chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The pt reported having swelling in the lips the day after the vaccine.  The patient had Juvederm lip fillers on 7/1/2021 and did not disclose to the pharmacy/pharmacist before having the Covid19 (Moderna) vaccine.  The patient reported taking diphenhydramine for the swelling, went to the instacare where she was prescribed prednisone for the allergic reaction.  The patient reported to have significant relief from the swelling by 6:30 P.M. that same day.
Information has been received from a nurse referring to 2 unspecified patients of unknown gender and age. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On 09-AUG-2017, 1 unspecified patient were vaccinated with improperly stored PROQUAD (Lot# N002325, expiration date 19-JUL-2018) (strength, dose, and route unknown) for prophylaxis, the diluent (unspecified lot #'s and expiration dates) used to reconstitute the vaccine above was properly stored. The vaccine was stored at 6 to 14 degrees Fahrenheit for 15 hours and 45 minutes. There had not been a previous temperature excursion and the phone call was a result of the data logger. No adverse effects were reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-708USA007019: US-009507513-1709USA009153: US-009507513-1709USA009152: US-009507513-1709USA009150: US-009507513-1708USA008578: US-009507513-1709USA007605: US-009507513-1709USA007604: US-009507513-1709USA007603: US-009507513-1709USA007602: US-009507513-1709USA007601.
vaccine was mixed with bacteriostatic saline, directed by CDC and pfizer to readminister.
Itchy face and arms around 11pm Oct 5th and lasted a few hours until I went to bed around 2am. I woke up around 5am Oct 6th and was having very bad body aches and nauseousness. Within an hour, I fainted twice and I am unsure how long I was unconscious for. Caused me to fall and hit my head when I fainted the second time.
EXTRACTION OF THE MODERNA VACCINE FROM THE VIAL WAS NOT CONSISTENT WITH A MODERNA TECHNIQUE (I.E. MORE THAN 20 BOOSTER DOSES WERE DRAWN UP FROM THE 15ML VIAL).
Patient stated that evening after receiving both vaccinations his left arm started to ache followed by swelling and redness (9/11/17). By 2 days after vaccination swelling and redness had spread from vaccination sites down to a few inches above his wrist. He came in to report the event to the pharmacy on 9/18/17 and the swelling and redness has receded to above the elbow. I counseled him that even though the reaction was getting much better he should still call his primary physician to report to them what happened as well to see if they would want to treat and so they could document the reaction to those 2 vaccinations.
Pt recvd vax 12AUG92 & exp extreme tiredness that lasted for half an hr following the vax; pt recovered the same day; no further details were provided;
local rxn, redness, swelling, itching, up to 1-2cm induration p/pt given tetanus rather than PPD;tx w/ice packs;still had 1mm induration, discoloration, one month later;
Breakthrough case. Woke up congested, and took a home COVID-19  test and tested positive. My Dr.'s office was closed, so I went to an urgent care and tested positive again. They prescribed PAXLOVID. It's been 3 weeks and I'm feeling much better. Have tested negative for COVID-19.
Could barely move fingers; Hard to walk; Tingling in fingers; Weakness; High fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Hard to walk), PARAESTHESIA (Tingling in fingers), MUSCULOSKELETAL STIFFNESS (Could barely move fingers), ASTHENIA (Weakness) and PYREXIA (High fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced ASTHENIA (Weakness), PYREXIA (High fever) and HEADACHE (Headache). On 05-Mar-2021, the patient experienced GAIT DISTURBANCE (Hard to walk) and PARAESTHESIA (Tingling in fingers). On 09-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Could barely move fingers). At the time of the report, GAIT DISTURBANCE (Hard to walk), PARAESTHESIA (Tingling in fingers), MUSCULOSKELETAL STIFFNESS (Could barely move fingers), ASTHENIA (Weakness), PYREXIA (High fever) and HEADACHE (Headache) outcome was unknown.            No concomitant product use was provided by the reporter.  No treatment medication was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-155550 (Patient Link).
On 5/5/00, left deltoid started to swell, client called HD and notified RN on 5/6/00, that left deltoid continued to swell, warm to touch, no fever noted, despite Tylenol and Motrin. On 5/6/00, went to MD and stated it was a reaction to the DTAP vaccine and to continue with Benadryl and Tylenol. Left deltoid was swollen the size of 1/2 of an apple; according to mom. Symptoms resolved completely by 5/8/00.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion; patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter stated that their facility had not been able to download the digital data logger, they had been put on hold at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna. The reporter stated that no adverse reactions were reported by any patients. No treatment medications were reported.
HPV vaccines given left upper arm on 9/1/2020.  Persistent pain.  Numbness and tingling at the injection site.  Sometimes radiating down to the left of her wrist.  No fever. Persistent pain after vaccination > 2 weeks prior.  Warm compress to area  NSAID x 1-2 weeks.  If no improvement in 1 week, patient to contact PCP Given prolonged symptoms, PCP does not advise patient to get #2 and #3 boosters.
Patient experienced feeling flushed and nauseated after receiving covid vaccine injection. Declines ED evaluation. No further symptoms reported on 12/19 follow-up
I got my shingles vaccine and flu shot on Thursday, Oct 1.   I noticed my arm was hurting that night and I just didn't feel right.  By Friday morning I did not feel well.  I tried to work on Friday but all I could do was lay down. I would start a call and thankfully they all ended early so I was able to lay down for 15-20 minutes before next call was to start.  By noon I had to tell my boss I couldn?t do it any longer and laid down on my futon by my workstation.  At 23:39 I remember getting mad at the girls who were fighting over roblox on the pc next to the futon and kicking them out of the basement.  It was a restless night of sleep.  My back was killing me from tossing and turning and sleeping wrong.  I got woozy frequently and had to rest but was able to replace my mom?s mail box on Saturday, but it took much longer than it should have. :(
Patient received a Flulaval shot by our pharmacy on 12/9/2021. Upon entry into the database it was discovered the patient had received the FLUAD Quadrivalent (LOT: 308518) on 10/1/2021.
Mother reported several hours after immunizations face became red, lips turned blue, had chills, nausea, fever 101.5. TYLENOL given. Mother reported improvement in symptoms 30 min after TYLENOL was given.
headache; nausea; cough; fatigue; This is a spontaneous report from a contactable nurse. A male patient of an unspecified age received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 18Dec2020 at a single dose for immunization. The patient's medical history and patient's concomitant medications were not reported. On 22Dec2020, the patient experienced cough and fatigue. On 23Dec2020, the patient got severe nausea, severe headache that continued through the night. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Has passed away; Severe allergic reaction; This case was reported by a nurse via sales rep and described the occurrence of death in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced death (serious criteria death and GSK medically significant) and allergic reaction. On an unknown date, the outcome of the death was fatal and the outcome of the allergic reaction was unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and developed a severe allergic reaction and was categorized as a contraindication to get second dose. The patient passed away since this information was given to the reporter. The reporter consented to follow up. This case has been linked to US2021AMR171275, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR171275:Same reporter.; Reported Cause(s) of Death: Death NOS
Tested negative on 5/31/22 but tested positive again on 6/6/22; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested negative on 5/31/22 but tested positive again on 6/6/22) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (No drug reported.).    On 19-Jan-2021 at 1:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested negative on 5/31/22 but tested positive again on 6/6/22). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 29-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 31-May-2022, COVID-19 (Tested negative on 5/31/22 but tested positive again on 6/6/22) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 06-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient did not take any medications within 2 weeks of starting COVID-19 treatment.  Company Comment:  This spontaneous case concerns a 70-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 that occurred on an unknown date after receiving an unspecified dose of mRNA-1273. Patient started Nirmatrelvir, Ritonavir (Paxlovid) COVID-19 treatment approximately 4 months and 5 days after mRNA-1273 vaccination. Patient tested negative for COVID-19 two days after completion of Paxlovid treatment and subsequently tested positive 6 days later. No information was provided on any other COVID-19 vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 70-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 that occurred on an unknown date after receiving an unspecified dose of mRNA-1273. Patient started Nirmatrelvir, Ritonavir (Paxlovid) COVID-19 treatment approximately 4 months and 5 days after mRNA-1273 vaccination. Patient tested negative for COVID-19 two days after completion of Paxlovid treatment and subsequently tested positive 6 days later. No information was provided on any other COVID-19 vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
pt c/o numbness in both hands, stomach cramps, fever 102; drinking fluids & taking APAP; pt was found crying; c/o discomfort 25AUG93 when mom returned home from work; had c/o not feeling well that AM;
17 minutes after injection patient notice a tingling in the left side of her face and the sensation that it was swollen ( it did not appear swollen) She also had a very strong metallic taste in her mouth. She administered her own Benadryl at 8:40. Patient began coughing and vomiting and became dizzy about 5 minutes later. At this time it was decided to administer Epi Pen 0.3mg and 911 was called. 8:50am pulse was 105 Blood pressure was 172/99 and O2 was 99 at 8:54 am O2 was 97 this is about the time the EMT's arrived and took over care.
pt tested positive for COVID on 9/3, admitted to the hospital 9/5. On supplemental oxygen, decadron and remdesivir
Initial report received from a consumer on 20/Oct/2005. A 40 year old female patient complained of her skin being "so sensitive", chills, "pounding behind eyes", aches all over, diarrhea frequently, bones ache, and flank pain over her kidneys after receiving the intramuscular injection of Fluzone, lot number U1792AA in the right deltoid on 19/Oct/2005 at 12:30 PM. It was reported the diarrhea, which was liquid in consistency started on the 19/Oct/2005 at 4:30 PM, four hours post immunization, and was still present at the time of this report on 20/Oct/2005 at 10:30 AM. Latency of other symptoms, treatment and recovery status not reported. Follow up information received on 24/Jan/2006 from a health care provider. Per the reporter, the patient did not follow up with them. He went to his own physician. Illness at the time of vaccination, other medication and pre-existing medical conditions were all unknown. Additional information is not expected.
Unusual and extremely heavy vaginal bleeding with clots. Now occurs every month for 2-3 weeks. Previous menses only happened 3-4 times a year for four days and was very light.
Infant developed Guillan Barre syndrome 5 days after vaccination  Nurse follow up on 07/21/04 states: "acute gastroenteritis."
11.2 x 7 cm area of swelling, erythema, heat, and tenderness at site of injection. Pt noticed redness and swelling at injection site 5 days after injection was given; however, admits that the onset may have been sooner and she may not have noticed as she had been wearing long sleeves.
Patient received the vaccine, no adverse reactions while at the facility/post observation time period.  Patient's niece came into the facility on 4/28/2021 and stated that patient was sick and couldn't move out of the bed after getting the shot.  After three days, patient went into Hospital and later expired on 4/27/2021.
Fever 38.2 Celsius, chills, body aches, head ache, nasal congestion, lower back pain, muscle soreness, sleeplessness that started about 14 hours post vaccination.
cold sweating; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweating), CHILLS (chills) and HEADACHE (headache) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced COLD SWEAT (cold sweating), CHILLS (chills) and HEADACHE (headache). On 24-Apr-2021, COLD SWEAT (cold sweating), CHILLS (chills) and HEADACHE (headache) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.     This case was linked to MOD-2021-089050, MOD-2021-089055, MOD-2021-089063 (E2B Linked Report).; Sender's Comments:  MOD-2021-089050:husband case MOD-2021-089055:wife 1st dosage MOD-2021-089063:wife 2nd dosage case
experienced nausea; This is a spontaneous report from a contactable consumer. The consumer reported that a 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: unknown), dose 2 via an unspecified route of administration on 06Feb2021 as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. Consumer states that she received the 2nd Pfizer COVID 19 vaccine on Saturday (06Feb2021). She has experienced nausea off and on and it was bad yesterday (09Feb2021). She was 71 years old. Outcome of the event was unknown on an unspecified date. The reporter considered the events as non-serious.   Information on about lot/batch number has been requested.
No signs of symptoms have been reported; Improper storage of product in use; This spontaneous report was received from a registered nurse concerning a 9-month-old female patient.      The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 27-JUL-2021, a temperature excursion occurred due to power outage. Temperature excursion was reported as follows: temperature -0.5 Celcius degrees (C) (1 hour 30 minutes) and 13.6 C (1 hour 40 minutes); time frame 2 hours 10 minutes (cumulative). There was no other previous temperature excursion. It was reported that there was miscommunication when reporting high/low reading of temperature, and initially, the site received clearance to use vaccines on 28-JUL-2021. On 29-JUL-2021, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscularly in the left thigh (lot # T033149, expiration date 19-NOV-2022) for prophylaxis (product storage error). On that date, temperature readings were corrected which changed outcome, but the vaccine had already been administered. No signs or symptoms were reported. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck devicelotnumber: T033149; expirationdate: 19-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA008884:
I woke up this morning with my arm very red around injection site, approximately 4 inches around. There was also slight pain, less than days after injection. There was also numbness in the arm. Redness subsided by the end of my work day.
11:30 after receiving vaccine client states he is feeling foggy.  Vital signs obtained by EMS:  BP 150/83, Pulse 74, O2 sat 97%.  11:30 am client states he if feeling better.  Client discharged home by EMS.
Patient  received the Pneumovax 23 on 08/30/20 per patient she called back to report swelling , itching, and redness.  She was seen by a prescriber 09/01/2020 .
Headache, Sedation, Myalgia, Arthralgia & Fever Narrative:
After having had COVID-19 in the fall of 2022 I started experiencing constipation. I was not sure if this could have been caused from having had the virus or not, so I waited a little bit to let my body get back on course. By February of 2023 I could not take, not being able to go to the bathroom regularly. My NP has me on a daily regimen of stool softener. I am now dealing with a pelvic prolapse that will have to be surgically sewn back in.
Right swollen Lymph node and right submandibular salivary gland swelling and lump (still with possible near future surgery) , swollen tongue(2 days) fatigue (2 days) arm pain at shot site (2 days), fast heartbeat (2 days)
A report was received from a customer on 10/24/2002, concerning a 60 year old female vaccinee who experienced injection site redness, swelling and hardness 1 day after, and flu-like symptoms 2 days after receiving the Fluvirin vaccine on 10/21/2002. On 10/21/2002, the patient received her flu vaccination in the left arm. One day later, the arm became red, swollen and was very hard at the injection site. On 10/23/2002, the vaccinee experienced flu-like symptoms including chills and coldness. The vaccinee last received flu vaccination several years ago with no allergic reactions.
Headache; Blood pressure went up; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age (reported as "Age 85: Unit Unknown") received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: not provided), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of COVID-19 vaccine on Wednesday 06Jan2021 and reported that on Friday 08Jan2021, she had a headache and blood pressure went up. Patient asked if these are side effects of the vaccine. Patient stated that someone saw on internet that high blood pressure can be from vaccine. Outcome of the events was unknown.  Information about batch/lot number has been requested.
Episode of apparent limpness, lethargy occurring during car ride home after vaccinations, lasting several minutes. Normal exam when subsequently reassessed, no treatment.
pt recv vax 23APR96 & 7MAY96 pt exp gen varicella-like rash w/10 to 30 lesions;pt recovered;