chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product (HUMIRA) for Psoriatic arthritis, Ankylosing spondylitis and Plaque psoriasis.    Concurrent medical conditions included Psoriatic arthritis, Ankylosing spondylitis and Plaque psoriasis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose., ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) had resolved.            No relevant concomitant medications were reported.   The reporter's causality for the event of headache with humira was not provided. The reporter's causality for the events of fever and chills with humira(adalimumab) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna   No treatment information was provided.
Pt described that the injection site was red, swollen, painful, and itching the night of receiving the vaccine. Pt came to pharmacy 3 days later and the injection site was still present and was approximately 2 inches in diameter.
I have Friends that got the Shingles Shot 11 of them now have shingles/ 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: I have Friends that got the Shingles Shot 11 of them now have shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient received shingles vaccine and now he or she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset  and laboratory test confirming shingles were unknown at the time of reporting. This case was 9 of 11 cases for the patient reported by same reporter. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104620:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104619:same reporter US-GSK-US2023AMR104617:same reporter
he had some issue not like headache just mental issue that he didn't feel like in head; he started smoking after again after quitting; This is a spontaneous report from a contactable consumer. This consumer reported for a 70-year-old male patient. A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0171 and expiry date: 31Aug2021), via an unspecified route of administration, in Arm Left, on 27Apr2021 at 16:27, as a single dose for COVID-19 immunization. The patient's medical history included COPD, Schizophrenia, UTI (took antibiotics), traumatic brain injury (when he was 16 or 17) and indwelling urinary catheter. Concomitant medication included Haloperidol for Schizophrenia, salbutamol (ALBUTEROL) for COPD, Diazepam, Trazodone for sleeping, and Ipratropium (Nebulizer). The reporter (care giver) stated that, the reporter spoke with a gentleman this morning about the adverse reaction that the reporter's partner had, he was nonverbal that's why the reporter was calling to check. The patient had his vaccine in the evening at 04:27, on 27Apr2021. He had around 08:30 quarter 9 and we were driving home around 9 o'clock and the reporter asked to patient that was he feeling weird, and the patient said yes. The reporter asked how the patient feeling weird. The patient said, in his head because he had this problem with his brain from his accident done, it was a little tricky because it was been years to start functioning in a way that he could relate to. The patient felt weird and low and he said his head, so he had some issue not like headache just mental issue that he didn't feel like in head, and he said today that's starting to go away that because the reporter asked him the question so the reporter just wondering if, he suggest when the reporter talk to the man early this morning and reported it. An hour, he took all the medicine he was taking and also his information. The reporter was wondering, he told the reporter to contact him for medical information and he gave the reporter this no to call him and he transfer the reporter and the reporter already too busy. The reporter already been over the phone so, the reporter would like to know if the reporter could help him to move this out of his system if that happen and the reporter would probably ask him not to have the second vaccine. The reporter wanted to know how he feel about that. When the reporter goes off, he was not the happy person actually. The patient started smoking after again after quitting 20 years ago after the vaccine. The reporter also stated that the patient said he was little better. The patient took little bit of Ganja by mouth not smoking it, that he made Ganja medicine and took little bit of that. He was taking it some of the local dispensary CBD and THC. The patient did not receive any treatment for the events. There was not a product complaint to report. There was a medical information request.  Information on Lot/Batch number was available. Additional information has been requested.
localized injection site reaction: redness, swollen and warm to the touch; localized injection site reaction: redness, swollen and warm to the touch; localized injection site reaction: redness, swollen and warm to the touch; This is a spontaneous report from a contactable Nurse. This Nurse reported similar events for 3 patients. This is 2nd of 3 patients.  A 82-years-old female patient received first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 21Jan2021 at SINGLE DOSE on right arm for covid-19 immunisation. Medical history and concomitant medications were none. The patient experienced localized injection site reaction: redness, swollen and warm to the touch on 24Jan2021 with outcome of not recovered considered as important medical event. Term highlighted by the reporter: Yes.Outcome of the events  was not recovered. Caller works in an assisted living facility.  Information on Lot/Batch has been requested.; Sender's Comments: Based on temporal association and currently known drug profile, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events 'localized injection site reaction: redness, swollen and warm to the touch'.  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.,Linked Report(s) : US-PFIZER INC-2021093798 Same reporter/drug/AE, different patient;US-PFIZER INC-2021093835 Same reporter/drug, different patient/AE
Lip droops down on R side of face when crying or drinking.  Began 1 week ago (approximately 4/30) ? mild Bells Palsy.
Had his 4 year check up with MMRV and DTap/IPV given yesterday afternoon. This morning Mom reported he had a glassy eyed look, but she did not take temp. They were running errands in the car when he became unresponsive, stiff and started drooling. He remained unresponsive, so she called 911 and was taken to the ED for further evaluation. Currently there.
A 13-year old female received an expired dose of Ipol with no reported adverse event; Initial information regarding an unsolicited valid serious case was received from the other health professional (Reference number- US-SANOFI-00550189) and transmitted to Sanofi on 06-Apr-2021.  This case involves a 13 year old female patient who received an 0.5 mL expired dose of suspect IPV (VERO) [IPOL] [lot number: not reported, expiry date: 13-Mar-2021] via an intramuscular route at the left deltoid, on 05-Apr-2021 for prophylactic vaccination (expired product administered) (latency : on the same day).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE).  It was a case of actual medication error due to expired vaccine used. At the time of reporting, reporter would like to know if the patient needs to be revaccinated if received an expired IPOL vaccine.   It was also reported that the lot number was unknown due to the lot number not being documented and the vial discarded.  At the time of reporting, patient had no adverse event..  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Information has been received from an 83 year old female with no known allergies and no reported medical history who approximately 31-JUL-2007 was vaccinated with ZOSTAVAX. Concomitant therapy included LIPITOR and blood pressure medication (unspecified). The patient reported that about 12 hours after getting the shot (on approximately 31-JUL-2007), she experienced blisters over the age spots on her arms (2 blisters on her left arm and one her right) and a red raised spot at the injection site. As of 21-AUG-2007, the patient was recovering from her experienced from her experienced. The patient did not seek medical attention. No additional information is expected.
screamed for 2 hrs; sl swollen leg; MD called Motrin ordered; started 3 hrs p/vax;
Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female patient who on 28-DEC-2010 was vaccinated with a third dose of GARDASIL (Lot # reported as 0922Z; Exp date in October 2012 (valid for VARIVAX (Merck)). The physician stated that the patient received GARDASIL and was discovered that the patient might be pregnant by urine test. The patient had been taking oral contraceptives and wanted to switch to an intrauterine device (IUD). The pregnancy test was run twice and both times was positive. No adverse effects were reported. Follow up information has been received from the physician concerning the female patient. Concomitant medication used during the patient's pregnancy included CYTOTEC, "200 microgram, every 8 hours, 3 times a day for aid in termination". It was reported that on an unspecified date, the patient underwent elective termination. The products of conception were not examined. It was unknown if the fetus was normal. Upon internal review elective termination was considered to be an other important medical event. Additional information has been requested.
I felt heart palpitations and noticed that my heart rate on my fitbit said 120. Even though I was just resting and sitting quietly, my heart rate stayed in the 115-120 range for several hours.
About 19 hours after vaccine until hour 36  after vaccine- fever - 101. body aches; chills; fatigue - I took Acetaminophen which didn't really help.  Sept 15, 2021 - estimated date of delivery Pregnancy  history - first pregnancy; it's been normal and healthy so far.
Low grade -fever; Fatigue; painful touch at the site of injection/ warm touch at the injection site; itchy rump at the injection site; swollen at the injection site; red at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (Low grade -fever), FATIGUE (Fatigue), VACCINATION SITE PAIN (painful touch at the site of injection/ warm touch at the injection site), VACCINATION SITE PRURITUS (itchy rump at the injection site) and VACCINATION SITE SWELLING (swollen at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fever since 14-Jan-2021, Fatigue since 14-Jan-2021, Painful arm since 14-Jan-2021, Itchy since 24-Jan-2021, Swollen arm since 24-Jan-2021 and Erythema on 24-Jan-2021.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Low grade -fever), FATIGUE (Fatigue), VACCINATION SITE PAIN (painful touch at the site of injection/ warm touch at the injection site), VACCINATION SITE PRURITUS (itchy rump at the injection site), VACCINATION SITE SWELLING (swollen at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site). At the time of the report, PYREXIA (Low grade -fever) had not resolved and FATIGUE (Fatigue), VACCINATION SITE PAIN (painful touch at the site of injection/ warm touch at the injection site), VACCINATION SITE PRURITUS (itchy rump at the injection site), VACCINATION SITE SWELLING (swollen at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.   Reporter did not allow further contact
Vaccine administered to 17 year old patient; 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 ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17 year old patient) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17 year old patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17 year old patient) had resolved. Not Provided      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 and treatment medication were not provided.
hives, hoarseness developed 17 hours after vaccine treated initially with Benadryl at home but due to no clinical improvement ED visit on 2/4/2020 treated with IV Benadryl, Pepcid and Solu-medrol
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided by the reporter. No treatment information provided by the reporter.
Developed wheezing. Seen in private physicians office and treated with Xopenex nebulization on11/7/06 and cleared on 11/8/06 visit of wheezing.
my knees swell incredibly; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (my knees swell incredibly) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Seasonal allergy and Shellfish allergy. Concomitant products included LISINOPRIL for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced JOINT SWELLING (my knees swell incredibly). The patient was treated with PREDNISONE at a dose of 1 dosage form and NAPROXEN SODIUM (ALEVE) for Pain, at a dose of 1 dosage form. At the time of the report, JOINT SWELLING (my knees swell incredibly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-295813 (Patient Link).
noted LA painful to touch and pain with ROM, axillary pain, redness, edema, body aches, also left hand middle finger noted redness and edema.
Redness at shot location Swelling Hot to the touch Rx ( antibiotic was prescribed by doctor It happened a week after the shot.
Headache within 15 minutes, feeling lightheaded like I'm stoned. extreme fatigue, dizzy upon standing, muscle ache down my back and legs, arms and the most painful aches in my arm pits. Very slight sneezing, runny nose.  Headache and dizzy upon standing went away within a few hours, but other symptoms started to get worse 24 hours later.  Did not seek any treatment or medication. Just resting.
Kinrix given subcutaneously instead of IM.  Patient was asymptomatic.  A second Kinrix was given IM.
Patient reported tingling  in her injection arm/hand after 15 minutes. Asked Patient to wait in the store for an additional 15 minutes.  Patient had no other symptoms and felt better after the additional 15 minutes. No Treatment needed.
Information has been received from a health professional concerning a 12 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 10-APR-2007, the patient was diagnosed with chickenpox. Medical attention was sought, The patient's outcome was unknown. No product quality complaint was involved. This is one of several from same source. Further information has been requested.
dreaming of every dead person that I know.  It's very, very strange; Panic attacks; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23May2021 11:30 (Lot number: EW0178) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (ongoing), notes: Caller reported that she developed depression because of school and stress. Concomitant medication(s) included: ZOLOFT taken for depression (ongoing). The following information was reported: ABNORMAL DREAMS (non-serious) with onset 24May2021, outcome "not recovered", described as "dreaming of every dead person that I know.  It's very, very strange"; PANIC ATTACK (non-serious) with onset 24May2021, outcome "not recovered", described as "Panic attacks".  Follow-up (09Jun2021): This is a spontaneous report from a contactable other HCP. A 55-year-old female consumer (patient) reported for herself that: Updated information: New events, Dosage details, Concomitant medications,   Additional Information: Vaccine was not Administered at Military Facility. AE(s) require a visit to Emergency Room, Physician Office. There were no Prior Vaccinations (within 4 weeks).  Communication: Report 1 of 2.  Caller declined transfer.  Caller provided with reportum reference number, and notified of survey prior to disconnect.   Follow-up actions are needed. Further information has been requested.  Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
Adverse reaction; A spontaneous report was received from a consumer, concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine and experienced adverse reaction.  The patient's medical history was not provided.  Concomitant medications were not reported.  On an unknown, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for the prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced an adverse reaction due to vaccine. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event adverse reaction was considered resolved on an unspecified date.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Horrible joint pain accompanied by pain, tingling,  burning, and pins/needles in hands and feet. Started w 1st shot has continued w 2nd shot. It's been 7 wks since symptoms started.
Redness and pain in left arm starting 3/29/23. Flu like symptoms also present