chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Erupcion in the neck and back of his head; had some pain in the injection site the next day after vaccination; Allergy in the neck and back of his head; Allergy in the neck and back of his head; Erupcion in the neck and back of his head; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Allergy in the neck and back of his head), HEAD DISCOMFORT (Allergy in the neck and back of his head), INJECTION SITE PAIN (had some pain in the injection site the next day after vaccination), MUSCULOSKELETAL DISCOMFORT (Erupcion in the neck and back of his head) and HEAD DISCOMFORT (Erupcion in the neck and back of his head) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Depression and Allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Allergy in the neck and back of his head), INJECTION SITE PAIN (had some pain in the injection site the next day after vaccination) and MUSCULOSKELETAL DISCOMFORT (Erupcion in the neck and back of his head). On an unknown date, the patient experienced HEAD DISCOMFORT (Allergy in the neck and back of his head) and HEAD DISCOMFORT (Erupcion in the neck and back of his head). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Allergy in the neck and back of his head), HEAD DISCOMFORT (Allergy in the neck and back of his head), INJECTION SITE PAIN (had some pain in the injection site the next day after vaccination), MUSCULOSKELETAL DISCOMFORT (Erupcion in the neck and back of his head) and HEAD DISCOMFORT (Erupcion in the neck and back of his head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Antidepressant pills and High blood pressure pills
My menstrual cycle was delayed by over two weeks after my first dose.  I have always been on a 27/28 day cycle  and my period was predictable. I have never in my life been more than a day late. The period itself was normal other than it being late. I?ve noticed that my periods since have been unpredictable in start day and pain level. They have been shorter and lighter; ranging from 2-3 days and minimal bleeding (being able to wait the full 8 hours before changing a tampon, rather than every 2-3 hours).
This was my 2nd shot, but the red lesion and swelling are at the 1st injection site.  I had red lesion, swelling after the first shot.And a fever, swelling and lesion after the second shot
Hives, on right shoulder and right hand, given 50 mg Benadryl.  Client went back to work after Benadryl was given and vitals remained stable, hives did not continue to spread.
9 of 10 pain in my jaw and under tongue and extreme swelling in my mouth lasting one week, tongue swelling, swelling of glands in mouth and jaw thereafter; diarrhea, anal swelling sensitivity and itching ongoing and mouth and continued mouth and jaw pain
Body aches, fatigue, shooting pain in entire back and ribs, cold sweats, breast pain, injection arm pain (at site and on lower arm), fluid in ears/earache, nausea, diarrhea
This case was reported by a pharmacist via sales rep and described the occurrence of erythema in a female patient who received SHINGRIX for prophylaxis. On 11th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, swelling and pruritus. On an unknown date, the outcome of the erythema, swelling and pruritus were recovered/resolved. It was unknown if the reporter considered the erythema, swelling and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness, itching and swelling for 8 days.
the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; This spontaneous report was received from a nurse referring to a male patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/allergies were unknown. On an unknown date in March 2018 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, lot# and expiration date were not reported), meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) (doses, strengths, lot # and expiration dates of all products were unknown) all via intramuscular route as routine vaccines and patient experienced flushing, dizziness, pallor, erythema and visual impairment after receiving the vaccines. The patient has not sought medical attention as the event occurred during office visit and was addressed immediately. The patient was monitored and recovered on the same day and was able to go home. No overdose and product quality complaint (PQC) involved. The reporter's causality assessment between the events and the suspect therapies was not provided.  This case has been cross linked to 1907USA004108 (sibling case).
The patient received the flu vaccine first and said it was fine - no issue. Then he received the Shingrix in the same L deltoid and states that when the needle was removed he felt that it hung up in his arm and felt like it pulled and he stated he said "Ouch."  It still hurts internally and sometimes feels spasms up his neck on the L side and sometimes has hand spasms. He's tried warm compresses but they do not give any relief.  The pcp he saw told him to see a neurologist. The neurology earliest appointments are in June/July 2023.
late onset dizziness and vertigo.  After both shots the dizziness occured 4-5 days later. Its ongoing and inconsistent.
Patient reports that she developed hives on the day after vaccination. Hives started on left upper arm and then migrated down left arm, up to neck and back and then right arms and legs. Hives lasted about 3 days, then resolved with itching that persisted for another 4-5 days.  She was examined in the clinic on 11/18. Her hives had resolved. Her Nexplanon was still in place and there was no erythema, swelling, or pain on palpation of the inserted device.
Local side effect at injection site (R arm): round, erythematous without pustular lesion 1.5 cm x 1.5 cm and tenderness on Right arm.
I got a rash all over my body, concentrated on my torso the night of the shot. I informed them when I got my 2nd dose and they said it's safe if it isn't within minutes of getting the shot. I got the rash on the second shot that night as well. Ever since I received the vaccine, I get a rash exactly the same as previously described, any time I get sick. I have had a cold or the flu 8 times since receiving the vaccine and have had a rash occur all over every time. The rash is itchy but no pus and not significantly raised. I have never had a rash occur any time while I was sick prior to the vaccine and it is the same rash I got from the vaccine. I KNOW it isthe vaccine that has changed something in my body to react differently when I get sick now and it is extremely worrisome.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years for COVID-19 immunization. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish. Concomitant medication(s) included: HUMALOG, start date: 31Mar2021; LISINOPRIL, start date: 01May2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Other medication in 2 weeks was reported as 'Yes'. Paxlovid was started on 21Sep2022 to 25Sep2022 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Administered to 118 patients; There was no excursion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered to 118 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was no excursion from freezer) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered to 118 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was no excursion from freezer). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered to 118 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was no excursion from freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was stated that, there was excursion from the freezer on 01-Oct-2021 and nurse used the excursion tool but there was no option for the excursion they experienced. The only tool gives the options for excursion above one hour and not less than that so the nurse dose not known about the analysis. The nurse stated that her team know the recommended temperature and wants to know if the vials were still okay to use because they were administered to 118 patients. The storage condition at the time of the excursion was frozen, vial size was 7.5 mL and maximum or minimum temperature reached was as follows; minimum 4.2 degree F and maximum 5.7 degree F. It was also stated that excursion duration was 6 minutes. On visual inspection the vials were thawed before administration and there were no color changes or anything abnormal. Total 10 vials/doses were impacted.  No concomitant medications were reported.  No treatment information was reported.
Dear Im a 24 years old man. I know my HIV status before three years. I have been without any serious sickness since then till the last week of January 2010 when I was hospitalized because of TB Meningitis. This happens just one week after my yellow fever vaccination. During my hospitalization my CD4 count was only 70 and I had confusion and memory loss. Besides I am not able to walk without a stick since then. By now I have finished my TB Meningitis medicine and left with the HAART. Just today while I browse your web I came up with this info people with severe immunodeficiency due to symptomatic HIV/AIDS or other causes, or in the presence of a thymus disorder shouldn't be vaccinated against yellow fever. I didn't know this at the time I get the vaccine. so this is to ask you if there is any thing I could do in this regard to improve my situation. I mean its effect on my memory and balance. Please help me in responding and briefing me any possible good measure I could take. Looking forward to your reply Regards,
No additional AE reported; She reported that an expired MMR II got administered to a patient today (7/5/2022); This spontaneous report has been received from a nurse concerning a 20-year-old male patient. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On 05-JUL-2022, the patient received a vaccine dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) lot # T022310, expiration date: 30-JUN-2022 (dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No additional events were reported.
It started out with pressure behind my eyes, then at 9 pm on 1/23/21 I started swelling on the left side of my face and my lips, and inside my mouth with a nodule inside my mouth under the skin right under my upper lip then the swelling started moving up my face onto the cheek on the left side and I started taking Benadryl and then about 6 pm on Sunday night it started to swell as well as the right  side of my face and lips. I called the ER and they told me to come to the hospital immediately so that's what I did.
chills; tiredness and, only extreme fatigue on the next day; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 25 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 22Mar2021 (Lot number: Ep7534) at the age of 25 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, single; Arm left; Lot number: En6198; Administration time: 17: 30), administration date: 26Feb2021, when the patient was 24 years old, for COVID-19 immunisation, reactions: "Headaches within 10 minutes of shot/headaches for 3 weeks after 1st dose", "Anxiety within 10 minutes of shot", "arm sore", "Nausea", "Fever". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "chills"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "tiredness and, only extreme fatigue on the next day". Therapeutic measures were not taken as a result of chills, fatigue. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient experienced fainting. Unspecified medical attention was sought. At the time of report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested. This is in follow-up to report (s) perviously submitted on 5/14/2007.
Pt recv vax on 11/24/98; on same day pt exp non-stop crying for 4 day
red indurated area 3in x 3in w/soft tissue swelling to lateral deltoid;
Fatigue and pain at injection site starting the morning after. Fatigue resolved by the end of the day.
mom called on 6/1 stating that after vaccine given on 5/26/21 (patient only received hep b in right thigh and rotavirus orally, no vaccine was given in left thigh) - mom stated patient had a red and bumpy rash on both thighs, from diaper line to knees. not improving with hydrocortisone alone. discussed continuing hydrocortisone and adding 3 days of oral prednisolone to improve reaction. Mom was to send photo by secure patient chart or email and never did; unable to verify exact location and nature of rash this time.
Narrative:  95yo male died on 12/12/2021 of unknown cause. Pt in assisted living (outside facility) for dementia. Pt with hx of: Bilateral hearing loss (SCT 95820000) Hyperlipidemia (SCT 55822004) & Benign hypertension (SCT 10725009). Pt had received covid vaccines outside facility on 1/29/21 & 2/19/21. Likely pt's death is not related to covid vaccines given pt's advanced age, comorbidies, and long length of time between death & date of vaccine administrations.
Pain in whole left arm and arm pit, down to ribs. Severe chills, unable to stop shaking or get warm. Chills started approximately 24 hours after the shot. 102 fever through the night and the full sweat with fever break about 7 hours after chills started. Full body pains thru the night. 36 hours after the vaccine, chills and fever were gone but soreness down my left side remained. 48 hours after, the chills came back and slight fever.
arthralgia, hives, petechia, dizziness, urticaria, insomnia, joint pain fr elbow & knees down; reported on 17AUG(2 still has some hives, urticaria, arthralgia; tx DPH; sx started approx 2 1/2 wks following vax;
Rash Narrative: sORE ARM FIRST DAY. NOTICED TODAY 1/21/2021 THAT IT WAS SLIGHTLY TICHY AND DAUGHTER POINTED OUT THAT THERE WAS A RED SPOT MEASUREING 5.5CM X 4.5 CM. NOT HOT TO TOUCH AND FLAT.
I had both of the shots. I came down shingles/suspected vaccination failure; shingles; It was just a horrible sensation; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feels awful. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and feels awful were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had both of the shots, then, right before the patient had the 1st Covid shot, the patient came down with shingles.  The patient did not get the rash, for which he\she so grateful.  It was just a horrible sensation where the rash would have been.  The patient got medication from physician and it went away in a few days. The patient said it was might be the stress of getting the Covid shot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Did not receive the  2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in July 2019).   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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
injection site/whole arm became a "big red thing that its hot"; injection site/whole arm became a "big red thing that its hot"; Itching; Injection site/whole arm became a "big red thing that its hot"; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (injection site/whole arm became a "big red thing that its hot"), VACCINATION SITE SWELLING (injection site/whole arm became a "big red thing that its hot"), PRURITUS (Itching) and VACCINATION SITE WARMTH (Injection site/whole arm became a "big red thing that its hot") in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037KWA) for COVID-19 vaccination.     The patient's past medical history included Breathing difficult and Heart disease, unspecified. Concurrent medical conditions included Allergic reaction to antibiotics since January 2021.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced NAUSEA (Nausea). On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site/whole arm became a "big red thing that its hot"), VACCINATION SITE SWELLING (injection site/whole arm became a "big red thing that its hot"), PRURITUS (Itching) and VACCINATION SITE WARMTH (Injection site/whole arm became a "big red thing that its hot"). At the time of the report, NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (injection site/whole arm became a "big red thing that its hot"), VACCINATION SITE SWELLING (injection site/whole arm became a "big red thing that its hot"), PRURITUS (Itching) and VACCINATION SITE WARMTH (Injection site/whole arm became a "big red thing that its hot") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No conmeds provided.  No treatment provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a physician's assistant (P.A.) concerning a 22-week-old male with a history of bronchiolitis who on 07-NOV-2007 and 08-JAN-2008 was vaccinated orally with a 2 ml first and second dose of ROTATEQ (lot# 653754/0139F and 657668/1390U), respectively. Concomitant therapy included an unspecified antibiotic, unspecified oral steroid therapy and ZITHROMAX. On 09-FEB-2008 the patient developed gastroenteritis. The patient was seen at the clinic and a stool culture for bacterial infection was performed. No results were reported. It was reported that, at the time of this report (11-FEB-2008), the patient was recovering. No product quality complaint was involved. Additional information is not expected.
Patient described a supersensitivity that lasted 2 days in the arm that the immunization was administered. She also described it as a numbness and tingly feeling about a week after the immunization.