chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have had consistent regular periods using Isobloom for several years, since my second dose of the vaccine I have missed 3 periods, I absolutely am not pregnant.; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 22Nov2021 at 08:00 (Lot number: unknown) at the age of 38 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: sulfa. Concomitant medications included: ISIBLOOM, VALTREX and unspecified WOMENS MULTIVITAMIN. Past drug history included: Septra, reactions: "Drug allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Anatomical site: left arm, Administration time: 08:00), administration date: 01Nov2021, when the patient was 38 years old, for COVID-19 immunisation.  The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 29Nov2021, outcome "not recovered", described as "I have had consistent regular periods using Isobloom for several years, since my second dose of the vaccine I have missed 3 periods, I absolutely am not pregnant". The event "I have had consistent regular periods using Isobloom for several years, since my second dose of the vaccine I have missed 3 periods, I absolutely am not pregnant." was evaluated at the physician office visit. Therapeutic measures were taken as a result of menstruation irregular.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Treatment included change of birth control pill with lower estrogen for menstruation irregular.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Developed rash generalized w/itching w/shakiness & flushed feeling; VS within normal limits. Seen in ER.  Given Epinephrin. Benedryl x 1 wk.
Developed redness + swelling of (R) arm noticed morning after vaccination by parents. (+) tenderness. Area of redness & induration spread over next 24 hours @ which time was seen in office by MD.
Seen Emergency Services on 4/15/21 Dr: Diagnosis with Vaccine reaction, initial encounter, near syncope, frontal headache, evaluated for possible vaccine reaction, received J&J vaccine 6 days ago, now headaches and episodes vision blacks out, pt does not have any thrombocytopenia, D- dimer negative, at this time does not feel needs CT of head, if s/s worsening or changes, return for imaging, supportive care at home, discharged home, tylenol or ibuprofen for headaches as needed, return if changes or worsening.
Redness and soreness at the injection site from arm down to elbow area. Family physican ordered antibiotics.
Internal Bleeding; Anaphylactic reaction; bad allergies; sinus migraine; acne on face/ back; nausea; vomiting; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INTERNAL HAEMORRHAGE (Internal Bleeding) and ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis.    Concurrent medical conditions included Latex allergy (latex allergy), Gluten intolerance (Gluten allergy) and Drug allergy (Tylenol). Concomitant products included MAGNESIUM CITRATE, MOMETASONE FUROATE (NASONEX), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), ASCORBIC ACID (VITAMIN C ACID), VITAMIN D3, MULTIVITAMIN AND MINERAL and FISH OIL for an unknown indication.   On 10-Sep-2020, the patient started TOFACITINIB CITRATE (XELJANZ XR) (unknown route) 11 mg once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERNAL HAEMORRHAGE (Internal Bleeding) (seriousness criterion medically significant), ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), HYPERSENSITIVITY (bad allergies), MIGRAINE (sinus migraine), ACNE (acne on face/ back), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, INTERNAL HAEMORRHAGE (Internal Bleeding), ANAPHYLACTIC REACTION (Anaphylactic reaction), HYPERSENSITIVITY (bad allergies), MIGRAINE (sinus migraine), ACNE (acne on face/ back), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment medications were reported.  Company comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Nausea and vomiting are consistent with the product known safety profile.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Nausea and vomiting are consistent with the product known safety profile.
Injection site pain; Tiredness; Headache; Joint pain; Fever; Nausea; Feeling unwell; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 23May2021 at 14:30 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took penicillin (MANUFACTURER UNKNOWN), and amoxicillin (MANUFACTURER UNKNOWN); both from an unknown date to an unknown date for an unknown indication and experienced allergy. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 02May2021 at 02:30 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23May2021 at 02:45 the patient experienced injection site pain, tiredness, headache, joint pain, fever, nausea, feeling unwell, and vomiting. All symptoms were lasting for 3-4 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the adverse events. The clinical outcome of the events injection site pain, tiredness, headache, joint pain, fever, nausea, feeling unwell, and vomiting were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Severe lymph node pain. Swollen and tender to touch. Pain radiates in chest area and back.
Information has been received from a registered nurse concerning a 70 year old female with reflux esophagitis, fibromyalgia and allergies to amoxicillin, BACTRIM, amitriptyline hydrochloride (MSD), RESTORIL, MOBIC, MACRODNTIN, and "caines" who on 03-APR-2008 was vaccinated SC in the left upper arm with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included aspirin, omeprazole (MSD), and CYMBALTA. On 04-APR-2008, the patient was examined in the office and was found to have developed a severe injection site reaction. He had a 7 cm by 7 cm area of erythema at the injection site of the left upper arm. Within the 7 cm area there was a 5 cm area of induration, warmth, and tenderness. The patient was prescribed BENADRYL, TYLENOL, and ice compresses. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Initial unsolicited report received from a healthcare professional via other company (Pfizer) (manufacturer report number 2015171240) on 29 June 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, route and site of administration was not reported) on an unspecified date. The patient's medical history was not reported. Concomitant medications included Cyclobenzaprine 10 mg, loatus, Levetiracetam 500 mg, Lorazepam 1 mg, LYRICA 200 mg 1 capsule by mouth three times a day-oral (expiration date 01 June 2017) from 01 June 2016 to 01 July 2016, metformin, morphine sulfate ER 30, oxycodone 5, vitamin 6, AMBIEN 10. On an unspecified date, following vaccination, patient experienced allergy to tetanus. Lab data and corrective treatment was not reported. Outcome of event was not reported. List of documents held by sender: none.
Admitted to hospital 8/7 with PPROM at 33w4d pregnant.  My water broke first thing in the morning as I was waking up for the day. I am on bedrest at the hospital until delivery. Delivering 8/18 at 35w0d. Estimated weight of baby is 4lb 10 oz.   I know there is probably zero connection between PPROM and my covid vaccine!
Multiple myeloma; This spontaneous case was reported by a consumer and describes the occurrence of PLASMA CELL MYELOMA (Multiple myeloma) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN and GLIMEPIRIDE for Diabetes.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced PLASMA CELL MYELOMA (Multiple myeloma) (seriousness criterion medically significant). At the time of the report, PLASMA CELL MYELOMA (Multiple myeloma) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  Prior to vaccine shots, patient was an active surfer and diver. In Sep-2021, there was some problem in his lower back, and the doctor diagnosed him with multiple myeloma. He mentioned he would be going for radiation treatment and chemotherapy in Dec-2021. Prior to those shots, he had no problem and after the shots, his whole life changed with the diagnosis of cancer. He thought the shot affected him with cancer. He mentioned he had no family history of such cancer. He had 4 siblings -  two sisters and two brothers, all alive. His parents passed away, but they never had this in his family. He wanted to sue this (Escalation to Legal). He mentioned that someone must be responsible for the vaccine, he did not think he could sue the federal government, but someone must be responsible. He mentioned he did not want to get vaccinated initially, he got it because his wife got Moderna, but from a different place.  COMPANY COMMENT: This is a spontaneous case concerning a 70-year-old male patient with no significant clinical history who experienced the unexpected event of PLASMA CELL MYELOMA The event occurred unknown unknown after second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about second dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is a spontaneous case concerning a 70-year-old male patient with no significant clinical history who experienced the unexpected event of PLASMA CELL MYELOMA The event occurred unknown unknown after second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about second dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Fever began 11/09/04. Macular rash began 11/11/04.
Started with abdominal pain  at 1pm went to ER at 7:30pm. Had bloodwork sono and ct scan. Showed appendicitis. Had surgery at 7am next morning. I am a pharmacist at the pharmacy where vaccine was administered. Filling form out in case it was the cause.
Broke out in small Whelts on arms and legs the day the vaccines were given. Low-grade fever - 99 deg-100 deg Diarrhea 2-3 times day Vomiting x2
Pt began to feel pain 2 days after administration of shot. Pt states that area of pain is growing around sight of injection. No bruising. No rash. No skin irritation.
11/15/06 felt sick in the stomach and arm hurt; 11/16/06 arm hurt and now red and swollen at site of Tetanus shot; 11/17/06 arm hurt and still red and swollen. Redness spreading down arm near shot site. Went to urgent care-instructed to take Benadryl and apply ice due to allergic reaction to Tetanus shot.
10July08-First Anthrax  vaccination was issued in my left arm.  Two days later my arm started to swell and became red at the injection site.  This adverse reaction lasted approximately one week after getting the vaccine.  I was bed ridden for three days; however, I decided not to go to the hospital because I was already off duty for the days I was ill. 04May09- Second Anthrax vaccination was issued in my right arm.  My right arm was very sore and became red and very swollen for approximately a week and a half after the vaccine was issued.  I was unable to move it without being in extreme pain. I had to prop it up while sitting or laying down. I was unable to sleep on it or move it while walking.  I took over the counter medication to relieve some pain, but it didn't help much so I decided not to take it again.
chest soreness/pain; pain with breathing/hurt to breathe; severe fatigue; soreness at injection site; This is a spontaneous report from a contactable other healthcare professional (hcp), reporting for herself.  A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot ELO142) , on 18Jan2021 at 09:00 intramuscular in Right arm at single dose for COVID-19 immunization.Medical history included allergy to Shellfish. Patient was not pregnant. Concomitant medication included ibuprofen (ADVIL) prophylactically, at 2DF daily on 18Jan2021 and at 2 DF each day through on 19Jan2021; vitamin D3; fish oil; ascorbic acid (VITAMIN C) and cyanocobalamin (VITAMIN B12). The patient experienced chest soreness/pain, pain with breathing/hurt to breathe, severe fatigue, soreness at injection site, on 14Jan2021 (as reported). Events were also described as follows: patient prophylactically took 2 ibuprofen 30 minutes before vaccine on 18Jan2021 at 08:30 am and got the vaccine on 18Jan2021 at 9am. She just had soreness at injection site that evening. She kept up with the ibuprofen (only 2 doses each day) through on 19Jan2021. On 21Jan2021 she felt severe fatigue and later in the evening she started to feel chest soreness/pain and pain with breathing. It felt muscular but she went to emergency department (ED) because it hurt to breathe. They did a cardiac and PE work up which was negative. The pain was relieved by Toradol IV. She was discharged from emergency department (ED) . She took more ibuprofen on 22Jan2021 when she started to feel the same, but lesser, symptoms and the pain went away. On 23Jan2021, so far patient felt okay. The final outcome of the events was reported as recovering.; Sender's Comments: Based on the temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events "chest soreness/pain, pain with breathing/hurt to breathe". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
moderate aching for 2 days.   Swollen tender arm with big red whelps.  Itching and burning since 10/16/19.  Still uncomfortable and today is Day 4
pt recv vax & devel 5 sec focal motor sz attributed to neurological immaturity;
Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer by the patient via an affiliate. This case involves an unknown age female patient who experienced intermittent high blood pressure, while she received vaccine MENACTRA and SOLIRIS. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. On 06-Sep-2018, the patient started taking SOLIRIS 300 mg intravenous (with an unknown batch number) for myasthenia gravis. On 28-Oct-2018, the patient experienced a non-serious intermittent high blood pressure 1 month 22 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and SOLIRIS. Other relevant tests included no lab data. Final diagnosis was intermittent high blood pressure. It was not reported if the patient received a corrective treatment. On 30-Oct-2018, the patient was recovered from the events. List of documents held by sender: none.
Evening of 8/17/2010 fever, headache 8/18/2010-fever, headache, chest pain, fatigue decreased appetite.
POST VACCINATION PT C/O DIZZINESS HAD A SYNCOPE EPISODE , UNRESPONSIVE. PT REPORTED NUMBNESS TO BILATERAL ARMS AND LIPS, POSITIVE GRASP BILATERALLY. PT, ABLE TO RAISE RIGHT ARM , UNABLE TO RAISE LEFT AR. COOL TO TOUCH.
7 MINUTES AFTER ADMINISTERING THE VACCINE THE PATIENT TILTED HIS HEAD AND  LOOKED AS IF HE FAINTED. LAID HIM ON THE FLOOR TILTED HIS HEAD. HE ASKED FOR WATER,  WE GAME HIM 12.5 MG OF BENADRYL AND HE STARTED IMPROVING OVER THE FLOLLOWING 30 MINUTES. CALLED CNCHECKED ON HIM AFTER 4 HOURS AND HE SAID EVERYTHING IS FINE.
Vaccines given on 4/26/01. Had fever and blotchy red rash to body within 12-18 hours after vaccines.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 10-JUL-2013 the patient was vaccinated with PROQUAD (Merck) injection, 5 ml, subcutaneous (lot number and expiration date unspecified). Other suspect therapies included on 10-JUL-2013 VARIVAX (Merck) (dose, route, route unspecified) (lot number and expiration date unspecified). No adverse effect was reported. The patients outcome was unknown. Additional information has been requested.
Joint aches since January 7, 2022. No fevers. No cough or chest pain. No lymph node swelling. No weight loss. Took Tylenol almost daily.
Administration error: A 76-year-old woman with a first series of Modera and a booster dose of Moderna, is inoculated with a fourth dose of 0.5ml of Moderna on February 19, 2022, an action which was not consulted with the leading professionals in charge of vaccination and did not follow the established guidelines for the booster dose of patients with immunological compromise.
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025120A and 025120A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (High blood pressure) since 07-Jul-2016 and Hypothyroidism (Low Thyroid) since 11-Mar-2014. Concomitant products included AMLODIPINE BESILATE (NORVAS) from 07-Jul-2016 to an unknown date for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) from 11-Mar-2014 to an unknown date for Hypothyroidism, FISH OIL from 06-Oct-2019 to an unknown date, ACETYLSALICYLIC ACID (ASPIRIN LOW) from 07-Jul-2016 to an unknown date, ASCORBIC ACID (VITAMIN C75) from 07-Jul-2014 to an unknown date and ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL PALMITATE, RIBOFLAVIN, THIAMINE MONONITRATE (MULTIVITAMIN 6) from 06-Nov-2010 to an unknown date for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Shingles, at a dose of 1 dosage form and GABAPENTIN for Pain, at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (Shingles) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  It was reported that patient had medical history of CLH from 08-JUN-2018.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up was received on 08-JUL-2021 and contain significant information updated patient demographics, medical history was added,concomitant medication were added and treatment medication was added.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Called today with swelling warm to touch and itching. Advised patient to take benadryl tonight and continue to watch. If worsening is seen tomorrow to let us know for further advisement. Patient was not overly concerned but did want to let us know and see what she should do.
Site: Pain at Injection Site-Medium, Additional Details: Pt. came in on 10-18-22 complaining of pain in his right arm due to the vaccine. He said that when he was given the vaccine, multiple injections were given. The first 2 times the syringe was injected, he saw the syringe was leaking. He also felt pain both times. The immunizer went to get another syringe for him. The 3rd and final injection was also painful, but did not leak. Pt states that his pain has gotten worse since that day, and has had trouble sleeping since that day.
Vaccine administered on 1/19/23 was past the Beyond Use Date (1/6/23). Individual was advised that the dose needs to be repeated.
Rhythmic "twitching" off and on-started about 2 hours after immunization and resolved in about 6 hours. Inconsolable crying started about 2 hours after immunization and lasted for 8 hours. All symptoms now resolved.
Later, that night around 6 I had the typical reaction very fatigue and joint pain and a low-grade fever of 100. Then I started having pain in the growing area and with the past shots it would normally be in the shoulders making difficult to even turn my neck. Here we are two weeks later, and I am still in so much pain that it is making me nervous. I called my Primary last week, and they did a UTI test and they also tried to test for blood cancer, but I declined that test. I go back for a follow up in a few weeks.