chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Medical Assistant administered 6 months to 4 year COVID-19 (maroon cap) vaccine to an 8 year old patient. No symptoms after vaccine was administered.
temperature excursion with AE; No adverse event; temperature excursion with AE, vaccines were administered; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (temperature excursion with AE, vaccines were administered), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In March 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (temperature excursion with AE, vaccines were administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (temperature excursion with AE, vaccines were administered), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (temperature excursion with AE, vaccines were administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE).    No concomitant medication were reported.  It was reported that Lost power the next day in the middle of the day at 12:00 PM. All the vaccine were placed into a frozen bag. Booster vaccines were then transported to another clinic. On 2-MAR-2023 to 28-MAR-2023 vaccines were administered to 26 patients. No reported symptoms.  No treatment information was provided by the reporter.  This case is of Patient 8 out of 26 Patients, as mentioned by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:patient no. 01 (Master case)
Increasing body aches spreading beyond injection location approx. 15-20  hours after injection.  Chills and moderate headache occurring approx. 30 hours after injection.  Dissipation of most effects except residual soreness at injection site after approx. 40 hours.
pediatric dose of Engerix-B to an adult patient; pediatric dose of Engerix-B to an adult patient; This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 35-year-old female patient who received HBV (Engerix B pediatric) (batch number k329e, expiry date 24th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th July 2021, the patient received the 3rd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 12th July 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that adult patient was administered with Engerix B pediatric, which led to adult use of a child product and underdose. No further events were reported. The reporter consented to follow up.
This literature marketed report as received from the authors of the below published article, refers to 55 students (young adults) of unknown age and gender, who had received RECOMBINANT (manufacturer unknown) and no longer had therapeutic levels of anti-HBs. It was reported that on an unknown date in 2014, an estimated 19,200 persons were newly infected with hepatitis B virus (HBV). While the rate of new infections had declined steeply since the implementation of a national HBV vaccination program, HBV continued to represent a potentially serious health threat. The HBV vaccination schedule most often used for children and adults was 3 intramuscular injections, with the second and third doses administered 1 month and 6 months, respectively, after the first dose. The retrospective chart review of 256 graduate students entered into a physician assistant program at a university had their hepatitis B surface antibody levels evaluated for positive immune responses. The resulting data suggested waning immunity 15 year after completing the primary HBV vaccination series. Test results revealed statistically significant differences (P=0.001) in the number of years since completion of the HBV vaccination series between participants who had therapeutic levels of anti-HBs and those who did not. The results showed that the students with therapeutic levels(n=201) had received their final injection of the vaccination series an average of 14.7 years prior, while students who were no longer at therapeutic levels of anti-HBS (55 students) (Hepatitis B surface antibody negative) had received their final injection an average of 17.3 years prior. The outcome was unknown. The study results suggested that there may be a need to have a universal booster approximately 15 years after completion of the initial childhood series of HBV immunizations. Immune memory was demonstrated in only 67% of population 15 years after vaccinate series completion. The data suggested that administering a booster dose of HBV during the typical person's college years may be more effective in protecting the population against a disease that is acquired mainly through adult behaviors, including sexual activity, tattooing, body piercing, medical mission travel, study abroad, and adventure travel. Additionally, health care professional students must be able to prove immunity with positive HBV titer test results in order to complete their education and clinical requirements. More clinical studies need to be completed to ascertain at what point after vaccination HBV antibody protection wanes. Additional information has been requested.
sore arm following vaccination; This is a spontaneous report from a Pfizer sponsored program, Pfizer First Connect, received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 20Dec2020 at a single dose for COVID-19 immunisation. Medical history included bone pain and arthritis (patient received a prescription of Prednisone today for bone pain and arthritis). The patient's concomitant medications were not reported. The patient reported receiving the first dose of the COVID-19 vaccine yesterday morning (20Dec2020). She mentioned experiencing a sore arm following vaccination. She then explained receiving a prescription of Prednisone today for bone pain and arthritis, after consulting with her foot doctor. She asked if she should she take this steroid treatment, and also asked if she should receive her second dose of the Shingle vaccine while being on the COVID-19 treatment. Outcome of the event was unknown.   Information on lot/batch number has been requested.
pt recv vax 23JUL96 & 25JUL96 pt exp tenderness & soreness @ inj site, w/a small knot & pink area @ the inj site;
At the need of May 2021  I woke up with some lower abdominal cramping, which I  believe is from a bacterial infection related to menopause. Even with the antibiotics that I take for it I still have pain in my lower pelvic uterus area. The pain isn't significant but it is there. I believe it is related to menopause. The doctors don't know what it is and they are still investigating.
This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender, the patients medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number, expiration date, concentration, dose and frequency were not provided) route of administration was reported as unknown. Information regarding concomitant medications were not reported. Additional information has been requested.
Patient felt like he was going to faint right after the vaccination, he was Diapheretic.  Onsite EMS was called vitals  BP 64/38 5 minutes later 90/52. Concern was patient never experienced such a reaction before. He was taken to Recieving Hospital.
Pt devel fever on 16APR92; Then on 17APR92 AM low grade temp; then while walking up stairs @ daycare collapsed turned red, ?stopped breathing, vomited, eyes fixed lasted 3min, sleepy p/episode w/t103.9;
I started getting symptoms of chills, fever, muscle aches, and scratchy throat. The next morning, I experienced lethargy, cough, and extreme tiredness. I received a positive COVID-19 test. I contacted my doctor and was prescribed PAXLOVID. I felt a heaviness in my chest. I experienced lethargy and fatigue for 6 weeks.
Continuos rash, hiver and  some lesions in the skin.  Brush sensations.
This was the second shot which was 2 months and 4 days after the first injection,,no issues from the first shot. So about 8am on Tuesday- 12 hours after the shot,  I started to feel achey. Over the next 8 hours it got worse. I had the chills, headache,very very achey all over, congestion- like the flu. Could not get comfortable.  Felt like my entire body was inflamed.  Went to sleep with warm clothes on about 3 hours earlier than normal around 7 pm. Had a tough time sleeping.  Sweated it out about 1am which was about 30 hours after the shot.  Had to pee quite a bit during the night also.  Got out of bed around 6 am and felt 80% better. By 9 am felt like a new man .   I rarely get sick and can?t remember the last time I felt this bad.  Had to be over 20 yeas. My sister, my brother in law , a friend at work have also told me they had issues after the second Shingrix  shot, but not the first shot.  Seems more common than what is being published to have this kind of reaction after the second shot.
About 2-3 hrs. after shot all my joints and muscles began aching.  As the day went on I fell worse, In the middle of the night I woke up with extreme chills- no fever- and felt like the onset of flu.  This continued throughout the next day.  I felt like I have been run over by a truck.  I have never had any reactions before other than a sore arm.  I called the pharmacy the next day.  I don't want any compensation etc.  I just thought you folks should know.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 08-JAN-2013, the patient was inadvertently vaccinated intramuscularly with a 1 ml dose of RECOMBIVAX HB (Lot # 0482Z) that had expired on 03-DEC-2012. No adverse effects reported. The outcome of the event was unknown. Additional information is not expected.
On 1/23/2021, I experienced a red lump at the injection site that was itchy and warm to the touch. I washed the area with Dr. Bronner?s soap, put some Arnica cream on it and the itchy ness  was gone a few hours later.
1ST DOSE WAS pFIZER ON 4/21, RECEVIED 2ND DOSE MODERNA
Pt devel Parotitis approx 5 days p/15mo old vax w/MMR on 18OCT91 & pt seen by MD on 25OCT91 & swelling of parotid gland was resolving; no further details were provided;
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 20-JUL-2015 the patient was vaccinated with dose 1 of RECOMBIVAX HB injection (lot number and expiry date not provided). On 14-AUG-2015, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot number and expiry date not provided). No adverse event reported. The outcome of inappropriate schedule of drug administration was unknown. No product quality complaint was reported. No further information was provided. Additional information has been requested.
Given DTAP/IPV/MMR on 07/31/2003.  Seen on 08/02/2003 for 8 x 6 cm, red, swollen area on right upper arm at DTAP shot site.  Also complained of itchiness at site.  Temperature 98.5F.
None that I really noticed for immediate onset and several days after, Just a sore arm.   Now 1 year later and on my 4th vaccine, the daily moderate to severe headaches have me really questioning the vaccine and timing of the daily onset of these headaches.
24 hours after shot, arm sore at shot site, with slight red rash, achy, slight chills and fever of 99° lasted for 24 hours and went away.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown dates, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) injection (dose, lot #, expiry date, route of administration and anatomical location were not specified). On an unknown date, after receiving the entire series of hepatitis b vaccine (recombinant) (manufacturer unknown), the patient's blood was drawn and did not show any titer for hepatitis B. The outcome of the event and the causality assessment were not provided. Additional information is not expected as no further information is available.
About 4 hours after the administration of the vaccine suddenly I began seeing bands of "floaters"  on my left eye. Is still going on.
Severe joint pain and fever with chills the second day after the vaccine.  Also I developed a headache that has been persistent since the date I stated onset of the symptoms, I still have the headache which is worse some days than others.
shock - hemoperitoneum - splenic rupture, also with portal vein thrombosis, PE, also had platelet count 11 on admission
May 3, Monday - 8am get vaccine - arm hurts more throughout the day - took two advil in evening before dinner around 6pm  May 4, Tuesday - 1 am feel very cold -2 am uncontrollable shivering/shaking for two hours before took 2 advil -generally okay compared to later days with mild migraine, dizziness, headache, fatigue, felt cold  May 5, Wednesday - did not go in for work - took two advil - felt dizzy and hot (temp was one degree higher but no fever)  May 6, Thursday - work for one hour, went home - dizziness, fatigue, headache, felt hot - difficulty driving - took two advil  May 7, Friday - work for four hours, went home -dizziness, fatigue, headache, body sore again - INTENSE brain fog, brain was confused/forgetful, randomly aware of where i was and wonder how/why i got there - difficulty driving - dont remember if i took to advil? maybe just one instead of two  May 8, Satuday - took two tyenol and drank more electrolytes - work for 6 hours and went home -some dizziness, fatigue, headache pounded when i talked or thought for too long, still some brain fog - slept when i got home, hard to wake up - took two tyenol in the evening - took L-theanine and ashwaghanda to hopefully calm nerves and help focus. I went to sleep right after so not sure if it helped with brain fog  May 9, Sunday -no headache unless i talked or think to much - hands got itchy when woke up - took l-theanine and ashwaghanda with coffee, no tyenol - slightly hot, dizziness, brain fog, still dizzy - tasks still took me a while to focus or remember (ex: when work starts, simple math) - work for 5 hours - took benadryl for itchy arms (probably from seasonal allergies or anxiety)  May 10, Monday - been a full week, still tired, confusion, and slight body ache - went to doctor regarding symptoms  May 11, Tuesday - today, same as yesterday- slightly tired, confused, body aches
Headache. Pain at the injection site. Ache's all over and slight nausea. I also have a low fever of 100.9.
Product storage error; poor quality vaccine administered; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided    The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Product storage error) and POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered).    No concomitant medications were reported. No treatment medications were reported.  This case contains information for the 81 of 100 patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-697752:Master case
pt recvd vax 3APR93 & noticed heat, redness swelling in lt upper arm on 4APR93; reported reaction on 6APR93 w/redness @ site; c/o pain in lt arm;
Follow up: Patient received casirivimab instead of intended COVID vaccine.  48-hr follow up revealed patient experienced arm soreness. Patient received COVID vaccine on December 31
I woke up with serious chills for 23 days straight. The chills were all day long but I was able to sleep. I went to the doctor and took several test. I tested positive for COVID-19 June 30th 2020.
fever, diarrhea & vomiting since 27JUN94; fever range 100-103 (according to mom) saw ER MD on 30JUN94 & was told pt probably had a virus & was placed on Advil & Pedialyte; 1JUL94 mom states pt is better
Pt recv 1 dose vax 05Oct95 IM. Jan98 Pt devel chickenpox w/over 100 lesions. No secondary infections. 2 siblings reported w/similar exp.(WAES98011240 & WAES98011484).
Right arm swollen and red. Went to urgent care. Dr wanted to start Keflex. Parents decided to wait. Improved by 03/01/2005.
12 hours after second vaccination I have persistent, sharp pain at the injection site and in the armpit and breast on the same side of my body as the arm that received the injection. It has perpetuate; Pain in the armpit; pain in the breast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administration date 05Mar2021 11:15 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MULTI VITAMINS & MINERALS. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Mar2021 20:15, outcome "recovered" (2021), described as "12 hours after second vaccination I have persistent, sharp pain at the injection site and in the armpit and breast on the same side of my body as the arm that received the injection. It has perpetuate"; AXILLARY PAIN (non-serious) with onset 05Mar2021 20:15, outcome "recovered" (2021), described as "Pain in the armpit"; BREAST PAIN (non-serious) with onset 05Mar2021 20:15, outcome "recovered" (2021), described as "pain in the breast". Therapeutic measures were not taken as a result of vaccination site pain, axillary pain, breast pain.  Additional information: 12 hours after second vaccination patient had persistent, sharp pain at the injection site and in the armpit and breast on the same side of the body as the arm that received the injection. It perpetuated overnight at the same level of pain into the morning (at time of this report, still less than 24 hours since the patient received the vaccination). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
flu; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu) and FATIGUE (fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Previously administered products included for Drug use for unknown indication: SULFA (SULFA DRUGS ALLERGY MENIFESTED BY FACE SWELLING) and PENICILLIN (PENICILLIN ALLERGY MENIFESTED BY HIVES). Past adverse reactions to the above products included Hives with PENICILLIN; and Swelling of face with SULFA. Concurrent medical conditions included Non-tobacco user.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) Unknown. On 18-Apr-2021, the patient experienced INFLUENZA (flu). In 2021, the patient experienced FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Unknown. On 18-Apr-2021, INFLUENZA (flu) had resolved. At the time of the report, FATIGUE (fatigue) had not resolved.            Patient was non alcohol user.  No concomitant medications were reported.  The patient did not recall of having weakness after receiving the second dose of Moderna vaccine. She stated that it was like a flu and fatigue that she experienced for a day and she was okay after a day.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event of influenza was no reasonable possibility and the  reporter's causality for the event of fatigue was not provided with RINVOQ(UPADACITINIB) .  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Back between shoulder blades went numb had tingling left hip and both ankles and under left arm. The pain left all areas except back. Doctor stated left side wasn't functioning; kidney function went down to 50%. Kidney function has also been increasing. Recommended not taking second dose.