutaneous; This case was reported by a nurse via sales rep and described the occurrence of intramuscular formulation administered by other route in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received Shingrix subcutaneously for 2nd dose, which led to intramuscular formulation administered by other route. The patient did not seek medical attention. The follow-up would not be possible as no contact details were available.
Received FLUMIST. Next day or so developed viral symptoms. 3 days later developed cerebellar ataxia.
first dose of Moderna vaccine at age of 17 years, 4 months; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose of Moderna vaccine at age of 17 years, 4 months) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose of Moderna vaccine at age of 17 years, 4 months). On 02-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose of Moderna vaccine at age of 17 years, 4 months) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Awelling and redness in his left triceps/biceps and into his lower arm. This developed last evening, earlier in the day he had been in the clinic and was given a Pneumovax.
Headache, weakness & dizziness starting afternoon after receiving vaccine and lasting 6 hours. Afterwards c/o weakness & dizziness lasting for 2-3 days.
improperly stored ROT ATEQ was administered today; No adverse event; This spontaneous report was received from a licensed practical nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 19-MAR-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number: 1688830 was verified as valid, expiration date was not provided but upon internal validation established as 04-DEC-2021, 2 ml, orally for prophylaxis. The vaccine experienced temperature excursion of 47.1 degree Fahrenheit for 10 minutes. There was no previous temperature excursion detected. The digital data logger was involved. No other adverse event was reported.