chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client's Mother reported that client began having "severe" headache with vomiting and a temp. of 102.5 within 24 hours of receiving a Tdap. Client was taken to her physician on 11/20/09 afternoon and treated with Zofran for  the N/V. Bloodwork was drawn at this visit. By Sat. 11/21/09, the Mother reports that the client was still nauseated, but not vomiting. Client still had a headache at this time. Mon. 11/23/09 the client's Mother reported that client had improved long enough on Sunday, the 22, to have a small meal. By 5:00 PM Sunday, it was reported that the client had begun to experience symptoms again: fever, headache, and nausea. After another follow-up phone call, the parent left a voice message stating that the client was "just starting to feel better" stating that client was still feeling weak, but the headache, fever, and N/V were gone. "It has been a really long 11 days" The Mother stated that she felt after talking with others that this was a vaccine reaction and that she plans to seek payment for an E.R. visit for hydration, 3 M.D. office visits, and the Motrin and Tylenol that were useed to help her recover.
This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (side effects from the Moderna vaccine related to my menstrual cycle/significant issues with my menstrual cycle since I received the vaccine, I should have, but it was light and only lasted 3 days) and MENSTRUATION IRREGULAR (listed the day that I should have started my period, but it never came, should have had another period, but didn't, I am referring to starting my period about 2 weeks sooner than I should have) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 042B21A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy. Concomitant products included VITAMIN D [VITAMIN D NOS] and ZINC for an unknown indication. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced MENSTRUAL DISORDER (side effects from the modern vaccine related to my menstrual cycle/significant issues with my menstrual cycle since I received the vaccine, I should have, but it was light and only lasted 3 days). On an unknown date, the patient experienced MENSTRUATION IRREGULAR (listed the day that I should have started my period, but it never came, should have had another period, but didn't, I am referring to starting my period about 2 weeks sooner than I should have). On 06-May-2021, MENSTRUAL DISORDER (side effects from the modern vaccine related to my menstrual cycle/significant issues with my menstrual cycle since I received the vaccine, I should have, but it was light and only lasted 3 days) had resolved. At the time of the report, MENSTRUATION IRREGULAR (listed the day that I should have started my period, but it never came, should have had another period, but didn't, I am referring to starting my period about 2 weeks sooner than I should have) had not resolved. 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. Treatment details were not reported by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: significant follow up appended; Vaccine details, event outcome and patient information are updated.
1053: After receiving COVID vaccine, pt c/o itchy throat; pt on immunotherapy and, if doesn't pre-medicate, can feel this.  1055: BP 118/72 HR 68 RR 16 SpO2 99% NAD; lungs clear; HR reg; skin w/d; no rash, drooling, N/V or difficulty swallowing  1100: Benadryl 25 mg po given 1115: Reports feeling good. Released home.
Redness around my vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness around my vaccination site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Previously administered products included for Product used for unknown indication: FLU on 03-Mar-2021. Past adverse reactions to the above products included No adverse event with FLU. Concomitant products included FLUTICASONE for Asthma, METOPROLOL, LOSARTAN and AMLODIPINE for Blood pressure, RIVAROXABAN for Paroxysmal atrial fibrillation, ALLOPURINOL, DOXAZOSIN, FISH OIL, OMEPRAZOLE, CYANOCOBALAMIN (VITAMIN B 12 LICHTENSTEIN) and MULTIVITAMIN & MINERAL for an unknown indication, CHOLECALCIFEROL.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 30-Nov-2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. In February 2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around my vaccination site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness around my vaccination site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 antibody test negative: negative (Negative) NEGATIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-402836, MOD-2021-402912 (Patient Link).
This spontaneous report was received from a certified pharmacy technician and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided. On 13-JAN-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M033335, expiration date 11-OCT-2017 (dose and route of administration were not reported). There were no adverse events reported. Product quality complaint (PQC) was not involved. Administered dose of vaccine was exposed to the temperature of 47 degrees Fahrenheit for 17 hours (date unspecified). A digital data logger was not involved. There were no previous temperature excursions. Additional information has been requested.
On 04/10/2021 I was getting ready for my hair appointment. I was brushing my teeth and I coughed up blood. I used blue or white tooth paste so I knew it was blood. I went to the ER. They said I had Pneumonia and Rhabdomyolysis which was breaking my muscles down. They said I was a little dehydrated and they gave me a bag of fluids. I went back on Sunday and they said I was still dehydrated and they gave me another bag of fluids. Once I spit the blood that morning and got to the ER no blood came up. When they released me to go home, as soon as I got ready to walked out the door, blood came out again. I did not cough any more blood after those 2 episodes. They sat us down on a chair and the doctor came and saw the blood and said she did not see anything but she said if anything else happened to come back. I came back the next morning and did some more blood work. My levels were coming down. I followed up with my doctor on Wednesday. I shared with her I thought it was the vaccine. Everything was fine after that. I continued doing my normal things. Then on 11/11/2021 I had my booster (FH8020) and on 12/3/2021 I coughed up blood again. I saw a streak of blood and I thought it was happening all over again. I went to urgent care. They did 2 COVID-19 tests and they came back negative. They sent me to the hospital to have a chest x-ray. I went back home and I coughed up blood again. I went to the ER and it was so packed we stayed until 6 PM. They did several tests. A few hours later I decided to go home because they were taking so long to see me. I saw my doctor on Tuesday and she ordered a CT scan again. They did a lot of tests and they said I did not have pneumonia or blood clots. I go back on 1/20/2021.
Myalgia, Arthralgia, Pain at site Narrative:  Other Relevant History:
My arm was pretty sore the first day and a few hours after the vaccine I got a headache. The headache lasted 48 hours but was worse on the second day. The pain in my arm turned into a big red welt and a hard lump. I took ibuprofen for two days to help with the swelling and headache.  The  lump at the injection sight was  probably 2 inches in diameter and raised a bit.
Staff member received one of 4 doses that came out of a 10 dose vial.
I started aching and having a sore throat on 04/04/2022 and then I started having a low-grade fever that night. I felt better the next morning and attributed my symptoms to allergies or a cold but by the end of the night, my sore throat had gotten worse to the point I couldn't eat, I was congested, and my fever got up to 100.7. By the next day I had lost my sense of smell but that seemed to go in and out based on how high my temperature was. I also had a lot of aches and pains along with some fatigue. I took a home COVID-19 test on 4/05 which was negative. I happened to have my yearly physical appointment on 4/05 but I had just tested negative and was feeling a reprieve in symptoms, so we didn't address any of that but by 04/06 I was feeling badly again so I took another home COVID-19 test on 4/07 which came back positive.
Pt. presented to EC with worsening cough and fatigue on 04/21/21.
patient was given the Adacel and it was then realized afterward that the patient had a tetanus shot previously; Initial information received on 26-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who previously taken a dose of TETANUS TOXOID (lot number and expiry date not reported via unknown route in unknown administration site) on an unknown date and again received a single dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6141AB , expiry date 15-Dec-2020) via intramuscular route in the left arm on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA); and HPV VACCINE (HPV VACCINE).  It was a case of actual medication error due to extra dose administered.  It was not reported if the patient had any adverse event.  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.
extensie saliva; dizziness/ motion sickness; nausea; Motion sickness; muscle aches; bone pain; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received Shingrix. On 25th July 2021, 2 days after receiving Shingrix, the patient experienced muscle pain, bone pain, dizziness and nausea. On 26th July 2021, the patient experienced motion sickness and increased salivation. The patient was treated with ondansetron (Zofran). On 27th July 2021, the outcome of the increased salivation was recovered/resolved. On an unknown date, the outcome of the muscle pain, bone pain, dizziness, nausea and motion sickness were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, bone pain, dizziness, nausea, motion sickness and increased salivation to be related to Shingrix.  Additional details were provided as follows: Pharmacist states patient received Shingrix last Friday. On Saturday she was ok, sunday she experienced muscle aches, bone pain.  Pharmacist is unsure of status of these symptoms. On Sunday, patient also experienced dizziness and nausea that persists.  On Monday, she still had bad dizziness and nausea. She felt like she had motion sickness. She went to the Urgent Care on tuesday and they prescribed Zofran which helped a bit but she is still having symptoms.  She also experienced extensie saliva on monday and tuesday but this symptom has resolved. No lot or expiration date available since patient got Shingrix at a pharmacy and the caller(Pharmacist) works at a MD office.
received flublok 10/8/2020 and within 20 minutes developed diffuse hives
Huge feverish rash in same place injection was given. Very hot to touch. Itchy, and red bumps. Stiff joints and muscles all over esp. in legs, arms, and neck
after the 2nd dose, 2 days later the patient felt she has arthritis, legs and hands were swollen, nuckles are swollen and painful and the patient can barely walk. she hiked 4 miles a day and now she cannot even go room to room
Fever 101.4 degF, headache, myalgia, lasting approximately 24 hours
Within 2 hours of the vaccine, patient was experiencing nausea and general feeling of unwellness. Within 3 hours, patient had a fever of 99.9. At 11 pm, patient had a fever of 100. Mother administered Tylenol and patient went to bed. Patient woke up around 4:30 am with her whole body shaking uncontrollably. Mother heard her stirring and went to check on her. Her temperature was 100. Mother sat and talked with her and offered a snack, drink, and more Tylenol. Mother checked her pulse, which was normal. Patient was coherent and able to communicate. Mother left the room to get snack and drink and heard something fall over in patient's room and Mother called out and waited a few seconds for a response. Patient did not respond. Mother went back in the room, as it was unusual for patient not to respond, and found patient sitting back up and placing her head in her hands, stating in a panicked voice that she felt she was going to throw up and that she was very hot and that her head hurt really bad. Patient stated that her ears felt weird and everything went black and she somehow fell over from a sitting position on her bed to laying on her bed and had landed on the dog. Patient was unaware that she had knocked over her water bottle and had no recollection of the loud sound it made as it fell over (unusual because loud sounds are very startling for her). The shaking subsided to a tremor a few minutes after the black out. Patient then reported feeling very cold and her temperature had risen to 101. Patient complained of an extreme headache and continued nausea. Mother took patient to Urgent Care, who performed bloodwork and an EKG, and then referred patient to the Emergency Room for an EEG.  ER repeated EKG and declined to do EEG and told patient to follow up with her doctor in 5 - 7 days.
little bit of pain with moving her hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 17:00 (Lot number: EN6202) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Therapy dates: 11Feb2021 at 13:00PM , NDC number: Unknown, Lot Number: EL9269, Expiry date: Unknown, dose 1), administration date: 11Feb2021, when the patient was 54 years old, for covid-19 immunisation, reaction(s): "redness and pain at the injection", "redness and pain at the injection". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "recovered" (14Mar2021), described as "little bit of pain with moving her hand".  Additional Information: Consumer reported, she received the first dose of the Pfizer COVID 19 vaccine on 11Feb2021 at 13:00PM in the left arm. After the first dose she had redness and pain at the injection site that gradually went away after three days. She also noticed a little bit of pain with moving her hand which also went away gradually after the second dose. States she received the second dose on 04Mar2021 at 17:00PM in the left arm. After the second dose she had no reaction; nothing at all. Mentioned she received the second dose at a different vaccination location from the first dose and it was done in some conditions that concerns her about whether she got the actual vaccine, and that the vaccine was at the limit of its expiration. She was also questioning whether the vaccine was stored properly. Mentions when she got to the vaccination location she discovered the vaccine was within 24 hours of the expiration of the product and it had been transferred from one area to another area because it was not used. She didn't know this ahead of time. She was unsure of the expiration date as it is not on her card. She was asking what if the vaccine is expired? Is there a way she can check to see if she has antibodies to COVID 19? Adds she had called before to ask about her health conditions and the interaction with the vaccine. She does not have a report reference number to provide from that call. They called her back and she had a very good experience. This will be a follow up.  No follow-up attempts are possible. No further information is expected.
On April 22, 2021, around 2:30 AM, my mother woke up vomiting and diarrhea, and was weak, she wasn?t able to keep anything down, stayed in bed all day.
I've been having a rash where I had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles before vaccination).   On an unknown date, the patient received Shingrix. On an unknown date, 1 year after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient had shingles before and got vaccinated but a year after the patient had a rash where the patient had shingles. The patient asked if it was that normal?
Per mother, child had "hives" or raised red areas from throat to the top of her thighs and posteriorly all of back to her buttocks. Child also complained of it being difficult to swallow, but no difficulty breathing. Also has redness where injection was given to left deltoid. Mother unsure of the time but was complaining by 5pm of these symptoms and that was when mother was first made aware. Mother spoke to Dr. who was on call for PCP and was instructed to give the child Benadryl and Calamine lotion when the child is symptomatic.
caller's wife has a cold but is scheduled for her second dose today; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (caller's wife has a cold but is scheduled for her second dose today) in a female patient of an unknown age 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 NASOPHARYNGITIS (caller's wife has a cold but is scheduled for her second dose today). At the time of the report, NASOPHARYNGITIS (caller's wife has a cold but is scheduled for her second dose today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient wife has scheduled for her second dose and wanted to know if she can still receive her second dose of Moderna as she has cold. When agent asked about further information to file AE caller became angry and did not provide any information about it. Caller denied consent for safety follow up.  No treatment drugs were reported. No concomitant drugs were reported.
(R) arm with pink, edematous, pruritic rash from deltoid muscle to elbow, sensation and circulation intact. Onset 24 hours after vaccine (L) deltoid measures 7 1/2" (R) 9 5/8".
Chills, Muscle Pain, Joint Pain, Exhaustion, Nausea, Rash, Hives     Nausea, Rash, Hives  lasted for 24 hours Chills, Muscle Pain, Joint Pain, Exhaustion lasted for 7 days
infectious endocarditis; cardiac symptoms; This is a spontaneous report received from a contactable Pharmacist reported for a female patient.  A female patient of late 50's-early 60's received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no/Lot number: not reported) received via unspecified route of administration on 30Dec2020 as dose 1, single for covid-19 immunization and bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no/Lot number: not reported) received via unspecified route of administration on 20Jan2021 as dose 2, single for covid-19 immunization. Patient medical history included heavy smoker and she had a pericardial window placed in her heart. It was reported that patient experienced cardiac symptoms approximately 2 months following the 2nd dose of the Pfizer-BioNTech COVID-19 vaccine. Patient was hospitalized due to events caused and she was admitted to the ICU and placed on a ventilator. Patient had a pericardial window placed in her heart and she received antibiotics at one point during her care and for what they thought could be an infectious Endocarditis, but no organism grew on culture. Treatment received for the events caused. Event took place after use of product. Outcome of the events was unknown.  The lot number for the vaccine (BNT162B2), was not provided and will be requested during follow-up.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.  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
Soreness and bruising noted at injection site on March 27, 2009. Noted discomfort on March 29 to injection site around 10, awoke client up, discomfort continued during the night. Did not take meds for discomfort. Right side deltoid swollen, hot to touch, and raised reddened areas noted. Bruising noted. Advised to apply ice pack 15 minutes on and 15 minutes off and to take ibuprofen and to seek PMD if gets worse.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were unspecified. Approximately in July 2013 (reported as "3 years ago"), the patient was vaccinated with first dose of ZOSTAVAX 19400 PFU subcutaneously (dose, vaccination site, lot # not provided). On 13-JUL-2016, the patient was vaccinated with second dose of ZOSTAVAX 19400 PFU (dose, vaccination site, route lot # not provided). No adverse effects were reported. The patient sought medical attention and called pharmacy. The patient was advised after the second vaccine was given. Product quality complaint (PQC) was not involved. Additional information is not expected since there was no consent to contact the reporter.