chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 20JUN95 & was found to be pregnant;f/u from pt husband indicated that during the pregnancy pt devel an HSV-2 infect tx acyclovir;7FEB96 pt delivered a healthy female;
Developed rash on fingers, r/hand and l/forearm.  Received flu shot 11/8/99.  Noticed symptoms 11/9/99.  Hydrocortisone 1% topically.
vomiting, fever 100.4, irritable, lt arm red, swollen, hot to touch 13-14 hrs p/vax; drowsy 24 hrs post vax;
Fatigue, GI upset, and Headache for 3-4 days post second vaccine
Left eye has been twitching; This is a spontaneous report from a contactable consumer (patient). This 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL0401), via an unspecified route of administration on 23Dec2020 at single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included fluoxetine hydrochloride (PROZAC) and clonazepam (KLONOPIN). Patient stated he got the vaccine at the hospital. Patient stated he was just calling because it was actually something that for the past like couple of weeks, it was like his left eye has been kind of twitching on an unspecified date. Patient stated he did not have lab work and treatment, it just happened like 2 weeks ago. Patient stated he did not visited any emergency clinic or physician's office and haven't seen anybody. Outcome of the event was unknown.
I received what I was told was the Pfizer Bivalent booster on 9-13-22, only to receive a call the next day telling me that they had mistakenly given me the original Pfizer vaccination.  They told me they were very sorry, but now I would have to wait an additional two months to receive the booster that would protect me from the omicron variant.  I have avoided getting COVID-19 for all this time being very careful to get vaccinated and boostered, wearing masks, staying six feet away from people inside, etc.  This is really devastating because now I have to fear getting the omicron variant.  I would really like to know if there is any way I can wait for less than two months to receive the booster that I thought that I was receiving on 9-13-22
Dev'd rash that spread over body and face swelling 1 d after vaccines, followed by rhinorrhea and cough. On 1/12/09 child was wheezing. Also taking amoxicillin simultaneously.
pt recv vax & w/in 2hr post vax pt exp erythema @ inj site & swelling in the shoulder area;pt had a knot in the deltoid area for 2-3 days;
Resident received second dose of C0VID -19  ON 2/2/21 on  2/3/21 resident had a fall after an episode of syncope
Dizzy spells; Felt really really horrible; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy spells) and VACCINATION COMPLICATION (Felt really really horrible) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 047A21A) for COVID-19 vaccination.     The patient's past medical history included Vertigo.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced DIZZINESS (Dizzy spells) and VACCINATION COMPLICATION (Felt really really horrible). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizzy spells) and VACCINATION COMPLICATION (Felt really really horrible) outcome was unknown. Not Provided          No concomitant medications reported by investigator   Patient stated that she has a history of vertigo but this time it's really bad, she's never experienced anything similar. She's been taking Benadryl at night (not during the day because she has to work) and it seems to help. She added that the pollen count in her location is currently high, and maybe that makes things worse.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up received and no new information was provided.
I got shingles from the shot/Suspected vaccination failure; I got shingles; This 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, unknown 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 Information: GSK receipt date: 22-Aug-2022 Reporter's comment: This case was received from the patient via interactive digital media. The patient got shingles from the shot. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
The night after vaccination her arm got red and swollen along with flu like symptoms including fever. She reported to the pharmacy 2 days later explaining her reaction and that the redness and swelling was still spreading on her arm. We called her MD and got her an appointment that day to see the MD and advised her to take oral BENADRYL and ice the arm until she sees her doctor because she might need prednisone or some steroid based on her doctor's judgement.
patient received his first dose of SHINGRIX one year ago and never received his second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose one year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-Nov-2022 Reporter's comment: The reporter was the Health-care professional (pharmacist) who was reporting on behalf of a patient.  She stated that the patient received his first dose of Shingrix one year ago and had never received his second dose. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 05-SEP-2017, the patient was vaccinated with a dose of GARDASIL 9 (strength and route were unknown) (lot# M040412 and expiration date 30-JUN-2019). On 15-NOV-2017 and 05-SEP-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N019923 and expiration date 30-JUN-2019; lot# N032956 and expiration date 13-JUL-2020) for prophylaxis (Incorrect product storage), respectively. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
606 doses were given after expiration date; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date place in refrigerator 29-10-2021 No concomitant medication were provided No treatment details were provided
Patient had well child visit 1/4/05 and received 4 month immunizations. Family traveled to another state. At 7:30 PM, Dad states he found patient pale and difficult to arouse; episode lasted 10 seconds. Patient taken to hospital ER where he was examined and admitted for 3 days for observation and work up.
Varicella received 5/1.  On 5/2 developed pain/erythema/swelling at injection site.  Tactile temp.  Rxn site improved on
This spontaneous report as received from a nurse (also reported as a medical assistant) and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients might have been vaccinated with improperly stored doses of PNEUMOVAX23 (dose, lot#, expiration date and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of  34.2 degrees Fahrenheit for 1 hour. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. Additional information is not expected, because there was no consent to contact the reporter.
received first dose January 2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2021, batch number 9Y92A, expiry date 2nd June 2023).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-APR-2022 Reporter's Comments: The reporter reported that patient wanted to get their second dose on reporting date. The reporter consented to follow-up. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Severe chills and body aches with a  fever of 102.8 the night of the vaccination until the morning, approximately 12 hours.  The day after the vaccination, fever dropped to 101, with continued body aches and fatigue.  On the third day, fever subsided, but body aches and fatigue lingered.  Injection site became red, raised and very sore almost immediately, and continued into the third day.
Patient received 1st vaccine on 3/24 with no issues reported.  Patient returned on FRiday for routine treatment and was afebrile, BP within normal limits and no compliants.  Left the unit stable post treatment.  Patient passed away on Saturday morning.  There was no hospitalization.  Patient went straight from home to the funeral home.  Daughter states that patient had been feeling warm since Wednesday.
Jynneos vaccine administered intradermally; Jynneos vaccine administered at dose 0.1 ml; Jynneos had a temperature excursion; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-002045 is a spontaneous case report initially received on 23-Aug-2022 from a nurse via Communication (reference number: USBAV22-1123) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On 18-Aug-2022, Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00003) had a temperature excursion (explicitly coded as 'product storage error').  On the same date, the patient was vaccinated with the affected Jynneos vaccine (batch number: FDP00003), at dose reported as 0.1 mL, administered intradermally (explicitly coded as 'underdose', 'inappropriate route of vaccination' and 'product administration error'), for monkeypox prophylaxis.   At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received from Bavarian Nordic on 24-Aug-2022 included the local BN case ID.  The case is linked to cases US-BN-2022-002030, US-BN-2022-002028, US-BN-2022-002046, US-BN-2022-002047, US-BN-2022-002048 and US-BN-2022-002049 concerning the same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated with the Jynneos vaccine, at dose reported as 0.1 mL, administered intradermally for monkeypox prophylaxis, and Jynneos vaccine had a temperature excursion prior the vaccination, which is considered as underdose, inappropriate route of vaccination, product storage error and product administration error. No associated adverse events have been reported with the reported medication error. The events of underdose, inappropriate route of vaccination, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose, inappropriate route of vaccination, product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the Jynneos vaccine, at dose reported as 0.1 mL, administered intradermally for monkeypox prophylaxis, and Jynneos vaccine had a temperature excursion prior the vaccination, which is considered as underdose, inappropriate route of vaccination, product storage error and product administration error. No associated adverse events have been reported with the reported medication error. The events of underdose, inappropriate route of vaccination, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose, inappropriate route of vaccination, product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Large 2" x 4" red, itchy area appeared on left arm exactly one week after vaccine was administered. Primary care doctor checked it on 1-23-2021 and thought it was inflammatory response to injection .No treatment advised  except to re-check in a few days.. It is slowly going away but not completely gone as of 1/28/21 and was rechecked by doctor today.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient had a worsening reaction to the flu vaccine for the last 2 to 3 years before the date of reporting. The reporter was unsure which flu vaccine the patient received since she received it at a different facility. The patient complained of redness and swelling that was localized to the injection site but it was large and did spread a little. It lasted about a week and she applied ice. The reporter did not have further information.
I noticed the redness the same evening, but it got worse by the next morning. The rash or redness spread and swelled. Its continuing to spread. I went alone emergency room on that Monday, and they prescribed Augmentin and told me to watch it over the next 3 days and if it got worse to come in. It still continues to spread. I am using a warm compress on it, and I plan to call the provider. It is covering a large area of my right arm. The provider basically looked at and said it seemed to be a reaction to the shot.
Dose 1 2/11/2021 Moderna Lot # 031L20A Pt was hospitalized with Covid 19 at Medical Center hospitalized 6/24/22-7/12/22. patient died 7/12/22
she initially receive her 1st dose in "April 2021" however, she had forgotten about the follow up doses, and "started over" again in October 2022. In October 2022 she received her "first dose" again, and receiver her "second dose" in December 2022.; No additional adverse effects reported; This spontaneous report was received from a female patient of unknown age, referring to herself.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date in April 2021, the patient was vaccinated with the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1st dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  However, she had forgotten about the follow up doses, and "started over" again in October 2022. In October 2022 she received her "first dose" again, and receiver her "second dose" in December 2022. She reported that she was on track to finishing her dosage series this month (Inappropriate schedule of product administration). No additional adverse effects or details reported.
Pt is a 84 y.o. female with history of hypertension, hyperlipidemia, coronary artery disease s/p stenting, heart failure with reduced ejection fraction (48%), TIA s/p right carotid endarterectomy, CKD stage 3, mild cognitive impairment who is brought in by her daughter for worsening functional decline, diarrhea, and a near syncopal episode. She has limited ability to provide history and her history was provided by her daughter.
10 days after receiving the first Moderna COVID-19 vaccination shot, the site of injection became red, swollen, painful, and hot to the touch. This was similar to when I fitter got the shot, but then it went away. After 10 days, it returned. It seems to be a localized reaction.
24 hours post vax, the pt developed an indurated, erythematous left deltoid at the site of injection.  6 x 4 cm. The pt moves arm well.
Approximately 16 hours after shot, had fever, chills, body aches, dizzy, nausesness, and vomiting. This was first flu shot. Patient had never had a flu shot prior to this shot.
1SEP92 c/o sore throat, swollen glands under chin; c/o fatigue & jt aches; seen by MD 8SEP92 & prescribed APAP for discomfort; sx lasted total 2 wks;
Pt recv vax on 10/27/98; on 10/28/98 pt exp papular rash on torso, back, arms & legs
Patient received the FLUZONE QIV NP vaccine 3 weeks apart instead of 4 weeks apart, with no reported adverse event; Initial information received  on 14-Nov-2022 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 10 months old female patient who received the influenza quadrival A-B [Fluzone Quadrivalent] vaccine 3 weeks apart instead of 4 weeks apart, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.  On 10-Nov-2022, the patient received dose 2 of suspect influenza quadrival A-B Vaccine suspension for injection with unknown strength (lot: UT7695MA, expiry date: 30-Jun-2023) via intramuscular route in the right vastus lateralis for Immunization, 3 weeks apart instead of 4 weeks apart with no reported adverse event (inappropriate schedule of product administration).  Action taken was not applicable.  Outcome: Unknown.   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.
Information has been received from a health professional concerning a 40-45 year old male who was vaccinated with a first, second and third dose of measles virus vaccine live. It was reported that the patient was vaccinated as a child and twice as an adult. On 5/31/02 it was reported that the patient "recently" had a titer drawn that was negative. Additional information has been requested.
Exact time of onset unknown.  Pt stated that he began to have fever, chills, and loss of appetite.  Symptoms began to resolve today.
Rec'd at around noon by 2:30 felt tired, had throat tickle and soreness cough took an oscullococcinum. By 4:30, I felt extreme fatigued had fever (unknown degrees) increased thirst rapid shallow breathing, queasiness, body aches, sore arm, by the next day, symptoms subsided - except for fatigue and soreness, which continued four Mondays.