chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt nauseous the day (Friday) of my first Covid-19 shot. The following day (Saturday) I had a fever of 103 degrees and I was shivering. My body was stiff and I had trouble moving. The next day (Sunday), my fever had reduced to 100 degrees. I still felt sore. Today (Monday), my fever is mostly gone, yet I am exhausted.   The day after my shot, I thought to go to the hospital, but I was too tired, and sore to move. Instead, I called Teladoc. They issued me medication for nausea and told me to take Tylenol for my fever. I realize that this is a typical reaction. I had a really bad bout of Covid-19 in December of 2020, which lasted for over a month in which I had a very high fever for long periods of time as well as memory loss, which I am still recovering from.
received the Moderna Covid-19 vaccine more than 12 hours after the vial was punctured; 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 (received the Moderna Covid-19 vaccine more than 12 hours after the vial was punctured) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2021 at 8:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021 at 8:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received the Moderna Covid-19 vaccine more than 12 hours after the vial was punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received the Moderna Covid-19 vaccine more than 12 hours after the vial was punctured) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.   This case concerns 4 patients.
Urticarial rash over upper arms and erythema over face.  No airway compromise, fever, vomiting, or dyspnea.
The spontaneous report concerning a female patient of unknown age was received from the patient's father. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with her fourth dose of GARDASIL, intramuscularly, (lot #, expiration date and anatomical location of administration were unknown), by an anonymous physician. Additional information is not expected as the patient did not wish to provide healthcare professional (HCP) contact details.
This consumer report (initial receipt 27-Nov-2012) concerns a 69-year-old female patient, who had a medical history of ovarian cancer. Concomitant medication included bevacizumab. On 10-Oct-2012, the patient received influenza vaccine (also reported as H1N1 [conflicting information] manufacturer and batch # were not provided). She also received CIPRO (batch no. not specified) on an unspecified date. On 11-Oct-2012 the patient developed pain in her calf. On 12-Oct-2012 the patient broke out in a lesion in her groin area and towards her lower back area. The patient sought medical attention and a culture was done on the lesions. She was later diagnosed with shingles. She was treated with CIPRO. The events improved. Reporter's comment: The consumer stated that she was unsure if the influenza vaccine or the CIPRO medication brought on the onset of shingles. She did not want to provide any additional information.
flu like symptoms; Loss of Appetite; headache; achy; Extreme Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), DECREASED APPETITE (Loss of Appetite), HEADACHE (headache), MYALGIA (achy) and FATIGUE (Extreme Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Concurrent medical conditions included Hypertension.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DECREASED APPETITE (Loss of Appetite), HEADACHE (headache) and FATIGUE (Extreme Fatigue). 04-Mar-2021, the patient experienced MYALGIA (achy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), DECREASED APPETITE (Loss of Appetite), HEADACHE (headache), MYALGIA (achy) and FATIGUE (Extreme Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: high (High) elevated temperature.         In concomitant medications high blood pressure medications were reported.   This case was linked to MOD-2021-052953 (Patient Link).
No additional AE reported; A dose of VARIVAX was administered after a temperature excursion; This spontaneous report has been received from a Physician referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 02-SEP-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number: W002601 with expiration date: 24-JAN-2024, administered for prophylaxis (strength and route of administration not provided) (product storage error) which had temperature excursion between 5.7F for 0 hours 30 minutes and 0 seconds, 6F up to 14F (9.1F} for 1 Hour 6 Minutes and 0 seconds and 6F up to 14F {10F) for 1 hour 8 minutes 0 seconds. No additional adverse event reported.
Information has been received from a physician concerning a 10 year old white male with no known drug allergies who was vaccinated subcutaneously with a first and second dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, on 03/11/1996 (lot 614677/1427B) and 10/06/1998 (627678/1170H), respectively.  On 01/13/2005 the patient experienced swollen right parotid.  It was reported that the patient   tested positive for mumps.  His serum amylase was 105 and the physician reported MMR.  Unspecified medical attention was sought.  In January 2005 the patient recovered.  There was no product quality complaint involved.  No further information is available.
6:45pm Jan 17th mom noticed welts & bruising on child's side.  She took her to the ER.  Seen by MD + welts & bruising spread down body to ankles, transported by ambulance to center.  Released 1-20-09.  1/27/09 Received hospital medical records of 1/19-1/20/2009. FINAL DX: no d/c summary available.  Allergy consult states: purpura, mild leukocytosis Records reveal patient experienced petechial maculopapular purpura rash & swelling of RLE w/right /ankle/foot arthralgia.  Taken to outlying ER where rash & swelling noted of bilateral LEs. Allergy consult done.  .
Information has been received from a physician concerning a child who was vaccinated with a dose of ROTATEQ (lot# not available) orally.  Child developed rotavirus after receiving the vaccine and was hospitalized.  This is one of two reports from the same source.  Additional information has been requested.
07/26/02 woke up this morning with circular rash around site of injection-some itching, no fever- Advised to apply anti-itch cream
This was on the following day- I was very fatigued and that was the only problem. I just stayed in bed and that helped me. On my left side I'm really weak, I have trouble going upstairs. I'm going to physical therapy. I started in late summer of August. In the last month I've had an issue where my leg has been swelling. I have a cardiologist and a vein doctor appointment in two weeks to research the issue. Not really for the leg weakness, but for the swelling. My asthma has also reappeared after 30+ years.
This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 47-year-old adult female patient. On 16-Oct-2018, the FLUCELVAX QIVc vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019] that underwent temperature excursion. The reporter assessed this as non-serious. This case (201805002) was cross-linked to the case: 201804745 reported by the same reporter. Follow up received from other non-health professional on 13-Nov-2018: The expiry date of the product (30-Jun-2019) was added in the product tab. The product start date (16-Oct-2018) was added in the product tab. The onset date of the events (16-Oct-2018) was added in the event tab. The narrative was amended accordingly. Significant case amendment (13-Nov-2018): The start date of the suspect product and event onset date was changed from '16-Oct-2018' to 'Oct-2018'. The narrative was amended accordingly.
Red localized injection site reaction. Area red and warm. 25 mg diphenhydramine given IM. Patient observed x30min. Redness and warmth subsided. Patient with no complaints.
Immediately after receiving vaccines - her L arm began swelling, blotchy appearing hives like reaction appeared on upper L arm from shoulder to elbow.  DTaP & varicella were given in L arm.   Ice pack applied & swelling & hives began to decrease.
Arm began to itch badly in the evening. The next morning the whole deltoid area was red, hot and hard. The itch has been intermediate, and the redness and heat is still present. The pattern of redness has shifted, but is still large.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned an  male of unspecified age. 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: Unknown) 1 total, dose was not reported, on an unspecified date in MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date in JUN-2021, the patient was diagnosed with Covid-19 and was sick for few days. Patient experienced suspected clinical vaccination failure. He was on rest at time of reporting. He was well with no medical condition. It was not known how he was diagnosed with Covid and which test was used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000184096 The suspected product quality complaint has been confirmed to be non voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0-20210660759-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
On 9/09/19 after receiving the flu vaccine in my right arm I began having pain at injection site followed my weakness in right arm. This lasted for several weeks. On 09/14/19 I had experienced numbness/tingling in extremities, i was extremely weak, became unable to walk or bear weight, I had difficulty speaking, difficulty breathing, dizziness, rapid heart rate with prolonged QT intervals.  I was released and then readmitted on 9/15/19 with weakness, inability to walk, severe body aches and difficulty breathing.
Crying, holding chest, yelling her heart is hurting, and horrible chest pain, I gave 6ml childrens Tylenol, crying and yelling continued until 10:05PM. I had left my house and rushed her at 9:15 PM to urgent care and when I got there at 10:05 PM they had just closed the doors and she had screamed herself to sleep.
This case was reported by a lawyer and described the occurrence of Bells Palsy in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unk). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgia, myalgias, Bells Palsy, fatigue, headaches, eye problems, numbness, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reportedly caused by vaccination with Lymerix. He also experienced decreased activities of daily life and decreased ability to participate in recreational activities. This case was assessed as medically serious by manf. (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries.
This spontaneous report as received from a 65 year old female consumer refers to herself. The patient had no pertinent medical history or drug reactions/allergies. The patient reported that she had received ZOSTAVAX ("standard dose") at the end of "November of 2013". Then in "March of 2014" she had received tetanus toxoid (unspecified dose and unspecified manufacturer). Concomitant medications included ZOCOR and unspecified "thyroid medication". Two days after receiving this tetanus shot, on an unspecified date in March 2014 the patient developed shingles. The patient still had the nerve pain associated with this to "this day" (reporting day on 11-SEP-2014). "Anti-viral" pills was given as the treatment for the events. "Various unspecified tests" were performed. The patient had sought medical attention by seeing physician. Outcome of the events was reported as not recovered. Additional information has been requested.
Light headedness for 4 hours Dizziness for 30 minutes Nausea for 3.5 hours
Itching; blisters started to dry out; blisters bleed; blister crack; pain; Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), pruritus (Verbatim: Itching), blister (Verbatim: blisters started to dry out), blood blister (Verbatim: blisters bleed), skin cracked (Verbatim: blister crack) and pain (Verbatim: pain). The outcome of the vaccination failure, pruritus, blister, blood blister, skin cracked and pain were not reported and the outcome of the shingles was recovered/resolved (duration 10 days).   It was unknown if the reporter considered the vaccination failure, shingles, pruritus, blister, blood blister, skin cracked and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pruritus, blister, blood blister, skin cracked and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and still experienced shingles. The patient stated that it was a very mild case of shingles on his/her right cheek right under his/her eye and it was lasted about 10 days. The patient reported that other than itching the only pain was when the blisters started to dry out especially when he/she smiled they had crack and bleed. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Fevers and chills for 48 hours; Fevers and chills for 48 hours; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 09:00 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Bee venom" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Penicillin for Allergies to Penicillin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 20Oct2021, when the patient was 61 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 2021, when the patient was 61 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), CHILLS (non-serious) all with onset 20Oct2021, outcome "recovering" and all described as "Fevers and chills for 48 hours". Therapeutic measures were not taken as a result of pyrexia, chills. Additional information: Facility where the most recent COVID-19 vaccine was administered was at Hospital The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (26Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Became dizzy, lightheaded and nauseous post-vaccine administration. Brought to observation; lied down on stretcher; symptoms resolved. Vital signs stable. Escorted to exit via wheelchair with no further issues to meet ride at 10:25. 09:48 initial BP 107/73, HR 75, RR 16, SATS 98% RA. 10:11 BP 108/73, HR 74, RR 16, SATS 98% RA. 10:15 standing BP 108/73, HR 80, RR 16, SATS 98% RA.
Nausea and dizziness starting about five hours after vaccination given in the morning and persisting throughout the day and evening.  Symptoms resolved by the next morning.  Also noted at 5:00 pm itching and redness at site of injection.
tinnitus in left ear nonstop since a few hours after 2nd vaccine shot of Moderna.
Six patients admininstered expired doses of the Moderna COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patients admininstered expired doses of the Moderna COVID-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patients admininstered expired doses of the Moderna COVID-19 vaccine). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Six patients admininstered expired doses of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided
Approximately ten hours after the vaccine, I began to run a fever and had chills and a headache. My arm was sore, which was to be expected, however, I had no problems other than that with the first dose. Therefore, I was quite surprised when I began to feel so ill after this second dose. I continued to run a 99-101 fever with chills, off and on, the following day and night. On the third day, which is today, I have had no fever or chills, however, my arm has been itchy all day around the injection site, and this evening I noticed that the redness at the site has spread out and is covering most of the outer part of my upper arm. It doesn't look infected or anything. Just sort of blotchy red and a little itchy and firm. Also, my headache has persisted for all three days, off and on. However, I get frequent headaches anyway so it is difficult to know for sure if it is related to the vaccine or not. I assume it is but cannot confirm... obviously. :)
Patient reported feeling lightheaded 15 minutes post flu immunization. RN evaluated patient, suggested he lie down, provided ice pack to the back of neck, provided fluids. Patient remained in the clinic area for 45 minutes. After 45 minutes, patient reported feeling well and agreed to continue with fluids and will eat lunch. RN advised he return to the clinic area if symptoms return.
Pt reports arm swelled from shoulder to elbow on 7/15/10.  Went to PMD who Rx cortisone cream.  States are still swollen.  Pt calling from neighbor's phone who didn't want to give number out.  States she has no other phone contact available.
Fever, chills, achy everywhere, sweating, headache. Felt like I had covid all over again except only for 36 hours.  Also sore, rashy arm.  Had to stay home from work the next & still felt bad the day after that.
Treatment of COVID-19; Treatment of COVID-19; BNT162b2 dose 1, dose 2, dose 3; COVID-19 VACCINE MODERNA dose 4; BNT162b2 dose 1, dose 2, dose 3; COVID-19 VACCINE MODERNA dose 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EK9262), in left arm, on 27Feb2021 as dose 2, single (Lot number: EN6203), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 67 years, in left arm for COVID-19 immunisation; COVID-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 21Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Hayfever" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "arthritis in many joints" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 21Apr2022, outcome "unknown" and all described as "BNT162b2 dose 1, dose 2, dose 3; COVID-19 VACCINE MODERNA dose 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jun2022, outcome "recovered" (28Jun2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jun2022) Positive; (30Jun2022) Negative; (02Jul2022) Negative. Therapeutic measures were taken as a result of vaccination failure, COVID-19 and included Paxlovid. Clinical course: Original symptoms started and positive 'CRP' test was done on 24Jun2022. Anti-viral details: COVID 19 Treatment (Paxlovid) was started from 25Jun2022 and stopped on 30Jun2022. Prior to rebound all fever and other symptoms were gone by 28Jun2022 and rapid antigen tests done on 30Jun2022 and on 02Jul2022 were negative.