chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer Covid-19 vaccine was stored in the refrigerator beyond the 10 week time duration and was administered 4 days after the last day of the 10 week duration.
30 minutes after: redness across neck, arms, chest and legs. Trouble catching breath, throat swelling. Itching, heart rate spike, numbness in feet, throbbing in head.
Vaccine administered 5/3/11 - seen in clinic 5/5/11 with 12 cm x 8 cm area of warmth and erythema around injection site right leg. - Area was observed. No treatment needed. - Patient had fever of T99 and was fussy.
I AM AN OPERATING ROOM NURSE.IT HAS BEEN 10 YEARS SINCE MY LAST TETANUS SHOT. I WENT TO EMPLOYEE HEALTH ON 5/15/07 TO BE RE-VACCINATED. BY 5/18 MY UPPER ARM WAS STILL SORE AND HAD A 4 INCH DIAMETER BRUISE. ON 5/23/07 I SHOWED IT TO SOME ANESTHESIOLOGISTS I WORK WITH AND THEY SAID I HAD A LOCALOZED REACTION TO THE SYRUM AND SHOULD REPORT IT TO FDA.VACCINE PRODUCED BY ADVENTIS PASTEUR INC.
About one minute after vaccination patients wife yelled for me. pt was in chair with unfocused eyes, moaning slightly, unaware of surroundings. called 911, but within one minute pt was better and seemed to be more aware. He spoke with paramedics and said he was fine. He said he has a fear of needles and had a similar situation when giving blood. He thinks it was unrelated to the flu vaccine and more a response he has to needles.
Itch in throat, upset stomach,  tightness in chest all started within 5 min Cough after 45 min
Extreme redness, warmth of left arm from shoulder to elbow.  Swelling also present.  Mother stated left arm looked much better than it had on 08/15/09.
Redness, pain & swelling at injection site with red streaks & warmth traveling up her arm to underneath her armpit.
child developed hives day after vaccination. Resolved over next 2 days-discussed with parent by phone only 1/15/2020 & 1/21/2020
Patient seen for WCC and catch up immunizations. KINRIX ordered and administered but patient was too old for product.
had bleeding at the injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (had bleeding at the injection site arm) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (had bleeding at the injection site arm). At the time of the report, VACCINATION SITE HAEMORRHAGE (had bleeding at the injection site arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-077735, US-MODERNATX, INC.-MOD-2021-077940, US-MODERNATX, INC.-MOD-2021-077965 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077735:cross linked case US-MODERNATX, INC.-MOD-2021-077940:cross linked case US-MODERNATX, INC.-MOD-2021-077965:cross linked case
Had 102.8 rectal temp, the night after apt shots 3-16-10.
PATIENT FELT LIGHT HEADED AND DIZZY. PATIENT ALSO STARTED SWEATING AND BLOOD PRESSURE WENT DOWN. WE HAD THE PATIENT LIE ON A MAT. WE MONITORED HER BLOOD PRESSURE 78/46 (10:45AM), 98/73 (10:50AM), AND 109/80 (10:56AM). PATIENT STATED THEY GET LIGHT HEADED AT TIMES AND SHE HAS NATURALLY LOW BLOOD PRESSURE. WE FANNED PATIENT AND HAD HER RELAX. AFTER A FEW MINUTES SHE FELT BETTER. SHE SAT UP FOR A LITTLE WHILE TO CHECK THE DIZZINESS. ONCE SHE FELT GOOD, SHE SAT BACK IN THE CHAIR AND WAITED A FEW MORE MINUTES. THEN PATIENT REQUESTED TO LEAVE BECAUSE SHE FELT FINE.
4 days after vaccination, previously controlled SVT returned in morning 9/23. Treatment was refractory to control with escalation with his current anti-arrhythmic class of medication. Control returned after addition of 2nd anti-arrhythmic class of medication.  Control obtained 2100 on 9/23.
Approx. 15 hours after dose, headache, very sore arm, extreme tiredness, felt like my entire coating of skin on my body was about to break out in Shingles (I have had them twice before), entire body simply hurt. About 20 hours after dose, fever of 100.4. On Saturday, Feb 2nd, noticed huge cold sore on upper lip. Also canker sore in mouth under tongue. By Wednesday, Jan 30,  fever and sore muscles and hurting body gone. Sore arm continued. Herpes breakout on upper lip continues as of this report. Canker sore still in mouth as of time of this report.
just not thinking clearly; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (COMIRNATY), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid mrna vaccine (Dose 1), for Covid-19 immunization, reaction(s): "2 hours of weakness"; Moderna covid mrna vaccine (Dose 2), for Covid-19 immunization, reaction(s): "2 hours of weakness". The following information was reported: THINKING ABNORMAL (non-serious) with onset Oct2021, outcome "recovered", described as "just not thinking clearly". Additional information  61 year old male who had received initial two shots of Moderna Covid mRNA vaccine opted to receive Pfizer/BioNTech booster. His reason was that he had experienced 2 hours of weakness after receiving the Moderna vaccine although he then stated it was associated with having increased energy levels. In view of this opted to receive COMIRNATY booster some time in October 2021 time frame. This was associated with few hours of just not thinking clearly. This resolved with no interventions on own and no additional sequelae.  The lot number for bnt162b2 was not provided and will be requested during follow up.
pounding in my heart; I have like trembling in my legs and then a radiation going through my body; I feel like there is some anxiety; I am having a hard time going to sleep; Mucus spilting up mucus 30 minutes after injection; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Aug2021, the patient experienced pounding in heart, had like trembling in legs and then a radiation going through body (ICE cold), feel like there was some anxiety, having a hard time going to sleep and mucus spilting up mucus 30 minutes after injection. It was reported that, the patient tried to lay down but was experiencing it is like pounding and she had like trembling in her legs and then a radiation went through her body and she also took some Calcium Magnesium, so she did not know if that was supposed to calm her, calm her down but she felt like there was some trembling going on her legs. The patient wanted to report that she was looping a pounding in her heart and she was having a hard time going to sleep. She feels like there was some anxiety. She reported she was going to call the advisor she was in the stress right now and she was not getting anywhere. She went to the ER and then administered 25mg antihistamine (Benadryl) on 03Aug2021. They ran an EKG and blood work full panel. Results were ok and she was sent home. Her symptoms samed all elevated after 30 minutes of taking Benadryl. She was fine the following day. The patient took Benadryl and antihistamines for Anxiety-legs, trembling-mucus. The patient was not taking any other products together with those Benadryl. Admission to hospital due to the event was reported as no. The patient underwent lab tests and procedures which included blood work: unknown result (Result work ok), EKG: unknown result, heart rate abnormal: abnormal, on an unspecified date. Therapeutic measures were taken as a result of events. At the time of report the patient was not taking any medication. The outcome of the events pounding in my heart and I feel like there is some anxiety was reported as not recovered. The outcome of the events I have like trembling in my legs and then a radiation going through my body and I am having a hard time going to sleep was reported as recovered. The outcome of the event mucus spilting up mucus 30 minutes after injection was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Vaccine given in LT deltoid. Patient alert and talking after vaccine given. She proceeded to waiting area. A 15-minute timer was set for observation. After 3 minutes, patient's daughter-in-law alerted nursing personnel with complaints of chest pain, blurred vision and clamminess. Provider notified. Vitals taken: BP 94/60; pulse 78; oxygen 99%. Chest clear. Notified EMS. EMS transferred patient to local hospital.
Caller never got the fever from the COVID, she did get the chills, but it was like she had a cold; tested positive for COVID-19/ Caller was diagnosed with COVID on 04Apr2021; tested positive for COVID-19/ Caller was diagnosed with COVID on 04Apr2021; This is a spontaneous report from a Pfizer-sponsored program, reported by contactable consumer (patient, self-reported). A 79-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EN6207 and expiry date was unknown), via an unspecified route of administration, in left arm, on 16Mar2021 at 11:15 AM, as a single dose for COVID-19 immunization. After vaccination, patient did not have any problems and not even hurt. Patient did not receive any previous immunization with the Pfizer vaccine considered as suspect. Patient did not receive any other vaccines on the same day as the suspect product. aPatient's ongoing medical history included lupus and type 2 diabetes. Patient's husband died of COVID in December. Her husband was in a nursing home and she could not be there with him. Concomitant Medications were not provided. Patient had blood work done a few weeks ago (results were not provided) and it was before she had any COVID symptoms. It was reported that on 04Apr2021, patient diagnosed with COVID-19 and was under 10-days quarantine. She had both a rapid test, and the three-day test and they both came positive for COVID-19. She did not have fever from the COVID. She had chills, but it was like she had a cold, or she thought it was allergies. Patient's next dose was scheduled on 13Apr2021and her quarantine time will be over the day before she was scheduled for her second dose of the vaccine. She wanted to know how to proceed with the second dose of vaccine with her condition. She caught with COVID from her daughter as her daughter's daughter has it. Her daughter visited her child in (Withheld), and they had COVID, so her daughter got it by visiting them. Her daughter was pretty sick, and she was having the worst of it, but the patient was not too bad. Seriousness of the events drug ineffective and COVID-19 were reported as medically significant. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot and batch number cannot be obtained. No further information is expected.
chills, fever, lost of appetite, very sleepy, sore arm beginning one week after injection
Pt received DTaP on 3-22-07 and was 7 years old.
Light headiness, tired, cold chills, hot flashes, developed broken blood vessels on top of feet, ankle shins and forearms, nausea, edema of feet, ankles and hands, painful when moving, no strength in extremities, feels like sticking needles all over body
got nerve damage - sciatica nerve is damaged for several months (all sciatica from back to ankle), left leg- limping, cannot walk, cannot sleep because of the pain. Took lot pf treatments, pain killers, Physical Therapy sessions, massage, chiropractor, etc.
Temperature gradually got higher over the duration of 2 days. Fever started 7 days after vaccination. went from 100.5 to 104 degrees F. Pt went back to doctor on 3/13/2002. Was told it was reaction to MMR. Gave Tylenol and Motrin. Pt was lethargic and cranky those 2 days.
Allergy to pollen ever since receiving vaccine.   Otherwise ONLY affected from April 'til June.
My life was on pause with the vaccination; 9 months of illness; This case was reported by a consumer via  interactive digital media and described the occurrence of illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (the patient received 1st dose on an unknown date and also experienced impaired quality of life, refer case US2021AMR202901).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced illness and impaired quality of life. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the illness and impaired quality of life were recovered/resolved.   It was unknown if the reporter considered the illness to be related to Shingles vaccine. The reporter considered the impaired quality of life to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient reported that his/her life was on pause with the vaccination and had 9 months of illness. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202901:same reporter, same patient, same suspect, different dose
Splotchy red areas at vaccination site, itchy. Face swelling, no trouble breathing noted.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.  No Medical History information was reported.  On 03-Apr-2021 at 10:38 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:38 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Age of patient was reported as 65.77 for dose administered on 03-Apr-2021.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.  This case was linked to MOD-2022-566976 (Patient Link).
Fever as high as 102.5 by 2:20 PM, swollen arm, fatigue.
This case was reported in a literature article and described the occurrence of vaccination failure in a 56-year-old male patient who received Influenza vaccine unspecified. Concurrent medical conditions included HIV infection. In September 2013, the patient received Influenza vaccine unspecified. On an unknown date, 122 days after receiving the Influenza vaccine unspecified, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant) and influenza A virus infection (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure and influenza A virus infection were unknown. It was unknown if the reporter considered the vaccination failure and influenza A virus infection to be related to Influenza vaccine unspecified. Additional information was provided: This case was reported in a literature article and described the occurrence of vaccination failure in 56-year-old male who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown). The patient was positive for Human Immunodeficiency Virus (HIV) infection. No information on patient's medical history or family history or concomitant medication was provided. On an unspecified date in the 1st week of September 2013, the patient received unspecified seasonal influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date in January 2014, between 4 and 5 months after vaccination, the patient was admitted to the hospital with an influenza-like illness. The patient was subsequently diagnosed with influenza A infection confirmed. The case has been considered as vaccination failure. The case been considered serious due to hospitalisation. Treatment was unknown. Outcome of the event was not reported. The authors did not comment on the relationship between influenza A infection and unspecified seasonal influenza vaccine. The authors further stated HIV-infected patients have a decreased immune response to influenza vaccination and any response they have quickly wanes, and this waning immunity places this population at higher risk for influenza infection later in the flu season. The authors stated that "the results of our study provide a clinical correlate to the impaired influenza serological response in HIV-infected patients observed in previous studies by showing that HIV-infected patients who were vaccinated early compared with late were more like to contract flu later in the season. Future studies with clinical endpoints should evaluate vaccination strategies to better protect HIV-infected patients from influenza."
Pt recvd Recombivax HB on 1MAY89, 21JUN89, & 30MAR90 & was a poss non-responder;
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 73-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Pt came into office with redness, swelling, tenderness, warmth to left thigh on 11-10-11. She had the shot on 11-8-11. Pt was given ZYRTEC b/c BENADRYL gives diarrhea.
Pain at the site; Little fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the site) and PYREXIA (Little fever) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the site) and PYREXIA (Little fever). At the time of the report, VACCINATION SITE PAIN (Pain at the site) and PYREXIA (Little fever) outcome was unknown.            No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-021366 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow-up received on 24-May-2021: no new information received
Fever - Body Ache - vomited - weak - and still weak today (tired feeling).
Three leftover vials of Pfizer COVID-19 vaccine (already used) were placed on a tray and left in the fridge from the previous date. Pharmacist did not realize vials were used up and thought that they were labeled with specific times for dilution for the current date. Two of the vials were diluted with 1.8 ml of sodium chloride 0.9% each and pre-drawn to be injected into patients scheduled for appointments from 10AM to 1pm (this included 10 patients; two patients had cancelled for the day).   Patient received injection and was later notified of mistake and asked to return on the same day to receive correct injection of diluent + active ingredient.
Patient was given vaccine that was mixed >6 hours prior to injection but less than <24 hours. It was stored in the refrigerator before administration.
High Blood Pressure and Pulse Temperature 102.3 Diarrhea  Vomiting
I received my shot on September 1st, which at the time didn't affect me or my daily activities. By the 3rd of September my breathing starting acting funny and my chest was getting tight. On September 17th it was hard for me to breathe, I went to the hospital for breathing treatments. On Monday (20TH) I went to the hospital because my breathing was hindering me from going to work, there I continues the breathing treatments.
pt recvd vax; local rxn; pain,swelling at site rt upper arm;swollen elbow to shoulder;recovered 1 wk later;
This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a improperly stored ROTATEQ, oral. Dose, lot number and expiration date were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
5 DAYS AFTER RECEIVING 2ND VACCINE, DEVELOPED SYMPTOMS INCLUDING VOMITING, CRAMPING AND FAINTING
no adverse event noted; but it was later discovered that the dose given for the 2nd dose moderna series was half dose of 0.25 ml and not the full 0.5 ml