chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11 hours after vaccination (12 midnight), I noticed a small redness on the injection site. Right after I saw that, I took a shower and  minutes after a shower I developed red itchy rash all over my arms and legs. Then my abdomen and back started to itch as well. Immediately I took  50 mg of Benadryl and went to sleep. Itch continued while I was trying to fall asleep. In the morning there was no rash on my body except for a small redness on my injection site. By the way, with the first shot that I had on December 19, 2020, Pfizer Lot # EH9899 in the same facility , I developed red, hot to touch, not raised rash all over my deltoid muscle of the left arm 2 days after the shot was administered and it lasted for 3 days with no change. Benadryl and Allegra did not help  with shot # 1.
5min local reaction @ site, red, swelling; 10min cough; 15min lost voice, hives, chills; Did not seek care, called MD;
Pt received first dose of Covid-19 vaccine 03/26/2021. Pt returned 4/28/21 to get second Covid shot.  Approximately 10 minutes later pt states not feeling well, feeling dizzy. RPH took blood pressure using automatic blood pressure machine. After erroring out, got a reading of 80/58, pulse 45. Pt was given a soda at her request as she stated thought her blood sugar might be low. Went to repeat bp monitor approximately 5 minutes later with error (erratic reading). 911 was called.
For the duration of a couple weeks after the second Pfizer shot, I sporadically would experience moderate heart palpitations, chest pains, and chest feeling heavy.   These symptoms would occur randomly throughout the day (typically when not doing any physical activity - i.e. driving in car or sitting on couch) and would last for several minutes.  It never got severe enough to the point where I went to see a doctor.  It has been 17 days since the second shot and I feel better and haven't experienced the pains in a couple days.
2 weeks after the first dose injections I began having symptoms of an HSV2 outbreak, although I am on suppression therapy.  I have never had one since my initial diagnosis.  I also began having numbness and tingling in both feet and hands.  The symptoms continued through the second vaccine dose on January 16.  The numbness and tingling in my extremities has become worse.  An increased dose of Valacyclovir has been ineffective in treating the HSV outbreak symptoms.
pt recv vax; 3-4 wk later, devel serum sickness w/ a prolonged febrile rxn for 1 mo;
NAUSE, DIARRHEA, , VOMITTING : Started around 1:00am  lasting until 10:00am HEADACHE,MUSCLE ACHE, FEVER: Started around 1:00am lasting until 2:00pm  Fatigue and general ill feeling started around 12:00noon and lasted until 10:00pm
expired dose of Menactra was inadvertently administered to a patient on 18Jul2019; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an 11 years old female patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and reported that expired dose of Menactra was inadvertently administered to a patient on 18Jul2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL); and HPV VACCINE (HPV VACCINE).  On 18-Jul-2019, the patient received a 1 dose of suspect 0.5 ml MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5948AB and expiry date: 03-Jul-2019 via intramuscular route in the left deltoid.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any 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 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.
Patient received vaccine with little to no pain on injection and then the next day the patient started having pain on injection site which was normal, but then a rash that was vertical and ran down majority of her arm starting at the shoulder and running past the elbow.
Severe flu like symptoms 12 hours after injection and persistent pain at injection site 2 months after vaccination.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA279805 (Same reporter). This case involves a male patient (age reported as 65 year old) who he received vaccine FLUZONE HIGH DOSE lot UJ038AB expiry date: 03-May-2019 via unknown route on 03-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was case of actual medication error due to vaccine under dose and extra dose administered. It was reported that reporter screwed on the needle and it was tight and sealed but there must be a crack or something because it was leaking out when she was giving it. The shot leaked and she administered another FLUZONE injection at the time. It was also a case of needle issue. It was not reported that if any adverse event was occurred or not. 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 Directive 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.
No additional information provided, no additional adverse event reported; The patient was administered with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and patient is in her 50's; This spontaneous report as received from a pharmacist referring to a female patient of unknown age. The patient's concurrent conditions, medical history, historical drug and concomitant therapies were not reported.  On 22-NOV-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis. The patient was administered with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and patient is in her 50's (product use issue). No additional information provided, no additional adverse event reported (no adverse event).
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 120 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
The patient experienced stinging; Burning burning at the time of the injection; felt tired; Threw up after receiving the vaccine; Pain at injection site/burning at the time of the injection; Unable to lift arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-MAY-2023, the patient received the 1st dose of Shingrix (right arm). In MAY-2023, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at injection site/burning at the time of the injection), injected limb mobility decreased (Verbatim: Unable to lift arm), tiredness (Verbatim: felt tired) and vomiting (Verbatim: Threw up after receiving the vaccine). On 18-MAY-2023, the patient experienced stinging (Verbatim: The patient experienced stinging) and burning sensation (Verbatim: Burning burning at the time of the injection). The outcome of the injection site pain and injected limb mobility decreased were not resolved and the outcome of the stinging, tiredness, vomiting and burning sensation were unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, stinging, tiredness, vomiting and burning sensation to be related to Shingrix.     It was unknown if the company considered the injection site pain, injected limb mobility decreased, stinging, tiredness, vomiting and burning sensation to be related to Shingrix.   Additional Information: GSK receipt date: 25-May-2023 This case was self reported by the patient.  The patient received the first dose of Shingrix last Thursday (the day before reporting).  The patient experienced stinging and burning at the time of the injection.  The patient experiences pain at the injection site on right arm and was unable to lift the arm.  The patient also reported that was felt tired and threw up after receiving the vaccine.  The adverse event filed consented to follow up. The patient gave consent to follow up with healthcare professional.  The patient did not have phone number or address of the clinic.
Information has been received from a medical assistant(also reported as office manager) referring to a12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 10-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program (VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
This spontaneous report was received from a nurse regarding a 1 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 23-APR-2018 the patient was vaccinated with a dose of PROQUAD lot# N034560 with expiration date: 03-JUN-2019 and VARIVAX lot# N028711 with expiration date: 13-OCT-2019 subcutaneously for prophylaxis. The reporter mentioned that this was not a product confusion. Concomitant therapies included sterile diluent (manufacturer unknown). No lot information was provided for the sterile diluent (manufacturer unknown) used to reconstitute the PROQUAD or VARIVAX. No adverse effects were reported.
15 year old female given intradermal influenza vaccine which is licensed for 19 and older. Was sent by her OBgyn to clinic under a program we have offering free flu to pregnant women/family members with out insurance to cover. Qualified for VFC and should have received IM flu vaccine.
No adverse effects until two days after the injection. Began as sharp pain in the left bicep, radiating to the tricep and elbow. Intense pain also spreads to the left shoulder and forearm. The pain usually begins in the morning if I am sitting at my desk with my arms bent to use the computer. Initially took ibuprofen for the pain, but later had to switch to naproxen as ibuprofen was no longer effective. If I am not working at my computer (i.e., up moving around most of the day), the pain usually will not set in until I sit down to watch TV for the night with my left elbow bent at a 90 degree angle. Discussed the condition with my primary care physician, who said it sounded like a nerve inflammation, especially considering the shot was given higher up in the arm and further around the back of the arm than in previous years. I received the seasonal flu shot last year with no problem, but did not get the H1N1 vaccine. This year's shot was a combination of seasonal and H1N1 (INFs pres free (AFLURIA) 9yrs-adult (Influenza)). The pain has been persistant since two days after receiving the flu shot (almost 60 days ago). Continuing with the OTC naproxyn as needed. Applying heat also seems to help in the evening. The pain does get so intense as to limit my ability to concentrate and work at my desk.
Mother describes child developed hives that were flat, pea-sized,what looked like a sm. blister in center and these moved around and would come and go.  Also had some swelling of eye lids, hands and left big toe and the swelling would come and go. No temp. but wouldn't eat. These symptoms developed about 26 hrs. after flu shot and lasted 1 1/2 weeks.  Did see Pediatrician on 12/10/2005 who wrote urticaria and prescribed Benedryl for the itching.  Doctor reported incident to us to report to VAERS.  Child has hx of Asthma.  Dr. recommended child not have flu shot next year or have child tested by allergist.
On 1/17/2021 I woke up with my face drooping. I went to the ER and was diagnosed with Bells Palsy.
This spontaneous report as received from a consumer refers to a patient of unknown gender aged 12 (details unspecified) (reported as family member of the reporter). No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with M-M-R II (dosing details, lot#, expiry date and route were not reported) for prophylaxis. On an unknown date, the patient experienced autism. The outcome of autism was unknown. The relatedness of the event to the therapy with M-M-R II was unknown. There were no product quality complaints (PQC) involved. Upon internal review autism was determined to be medically significant. This case is related to case number 1702USA011534 and 1702USA011535 via same reporter link. Additional information is not expected as the reporter did not wish further contact. Sender's Comments: US-009507513-1702USA011534: US-009507513-1702USA011535.
Glucose blood increased; This non-serious case was reported by a consumer and described the occurrence of blood glucose increased in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included cetirizine hydrochloride (Zyrtec), lamotrigine and simvastatin.   On 03-MAY-2023, the patient received Shingrix. On 04-MAY-2023, 1 days after receiving Shingrix, the patient experienced blood glucose increased (Verbatim: Glucose blood increased). The outcome of the blood glucose increased was not resolved.   It was unknown if the reporter considered the blood glucose increased to be related to Shingrix.     It was unknown if the company considered the blood glucose increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-MAY-2023 This report was submitted by patient via the online direct entry reporting system.  The patient suffered from Glucose blood increased the day after receiving Shingrix vaccine. The patient had high IgE level, high cholesterol bad cholesterol level. The reporter consented to follow up.
Pt received 0.5ml of FLUZONE vaccine instead of 0.25ml on 10/22/18.
positive for Covid; positive for Covid; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4486960-00.   A 44-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, citrate free, subcutaneous for psoriatic arthropathy. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Jul2022, outcome "not recovered" and all described as "positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Positive. The action taken for adalimumab was unknown. Clinical course: On unknown dates, the patient experienced positive for COVID and got sick after first COVID Vaccine booster dose. On an unknown date, got sick after first COVID Vaccine booster dose resolved. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of "positive for covid" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.
Left upper thigh, large area of edema and erythema. No evidence of infection at site
swelling in the area of the parotid gland on the right side of my neck - mass about the size of a walnut
Initial report was received 18 October 2011 via a company sponsored website from a consumer, who is the patient. A female child (age not reported received an injection (route and site not reported) of DTaP, manufacturer and lot number not reported, on an unknown date. The patient's medical history was not reported. The patient was vaccinated as an infant and was included in the first round of the joint TDaP vaccines as opposed to the separate TD and P vaccines. On an unknown date, the patient was diagnosed with pertussis when she was in the second grade and was in and out of school for most of her second and third grade years. The patient's mother was told three very distinct times to take the patient home and make her comfortable because that was the only thing they could do. The outcome was not reported. Documents held by sender: None.
swelling @ inj site (ant thigh) treated w/cold compress & DPH-pt responded well
Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.  The vials were placed in refrigerator on 06-Dec-2021.   This case was linked to MOD-2022-449524 (Patient Link).
administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 2:35 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 2:35 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Vaccines were not frozen at time of administration. Vials only punctured right before administration - during COVID-19 vaccine clinic all doses were drawn from vial due to high-pace clinic. On 27-Apr-2021, Excursion time was 9 AM, temp was 35, total doses given for the day was 42, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 27-Apr-2021. 8 vial was moved to clinic. Vaccine BUD date was 19-May-2021. Vials only punctured right before administration Vial was stored on cooler 1 , on 27-Oct-2021, Excursion duration At 8 AM: 41, 9 AM: 35, 10 AM: 36, 11 AM: 38, 12 PM: 43, 1PM : 43, 2 PM : 44, 3 PM: 43, 4 PM: 43. Fisher brand traceable temperature monitor was used to record hourly temperatures. It was reported that unknown number of patients were 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.   No Treatment medication reported.