chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered AS01B Adjuvant; administered AS01B Adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 52LX4, expiry date 4th April 2023) for prophylaxis.   On 10th February 2022, the patient received the 2nd dose of Shingrix. On 10th February 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received AS01B adjuvant of Shingrix without the lyophilized antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
GUARDIAN REPORTS CHILD'S RGIHT UPPER ARM RED, WARM, AND PAINFUL. REPORTS EXTENDS FROM ABOVE THE INJECTION SITE TO A COUPLE OF INCHES ABOVE THE ELBOW.
Vaccine was administered after being vial was left out for longer than the 12 hour period. Patient has experienced no adverse effects.
febrile seizure 6 days p/MMR; pt also w/URI-WBC=17;
MULTIPLE SKIN LESIONS ALL OVER BODY 3 WEEKS AFTER VACCINE ADMINISTRATION TREATMENT - ACYCLOVIR (1 TSP POQID X5D)
No further information was provided; PNEUMOVAX 23 was administered to three patients after the excursion occurred; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-OCT-2021, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T039322, (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered vaccine experienced temperature excursion of 23.9 degrees Celsius for 31 minutes on 11-OCT-2021. There were no previous excursions reported. No additional adverse event was reported.  This is one of tree reports from the same reporter. ; Sender's Comments:  US-009507513-2110USA005005: US-009507513- 2110USA004979:
This literature marketed report as received from a other health professional refers to a 5 month old female patient. On an unknown date the patient was vaccinated with PEDVAXHIB. Concomitant therapies were not reported. On an unknown date the patient experienced blotchy skin rash. There was no associated shortness of breath or wheeze. The reporter opted not to perform skin testing due to the mild nature of the reaction and the desire to avoid excessive skin tests in this very young patient. The patient was administered the vaccine antigens individually, each at the next recommended dosing interval, in challenge doses. The reporter selected alternative preparations to administer based on subsequent reactions and components of the individual vaccines, using the CDC's Vaccine Excipient and Media Summary which lists all components of commercially available vaccines. Haemophilus b antigen was determined to be the causative agent. Conclusions: Identifying the causative agent in a patient with a vaccine reaction is critical to minimize the change of reaction recurrence which, if IgE-mediated, could be life-threatening upon reexposure. Concurrently, the necessity of immunization cannot be overstated. Many reactions are often attributed to vaccine excipients. In this case, careful evaluation demonstrated that the rash was in response to the hemophilus b antigen itself. The outcome of blotchy skin rash was reported as recovered after 20 minutes without treatment. The reporter considered blotchy skin rash to be related to PEDVAXHIB. Additional information is not expected.
Swollen eyes, full feeling, uncomfortable in abdomen, night sweats, itchy hands and feet.
I had no effects the day of the vaccine. When I woke up the next morning (2/11/2021) I had a rash on my face. It looked like small white heads. I popped a couple of them and then noticed they were all over and my face was red under the bumps. It itches, but there is no pain.
Tinnitus, weakness, headache, loss of thought process, can?t walk.  Lasts about 80 minutes.  3 episodes so far.  First time called Para medics, second time 4 days later went to Emergency room, CT scans, blood  work, given fluid IV.  12 hours later same symptoms went back to ER told just lay down.    First event  3/11
On day 8, the injection site arm throbbed, got very swollen (probably an area of 6"x6") very red, hot and itchy.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age who in 2011, was vaccinated with the first dose of GARDASIL and today, on 07-JUL-2012, received the second dose of GARDASIL (Doses, routes and lot numbers not reported). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 53 year old male. The patient's weight was 175 pounds, and height was 70 inches. The patient's concurrent conditions included: hypertension, penicillin allergy, sulfa drug allergy, seafood allergy, fish allergy, seasonal allergies, alcohol user, and smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027 expiry: 29-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. Concomitant medications included apixaban for hypertension.  On 20-OCT-2021, the patient experienced confirmed covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection. This report was non-serious. This case, from the same reporter is linked to 20211039865.
Patient complains of sore arm lasting longer than she has ever experienced with flu shot in the past. Seen by MD with continued soreness on 11/7/19. Outcome unknown
Rash on back of hands, palmar aspect of fingers, upper arms, anterior thighs, posterior lower legs, heels and plantar aspect of feet. It's red and itchy.  Looks like multiple separate round circles ranging in size from punctate to as big as a nickle. I woke up with it Sunday morning and slowly more spots have appeared. None of the original spots have started fading, all of them still itch.
Patient reported injection site to be red & swollen. Observed area to approximately 2-3 in diameter. Informed Pt to take BENADRYL, pt reported marked improvement.
Patient did not receive the second dose of the Moderna COVID-19 vaccine, and 49 days have elapsed since the first dose; 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 PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of the Moderna COVID-19 vaccine, and 49 days have elapsed since the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of the Moderna COVID-19 vaccine, and 49 days have elapsed since the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of the Moderna COVID-19 vaccine, and 49 days have elapsed since the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication were provided. No lab data has been provided by the reporter.    Reporter did not allow further contact
2 1/2 cm tender induration on left arm at Varivax site 2 days after administration. No Rx required, resolved spontaneously. No systemic symptoms.
Fever 8 days, followed by rash that lasted 2 days. Now extremely cranky.
Severe disruption in menstrual cycle. Period came 14 days early, with significant difference in PMS symptoms, heavier flow, worse cramping and hormonal effects felt for 2 weeks after.   Have Mirena IUD.
RC'D MMR 9-11-12 next day extreme joint muscle pain in (L) arm were given. Feels week. No OTC relive. Here today 10-12-12 still the same. No redness, swelling, rash, or fever just weakness and joint pain in the (L) arm were given.
Area is warm to touch; Really swollen, it got to the size of nickle; Pretty good sized bump; Discolored where bump is; It bruised right away; It's feverish on and off/it's feverish on and off; Dizziness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (It bruised right away), VACCINATION SITE MASS (Pretty good sized bump), VACCINATION SITE DISCOLOURATION (Discolored where bump is), VACCINATION SITE WARMTH (Area is warm to touch) and VACCINATION SITE SWELLING (Really swollen, it got to the size of nickle) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced VACCINATION SITE BRUISING (It bruised right away), PYREXIA (It's feverish on and off/it's feverish on and off), DIZZINESS (Dizziness) and NAUSEA (Nausea). On 27-Sep-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Discolored where bump is). On an unknown date, the patient experienced VACCINATION SITE MASS (Pretty good sized bump), VACCINATION SITE WARMTH (Area is warm to touch) and VACCINATION SITE SWELLING (Really swollen, it got to the size of nickle). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 23-Sep-2021, PYREXIA (It's feverish on and off/it's feverish on and off), DIZZINESS (Dizziness) and NAUSEA (Nausea) had resolved. At the time of the report, VACCINATION SITE BRUISING (It bruised right away), VACCINATION SITE MASS (Pretty good sized bump), VACCINATION SITE DISCOLOURATION (Discolored where bump is), VACCINATION SITE WARMTH (Area is warm to touch) and VACCINATION SITE SWELLING (Really swollen, it got to the size of nickle) 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 did not provide any causality assessments.   This case was linked to MOD-2021-333519 (Patient Link).
Severe lower back muscle spasms.  Ibuprofen (1000 mg: 12 hours) along with rest & stretching exercises provide slight and brief temporary lessoning painful spasms.
This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-MAY-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L032761, expiry date 24-FEB-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Redness, swelling and pain at injection site. Headache, malaise and fever of 102F.
Dizzy spells (room spinning,  nausea) for first 2 weeks. Now only having light headed and nausea spells no dizziness.  Does  seem to be getting less severe as time goes by but still having spells.  Had an MRI done on 04/26/2021 of my head and everything came back normal.
sore arm; 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 (159558). The reporter is the patient.  A 87 year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BABY ASPIRIN. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Unaddressed medical questions were forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection site is hot to the touch an a little swollen; Injection site is hot to the touch an a little swollen; Tired; fever; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE WARMTH (Injection site is hot to the touch an a little swollen), PYREXIA (fever), VACCINATION SITE SWELLING (Injection site is hot to the touch an a little swollen) and FATIGUE (Tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concurrent medical conditions included Allergy to antibiotic (CEFTIN). Concomitant products included LORAZEPAM and CITALOPRAM for Anxiety, ATORVASTATIN for Cholesterol, TEMAZEPAM for Sleep disorder NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) and CALCIUM CHLORIDE, GLYCINE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE (CENTRAMIN) for an unknown indication.   On 30-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site is hot to the touch an a little swollen), VACCINATION SITE SWELLING (Injection site is hot to the touch an a little swollen) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (Injection site is hot to the touch an a little swollen), PYREXIA (fever), VACCINATION SITE SWELLING (Injection site is hot to the touch an a little swollen) and FATIGUE (Tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown)   This case was linked to MOD-2021-251834 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: Reporter details updated, new events updated, concomitant medication and treatment details were updated. On 08-Jul-2021: Significant follow-up appended
Patient went to the E.R. with the following symptoms: sore throat, cough, congestion, and sneezing. This happens 3 days after vaccination. After long consultation, the patient still believes that his symptoms have been caused by the Flu vaccine. The ER doctor gave patient a prescription for Penicillin.
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient's information was updated. On 11-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Patient called me today (4/27/21). Said she got a very red face yesterday. Went to Dr. who prescribed prednisone and doxycycline. When she called me today, she complained of trouble breathing. I impressed upon her the urgent need to call back to the doctor and expressly tell them that she had this Moderna shot on 4/16/21. It was 4:38 pm when I spoke with her, and told her to call now so she could catch them before they leave the office.
Flu-like symptoms (second dose); Sore arm (second dose); Tired (second dose); This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms (second dose)), MYALGIA (Sore arm (second dose)) and FATIGUE (Tired (second dose)) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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 an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms (second dose)), MYALGIA (Sore arm (second dose)) and FATIGUE (Tired (second dose)). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms (second dose)), MYALGIA (Sore arm (second dose)) and FATIGUE (Tired (second dose)) outcome was unknown.      The patient has a half lung.  Concomitant medications included blood thinners, kidney medications and heart medications.  Treatment information was not provided.
My arm doesn't feel quite right.; I'm not in pain but it feels different.; Also ot seems that my entire body has undergone changes.  I'm waking up earlier I feel fatigued.; Also ot seems that my entire body has undergone changes.  I'm waking up earlier I feel fatigued.; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (My arm doesn't feel quite right.), FEELING ABNORMAL (I'm not in pain but it feels different.), INSOMNIA (Also ot seems that my entire body has undergone changes.  I'm waking up earlier I feel fatigued.) and FATIGUE (Also ot seems that my entire body has undergone changes.  I'm waking up earlier I feel fatigued.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 24-May-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 LIMB DISCOMFORT (My arm doesn't feel quite right.), FEELING ABNORMAL (I'm not in pain but it feels different.), INSOMNIA (Also ot seems that my entire body has undergone changes.  I'm waking up earlier I feel fatigued.) and FATIGUE (Also ot seems that my entire body has undergone changes.  I'm waking up earlier I feel fatigued.). At the time of the report, LIMB DISCOMFORT (My arm doesn't feel quite right.), FEELING ABNORMAL (I'm not in pain but it feels different.), INSOMNIA (Also ot seems that my entire body has undergone changes.  I'm waking up earlier I feel fatigued.) and FATIGUE (Also ot seems that my entire body has undergone changes.  I'm waking up earlier I feel fatigued.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she is  diabetic but it's controlled well by pill. Treatment information was unknown.
Vaccination on Wednesday. Felt normal fatigue and pain Wed/Thu/Fri. Felt completely fine Fri evening and Saturday. Woke up Sunday with severe dizziness and slight ringing in ears. Rest didnt help. Took Benedryl and seemed to get better in the night. Woke up Monday again with dizziness. Slightly better but still not able to work or do activities. Pharmacy referred to Physician - waiting for that appointment.
Nauseous; I was definitely sick; I throw up like 6 times and I had a pain in my stomach by that; Headache; This is a spontaneous report from a contactable consumer. This 70-years-old (at the time of vaccination) female consumer reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EN5318) NDC, UPC number, expiry date; unknown via an unspecified route of administration on 12Feb2021 at single dose on right arm for covid-19 immunisation. Patient's weight was 52.62 kg and height 163 cm. Patient's medical history included cirrhosis of liver and blood thinner (dates unspecified). Concomitant medications included unspecified medication, lot number; unknown, Reason for no lot number; suspect was captured for query, expiry Date of Unspecified Medication; Not Supplied, Unspecified Medication manufacturer; Moderna from an unspecified date to an unspecified date at unspecified dose and frequency for unknown indication (Other Products: Yes). Consumer stated, "I wanted to tell you about the side effects I have had from the Pfizer Shot, I had it on 12Feb2021 and next day on 13Feb2021 I have just slight headache and that was fine that went away and then the 5th day on 17Feb2021 that night I throw up. I was definitely sick, I throw up like 6 times and I had a pain in my stomach by that threw up 6 times and then the next morning I was nauseous though I had a piece of dry toast and then I felt better when the day went on but then this week on Monday, Tuesday, Wednesday and today I feel better but I am still kind of nauseous. I want to report it but I don't know if that's common. Is that common for this shot." Treatment was not given for the AEs. When asked about lab test, consumer stated, "Yes, I did but not today, I tell you some other blood thinner." (Further clarification was unknown). Consumer added, "I was just wondering if I could have the different shots (Unspecified Medication) maybe like the Moderna one that would help." The outcome of events was recovering and for nausea was not recovered.