chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menstrual cycle changes since fully vaccinated. First break through bleeding, then early menstrual cycle and now late menstrual cycle. Menstration has not been normal since fully vaccinated with Moderna vaccine. Other side effects included body aches, fatigue, fever etc. for 2-3 days post vaccine.
Fever, fatigue, headache, light headed, body aches. Took Tylenol and rested. Lasted less than 24 hours.
swollen tongue, difficulty breathing.  benadryl 25mg iv push, solu-medrol 125mg iv push, epi 1/1000 (0.3ml sub-q x1); symptoms improved.  presented to er at 13:27 and discharged at 15:07
received 2 doses of adjuvant only; received 2 doses of adjuvant only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number L4H5, expiry date 25th January 2022) for prophylaxis.   On 13th September 2021, the patient received the 1st dose of Shingrix. On 13th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The nurse reported that, the patient received 2 doses of Shingrix adjuvant only, no lyophilized portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Adcel vaccine that was given to a patient, 5 days past the expiration date, no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 15 months old female patient who received a 0.5 mL dose (4th dose in series) of expired vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: C52881AA, expiry date: 05-Oct-2019) via intramuscular route in left thigh on 10-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used. Adacel vaccine that was given to a patient, 5 days past the expiration date.   At the time of reporting, no adverse event was reported.   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.
redness that is warm to the touch at injection sight. Redness is getting bigger by the day. Should I be concerned????????????
I noticed the ringing in my head in October. I blew it off thinking it would go away and didn?t do anything about it and it wasn?t too irritating. End of November right after thanksgiving, I had dizzy spells and the room was spinning and it was waking me up in the middle of the night. I called the facility call center 12/04/2021 after experiencing a week of dizziness. They referred me to head and neck doctor and they did a bunch of tests, said I had vertigo in both ears. Ringing in both ears could be caused by anything. Referred to Auditory doctor and vestibular physical therapist. They had me do some exercises to get the dizziness to subside. they did a maneuver to put the crystals back in my ears and it has helped a bit. Still continue to get dizzy but sitting still helps. Ringing in my head is still pretty constant. Had an appointment with audiology yesterday, hearing has gotten worse, and the ringing in my head was tinnitus and they don?t know what causes that and it could be here to stay. Could be unrelated to the booster but they both came on after receiving the booster vaccination. The audiology doctor has scheduled me for an MRI for my ears to see if there are any tumors.
Got both shots. Shingles.; Shingles; almost killed me; pain was excruciating; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization, GSK medically significant and life threatening), shingles (serious criteria hospitalization and life threatening), near death experience (serious criteria GSK medically significant and life threatening) and pain. On an unknown date, the outcome of the vaccination failure, shingles, near death experience and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, near death experience and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient got both shots of shingles vaccine and experienced shingles. The patient stated that shingles put him/her in the hospital, almost killed him/her. The patient also experienced pain and the pain was excruciating. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Parent Denies adverse Reaction RIT wrong dose 0.5ml instead of 0.3 mL dose given.
Not feeling well; Strong bone pain; Missed the appointment for the second dose; could not drive; felt like a hardness in my arm; I massaged my arm, it was red; Where I got the vaccine like it crystalized; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (I massaged my arm, it was red), MALAISE (Not feeling well), BONE PAIN (Strong bone pain), PRODUCT DOSE OMISSION ISSUE (Missed the appointment for the second dose) and VACCINATION SITE CALCIFICATION (Where I got the vaccine like it crystalized) in a 73-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.     Concomitant products included PARACETAMOL (TYLENOL) for Pain in leg, ATORVASTATIN, IRBESARTAN and Aspirin.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Apr-2021, the patient experienced ERYTHEMA (I massaged my arm, it was red), VACCINATION SITE CALCIFICATION (Where I got the vaccine like it crystalized) and VACCINATION SITE INDURATION (felt like a hardness in my arm). On 30-Apr-2021, the patient experienced MALAISE (Not feeling well), BONE PAIN (Strong bone pain), PRODUCT DOSE OMISSION ISSUE (Missed the appointment for the second dose) and DECREASED ACTIVITY (could not drive). At the time of the report, ERYTHEMA (I massaged my arm, it was red), MALAISE (Not feeling well), BONE PAIN (Strong bone pain), PRODUCT DOSE OMISSION ISSUE (Missed the appointment for the second dose), VACCINATION SITE CALCIFICATION (Where I got the vaccine like it crystalized), DECREASED ACTIVITY (could not drive) and VACCINATION SITE INDURATION (felt like a hardness in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication includes acetaminophen (Tylenol)
This infant had a fever, coryzal symptoms; approximately 24 hours post-vaccination. She was seen in the ER.
nerve pain in leg, confusion, right side of head pain, extreme elevated blood pressure, face twisted, Bell's Palsy
Initially, fatigue, joint pain, injection location soreness, then 3 days later I started getting heart palpitations that lasted for 2+ days (Thurs, Fri and part of Sat.), continued fatigue and shortness of breath.
3 days after receiving vaccine, lost voice completely. Also had a non productive cough. Three weeks later voice is 98% back.
This case was reported by a healthcare professional via a sales representative and described the occurrence of rash in an adult male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 7 October 2008 the subject received a dose of FLUARIX at 0.5 ml. On 7 October 2008, and into the next day, the subject developed a generalized itchy rash. On 21 October 2008, the events of rash and itching were resolved. The healthcare professional considered these events unrelated to vaccination with FLUARIX. Similar events occurred in three additional subjects. Linked cases include: A0753760A, A0753769A and A0753771A.
4 hrs after receiving MMR and Hep A vaccines, pt's face and arms were flushed and itching at areas, pt was febrile during episode but continued after fever resolved until the next morning. No rash, also large local reaction at (L) thigh.
Second dose >36 days later (after 41 days of 1st dose, 2nd dose taken); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose >36 days later (after 41 days of 1st dose, 2nd dose taken)) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose >36 days later (after 41 days of 1st dose, 2nd dose taken)). On 21-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose >36 days later (after 41 days of 1st dose, 2nd dose taken)) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-320320 (Patient Link).   Reporter did not allow further contact
itchy, redness and hot to touch at site. Lymph node pain and enlargement under armpit or right arm where the vaccine was administered.
Pain in Deltoid Muscle at injection site got progressively worse after injection. Used Tylenol an hour later with minimal affect. Applied Aspercream to site 14 hours later with minimal affect.  Never had that kind of Soreness in my arm after a vaccine that continued into the next day.
Severe Nausea; Diarrhea; Light-headed / Dizziness; Weakness; got weak legs; Weakness; got weak legs; Numbness in legs; Mild disorientation every now and then; This is a spontaneous report from a contactable consumer (patient's husband). A 36-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0170), via an unspecified route of administration on 06May2021 (at the age of 36-years-old) at 2nd dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included bupropion, citalopram, and propranolol. Historical vaccine included first dose of BNT162B2 (lot number: EW0153) taken on 15Apr2021 at the age of 36-years-old for COVID-19 immunization. The reporter stated that 5 hours after the second shot of BNT162B2, on May2021, the patient experienced severe nausea, diarrhea, light-headedness, and dizziness. The patient also had weakness, weak legs, numbness in her legs, and mild disorientation every now and then. The patient was brought to the hospital twice at the emergency room for these. The reporter stated that in the emergency room, the patient was only given anti-nausea medication, like ondansetron (ZOFRAN), and nothing else. Outcome of all the events was unknown.   No follow-up attempts are needed. No further information is expected.
not feeling well; Night sweats; Throat soreness; sinus infection , nostril hurts; sinus pressure; aching near eye; Chills; Fever; headache; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), NIGHT SWEATS (Night sweats), OROPHARYNGEAL PAIN (Throat soreness), SINUSITIS (sinus infection , nostril hurts) and PARANASAL SINUS DISCOMFORT (sinus pressure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 MALAISE (not feeling well), NIGHT SWEATS (Night sweats), OROPHARYNGEAL PAIN (Throat soreness), SINUSITIS (sinus infection , nostril hurts), PARANASAL SINUS DISCOMFORT (sinus pressure), EYE PAIN (aching near eye), CHILLS (Chills), PYREXIA (Fever), HEADACHE (headache) and MYALGIA (Myalgia). At the time of the report, MALAISE (not feeling well), NIGHT SWEATS (Night sweats), OROPHARYNGEAL PAIN (Throat soreness), SINUSITIS (sinus infection , nostril hurts), PARANASAL SINUS DISCOMFORT (sinus pressure), EYE PAIN (aching near eye), CHILLS (Chills), PYREXIA (Fever), HEADACHE (headache) and MYALGIA (Myalgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information were not provided. No treatment medications were reported   This case was linked to MOD-2021-075012 (E2B Linked Report).; Sender's Comments:  MOD-2021-075012:
pt c/o hard knot in (L) deltoid muscle hot to touch and tender. Vaccine given 6/25/07. Denies streaking and/or fever. Advised to apply ice and take Motrin 600 TID
diarrhea; allergic reaction; hives; nausea; rash; vomiting; Initial information regarding an unsolicited valid non-serious case was received from a consumer/ non-healthcare professional via Medical Information (Reference number- 00512839) and transmitted on 10-Mar-2021.   This case involves a 71-year old female patient who experienced diarrhea (diarrhoea), allergic reaction (hypersensitivity), hives (urticaria), nausea, rash and vomiting, after she received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  Medical history included drug allergy (she had an allergy to Thermasol).  Past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and PARACETAMOL (TYLENOL).  On an unknown date, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [lot number: UH442AB and expiration date: unknown] at an unknown dose via unknown route in an unknown site of administration for prophylactic vaccination.  On an unknown date, patient experienced diarrhea (diarrhoea), allergic reaction (hypersensitivity), hives (urticaria), nausea, rash and vomiting, (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events was unknown, at the time of reporting.
I had a cough, congestion, sore throat a low-grade fever, I felt like I had a head cold with weird feelings throughout my body. I took two home COVID-19 test, the first one came back negative. I waited and took the test again the next day this time it was positive. I called my doctor to let him know I tested positive. He prescribed the antiviral molnupiravir. Within twenty fours I started feeling better and I am now feeling one hundred percent like myself.
pt recv vax 13MAY96 & 17MAY96 MD was running a UA on pt who had suspected UTI;analysis revealed presence of bilirubin in pt urine;pt is asymptomatic for hepatitis;MD rechecked pt urine twice & it was positive for bilirubin 2nd & 3rd time;
Received a vaccine that underwent a temperature excursion; No adverse event; Received a vaccine that underwent a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion).    The patient had a weight of 30.6# (unit not specified). No concomitant medication was reported by reporter. The patient had Moderna administration location on LQ (unspecified). Some vaccines were stored in the freezer and other vials in the refrigerator. The excursion occurred on 7-Aug-2022 and was picked up by state review of the temperature data logger 2 weeks later after the excursion. Total 38 patients received this. Number of vials/doses impacted: 13 vials Some vials were used on patients punctured and discarded within 12 hours. 5 vials were in the freezer 2 were in the refrigerator. The vaccine underwent one temperature excursion one in the freezer and one in the refrigerator. 1 refrigerated vial was with lot number AS1412B and expiration date 10-Feb-2023. Maximum or minimum temperatures reached was 14 degrees Celsius for 3hr 5min. Vial was moved from freezer to refrigerator on 8-Aug-2022. Those were administered or discarded. Proposed desired used by date was 18-Aug-2022. No adverse events  No treatment medication was reported by reporter.
Suspected vaccination failure / shingles; shingles; very itchy; rashes; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received Shingrix. In December 2020, between 1 and 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and rash. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient him/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. In December 2020, the patient became very itchy and had rashes and was diagnosed with shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.
Patient had redness trailing from vaccination site on left arm. Patient was instructed to see her doctor if redness became worse or if redness continued to spread. She was also informed that as pharmacists, we are not trained in diagnosis and that if she feels uncomfortable about the redness, that she should see her physician.
This spontaneous report was received from a Licensed Vocational Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unknown date, the patient was vaccinated with the improperly stored dose of ROTATEQ (orally, lot # K016261, expiration date on 23-JUN-2016; dose was not reported). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion of 34 degrees Fahrenheit for 7 days. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same source. Additional information has been requested.
Low grade fever, chills, body aches, fatigue started the night of the second vaccine. lasted for one night. On the second day I mostly just experienced fatigue.
Information has been received from a health professional concerning an 8 yr old female who, as an infant, was vaccinated with a 0.5ml SC dose of varicella virus vaccine live. In the spring in approx Apr 2005, the pt had classic appearing herpes zoster involving the left back, fifth rib area. It was not cultured. The pt was treated with oral acyclovir. It was reported that the pt recovered. No product quality complaint was involved. No other information was provided. Additional information has been requested.
After first dose of vaccine on 9/21/21, I felt slightly disoriented and achy. The main side effect that is unchanged to this date is a metallic taste of food and drink. I can no longer tolerate sweets of any kind, real sugar is the absolutely worst. I can no longer drink coffee or I get very sick. And that's if I;m able to even swallow it. I told my physician at the time and was told it would probably go away soon. It has not. I have lost 12 pounds so far.  Smell of food is exactly as it should be. And I still get hungry. I can still taste all foods but the taste is also bitter and metallic. Sweets are metallic but so super sweet I can't stand them. Things smell great, just don?t taste that way.  On 10-19-21 I received my second dose. You could still see the first injection site from first dose of vaccine.  I immediately had a taste in my mouth that was bitter. I also started to feel bad. Nurse noticed my left ear was red and I told her it was itchy.  She checked on me in about 5 min. The bottom of both of my feet were itching, left arm at injection site and left ear.  I overall did not feel well. By that evening aprox 6 pm I had severe muscle weakness and pain. I was nauseous and felt absolutely terrible. By the next morning I was worse. It was hard to move because of weakness and pain. I contacted my physician then. I was told to put hydrocortisone cream on my itchy places and wait 24 hours. I have never felt this bad to this date over anything else.
10:58 am - chills 11:20am - headache  11:30 am patient took Tylenol 500mg  11:45am- Nausea advised to go to the ER for further evaluation   Patient refused to go to the ER and said he will be fine.  He don't want to go to the ER.   BP: 122/90 Pulse: 76 o2- 99%      Signed a letter stating patient refuses to go to the ER.