chrisvoncsefalvay/vaers-outcomes huggingface dataset:
loss of hearing; resistant staph infection; postherpetic neuralgia; vision issues; heart complications; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 73-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-OCT-2012, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, dose#, route of administration and anatomical location, lot#, expiration date were not specified) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: multiple outbreaks of herpes zoster, postherpetic neuralgia, vision issues, loss of hearing, heart complications and resistant staphylococcus infection. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the evens of loss of hearing and resistant staphylococcus infection were determined to be medically significant.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 2:31 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 2:31 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 24.02.  Concomitant products were not provided.  On 12-Jan-2021, Excursion time was 08 AM and 09 AM, temperature was 34, total doses given for the day was 30, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 12-Jan-2021. 3 vials were sent to clinic. Vaccine BUD date was 07-Feb-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
I was sick for 3 days; Achy back; I had chills; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I was sick for 3 days), MYALGIA (Achy back) and CHILLS (I had chills) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced ILLNESS (I was sick for 3 days), MYALGIA (Achy back) and CHILLS (I had chills). On 02-Apr-2021, ILLNESS (I was sick for 3 days) had resolved. At the time of the report, MYALGIA (Achy back) and CHILLS (I had chills) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-655853, MOD-2022-655858 (Patient Link).
Mother noticed 2 days after vaccine given, redness and swelling. 5cm by 3cm of erythema, edema, tenderness and warm to touch. Keflex 250, 1 teaspoon QID and Motrin 100, 1 3/4 teaspoon QID.
Itching that started in my right ankle at night. The following morning, my chest became very itchy. Throughout the day, more parts of my body became extremely/intensely itchy and I developed red plaques/rash on my trunk/under the breasts, on my back, on my shoulders/blades. I took 1 dose of Benadryl 25mg, which helped a lot, but then later at night, the itchiness came back. I called the on-call service for my doctor's office, and per the recommendation of the nurse, I applied hydrocortisone 1% cream to the affected areas.  I had difficulty sleeping due to the itching, so I took Benadryl 25mg. By the morning, the itching/rash improved a lot. Later in the day, there was some mild itching that I treated with hydrocortisone. I am currently 4.5 months pregnant with an expected due date of May 4th 2022.
Intractable vomiting after Rotateq oral vaccine administration.  One hour after administration my daughter was breastfed and given avocado and put down for a nap.  She awoke out of sleep coughing and had a very large emesis.  She proceeded to vomit for the next four hours every 15-20 minutes, ending in dry heaves.  Returned to pediatrician's office for recheck and MD prescribed Zofran and Pedialyte.  After giving Zofran she was able to tolerate Pedialyte given from a syringe.
Developed superficial venous thrombosis on left thigh. Started Ted Hose daily, Xarelto 15mg PO Daily x 56 days 5/24/21-8/18/21
administered 2 day after the expiry date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 2 day after the expiry date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 2 day after the expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 2 day after the expiry date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were not reported by the reporter. No treatment mediations were reported by the reporter.
2:30 PM vaccine listed above given, 3:02 PM cheeks flushed with slight swelling of lips, Benadryl & Pepcid taken per employee. 4:35 PM symptoms resolved,  6:34 PM employee to ER with rash, itching, and trouble swallowing.  Treatment received of  Benadryl and Solu-Medrol, symptoms improved and employee DC to home.  FU this am, employee states she has a HA and has taken med for, no further problems noted.
swelling al injection site; Injection site pain; Injection site redness; the vaccines was given subcutaneously not intramusculary; This case was reported by a pharmacist via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 92NA4, expiry date 22nd November 2021) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 31st July 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced extensive swelling of vaccinated limb, injection site pain and injection site erythema. The patient was treated with ranitidine hydrochloride and hydroxyzine hydrochloride (Hydroxizine). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but the patient could be 49 or 50 years old. The patient received Shingrix on right arm. The pharmacist reported that patient had received Shingrix and reported a local injection site reaction. Pain redness and swelling with a diameter of 6 inches around. The patient was seen by doctor's office that administered Shingrix and was prescribed hydroxizine and ranitidine. The patient went to pharmacy to pick up prescription and told the pharmacist what happened. The patient showed the pharmacist her injection site the pharmacist believed under further evaluation that the vaccine was given subcutaneously not intramuscularly, which led to wrong route of vaccination. The pharmacist stated that the redness began at the top of the tricep muscle and radiated down the arm. The reporter did not consent to follow up.
I believed vaccine caused anxiety attacks and depression. I could not leave the house without fear. I needed multiple therapy sessions and multiple medications to help overcome illness.
Patient received first dose of Pfizer COVID-19 vaccine, lot #EL9264, on 1/30/2021 at 1300. Patient has a history of allergies to Bactrim (hives), Clindamycin (unknown), nitrofurantoin (rash), penicillins (unknown), yellow dyes (hives), and azithromycin (unknown). When asked, patient states all of her allergies result in a rash treated with Benadryl--has not experienced anaphylactic shock or any life-threatening reactions. Patient was in waiting area and noticed that she felt flushed. Patient was brought back to exam room and examined by pharmacist and nurse. Erythema present at injection site, down arm, on neck, and face. Skin was flat and warm. Patient reported feeling anxious, but no nausea, dizziness, shortness of breath, or other symptoms. No swelling was noted in extremities or in lips or tongue. Blood pressure was 170/110 and heart rate was 130 bpm. Patient was given diphenhydramine 75 mg PO (was offered 50 mg but patient reported she typically takes 75 mg for past allergic reactions) and asked to stay for 30 more minutes. After 30 minutes, blood pressure decreased to 150/90 (pt has documented history of white coat syndrome), skin was less erythematous and the area of redness decreased. Asked patient if a family member could be called to pick her up; patient declined stating she lives just a few minutes away. Patient was instructed to seek emergent care if she develops difficulty breathing or other signs of anaphylaxis.
Patient presents on 3/7/21 with shortness of breath.  She has been very weak and been coughing for several days.  Her shortness of breath is severe.  She is now requiring noninvasive ventilation to maintain oxygen saturations in the emergency room. She is otherwise quite groggy and sleepy and very poor historian.  She is also in respiratory distress, receiving noninvasive ventilation with BiPAP. Required inpatient admission to ICU.
Red streak around area where she got the pneumonia shot on 10/1/13 no swelling. Tender and warm to touch.
New numbness to the tip of the tongue on the left side only, starting 8/23/21
recent diagnosis of COVID; EMS brought pt to ED in cardio-pulmonary arresily reports she has had some SOB, been weak and fatigued since being diagnosed with COVID; she has not moved around a lot; she became acutely SOB before collapsing; EMS was called; she was placed on O2; then went into Ventricular fibrillation, was shocked, CPR started, intubated; transferred to ED; given epinephrine, calcium, magnesium, bicarbonate, and tenecteplase for possible pulmonary embolism; the pt died in the ED
JAW OPENING AND CLOSING VIOLENTLY ON IT OWN; STIFFNESS IN ANKLES; DIFFICULTY WALKING; LACK OF COORDINATION; EQUILIBRIUM AND BALANCE COMPROMISED; BAD DEXTERITY; ITCHING AROUND THE MOUTH; HANDS AND FEET CURLED DOWN; NUMBNESS (HANDS AND FEET); ELECTRICAL IMPULSES IN FACE AND SCALP AND ELECTRICAL IMPULSE AROUND MOUTH AND HAND; TINGLING AROUND THE MOUTH; PAIN IN ANKLES; TINGLING IN EXTREMITIES (HAND AND FEET); CONSTANT BRIGHT LIGHT FLASHING; LIP HANGING; UNCONTROLLABLE MOUTH MOVEMENT AND JERKING; MILD FLU LIKE SYMPTOMS; LACK OF APPETITE; TWITCHING ALL OVER; TREMORS; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 182 pounds, and height was 68 inches. The patient's past medical history included extreme motor vehicle accident (other driver was drunk), and broken neck, and concurrent conditions included penicillin allergy. The patient was previously treated with methadone.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2042T21H, and expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. Concomitant medications included oxycodone.  On MAY-2021, the subject experienced tremors. On MAY-2021, the subject experienced twitching all over. On 05-MAY-2021, the subject experienced mild flu like symptoms. On 05-MAY-2021, the subject experienced lack of appetite. On JUN-2021, the subject experienced uncontrollable mouth movement and jerking. On an unspecified date, the subject experienced numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, tingling around the mouth, pain in ankles, tingling in extremities (hand and feet), constant bright light flashing, and lip hanging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from mild flu like symptoms, and lack of appetite on 08-MAY-2021, was recovering from tremors, had not recovered from numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, uncontrollable mouth movement and jerking, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, pain in ankles, tingling around the mouth, twitching all over, and tingling in extremities (hand and feet), and the outcome of constant bright light flashing and lip hanging was not reported. This report was non-serious.
approximately 10 mins after shot patient noted burning in arm that extended to chest and "a little lightheaded". VS reassuring, exam unremarkable. No signs of anaphylaxis. Symptoms improved upon discharge, VS remained stable. Last follow up was at 1500 2/24/22 (2 hours after shot), reported feeling better. Arm sore.
Diarrhea, constipation for 4 months, fatigue, ceasing of menstruation for 4 months, chills, feeling overall unwell, dizziness, headache, nausea
Had four of your COVID-19 vaccinations/ taking Paxlovid now; Had four of your COVID-19 vaccinations/ taking Paxlovid now; 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 male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had four of your COVID-19 vaccinations/ taking Paxlovid now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Even that he got Covid once vaccinated. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was taking Paxlovid (Nirmatrelvir tablets; ritonavir tablets) as treatment for Covid-19 on an unknown date.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Expiration on the Moderna was 08/31/2021 and Vaccine was given on 09/02/2021.
Booster; she had fever after the booster for two days and then it went away; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 08Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "she had fever after the booster for two days and then it went away". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On 08/DEC/2021, last week Wednesday, the patient took the booster for COVID-19 (corona virus disease 2019) so her doctor had her skip her Enbrel last Saturday 11/DEC/2021. On an unknown date in DEC/2021, she had fever after the booster for two days and then it went away. The patient now had new symptoms of fever and she did not know what from. On 15/DEC/2021, a day prior to this report, the patient had a urine sample checked and was waiting for the results. The fever was currently gone when on Tylenol and she did not have any urinary symptoms. The patient would wait for the results and call her health care professional (HCP) if still having fever or on antibiotics when due for her Enbrel on Saturday. On 15/DEC/2021, urine sample was performed. Treatment for the event fever included Tylenol (paracetamol). The causal relationship between the event pyrexia and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. No further information has been requested. Etanercept (ENBREL) is under agreement with Amgen. Causality Assessment: Fever Per Company (Amgen) = No.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
little redness today; little red dots about 8 inches around the injection site up to elbow; little bit of swelling/  5 inches wide swelling, raised swelling/ there is little bit of swelling today; great deal of pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (little bit of swelling/  5 inches wide swelling, raised swelling/ there is little bit of swelling today), PAIN (great deal of pain), ERYTHEMA (little redness today) and VACCINATION SITE ERYTHEMA (little red dots about 8 inches around the injection site up to elbow) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 17-Sep-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 17-Sep-2021, the patient experienced SWELLING (little bit of swelling/  5 inches wide swelling, raised swelling/ there is little bit of swelling today), PAIN (great deal of pain) and VACCINATION SITE ERYTHEMA (little red dots about 8 inches around the injection site up to elbow). On 20-Sep-2021, the patient experienced ERYTHEMA (little redness today). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 milligram and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING (little bit of swelling/  5 inches wide swelling, raised swelling/ there is little bit of swelling today), PAIN (great deal of pain), ERYTHEMA (little redness today) and VACCINATION SITE ERYTHEMA (little red dots about 8 inches around the injection site up to elbow) outcome was unknown.
Pediarix and prevnar given 09/04/2003; Pedvax given 09/10/2003, on the night of 09/10, developed rash.  Seen in office on 09/11/2003, diagnosed with erythema multiforme confounding factor given applesauce on 09/10 for 1st time (mom allergic to apples).
LEFT EYE SWELLED; LARGE PURPLE VEINS ON TEMPLES; BODY ACHES; CHILLS; TEMPERATURE; SEVERE HEADACHE; This spontaneous report received from a patient concerned a female 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 and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced left eye swelled, large purple veins on temples, body aches, chills, severe headache and temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the large purple veins on temples, fever, chills, body aches, severe headache and left eye swelled was not reported. This report was non-serious.  This spontaneous report received from a patient concerned a female 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, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced left eye swelled, large purple veins on temples, body aches, chills, temperature, and severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the large purple veins on temples, temperature, chills, body aches, severe headache and left eye swelled was not reported. This report was non-serious.
Extremely stiff muscles and joints, pale skin and cold sweats (cold temp), intermittent nausea throbbing headache.
Patient called the next day complaining from a sore arm, she said she had a large whelp on her arm, she said if she doesn't get better she is going to see the dr., she goes to the urgent care a couple of days later.