chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ache; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: ache). The patient was treated with acyclovir. The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR083310   Additional Information: GSK Receipt date: 13-JUN-2023 The patient age was mid-70. The patient reported aches after each dose. Treated with acyclovir. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2023AMR083310:same patient same reporter
lost voice; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (lost voice) and FATIGUE (extremely tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 031A21A) for COVID-19 immunisation.     Concomitant products included LISINOPRIL, ZOLPIDEM TARTRATE (AMBIEN) and HYDROCODONE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced APHONIA (lost voice) and FATIGUE (extremely tired). On 04-Mar-2021, FATIGUE (extremely tired) had resolved. On 06-Mar-2021, APHONIA (lost voice) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       As reported patient was extremely tired for two days and lost voice for four days after first shot. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-065183 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065183:2nd dose case
consumer states that pt recvd vax & exp somnolence for 2 days; became very irritable (crying frequently not-high pitched); persisting 2-3 wks; no fever or inject site rxn; pt behaves as if has colic; pt recovered; vaccinating MD confirms rt
persistent, intense itching - diffuse, no rash, lasted over a year; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Lot number: FF8841) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number: 30145BA, dose number: 1), for Covid-19 Immunization. The following information was reported: PRURITUS (medically significant), outcome "recovering", described as "persistent, intense itching - diffuse, no rash, lasted over a year". The event "persistent, intense itching - diffuse, no rash, lasted over a year" required physician office visit. Therapeutic measures were taken as a result of pruritus which includes UV therapy and hydroxychloroquine.; Sender's Comments: On the basis of the limited information available in this report, a medically meaningful assessment of the case cannot be made. Details regarding the drug-event temporal relationship and clinical course are not provided. However on conservative basis, the possible causality cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. This case will be reassessed once additional information is available.
3-23-07 Acute edema and redness 2 hours after injection - progressing thru 3-25-07 - Redness measuring approx 6 cm - afebrile - seen 3-26-07 by this nurse - continued edema, heat, redness 4.5 cm - Lymphedem - axilla
minor side effects with the second one / side effect / was / shivering; uncontrolled shaking of hands; This case was reported by a consumer via interactive digital media and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shivering and tremor of hands. On an unknown date, the outcome of the shivering and tremor of hands were recovered/resolved.   It was unknown if the reporter considered the shivering and tremor of hands to be related to Shingrix.  Additional details were provided as follows: The reporter had reported for himself/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient had shivering. The patient stated that, he/she would not call it that because shivering would seem to have something to do with being cold. It was uncontrolled shaking of hands. The patient was trying to text and could not. The patient went to bed and he/she was fine the next day. The patient stated that, good thing about the vaccine was, it stayed protective above 85 percent for 4 years.
This case was reported by a nurse via sales rep and described the occurrence of fever in a 57-year-old female patient who received SHINGRIX (batch number P45M9, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (injection site pain, nausea, headache and chills after receiving 1st dose on 14th May 2018, refer case US2018GSK203655). On 2nd November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, 10 hrs after receiving SHINGRIX, the patient experienced fever, headache, nausea, chills and injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, headache, nausea, chills and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, headache, nausea, chills and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the left deltoid. The patient experienced fever of 104 degree F, slight soreness at injection site, headache, nausea and chills which lasted for 3 days. The nurse did not agree to follow up.
Pt is complaining of shortness of breath and dizziness. As well as typical post-covid vaccination symptoms (i.e. aches, fever/chills). All symptoms started roughly noon - vaccination was around 4PM the previous evening.
CONFUSED AS OBTAINING DIFFERENT DATES WHEN SCANNING BAR CODE FOR EXPIRY DATE; This spontaneous report received from a pharmacist 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: 1805018, and expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced confused as obtaining different dates when scanning bar code for expiry date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confused as obtaining different dates when scanning bar code for expiry date was not reported. This report was non-serious.
Patient reported severe skin reaction at site of injection that had spread over large portion of upper arm. Patient visited doctor and received steroid injection.
Soreness in arm and neck. Approx. 14 hours after injection began/ body ache; Slight fever; chills; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported), dose 2 via an unspecified route of administration on 16Feb2021at 08:00 (age at vaccination: 38-year-old),  as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number not reported, age at vaccination: 38-year-old), on an unknown date for covid-19 immunization. No covid prior vaccination and not tested for covid post vaccination. On 16Feb2021 at 22:00 approx 14 hours after the injection, the patient experienced soreness in arm and neck, slight fever, chills and body aches. No treatment was received for the events. The outcome of all events was unknown.  No follow-up attempts are possible. Information about lot/batch number can not be obtained. No further information is expected
Fever, chills, headache, congestion (nasal & chest), rapid heartrate. Start approx. 5:30pm on 10/18/11 and "in full-force" at 7PM. Symptoms began subsiding Wed (10/19/11) afternoon.
Reported to Employee Health with urticaria, mild edema of eyelids, chin and upper lip.
Runny nose Fatigue Headache Muscle pain Joint pain Tenderness at the injection site
After 10 minutes became sweaty and hyperventilating  B/P 134/94 P 95 R 24 patient reported she was diabetic and felt blood sugar was low. Gave 2 apple juice and a few M M's
Pt was dx with cellulitis on 12/15/14. Pt put on KEFLEX.
COVID positive diagnosis 28Jul2021; COVID positive diagnosis 28Jul2021; This is a spontaneous report from a contactable consumer. A 62-years-old female consumer (patient) reported for herself.  A 62-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection.), dose 1 via an unspecified route of administration, administered in left arm on 04Mar2021 at 12:00 (Lot number: unknown) as dose 1, single, dose 2 via an unspecified route of administration, administered in right arm on 25Mar2021 at 10:45 (Lot number: unknown) as dose 2, single for COVID-19 immunization (at the age of 62-years-old). Medical history included moderate to severe atopic dermatitis. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. Patient had no COVID-19 prior vaccination. Patient had no known allergies. Concomitant medication included acetylsalicylic acid (BAYER ASPIRIN) in two weeks. The patient experienced COVID-19 positive diagnosis on 28Jul2021. Adverse event start on 22Jul2021 at 01:45 PM. Seriousness criteria-results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect all reported as no. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on post vaccination on 28Jul2021. Adverse event resulted in, Doctor or other health care professional office/clinic visit. Adverse event treatment include Medrol dosepak. The outcome of the event COVID positive diagnosis 28Jul2021 (covid-19) was not recovered and unknown for another event.  Information about lot/batch number cannot be obtained. Information on the lot/batch number has been requested.
Presented to Emergency Room with shortness of breath and decreased O2 sats on pulse oximetry.  Recently treated at Hospital twice over the past month.  Received Ceftriaxone and Azithromycin at Hospital from 8/31-9/7/2021 for Pneumonia.
covid-19; sick; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (covid-19) and ILLNESS (sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 COVID-19 (covid-19) and ILLNESS (sick). At the time of the report, COVID-19 (covid-19) and ILLNESS (sick) 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 reported. Treatment included- Antibody treatment, Z-pack
Fever over 101.00 recording at approximately 2.30AM, patient had taken dose of tylenol at approximately 1:30 after feeling very warm in bed with chills, joint pain and body weakness; symptoms lasted for about 24 hours. Several days after symptoms of body weakness and tiredness
Within 15 minutes I started getting lightheaded and sweaty.  I called nurse over and told her I needed to lie down.  She pointed to the gurney but it was too far away and I was too weak so she had me out my head between my knees.  Another nurse brought me a bottled water and pack of crackers.  I drank the water slowly and started feeling better after 30 minutes.
Inappropriate schedule of vaccine administered; Overdose; fever; muscle and joint aches; muscle and joint aches; weakness; nausea; stomach cramps; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 (Lot number: FC3183) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: I had previously had Covid. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/lot number: FC3183, Route of administration: Intramuscular, Anatomical Location: Arm Left), administration date: 27Aug2021, when the patient was 49 years old, for Covid-19 immunization, reaction(s): "excruciating headache", "fever", "chills", "muscle and joint aches", "muscle and joint aches", "weakness". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "fever"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "muscle and joint aches"; ASTHENIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "weakness"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "nausea"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "recovered" (2021), described as "stomach cramps"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 27Aug2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; OVERDOSE (non-serious) with onset 27Aug2021, outcome "unknown", described as "Overdose". Therapeutic measures were not taken as a result of pyrexia, myalgia, arthralgia, asthenia, nausea, abdominal pain upper.  Additional information: Reporter stated that, patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient was not diagnosed with COVID-19 prior to vaccination and patient had not been tested for COVID-19 since the vaccination. Patient was not hospitalized and no hospitalization prolonged. After second dose: fever, muscle and joint aches, weakness, nausea, stomach cramps. These lasted 48 hours. I had these symptoms after each dose even though I had previously had COVID.  No follow-up attempts are possible. No further information is expected.
I wasn't feeling good so I did not go and I did not get a second appointment since then; I still did not get the second shot; I did not get a second appointment since then and I did not get an appointment, they have new waiting for appointment, so this is almost 2 months since I got it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Feb2021 (Lot number: EN6200) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D 2000. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I wasn't feeling good so I did not go and I did not get a second appointment since then; I still did not get the second shot"; PRODUCT DOSE OMISSION ISSUE (non-serious), outcome "unknown", described as "I did not get a second appointment since then and I did not get an appointment, they have new waiting for appointment, so this is almost 2 months since I got it".  Additional Information: She was just trying to ask a question, she got the Pfizer on February 18 and she was supposed to get it back on March 11, the second one and she wasn't feeling good so she did not go and she did not get a second appointment since then and she did not get an appointment, they have new waiting for appointment, so this was almost 2 months since she got it, she was going to have to take the Pfizer all over again or she still can get the second shot (Unspecified Medication). She reschedule for her second shot and she still cannot get an appointment to go, so she still did not get the second shot.  No follow-up attempts are possible. No further information is expected.
No additional AE details; Product storage error; This spontaneous report has been received from a medical assistant, regarding a 5-year-old female patient. The patient's pertinent medical history, previous drugs reactions or allergies and concomitant medications were not reported.  On 23-MAR-2022, a varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U025790, which was determined to be valid, with an expiration date of 19-AUG-2023) underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours and -10 degrees C up to 8 degrees C for 1 hour 30 minutes. It was stated that a data logger was involved. There was no previous temperature excursion reported. Then, on 12-APR-2022, the patient was vaccinated with the second dose of the aforementioned improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneously (sq) as prophylaxis (dose and anatomical location were not reported) (product storage error). It was stated that the event was attributable to the device component malfunction, however there is no device involved. No additional adverse event was reported.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2204USA009330: US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852: US-009507513-2205USA008008: US-009507513-2205USA008028: US-009507513-2205USA008051: US-009507513-2205USA007982: US-009507513-2205USA008105: US-009507513-2205USA008189: US-009507513-2205USA008004:
Within the hour I had nausea and a small headache. My arm started to hurt within 4 hours and got so bad I couldn't touch it later that night. Body aches and chills happened around 8pm and continued for the next day. Today is 4/23/21 and symptoms are better. I'm only feeling fatigue and a little soreness in my arm.
Information has been received from a physician concerning a patient who was vaccinated with a dose of PROQUAD. It was reported that after receiving the vaccination the patient developed neutropenia. Unspecified medical attention was sought. Additional information has been requested.
This spontaneous report as received from a physician assistant refers to a 64 year old female patient with allergy to codeine, rheumatoid arthritis, hepatitis B, hyperlipidemia, hypertension, latent tuberculosis, chronic renal insufficiency, stroke, myocardial infarction, venous stasis, eczema and anemia. The patient's medical history included right-sided Carotid endarterectomy (CEA). On 14-OCT-2013 the patient was vaccinated with ZOSTAVAX (route, dose and lot # were unknown). The physician assistant reported that a patient almost lost her voice within 24 hours after receiving ZOSTAVAX on 14-OCT-2013. The physician assistant reported that the patient almost lost their voice becoming very hoarse. The physician assistant reported that the patient continued to have trouble with "phonation" and her voice was sometimes very weak, but the physician assistant stated it was getting better. None of treatment was given for adverse event. None of lab diagnostics studies was performed. The patient sought medical attention via contacting physician assistant. Upon internal review, loss of voice was considered to be a medically significant event. Additional information has been requested.
12/31/05 6 pm fever like symptoms used infant Tylenol. 1/1/06 8 pm fever like symptoms used infant Tylenol. 1/1/06 seemed to have trouble swallowing when eating-seemed related to congestion-gave Pediacare.  1/1/06 morning noticed mild measle like rash on face and body.  Also noticed increased episodes of tightening fists and body tensing.  Still feeling effects at the time of reporting.
Gave pt 0.05ml in the left deltoid and realized had underdosed and gave additional 0.45ml in the left deltoid to complete the 0.5ml dosage
Information has been received from a registered nurse referring to eleven unspecified patients of unknown age and gender. On multiple unspecified dates, the patients were administered improperly stored VARIVAX (Merck) (lot# reported as K015972; expiration date: 23-SEP-2016, lot# L010148; expiration date: 24-MAR-2017, route and dose were unknown). No adverse effect were reported. Additional information has been requested.
short of breath; strong heart palpitation; feeling unwell; drowsy; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (short of breath), PALPITATIONS (strong heart palpitation), MALAISE (feeling unwell) and SOMNOLENCE (drowsy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20/2A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] and ESCITALOPRAM for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced DYSPNOEA (short of breath), PALPITATIONS (strong heart palpitation), MALAISE (feeling unwell) and SOMNOLENCE (drowsy). At the time of the report, DYSPNOEA (short of breath) and MALAISE (feeling unwell) outcome was unknown and PALPITATIONS (strong heart palpitation) and SOMNOLENCE (drowsy) had resolved.        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.   Treatment information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Awoke 10/5/17 morning after flu vaccine and unable to blink left eye,or raise left eyebrow, numbness tingling left side of face. Unable to open mouth fully. Has left sided facial palsy that involves the forehead.
Vaccinator team discovered patient received the 50mcg/0.25mL moderna dose instead of the  Young pedi moderna dose of 25mcg/0.25mL following their QA review of administrations for  the day.  Clinical leads were notified that day and parent for patient was called and notified of error. Parents advised to monitor for any unusual side effects.