chrisvoncsefalvay/vaers-outcomes huggingface dataset:
43-year-old male patient/Shingrix was prescribed by medical order based on his medical history of Systemic Mastocytosis; 43-year-old male patient was provided the 1st dose of Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of off label use in a 43-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included systemic mastocytosis.   On an unknown date, the patient received the 1st dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced off label use (Verbatim: 43-year-old male patient/Shingrix was prescribed by medical order based on his medical history of Systemic Mastocytosis) and inappropriate age at vaccine administration (Verbatim: 43-year-old male patient was provided the 1st dose of Shingrix vaccine). The outcome of the off label use and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 29-SEP-2023 The patient reported that he was provided the 1st dose of Shingrix vaccine 4 months ago (from the reporting date). The patient reported that Shingrix was prescribed by medical order based on his medical history of systemic mastocytosis. The patient reported that the vaccine was provided at a local pharmacy. No immunosuppression medications were taken at the time of the vaccine, and patient was not immunodeficient at the time of the Shingrix vaccine. The patient was below 50 years when received the Shingrix vaccine and he was not immunodeficient, which led to off label use and inappropriate age at vaccine administration. The reporter did not consent to follow-up.
The pt developed local redness and swelling on left upper arm and shoulder after receiving the vaccines. This lasted for 24 hours then gradually decreased at 5:00 am the following morning. Symptoms have resolved and the pt was able to have full use of arm. Diagnosis: Local reaction to immunization.
Progressed to burning tongue; Mouth with excessive salvation; Within 15 min started with "fuzzy" tongue; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 06Mar2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, fibromyalgia, asthma, Irritable Bowel Syndrome (IBS), dysautonomia (Postural Orthostatic Tachycardia Syndrome (POTS)), hypothyroidism, vitamin D and B deficiencies, history of autoimmune hemolytic anemia and autoimmune pancreatitis. The patient was allergic to sulfa drugs, wheat, soy, sesame, scallops and nuts, was lactose intolerant and had intolerance to fructose. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and hydroxychloroquine (MANUFACTURER UNKNOWN); both taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received ciprofloxacin (CIPRO), clindamycin (MANUFACTURER UNKNOWN), daptomycin (MANUFACTURER UNKNOWN) and duloxetine hydrochloride (CYMBALTA) and experienced drug allergy with all these medications. On 06Mar2021 at 13:15, within 15 minutes, the patient experienced fuzzy tongue and on the same day at 13:30, it had progressed to burning tongue and then mouth with excessive salvation. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with diphenhydramine (BENADRYL) 50 mg x 2 doses. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fuzzy tongue, burning tongue and mouth with excessive salvation were recovered on an unknown date on Mar2021.  No follow-up attempts are needed. No further information is expected.
recalls flu-like sx immed p/vax AUG91;temporal onset of muscle pain, particularly in lower back;dx as fibromyalgia;
after the first shot I had unusual menstrual bleeding , cramping pain. I was experiencing pcos symptoms prior, but had never had such prolonged bleeding. fast forward to Jul 20, 2021 I had begun to period just 8 weeks after my dose 2. I ended up bleeding for 35 days straight. heavy flow with clotting. I have been on birthcontrol progesterone for one week to attempt to regulate/stop bleeding.  It has begun to taper to a light spotting. as of now im still experiencing bleeding. When I contacted the on-call doctor they advised me to report just in case it is related to the vaccine. both prolonged episodes of heavy bleeding occurred after the vaccines, and I have no history of bleeding like this ever.
pt had rxn the size of eraser tip to the site where inj given;given DPH;pt agreed to stay x 1hr site was cont eval until MD agreed child could go home;
has been experiencing lost vision on one eye; ringing of his left ear; major pain on the top of his head and back of the neck; blurring of vision all the time; major pain on the top of his head and back of the neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old male patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) at the age of 55 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: BLINDNESS (medically significant) with onset 2021, outcome "not recovered", described as "has been experiencing lost vision on one eye"; TINNITUS (medically significant) with onset 2021, outcome "not recovered", described as "ringing of his left ear"; HEADACHE (medically significant), NECK PAIN (medically significant) all with onset 2021, outcome "not recovered" and all described as "major pain on the top of his head and back of the neck"; VISION BLURRED (medically significant) with onset 2021, outcome "not recovered", described as "blurring of vision all the time". The events "has been experiencing lost vision on one eye", "ringing of his left ear", "major pain on the top of his head and back of the neck", "blurring of vision all the time" and "major pain on the top of his head and back of the neck" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (2021) unknown results, notes: undergone an MRI for his eye and brain; magnetic resonance imaging head: (2021) unknown results, notes: undergone an MRI for his eye and brain. Therapeutic measures were taken as a result of blindness, tinnitus, headache, vision blurred, neck pain.  Additional information: Treatment received with prednisone, benadryl, codeine and morphine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 3:42 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Oct-2021 at 3:42 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vial was stored in frozen storage which was in super cold freezer. On 19-Nov-2021 vial was went from super cold freezer to the refrigerator. 70 vials were still in the ultra cold freezer, 8 vials were in the refrigerator, so a total of 78 vials were affected. Vaccine vial state changes were noticed and vial was never refrozen. None of the vials were punctured before the event. Temperature excursion remained for 1 month.  No treatment medication was reported by reporter.   This case was linked to MOD-2021-402935 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2022: Follow up received contain non significant information.
Patient developed rash, itching and throat swelling shortly after administration of 2nd Pfizer COVID vaccine dose.  Treated with IV Benadryl 50mg, symptoms resolved within 15 min.
pt recvd vax & 2 wks later had red rash w/ HA & flushing & dec t X 3-4 days; 3 wks p/ vax c/o joint pain in all joints;
I took all of my medications around 9pm on 4/21/2021 (was fatigued, went to bed early). I woke up on 4/22/2021 with continual brain synapse misfirings (brain zaps) which occurs from anti-depressant withdrawal. It's as if the venlafaxine was not absorbed by my body. I became despondent, severely depressed, anxious, cried non-stop with the brain zaps occurring non-stop. I felt as though I was having a nervous breakdown. I went to sleep that evening (took all my medication per usual) and work up the next morning fatigued but the brain zaps were gone and emotionally I was feeling much better.
received my COVID vaccination yesterday and I am breastfeeding my 10 months old baby; Rash underneath the neck area, underneath his chin; This is a spontaneous report from a contactable consumer(mother).   A 10 month old patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: EW0177,expiry date 31Aug2021) via an Trans mammary route of administration on 22-MAY-2021as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant were not reported . On an unspecified date the patient had experienced rash underneath the neck area and underneath his chin .It was reported that reporter  gonna call the paediatrician too to ask, no right now its not a best time, she was gonna call right know. The clinical outcome of the events were unknown.   No Follow-up attempts completed. No further information is expected.
slight blurriness in the center of vision; NEED TO BLINK MORE OFTEN; TEETH CLATTERING; CHILLS; HEADACHE/LOW GRADE HEADACHE IN FOREHEAD, TOP OF HEAD AND EACH TEMPLE; This spontaneous report received from a patient 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, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 15:39 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced slight blurriness in the center of vision. On JUN-2021, the subject experienced need to blink more often. On JUN-2021, the subject experienced teeth clattering. On JUN-2021, the subject experienced chills. On JUN-2021, the subject experienced headache/low grade headache in forehead, top of head and each temple. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from teeth clattering, and chills on JUN-2021, and had not recovered from headache/low grade headache in forehead, top of head and each temple, slight blurriness in the center of vision, and need to blink more often. This report was non-serious.
muscle aches in arm, buttocks, legs, knees (3-4 days p/red blotches);cont to have sx of aches/stiffness;
2 year old was given NOVARTIS vaccine for ages 4 and older - as of 11/9/09 has had no signs or symptoms of reaction of any kind.
Associate went to ER with arm pain, redness and swelling around the injection site.  Diagnosed with cellulitis.  Was unable to lift her arm up fully for days.  Seen by PMD and ER.  Treated with antibiotics
A cellulitis developed on the anterior surface of the right thigh at the injection sites (10cm x 6cm area of erythema).  Pt was treated with IV clindamycin with good clinical improvement. Discharge summary states agitiation, fever. msv
Information has been received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of PROQUAD (lot # M004893, expiration date 26-JUL-2017 and lot # M017335, expiration date 05-OCT-2018) administered subcutaneously (dose and anatomical location were not reported). No adverse effects were reported. Temperature Excursion Details: Temperature:-13.3 Celsius (C). Time frame: 4 hours. Previous temperature excursion? No. No data logger was involved. This is one of two reports received from the same source. Additional information has been requested.
Vaccination of underage individual.  Mom indicated a false birthday on form, which was later confirmed with PCP's office.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 23-APR-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD (strength, dose and route of administration were not reported) (lot # N029879, expiry date: 22-APR-2019) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (lot number and expiry date were reported as unknown). The vaccines were exposed to a temperature of 6 degree Fahrenheit (F) to 14 degree F for a time frame of 45 minutes and 15 degree F to 46 degree F (32.01 degree F) for a time frame of 8.5 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved.
pt recv vax between 24OCT96 & 1NOV96 & devel a fever & stiff neck 24hr p/vax;
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired second dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091B21A and 047B21A) for COVID-19 vaccination.     medical History not reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired second dose). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received an expired second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   NO treatment Drug was reported
On 11/09/2000, the patient developed chickenpox with 20-30 lesions on the body. Follow up was received from a physician. This episode was not considered related to varicella virus vaccine live "as the vaccine was given on 09/04/1998". Additional information has been requested.
(1) Redness / itching night of vaccination @ injection site applied Benadryl cream + took Benadryl tablet  (2) symptoms lessened over next couple days
Shortly after giving vaccine, discovered that the dose of varicella vaccine that was administered expired in June 2015. Public health contacted. Student contacted via his school nurse. Will repeat dose in 4 weeks.
Lip Swelling; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 31Mar2021 at 10:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder and also allergy to nickel and sulfur.  Concomitant medications included thyroid (ARMOUR THYROID), escitalopram (MANUFACTURER UNKNOWN) 5 mg and progesterone  (MANUFACTURER UNKNOWN) 200 mg, all for unknown indications from unknown dates. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the  left arm on 10Mar2021 at 10:30 (at the age of 62-year-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 01Apr2021 at 21:00, the patient experienced lip swelling. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of lip swelling and included treatment with oral steroid progesterone. The clinical outcome of the event lip swelling was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
9-22-10 - Vaccine given - pt tense-resistant - no prior hx of tetanus known 9-24-10 - mother brings child in clinic - seen by FNP. Left arm - erythema - tautness - warmth from shoulder to elbow DX: cellulitis - advised to go to ED for f/u mother declined - gave BENADRYL - mother reports no problems
Patient's enter upper arm became bruised and swollen the morning after receiving the flu shot. It appears yellow closer to her shoulder and then purple/red closer to her elbow.
Patient presented redness about quarter size around vaccine area. VARICELLA was given in this extremity.
Sore arm, generalized body aches, headache, fatigue, fever (101.8). Improved following one dose 400mg ibuprofen.  Following day 1/24/21 all symptoms resolved with the exception of body aches.
Suspected vaccination failure; My husband was Vaccinated and still had singles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient received Shingles vaccine and experienced shingles. The reporter mentioned that the patient did not had a serious reaction. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Chills, fever and flu-like symptoms, extreme exhaustion and lethargy, nausea.
Inconsolable crying - evening of immunization, jerk like movements 10/18/06
Pt received her Pfizer Covid 19 booster shot.  While she was waiting for her mother to receive her vaccine she fell (passed out).  Pt states ¨she started to feel nausated¨, then passed out and was surrounded by her mother and staff.  Pt complained of pain to the back of her head.  Vitals signs were taken and then escorted to recliner and continued to be monitored for her duration of stay.  Vitals were taken again and mother was advised to take pt to immediate care due to her hitting her head.  Pt? mother refused and stated she did not fall that far to have a concussion.  Pt? mother was given instructions regarding signs and symptoms that may be concerning.  Mother verbalized she would call her pediatrician and monitor patient.
Monovalent doses administered after the BUD to patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in an adolescent patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No concomitant medication information was reported. Monovalent doses administered after the BUD to patients 12 and up. Breakdown of doses is as follows- 37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A. No treatment medication information was reported.
Contracted COVID  for a 2nd time with symptoms of scratchy throat, headache, loss of appetite, persistent cough, congestion,, mucus.  Went to urgent care facility, as directed by my internal med doctor and received treatment.  Nurse took the following:  Blood pressure, temperature,, height and weight.  Tested positive for administered COVID test.  PA-C  prescribed Paxlovid medication (150  mg)  taken over a period of 5 days. Quarantinee for a period.of 10 days.
2 days p/inject noticed redness & warmth below inject site on inside of arm; spread down arm to cover upper inner arm; c/o pain as well as swelling; 11NOV91 seen by MD; 12NOV91 seen by MD again dx cellulitis;
pt recv 1st vax;platelet count was 34,000;f/u info: no tx but platelet up to 92,000;to MD for bruising,petechiae;platelet count 33,000;11jan95 was 9000;hospx24 hr,tx w/IV gamma globulin;24jan95 platelet 291000 & 456000 respectively;
Fever of 101.5, body aches, chills, headache, fatigue, no appetite. Started in evening day of injection. Got much worse during the night culminating in fever. Took Tylenol which didn't do anything. Took Advil which relieved the fever, but not the aches. The aching stopped by end of third day. Still extremely fatigued as of 4th day.