chrisvoncsefalvay/vaers-outcomes huggingface dataset:
syncope; I've experienced right eye pain; right arm muscle / right leg muscle / pain; right arm / right leg / joint pain; Fatigue; Swelling at injection site; leakage to injection site.; Rhinitis; insomnia; coughing,; dizziness; This case was reported by a nurse and described the occurrence of syncope in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th October 2020, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 14th October 2020, less than a day after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced syncope (serious criteria GSK medically significant), eye pain, muscle pain, joint pain, fatigue, injection site swelling, injection site leaking, rhinitis, insomnia, cough and dizziness. The patient was treated with paracetamol (Acetaminophen) and ibuprofen. On an unknown date, the outcome of the syncope, eye pain, muscle pain, joint pain, fatigue, injection site swelling, injection site leaking, rhinitis, insomnia, cough and dizziness were unknown.   It was unknown if the reporter considered the syncope, eye pain, muscle pain, joint pain, fatigue, injection site swelling, injection site leaking, rhinitis, insomnia, cough and dizziness to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient age group was not reported but it was captured as per qualification (nurse) of the patient. The age at vaccination was not reported. The nurse reported that, he or she experienced right eye pain, right arm muscle and joint pain, right leg muscle, joint pain, fatigue, swelling at injection site, leakage to injection site, rhinitis, insomnia, coughing, syncope and dizziness. The reporter had all these lovely things didn't have before this flu shot.
Fever started the day of vaccination ranges from 99.0 to 99.9.  Has not taken any fever-reducing medication.
hallucinations; neurological disorder classified as early Alzheimer's/dementia; neurological disorder classified as early Alzheimer's/dementia; neurological disorder classified as early Alzheimer's/dementia; This is a spontaneous report from a contactable pharmacist. An 80-year-old female patient (non-pregnant at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17May2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. Unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. On 17May2021, the patient was admitted to the hospital due to hallucinations, neurological disorder classified as early Alzheimer's/dementia. AE resulted in Emergency room/department or urgent care, Hospitalization. Unknown if patient had treatment received for events. The outcome of the events was unknown. This report was assessed by the reporting pharmacist as serious; the seriousness criteria was caused/prolonged hospitalization.  Information on the lot/batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment. Based on the limited  information provided, the reported events are likely intercurrent condition that is unrelated to BNT162B2. This case will be reassessed once additional information becomes available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Child was sitting on mother's lap and lost consciousness, child was laid down and mask removed.  Vital signs were stable. Child regained consciousness immediately.  Client drank some water and was able to sit up and stand up without feeling dizzy.  Client discharged home with mother.
Covid booster; Sore arm; Pain in her shoulders, joints, and muscles; Pain in her shoulders, joints, and muscles; Pain in her shoulders, joints, and muscles; skin is tender; she is in a lot of pain; Arthritis; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 96 year-old female patient received bnt162b2 (BNT162B2), administration date 04Oct2021 (Lot number: FF2588) at the age of 96 years as dose number unknown (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 2021 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1 ; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose number: 2 ; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 04Oct2021, outcome "unknown", described as "Covid booster"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "Sore arm"; ARTHRALGIA (non-serious), ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset Oct2021, outcome "unknown" and all described as "Pain in her shoulders, joints, and muscles"; PAIN OF SKIN (non-serious) with onset Oct2021, outcome "unknown", described as "skin is tender"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "she is in a lot of pain"; ARTHRITIS (non-serious) with onset 2021, outcome "unknown", described as "Arthritis". The events "sore arm", "pain in her shoulders, joints, and muscles", "pain in her shoulders, joints, and muscles", "pain in her shoulders, joints, and muscles", "skin is tender", "she is in a lot of pain" and "arthritis" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, arthralgia, arthralgia, myalgia, pain of skin, pain, arthritis. Additional information: Expiry Date and NDC number of Pfizer covid booster was unknown. Patient was trying prednisone for a month now and it does not help it all. She does not have it handy to provide lot, ndc, or expiration date. There was a Product Complaint.  No follow-up attempts are possible. No further information is expected.
This lot number expired in refrigerator on 1/17/22. It was not taken out of the refrigerator and was given after that date.
(L) arm swollen and hard in the area where vaccine were given. Gave pt an ice pack to put on swollen area.
given the Covid 19 vaccine and subsequently tested positive for SARS CoV2 a day or so later; given the Covid 19 vaccine and subsequently tested positive for SARS CoV2 a day or so later; This is a spontaneous report from a non-contactable healthcare professional via Pfizer sales representative. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, from an unspecified date, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient was given the COVID 19 vaccine and subsequently tested + for SARS CoV2 a day or so later on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
Case number PHEH2012US011717 is an initial spontaneous report received from a nurse on 07 Jun 2012 and a follow up received from the nurse on 02 Jul 2012. This report refers to a female patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that she was vaccinated intramuscularly into left deltoid muscle, only with the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X11065) and did not receive the MenA lyophilized conjugate vaccine component on 07 Jun 2012. On the same day concomitantly she was vaccinated with Typhoid vaccine (manufacturer unknown, batch number: G0508-1) intramuscularly into his right deltoid. No adverse event was reported following the maladministration. On 14 Jun 2012, she was vaccinated with the whole dose of MENVEO. No other information was available. Follow up information received from the nurse on 02 Jul 2012: Updated concomitant vaccine given on 07 Jun 2012, and the patient was revaccinated with whole dose of MENVEO on 14 Jun 2012.
my arm  was black and blue,  I woke up with   head hurting diarrhea for 4 days, then I started having whelps all the way to my ears and down my chest and today Feb     26 I still have them but not as bad.    Is it ok to take my 2nd shot  March 8th ?
This report was received from Novartis (manufacturer report number S2010US32233) concerning an 11 year old female patient with a history of 2 cases of chickenpox even after receiving VARIVAX (Merck), who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (Lot # and route not reported). It was reported that the patient increased in sleep patterns, drinking like there is no tomorrow and exposed to chickenpox. At the time of the report, the outcome of the patient was not reported. This was originally reported by a consumer. Additional information has been requested.
This case was reported by a consumer and described the occurrence of pain localized in a 62-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of heart rate increased (also experienced shaking of hand, calves quivered, local pain, joint pain and low energy, refer case US2018GSK108687). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced pain localized, joint pain, muscle pain, influenza-like symptoms, fever, night sweat and energy decreased. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain localized, joint pain, muscle pain, influenza-like symptoms, fever, night sweat and energy decreased were recovered/resolved. It was unknown if the reporter considered the pain localized, joint pain, muscle pain, influenza-like symptoms, fever, night sweat and energy decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced local pain for 3 days, extreme joint and muscle pain like the flu after 12 hours after vaccination and continuing for 24 hours. The patient also experienced low grade fever, night sweats and low energy for 3 days. The patient was back to normal after this period.
Severe fatigue for going 6 weeks, swollen lymph nodes, severe inflation, joint aches
pt recv vax; swelling, erythema, pain at site extending to elbow; tx w/ dph & cool packs;
Had all the shots and still got a bad case/Suspected vaccination failure; Bad case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 3-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient had all the shots and still got a bad case of the shingles. The reporter denied for follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Elevated resting heart rate; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Elevated resting heart rate) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     The patient's past medical history included Heart murmur (history of heart murmur/double beat).    On 26-Jul-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 HEART RATE INCREASED (Elevated resting heart rate). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Elevated resting heart rate) 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.   Concomitant products were not provided/unknown. Reportedly, patient's Blood Pressure was normally it's in the 70s and now in the 100s.Patient further stated this morning her heartrate was 100 and then it dropped to 98 after she sat down for a few minutes. Patient states she also also recorded a 102 resting heart rate.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 7th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain, fever and feeling unwell. On an unknown date, the outcome of the injection site pain, fever and feeling unwell were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, fever and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain at shot site, fever of 100.4 degree F and not feeling well. The reporter stated he only wanted to know that how long the effects might last.
Information has been received from a registered nurse concerning a male who an approximately 01/03/2001, was vaccinated with a first dose of hep B vaccine recombinant. Immediately after vaccination, the pt complained of feeling unfocused, dizzy, hot, sweaty, like something in the chest-tightness that lasted only seconds. The pt also reported weakenss and tinnitus. The nurse stated she would like the lot checked. Unspecified medical attention was sought. Another pt had a similar experience after vaccination with the same  lot. The records of testing prior to release of this lot have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Moderate pain/ pain was only from her shoulder to her elbow; Moderate pain/ pain was only from her shoulder to her elbow; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) intramuscular, administered in the left arm, on 09Apr2021, 12:00 (batch/lot number: EP6955) at the age of 47 years old, as DOSE 1, SINGLE for COVID-19 immunization. The patient received the vaccine at a Pharmacy/Drug Store vaccination facility. The patient's medical history included anxiety from an unknown date and ongoing, and pain from an unknown date. Concomitant medications included escitalopram oxalate (LEXAPRO) taken for anxiety from 2019 and ongoing; and paracetamol (TYLENOL) oral taken for pain from 09Apr2021 and ongoing (as reported). There were no prior vaccinations. The patient reported that after the first dose on 09Apr2021, she had moderate pain, nothing serious. The pain was only from her shoulder to her elbow. The outcome of the event "moderate pain/ pain was only from her shoulder to her elbow" was unknown.   Follow-up attempts are completed. No further information is expected.
Vaccine expired on 24-April-2022, vial was initially stored in the refrigerator on 23-Jun-2022 and unused portion was put in refrigerator; No adverse event; Dose administered after manufacturer date of expiry to 12 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients), PRODUCT STORAGE ERROR (Vaccine expired on 24-April-2022, vial was initially stored in the refrigerator on 23-Jun-2022 and unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 45-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 24-April-2022, vial was initially stored in the refrigerator on 23-Jun-2022 and unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients), PRODUCT STORAGE ERROR (Vaccine expired on 24-April-2022, vial was initially stored in the refrigerator on 23-Jun-2022 and unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 24-April-2022, vial was initially stored in the refrigerator on 23-Jun-2022 and unused portion was put in refrigerator).    No concomitant medications were reported. Number of doses/vials was reported as 200 doses 20 vials. The vial was initially stored in the refrigerator on 5-May-2022, 6-May-2022, 19-May-2022, 02-Jun-2022, 09-Jun-2022 and 23-June-2022. Office manager explained that vaccines were removed from the freezer on date of appointments to be used, and the unused portion was put back in refrigerator. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-619547 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-619547:
approx 2 mins of p/vax pt became nauseated, diaphoretic, state feels funny; had pt put head between knees, wet cool cloth to face, neck; pt stayed in this position for 1-2 mins; arms cold, clammy; ashen skin color; BP 60/40;
As stated in the patient information, First time filling out. After taking a shower, there were hives on the back of my legs at least 3 - 4 inches. Prevented myself from itchy any further in case it worsens. Today my wrist on my left arm started to feel itchy.  Been keeping myself hydrated and would feel more muscle pain from time to time. The moment I felt relaxed is when I feel body aches. It is tolerable but this is only day 2 and will be getting my 2nd dose in March.
muscle tightness; bell headache; no second dose since 12Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (muscle tightness), HEADACHE (bell headache) and PRODUCT DOSE OMISSION ISSUE (no second dose since 12Feb2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TIGHTNESS (muscle tightness), HEADACHE (bell headache) and PRODUCT DOSE OMISSION ISSUE (no second dose since 12Feb2021). At the time of the report, MUSCLE TIGHTNESS (muscle tightness), HEADACHE (bell headache) and PRODUCT DOSE OMISSION ISSUE (no second dose since 12Feb2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
URTICARIAL RASH STARTING ON CHEST AND UPPER BACK AS WELL AS LICTHEN PLANUS LOOKING LESIONS TO TORSO.
I had a bad flare up of my medical condition POTS which caused dizzenesnd I s, fatigue, and I couldn't do much of anything. Usually when I get a flare up it goes away for some time but its a little different now. I got a yeast infection and I haven't had one in over 30 years.
body and muscle aches, last night had fever 102, nausea, low appetite 101 today, took Advil other symptoms have stayed the same fever controlled with medications arm also sore at vaccine site, but no warmth, redness or swelling denies SOB, difficulty swallowing or breathing
The patient was seen in the ED on 10/8/23 with cough, fatigue, poor appetite, myalgias, and fever that began three days prior. A COVID PCR test done in the ED resulted positive. Ultimately, the patient was admitted to the hospital from 10/8/23 - 10/12/23, with discharge diagnoses including pneumonia due to COVID-19 virus and secondary acute hypoxic respiratory failure, among other diagnoses. During admission, the patient required supplemental O2, however was able to wean to room air by discharge. She was briefly on dexamethasone.   Of note, the patient has received three doses of the Pfizer monovalent COVID vaccine (given 2/2/2021; 2/23/2021; 10/27/2021).
Developed swelling, leg pain and shortness of breath within 10-14 days following his 1st covid 19 vaccine, was diagnosed with a DVT and pulmonary embolism on CT scan in the hospital, did require hospitalization.
pt recv vax 8NOV95 & pt failed to seroconvert;no further details were provided;
This spontaneous report as received from a physician via company representative refers to two patients of unknown demographics. The reporting physician stated that "over the course of the last three years, on unspecified date two patients were vaccinated with ZOSTAVAX (lot#, route of administration, expiration date, dose not provided), and later, on unspecified date, developed a mild case of shingles. At the time of vaccination all two patients were 65 years of age or older. The outcome of the event for two patients was reported as recovered from shingles (date of recovery not provided). The relatedness between the event and vaccination with ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information is not expected.