chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eyes constantly itch; Eyes crustty in the morning; Eyes tear and drip; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (Eyes constantly itch), EYELID MARGIN CRUSTING (Eyes crustty in the morning) and LACRIMATION INCREASED (Eyes tear and drip) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced EYE PRURITUS (Eyes constantly itch), EYELID MARGIN CRUSTING (Eyes crustty in the morning) and LACRIMATION INCREASED (Eyes tear and drip). At the time of the report, EYE PRURITUS (Eyes constantly itch), EYELID MARGIN CRUSTING (Eyes crustty in the morning) and LACRIMATION INCREASED (Eyes tear and drip) had not resolved.            No concomitant medication information was provided  No treatment product information was provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Fever, Chills, Body Aches, Extreme Fatigue - Lastedr 24 hours
weakness chill fever lack of appitate sore shoulder about 2 inch red spot around shot sitel.
Case number PHEH2014US003671 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 13-year-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: 004011) intramuscularly on 15 JAN 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014 of the data received on 21 FEB 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Patient reports on and off "heart pain" that started after receiving the vaccine. He states, "feels like it's inflammed".  Advised to talk to physician/be seen by physician.
Within 24 hours post vax, pt developed a morbilliform rash accompanied by fever of 101.
1st dose on 09Jul2022, 3rd dose on 19Sep2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 52-year-old male patient who received HAB (Twinrix) (batch number J477Y, expiry date 20th May 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX) and HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 19th September 2022, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 19th September 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The pharmacist asked that the 3rd dose was considered to be valid or he has to come in for the full dose in January or any safety data for early 3rd dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received 3rd dose of Twinrix earlier than the recommended interval, which led to shortening of vaccine schedule.
diffuse hives 8 hrs p/1st dose which responded to DPH; Bitten by a field mouse while it was being released; was transporting animal in basket; It jumped out of basket & when trying ot recapture it bit the child; will not cont series;
no known adverse event. Patient received duplicate vaccine 3 mos apart. No signs or symptoms 24hrs post receiving vaccines.
Developed generalized rash anterior and posterior thorax, denies SOB, wheezing.  Self treated with Benadryl with relief.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 24-year-old male. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographics were received. Additional information was received on 12-May-2009: product complaint investigation results.
Approx 24-30 hrs after given vaccination (Shingrix) reddness developed near injection site but not directly at injection site. Reddness began spreading on deltoid area becoming warm and slightly swollen by day 5 after given the injection. On day 6 area became itchy and migrating toward inner arm, remaining red, warm and swollen
Pfizer booster; I had the two Pfizer vaccines and the Pfizer booster and had no problem with any of those other than my arm hurting that's it.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 60 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "brain aneurysm" (unspecified if ongoing), notes: patient had brain aneurysm just last year; "quadruple heart bypass" (unspecified if ongoing), notes: patient had quadruple heart bypass. The patient's concomitant medications were not reported. Past drug history included: Oxycodone, notes: even after my heart surgery patient had oxycodone and only took two of those. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "arm hurting"; Bnt162b2 (Dose 2), for Covid-19 Immunization, reaction(s): "arm hurting". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer booster"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I had the two Pfizer vaccines and the Pfizer booster and had no problem with any of those other than my arm hurting that's it.".  The lot number for bnt162b2 was not provided and will be requested during follow up.
CERVARIX was given to a male patient while this vaccine should be given to female patients only.
Within an hour of the vaccine and I began to feel light headed and disoriented. I started to feel a slight headache and I noticed that my heart rate increased. By 3:10pm, my BP was 104/76 with a HR of 102. About an hour later, and after taking Flecainide, the episode let up. Then on Sunday, I another episode of AFIB around 6:00pm.
Patient received 0.5ml of Covid Vaccine instead of recommended 0.25ml for their age.
LPN on staff administered 3rd dose of varicella when only 2 doses are needed.  2nd dose was administered in March and this extra dose was administered June 1, 2022.  Patient outcomes are unknown at this time.  RN Supervisor has reached out to patient's parent via phone without success.
Client experienced syncope with in seconds of receiving vaccine. Assisted to wheelchair. Brought to EMS Observation area. Vitals monitored. Client recovered and left site in stable condition.
No A/E. Vaccine was stored in freezer beyond the  14 day max. Was stored in freezer for 23 days.
Immediate itching at site of injection, generalized pruritis, Headache, nauseated, shakey, sensation, rash surrounding site of injection, erythematous, very fine papules.  BP elevated--142/96, heart pounding.
This spontaneous report as received from a Licensed Practical Nurse refers to a 6 month old female patient. The patient was administered an initial dose of PEDIARIX on 02-JAN-2014. Patient was administered a second dose of PEDIARIX on 18-APR-2014 and additionally a dose of RECOMBIVAX HB (lot # H018689, exp date as 07-NOV-2014, 0.5 ml, intramuscularly) instead of the prescribed dose of PEDVAXHIB on 18-APR-2014. This was a staff error only. No adverse events were reported. The outcome was unknown. Additional information has been requested.
pt recvd vax & devel sore throat 21 days following vax; No further details were provided;
pt recv vax & exp a sore arm w/red spots around the inj site & a mild fever;MD noted that red spots were not vesicular or macular papular & had no drainage;
after the vaccination, patient walked to the waiting chairs. 10 minutes later, she was pale and light headed. she sat back into the chair and started losing consciousness as the pharmacist called 911 at 1:03 pm.  Her eyes rolled back and she started shaking  while her brothers were supporting her in the chair making sure that she wouldn't fall out of the chair. she stiffened up and kept shaking while foaming at  the mouth slightly. she started coming back to consciousness as she sat up and coughed up mucous. she started to feel better after this event as I also got her some water. Paramedics then arrived and took over care for her a few minutes later.
severe body aches; severe chills; night sweats; Fatigue; This is a spontaneous report from a contactable Physician (patient). A 55-year-old male patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at 12:00 at single dose in left arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose bnt162b2 in Dec2020 three weeks ago at 12:00 noon in the left arm for covid-19 immunization and experienced mild pain at the injection site which lasted two days and then was gone. The patient experienced severe body aches, severe chills, night sweats, and fatigue on 07Jan2021. Event details: The patient reported that he received the first dose of the Pfizer COVID 19 vaccine three weeks ago at 12:00 noon in the left arm. He did not know the exact date. After the first dose there was mild pain at the injection site which lasted two days and then was gone. He received the second dose of the Pfizer COVID 19 vaccine on 06Jan2021 at 12:00 noon in the left arm. He noticed 12 hours later severe body aches, severe chills, and night sweats. He also felt fatigue. Everything had mostly resolved except for the night sweats and they were still pretty severe. All events were reported as serious by reporter per medically significant. The outcome of event night sweats was not resolved, outcome of other events was resolved on 10Jan2021.  Information about lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported severe body aches, severe chills, fatigue and night sweats, and the administration of the COVID 19 vaccine, bnt162b2, based on the reasonable temporal association.   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 RA, IEC, as appropriate.
next day after vaccination patient experienced- tiredness and sore arm and itchy arm Patient too Benadryl and that helped During the summer (late June and early July) Joint pains  in knees Pain during exercising in the joint areas. Patient has not see a doctor for the joint pains yet. patient feels pains in joints during walking or daily motion or movement
Potential third dose administration; Possible dose administered outside of temperature range; soreness; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (soreness), HEADACHE (Headache), TEMPERATURE INTOLERANCE (Possible dose administered outside of temperature range) and DEVICE USE CONFUSION (Potential third dose administration) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031721A and 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 19-Mar-2021, the patient experienced PAIN (soreness) and HEADACHE (Headache). On 12-Apr-2021, the patient experienced TEMPERATURE INTOLERANCE (Possible dose administered outside of temperature range). On 19-Apr-2021, the patient experienced DEVICE USE CONFUSION (Potential third dose administration). At the time of the report, PAIN (soreness) and HEADACHE (Headache) had resolved and TEMPERATURE INTOLERANCE (Possible dose administered outside of temperature range) and DEVICE USE CONFUSION (Potential third dose administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol. Concomitant medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080352 (E2B Linked Report).; Reporter's Comments: The consumer is taking Tylenol, as advised by their HCP to try to alleviate the symptoms.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080352:1st dose case
Initial and follow-up information has been received from a nurse concerning a 67 year old female with hypertension who on 16-SEP-2008 was vaccinated inadvertently with VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD).  Concomitant therapy included DYAZIDE, aspirin and multi vitamins.  The nurse reported that it was a combination of events that led to the human error.  The physician's assistant took the vaccine out of the freezer and handed it to the nurse to administer.  The office was very busy.  The vials had the term "VARICELLA" on the label.  The formulations were similar in that one is HERPES ZOSTER and the other is HERPES SIMPLEX.  And both were stored in the same refrigerator/ freezer.  The nurse suggested that it might be helpful if the label was easier to read to distinguish the two vaccines as the names were similar.  But she admitted it was more an issue of two people handling the vaccine and the very busy conditions in the office that day.  No adverse effect reported.  On 23-SEP-2008, "today", the patient was scheduled to follow up later.  On 29-SEP-2008, it was reported that the patient was contacted and denied any problems/symptoms after vaccination.  This is one of several reports received from the same source.  Additional information is not expected.
left hand middle knuckle swollen, pain radiating down middle finger. ball of left foot swollen, numbness and pain right foot has minor tingling and pain agitated easily
Redness and swelling at inj site 2"x 1" which started 24 hrs later. Resolved within 48hrs.
Patient has received 3 doses of Shingrix with our pharmacy. First set administered 2/16/19 and 5/4/19. Patient then received 3rd dose on 11/21/21 believing that it was their 1st. Presented today for a 4th vaccine but was not given upon discovery.
After my second vaccine in May 2021 I started to experience heart pounding, palpitations and intermittent shortness of breath. I also had an eye infection, (I have never had any type of eye infection.) The palpitations were so bad I stopped all medication and supplements. My Dr. thought it was thyroid related and switched my medication to NP thyroid. I stabilized to some degree finally in November 2021. My stabilzaion period lasted until I took the booster in February 2022. I am now into a full-on palpitation event. I have pounding and then palpitations. I am very athletic and exercise everyday for at least 1 hour and 30 minutes.
experienced non painful blisters around injection site; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site blisters in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 75BFS, expiry date 28-JAN-2025) for prophylaxis.   On 02-OCT-2023, the patient received Arexvy. On 03-OCT-2023, 1 days after receiving Arexvy, the patient experienced injection site blisters (Verbatim: experienced non painful blisters around injection site).  The outcome of the injection site blisters was resolving.   It was unknown if the reporter considered the injection site blisters to be related to Arexvy.     It was unknown if the company considered the injection site blisters to be related to Arexvy.   Additional Information: GSK Receipt date: 05-OCT-2023 The reporter reported that patient received Arexvy vaccine in pharmacy and day after vaccination patient had non painful blisters around injection site. The reporter spoke with the patient on the morning of reporting day and patient told that the blisters had subsided some. The reporter consented to follow up.
Our 8 year old son received the H1N1 vaccine about a week ago.  Everything was fine but his asthma symptoms have elevated severely with little to no elevated cardio. But also, the same morning of the 26th my wife noticed my son's jaw making erratic side to side movements and severe teeth grinding.  She asked him to stop it because she thought he was doing it on purpose.  He said he wasn't, he said he didn't know why it was happening.  Then a few moments later, one of his legs started to twitch violently, he also said he wasn't doing it, it was just happening. The same evening while watching TV, this scenario happened again, only I observed it.  I said why are you doing that with your jaw, he replied, "I'm not doing it."  Then his right leg started to shake uncontrollably, I witnessed it. I said what is going on with your leg, again, he said, "I don't know, I'm not doing it."  Today is the 27th the third episode has happened, at 4:45pm his jaw started to make uncontrolable side to side movements he said he can't stop it from happening. I DON'T KNOW WHAT TO DO, THIS HAS NEVER HAPPENED.  He has no history of spasms or seizures EVER!!
blowing nose; feeling cold; headcold; chills; This case was reported by a consumer and described the occurrence of head cold in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2020, the patient received the 1st dose of Shingrix. On 7th December 2020, 3 days after receiving Shingrix, the patient experienced runny nose and feeling cold. In December 2020, the patient experienced head cold and chills. On an unknown date, the outcome of the head cold, chills and runny nose were not recovered/not resolved and the outcome of the feeling cold was unknown.   It was unknown if the reporter considered the head cold, chills, runny nose and feeling cold to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the dose of Shingrix and developed a headcold and chills. Patient also reported that blowing nose a little in morning. The outside temperature was fairly warm but patient felt cold. Patient suspected if symptoms are from Shingrix vaccine or if a covid test was warranted. The reporter did not consent to follow up
Headache, Arthralgia, Fever, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE,  Narrative:
This spontaneous report as received from a nurse refers to a 7 month old patient of an unknown gender. On 16-FEB-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Reactivation of Human Herpesvirus 6 infection, chronic hypoglycemia
Patient received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number abxA87az, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 9th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's Comment: The patient received an expired dose of Bexsero. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Bexsero which was already expired, which led to expired vaccine used. This is one of 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022068142:Same reporter. US-GLAXOSMITHKLINE-US2022068148:Same reporter.
Muscle pain and fatigue, body aches, fatigue onset 3 hours after vaccine and lasted until 10pm the following day. Constipation started 2 days after vaccine dose and has continued to be present and currently experiencing. Injection site pain starting immediately after initial dose and continuing until today. Extreme right leg, outer thigh and right calf pain starting 3 hours after vaccine and continuing every day up to the present day. On going moderate to extreme pain in the right leg.