chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature at 101.5F; mild frontal headache; This is a spontaneous report from a contactable nurse.  A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on 27Apr2020 at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced mild frontal headache on 28Apr2020 and temperature at 101.5 F on an unspecified date.  It was reported that the patient got mild frontal headache in the morning. On unspecified date temperature was at 101.5 F, and 2h later came down to 99.2F. The events were non serious. The outcome of the event mild frontal headache was unknown. The outcome of the event fever was recovered on unspecified date.   No follow-up attempts are needed. No further information is expected. information about lot/batch number cannot be obtained.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccinated with a dose that was refrozen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. Concurrent medical conditions included Hyperlipidemia, Hemiplegia, Edema and Prediabetes. Concomitant products included METFORMIN, CELECOXIB (CELEBREX), FUROSEMIDE and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication. On 02-Aug-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccinated with a dose that was refrozen). On 02-Aug-2021, PRODUCT STORAGE ERROR (Vaccinated with a dose that was refrozen) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRODUCT STORAGE ERROR (Vaccinated with a dose that was refrozen) to be not related. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Additional information received on 06-AUG-2021 contains, updated the patient race, added medical history, added doctor and vaccine facility information, added concomitant medications information.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 3:02 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 3:02 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 69.46.  Concomitant products were not provided.  On 27-Oct-2021, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 4 vials were sent to clinic. Vaccine BUD date was 04-Nov-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient received both flu and pneumonia vaccines in the office on 10/7/14. One in each arm. Patient gave verbal consent to have one injection in each arm. Patient waited recommended time in the waiting room after vaccination with no adverse reactions. Patient called the office in the AM on 10/8/14. Patient stated that the previous night he felt "crummy" and "had a fever - although did not check it with a thermometer." Patient stated that left arm was swollen, red and warm. Offered a patient and appointment in the office. During the conversation patient stated that he "just remembered" that he had a Vantas implant in the left arm. Patient called back aproximately an hour later to schedule an office appointment. Patient was seen in the office at 1:45 pm. Patient upper left arm down to elbow was red, warm and swollen. At the injection site on the right arm, area was reddened, raised and warm. MD treated patient with Keflex for cellulitis.
Metal taste; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Mar2021 13:00 (Lot number: EN6208) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DYSGEUSIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Metal taste".  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received unspecified other medications within 2 weeks of vaccination. Patient experienced Metal taste after first vaccine and lasted 4/5 Days. Prior to vaccination, patient was not diagnosed with COVID-19. The patient has been not tested for COVID-19 since the vaccination. Patient also received dose 2 on 04Apr2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021374583 same patient, different vaccine dose, partial same event
Got shot a year ago and had them/Suspected vaccination failure; Had them abou2 months ago; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got a shot well over a year ago and had them about 2 months ago from the one side of his/her naval around left side to middle of his/her back in a 2 inch space. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
non-raise rash on left forearm (petechia), non-itching, erythema  recommend to see PCP if symptoms worsen
Some pain, redness and swelling at injection site. Nausea, tiredness then fatigue, headache (brief sharp pain on right side of head), chills and shakes, fever/sweating, and vomiting until ~mid afternoon. Tiredness and some dizziness today.
she had another episode the other night that it woke her up/then it woke her up again a couple nights ago, out of her sleep; she experienced pins and needles and tingling in hands for about a day and night after the shot; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 20Jun2022 as dose 1, 0.3 ml single (Lot number: FM0173, Expiration Date: 12Aug2022) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine since she was a teenager" (ongoing). There were no concomitant medications. The following information was reported: PARAESTHESIA (medically significant) with onset 20Jun2022, outcome "unknown", described as "she experienced pins and needles and tingling in hands for about a day and night after the shot"; SLEEP DISORDER (non-serious), outcome "unknown", described as "she had another episode the other night that it woke her up/then it woke her up again a couple nights ago, out of her sleep". Clinical course: Caller stated she was calling about the gray cap Covid 19 vaccine, stated a patient had a reaction to first vaccine and was due for her second dose, explained she experienced pins and needles and tingling in hands for about a day and night after the shot. Clarifies she had another episode the other night that it woke her up. She had pins and needles and tingling that night; and then it woke her up again a couple nights ago, out of her sleep, with that. Caller wanted to know if it is safe for the patient to get her second dose.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events paraesthesia and sleep disorder and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further information is 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.
a patient received a fourth dose of Typhim Vi via oral route one day too soon/No AE; a patient received a fourth dose of Typhim Vi via oral route one day too soon/No AE; Initial information received on 29-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown demographics patient who received a fourth dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] via oral route one day too soon lot 3003279, expiry date: May-2020 via oral route in unknown administration site on an unknown date.   The patient's past vaccination(s) included TYPHIM VI three doses.  The patient's past medical history, medical treatment(s) and family history were not provided.   It was an actual medication error due to inappropriate schedule of vaccine administered and inappropriate route of vaccination.  Symptoms: None reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  List of documents held by sender: none.
Nausea, vomiting and a lot of diarrhea. Symptoms started about 3pm March 26, 2013. Vaccine was given 10:30am on March 25, 2013.
severe chills, fever 100.4, headache, extreme tiredness, arm red and warm about 4 inch patch
This spontaneous report as received from a consumer refers to a 5-year-old male patient (step-son) with no pertinent medical history and drug reactions/allergies. On 12-JAN-2013 the patient was vaccinated with, 0.65 milliliter (ml) ZOSTAVAX (lot#, expiration date and route not reported). Concomitant medications included: M-M-R II (lot#, expiration date and route not reported) administered on the same date. The patient was supposed to get VARIVAX and M-M-R II at the time of his check-up on 12-JAN-2013. He was given M-M-R II and ZOSTAVAX. The ZOSTAVAX was administered by mistake. He had an injection site reaction at the location of the ZOSTAVAX. It was the size of half-dollar, is red and extremely hard. Treatment was not rendered for the event. No laboratory diagnostic tests were performed. The patient called the Health Care Professional (HCP) and sought medical attention. The events did not resolve at the time of this report. Additional information has been requested.
pt brought to ED with AMS; found to be positive for COVID; CT/CTA of brain and neck showed no acute findings; pneumonia; given broad spectrum ABX; MSSA Bacteremia, given Ancef; compression fracture of L1 and T4; treated for pain; given Vitamins C & D, zinc; DNR/DNI; transitioned to hospice care; dc'd to Hospice where he passed away
Lost appetite; runny nose; back aches; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DECREASED APPETITE (non-serious), outcome "unknown", described as "Lost appetite"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; BACK PAIN (non-serious), outcome "unknown", described as "back aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache started around 11am and gradually worsened. Not relieved much by ibuprofen. Became very fatigued in the afternoon. Fever started around 6pm and is up to 100.3 with ibuprofen on board.
In November 2022, I experienced terrible itching of both of my ankles. I also had a lot of ankle swelling, as I had just been traveling. I kept experiencing itching. I developed a pustular rash that extended from the tops of my feet to the area halfway up my calves. I thought that maybe this had been caused by a soap or detergent I had used, because I had recently used brands I didn't normally use. I went to my PCP, who diagnosed it as vasculitis, which she thought had been induced by amiloride I had recently taken. I then stopped taking amiloride and switched over to spironolactone, and everything seemed to clear up really well until early April 2023. During that period, the symptoms returned. I had the pustular rash in the same places as before again, only it was worse. This time around, the rash spread up my thighs, to my abdomen, to my chest, and to my back. I went back to the PCP. This time, she knew for certain that I had vasculitis, but she was unsure how to proceed. She didn't know whether I should discontinue other medications, or if we were missing something else skin-related. I was referred to a dermatologist. The dermatologist affirmed that it was vasculitis, and she decided to do a punch biopsy, the results of which just showed signs of vasculitis. She then gave me a Kenalog injection. After the Kenalog injection, everything cleared up, including the rash and the itching. Ultimately, the dermatologist concluded that the vasculitis was edema-related. She told me that when traveling, I should wear support hose and keep my legs elevated and then see if those help prevent future incidents of vasculitis. She also told me that if I had any more skin issues, I am to return to her office.
fever, body aches and pain, chills, extreme fatigue (unable to move), sore arm, headache.  extreme side effects started about 12 hours after vaccination. moderate side effects (headache, sore arm, fatigue) started a few hours after vaccination.
no additional ae; expired STERILE DILUENT that was used to reconstitute VARIVAX; Product preparation issue; This spontaneous report was received from a nurse, referring to a patient of unknown age. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 01-JUN-2023, the patient was inadvertently administered with expired STERILE DILUENT (lot #T029529 was valid, expiration date 16-APR-2023) that was used to reconstitute varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis. No temperature excursion. No symptoms reported. (Expired product administered, Product preparation issue, No adverse event); Sender's Comments:  US-009507513-2307USA005044:MSD
On Wednesday, February 24th I received the first dose of the Moderna vaccine. On Friday evening I developed joint pain and swelling in my left should blade, my right wrist and my left large toe. The pain in my shoulder and my wrist is excruciating and I have not been able to sleep properly.  I have very limited mobility and cannot grip with or use my right hand.  I started taking 200 mg of ibuprofen on Friday night with food but it did not seem to reduce the pain. Through the night that night I increased my dose to 400 mg and felt some relief in my shoulder but my hand is still very painful. My toe is uncomfortable but tolerable. I used tiger balm several times on my wrist but that did not help. I also put it on my back and it seemed to help as long as I did not move. If I moved a felt a very sharp pain under my shoulder blade.  I used ice on my hand and it only benefited briefly. I couldn't apply it at night and therefore couldn't sleep.  I am unable to move or function as I normally would due to the sharp pains in my back/shoulders and right hand. Unable to function without assistance and cannot go to work.
pt recv vax 28MAY97 & 9JUN97 mom called & reported rash on child's face, back, chest, neck & groin;pt sl cranky & afeb;instructed mom to observe child & given APAP for inc temp q 3-4hr;TC to mom on 10JUN97 rash is resolving;
I experienced exacerbated neurological symptoms after the 2nd shot. They include bad headaches, my vision was double few times and the vertigo symptoms came back. I contacted my specialist as well as the PCP office. In the former (PCP office) I received a ketorolac tromethamine 60 mg/2 mL injection (10Jun2021) and prescribed an acetaminophen 650 mg tablet 4h after ketorolac injection. The second dose of ketorolac was received on 23Jun2021 at the Neurologist office (Dr.). Injection by a nurse.
This patient complains that 48 hours later he developed a blotchy rash on his head and arms with an itch to his head. The patient took over the counter Benadryl with resolution of rashy itch.
Systemic: Body Aches Generalized-Severe, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Additional Details: pt experienced severe headache, fever, body aches, chest tightness, shortness of breath, generalized pain. went to dr for evaluation and EKG showed pt had myocarditis that she did not previously have history of. pt and dr both believe this was a result of booster vaccine.
1/4/21 around 10am became extremely nauseated, clammy, dizzy and hot.  No temp and had just received COVID POC test and was negative.  Left to go home and had loose stool then chills, body aches, hot spells, and extremely tired.  Could not stay awake and was in brain fog.  Slept all day, all night and all day on 1/5/21.  No appetite, stuffy nose, headache, chills and hot spells, no fever,  Again unable to stay awake.
Approx. 11:30 on 4/26/01, received shots and that evening had a 2" diameter with "bee sting look". By 4/27/01 AM, had redness and swelling to the elbow. He was given Tylenol. Child complained of bad arm. By 4/28/01 PM, redness and swelling to wrist. Child was taken to ER and given Benadryl (cortisone med given to mother to give to child but she held). Gave Benadryl every 6 hours. By 4/29/01, symptoms were gone. Mother did not take temperature.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On 27-AUG-2013, the patient was vaccinated with the first dose of VAQTA 25/0.5 U/ml (route, dose, lot and expiration date were not reported). On 26-JAN-2013, less than six months later, the patient was vaccinated with the second dose of VAQTA 25/0.5 U/ml (route, dose, lot and expiration date were not reported). No adverse effects were reported. Additional information has been requested.