chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching on torso for 3 weeks now; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 14Apr2021 at 09:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received other medications within two weeks of COVID-19 vaccine, names were unspecified. The patient previously took acetylsalicylic acid (ASPIRIN) from an unknown date for an unspecified indication and experienced drug allergy. On 14Apr2021, the patient experienced "itching on torso for 3 weeks now". The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event "itching on torso for 3 weeks now" was not recovered at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the right arm on 05May2021 at 09:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.  Concurrent medical conditions included Type 2 diabetes mellitus.On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 06-Dec-2021 at 3:26 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) had resolved. Not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment information was provided. This case was linked to MOD-2021-407228 (Patient Link).
Varicella vaccine adm. on 6/10/09. Mother noted "small red bump" at site yesterday. Larger red round spot today. (Left triceps area) (6cm diameter) Slight itching and soreness; no other Sx.
The morning of 07/19, she woke with "severe exhaustion", fever at that point, no number but felt like she was burning up some point in the day. Patient found it hard to move that day, arms and legs were tired "she did not want to move", she was drinking well, water and pedialyte. On 7/20 arms and legs felt heavy the next day, fever resolved, appetite coming back, mother helped her she was dizzy. 7/21 improved, easier to walk, arms and legs hurt still, can't walk as far, she gets pain upper arms and thighs but it is improving. "knees have been locking a lot". Seen in the office on 07/25/2019 her exam was normal and her symptoms better. Referred to Neurology for further examination. The Neurologist findings were " Given the normal strength and reflexes and lack of any sensory complaints, there is no concern for an autoimmune post-vaccine demyelinating process. Most likely this represents a post-vaccine reaction with flu-like symptoms which seem to be improving." The patient is feeling better and will follow up in office on 07/30/2019.
Fever Narrative:  fever 102.5 x24 hrs, chills, body aches, weakness, unable to get out of bed for 24 hours.
patient called and reported that she had a  1inch (quarter diameter) spot on the arm that she received the injection. She said she had a similar reaction to the first  vaccines in the same arm. She  She also felt that her lymph nodes were swollen. The site was itchy and was red. symptoms were brief and have resolved.
12/24/20  0900 - site soreness, 1100 body aches, chills, 1300 low grade temp, 1430 102.5 temp, temp continuing to rise to 104, headache 12/25/20 continue with fever and body aches, dizziness, headache (unresolved with naproxen, maxalt, tylenol), significant site pain and lymphadenopathy and pain to right axilla 12/26/20  fever resolved, headache resolved by about 1400.  12/27/20 lymphadenopaty/axilla pain resolved
Injection given 10/11/02, right Arm IM, On 10.12/02 noted swelling & redness around injection site. On 10/13/02, skin was red, Swollen skin stretched, Pt took Benadryl & Bufferine. On 10/13/02, went to ER because the swelling was moving to forearm & down toward wrist. On 1/15/2002, returned to ER and was put on antibiotics. At present, pt is fine with no effect.
Twelve patients had inadvertantly received a 0.1 ml., intradermal administration of Tet Tox ADS USP, lot number UL298AA, "instead of Tubersol", on an unspecified date. Per the reporter, post-administration"the patient's complained of itchiness and red raised swollen areas (the largest area described as 1.5 by 1.5 inches). Recovery status "varies" per the reporter. Additional information was not provided.
patient involved has not reported any symptoms or medical concerns due to the administration of the dose of VAQTA; 2 month old patient that was inadvertently administered a dose of VAQTA; This spontaneous report was received from nurse and refers to a 2-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-OCT-2023, the patient was inadvertently administered a dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, at a dose of 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, anatomical location, and route of administration were not provided) due to an error in processing of the HCP involved during a routine vaccination appointment (Inappropriate age at vaccine administration). It was stated that the patient involved has not reported any symptoms or medical concerns due to the administration of the vaccine.
Found out I was anaemia; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (Found out I was anaemia) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAEMIA (Found out I was anaemia). The patient was treated with BLOOD, WHOLE (BLOOD FOR EXCHANGE TRANSFUSION) for Anaemia, at a dose of 3 blood transfusions. At the time of the report, ANAEMIA (Found out I was anaemia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided
About 3 1/2 months after vaccination of dose 3, I started having a pretty intense headache and generally did not feel well. I was having insomnia. I went to the doctor in December 2021 and I was noted to have high blood pressure. They gave me an aspirin due to blood pressure being in stroke range. I was put on blood pressure medication and it did not lower my blood pressure. After 10 days, I was switched to a different blood pressure medication as well as a diuretic and these did not work well either. In January 2022, I was switched to a 3rd blood pressure medication (BYSTOLIC). Later in the month of January 2022, I had a spiking headache that was over my left eye. I lost my ability to speak and write. My cognitive ability was also affected and I was having difficulty texting and I knew I was having a stroke. I went to the doctors office but by that time I could speak but it was slow. I was also having problems walking. My blood pressure was really high. My doctors office complex is very large and so we did a CAT scan of my head which showed normal. I also had an MRI a few days later at the hospital and it showed I had no active bleeding but could not rule a stroke out. My doctor added a 2nd blood pressure medication (losartan). He told me my symptoms went on longer than a TIA. I started monitoring my blood pressure at home. In July 2022, I had another episode of a spiking headache over my left eye again but I could talk. I did have numbness down my left arm. I was aware of what was happening. I did see a lot of pretty colors in both eyes. I went back to my primary care doctors office and I saw a different doctor in my doctors practice and I had another CT scan of my head but it returned as normal results. I had another MRI a few days later and it showed that I did not have an active bleed. I was given a prescription for a diuretic as needed for elevated blood pressure but I do not like the way it makes me feel and is not really effective. I have subsequently had a lot of blood work done but this was not related to my symptoms. All came back normal. My headache has lessened in severity but has never gone away. I am still having problems controlling my blood pressure.
17 year old got the booster shot; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got the booster shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer on 07-May-2021 and Pfizer on 28-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got the booster shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 26-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got the booster shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  Treatment medication were not reported.
Large Area of Erythema mild swelling On Anterior Left shoulder and medial lateral left upper arm No cellulitis, fever or pain.
expired menactra vaccine was given to a patient; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who received an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [Menactra] lot U5948AB expiry date: 03-Jul-2019 via unknown route in the left deltoid on 12-Jul-2019 .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  It was actual medication error due to expired vaccine used.  It was not reported if the patient experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
Information has been received from a physician concerning a 19 year old male patient with rheumatoid arthritis who on 17-OCT-2008 was vaccinated with PNEUMOVAX 23 (lot# 657525/0554U). Concomitant therapy included ENBREL and NAPROSYN. On 17-OCT-2008 the patient experienced cellulitis and fever. The patient is currently hospitalized. The physician requested that a lot check. This is one of several reports from the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the center and was released. Additional information has been requested.
possible grand mal sz p/fussiness & crying for 8hr;fever up to 102;child well @ time of vax;
Dose 1:  Day 7 - April 1st eve muscle discomfort in shoulder blade, neck and arm at site of shot. Initially only sore arm at site of shot or a few days (felt vaccine the second it entered arm)  then I was fine before muscle discomfort set in.  Day 8 - arm was a bit itchy, dull red spot. By morning of Day 9 had a 2 x 3 inch red blotch / rash.  Itchy, a bit swollen, hot to touch. Lasted 3 days. Muscle discomfort continued up to second shot and is still not 100%.  May be unrelated - cramping in left calf around Day 11/ 12 which turned into sciatica after some days- on and off now.  Dose 2:  April 22nd -  Less arm soreness after shot.  Eight hours after shot - 100.7 fever, chills, aches.  Aches and low grade fever, some fatigue lasted for a little over 2 days then fine.  Can still feel effects in shoulder blade and neck muscle - more tolerable now though.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 26Feb2022 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: PULMONARY PAIN (non-serious), outcome "unknown", described as "pain in lungs"; COUGH (non-serious), outcome "unknown", described as "Dry cough"; MALAISE (non-serious), PAIN (non-serious), outcome "unknown" and all described as "not feeling well and is in pain"; ANXIETY (non-serious), outcome "unknown", described as "worry". Additional information: Took the third dose on Saturday, 26Feb2022, six days ago. Clarified product as Pfizer Covid vaccine. Has pain in lungs. The lungs are hurting for three days now. Reporter was kind of worried, Lungs feels like they hurt, dry cough and lungs hurt a lot. Reporter not feeling well and is in pain. Starting to worry. Didn't have this with second one but did with the third. Reporter was not sure what was in the shot because it doesn't specify on the papers. They need to know the chemicals inside the shot. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediately after receiving vaccine, a large, red welt formed at the injection site. The welt was hot and sore to the touch for approximately 4 days post vaccine.  On 11/27, I tested positive for COVID after attending a conference. I received notification from the conference of some individuals testing positive. I took 2 separate home tests and both confirmed positivity. Overall, I had mild systems - headache, fatigue, congestion for 5 days. I tested negative on 12/6 and felt good.  However, I noticed a little loss for words and that still continues.  On Dec 18, I woke up with congestion, sore throat and no voice. I went to urgent care and they diagnosed me with a sinus infection and prescribed doxycycline hyclate 100mg (2 times daily for 10 days), benzonatate 100 mg (as needed for cough - up to 3 daily), and albuterol inhaler every 6 hours for 10 days.
Information has been received from a physician concerning a female who was vaccinated on an unspecified date with GARDASIL (lot# not provided). Concomitant therapy included DEPO-PROVERA. Subsequently the patient experienced extreme drowsiness within an hour after receiving the GARDASIL. Subsequently, the patient recovered from extreme drowsiness the next day. The patient sought medical attention by speaking with the physician. This is one of several reports received from the same source. Additional information has been requested.
Instant upper chest pains and later armpit pain (lymph nodes.) Headaches and overly fatigued. Still in effect two weeks + later.
Patient was underage (14) and received a dose of Moderna as booster 3rd dose. Moderna is only approved for age 18 or over. Previous 2 doses were Pfizer.  Called patient next day and they did not feel well.  Will follow up with doctor's office on Monday.
Home Ag: Positive; Home Ag: Positive; ST; mild cough; myalgias; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: EP6955), on 07May2021 as dose 2, single (Lot number: EL3247) and on 05Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 29 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (medically significant) with onset 11Apr2022, outcome "unknown", described as "ST"; COUGH (medically significant) with onset 11Apr2022, outcome "unknown", described as "mild cough"; MYALGIA (medically significant) with onset 11Apr2022, outcome "unknown", described as "myalgias"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Apr2022, outcome "unknown" and all described as "Home Ag: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, oropharyngeal pain, cough, myalgia. Therapeutic measures were taken as a result of covid-19.  It was reported that it was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19 and Since the vaccination, the patient was been tested for COVID-19. It was reported that out with friends to escape room and dinner 09Apr then sx 11Apr late ST mild cough myalgias and positive Ag test 12Apr2022. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
Myalgia, Fever, VERTIGO; COUGH; CONGESTION Narrative:  Other Relevant History:
shingles; This initial spontaneous report has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history.    On 04-SEP-2013, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine for the long-term prevention of shingles (dose, route, and lot number not provided). On an unknown date, the patient experience shingles. Subsequently, the patient was treated by a healthcare provider. The outcome of the event was unknown. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and cost include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
This spontaneous report as received from a nurse refers to a 54 year old patient. Medical history and concurrent conditions were not reported. On 27-FEB-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
From 12-24 hours after receiving the vaccine I experienced: Chills, fever, arm soreness, racing heart, joint stiffness
9FEB96 c/o fever, muscle aches, nausea, some vomiting, h/a, sore throat & hoarseness;20MAR96 & 3JUN95 same sx;was not treated by MD, only took cold medicines & APAP