chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no energy; wants to sleep all the time; Sick to her stomach; body aches, especially in her legs and ankles were hurting her.; Unsteadiness on her feet; sporadic headaches; She is having chronic fatigue/I couldnt get off of the couch; loss of appetite; body aches; passed out; This is a spontaneous report from a contactable female consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ERG733, Expiration date: unknown), via unspecified route, administered in left arm on 24Mar2021 15:00 (at the age of 58-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history includes bipolar disorder and history of anxiety. Concomitant medications include Lithium, Alprazolam and Olanzapine, she has been on these medications for 24 years. On 25Mar2021, 9 hours after the vaccination, the patient experienced chronic fatigue, loss of appetite, body aches, no energy, sporadic headaches, and wants to sleep all the time, unsteadiness on her feet and on 26Mar2021 she experienced sick to her stomach. She stated that then Thursday for 2 1/2 weeks till her second dose she was so tired, chronically tired that she would have to take naps by 1400 each day, she couldn't keep her eyes open, and would fall asleep for 2 hours and get up at 1600. She stated that she kept getting these sporadic headaches, body aches, especially in her legs and ankles were hurting her. It seemed to get better close to the second dose. She has never experienced this in 24 years, so she think this is from the vaccine because the vaccine was the only difference in her life. She stated when she passed out on that Thursday and slept all day, it almost felt as if she was in lithium level toxicity. She wasn't steady on her feet. She stated it feels like lithium toxicity. She wanted to know if anyone has reported an interaction with lithium and the vaccine. She has been on Lithium since 1996, for 24 years she has been on 900mg of the product. The caller wanted to know if there is a drug interaction with Olanzapine and the vaccine. The caller wanted to know if there is a drug interaction with Alprazolam and the vaccine. Patient is concerned about interaction between vaccine and concomitant medications. She was taking Tegretol and recently was taken off it. She went through hell the first 2 weeks and then during that third week she was feeling a little bit better, not quite as tired and she is making it through the day without that 2 hours nap. Caller stated the COVID Vaccine had put her mind at ease after she received the vaccination, but what she is experiencing is not normal. She is going to doctor to get blood work, Lithium Level, CBC, thyroid, the full gambit of test on 16Jun2021. The event passed out assessed as medically significant. The outcome of the events limb discomfort was recovered on 26Mar2021, events fatigue, headache and abdominal discomfort was found recovering. Outcome of events asthenia and hypersomnia was unknown, and outcome of reduced appetite and pain was not recovered.  No follow-up attempts possible. No further information expected.
Received 2nd Pfizer dose at approximately 1:00 pm on Feb2, 2021.  t approximately 2:00to 3:00 AM, Feb3, 2021 , I was having difficulty breathing.   Went to hospital where I was tested for Covid and pulmonary embolism.   Both negative.   Diagnosed with extreme micro valve regurgitation.   Sent me to Heart Center.     First thought I had an underlining heart condition, spent 3 weeks in the hospital under the care of Dr.   End result after months of testing.    Extreme reaction to the Pfizer shot
significantly heavier and more painful (re: cramping) menstruation.  Starting August 2021 and observed to date.
Information has been received from a physician concerning a 22 year old female who on an unspecified date was vaccinated with Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). Approximately two and half weeks after the vaccination, the patient experienced abdominal pain, nausea, chills and muscle aches. She was hospitalized for 5-6 days. Multiple unspecified CT-scans, x-rays and blood tests were performed. All the results were negative. She was treated with an unspecified antibiotic. Subsequently, the patient recovered. The physician felt that the abdominal pain, nausea, chills and muscle aches were disabling. Additional information has been requested.
Information has been received from a medical assistant(also reported as office manager) referring to a12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 18-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. ; Sender's Comments: US-009507513-1704USA014784:
This spontaneous report was received from a consumer, referring herself, a 58 year old female patient. The patient's concurrent conditions included drug reactions/allergies to penicillin and sulfa drugs. The patient did not have any medical history. On 15-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # and expiration date were not reported) (route, dose and indication were not provided). The patient did not have any concomitant therapy. On an unspecified date in 2015, few hours after the administration the patient experienced "redness and swelling at the insertion site". The patient did not received treatment for the events and she did not sought medical attention. It was not performed any lab diagnostic studies. It was also reported that it was not involved a product quality complaint. At the time of the report, the outcome of injection site erythema and vaccination site swelling was reported as recovering. Additional information is not expected because it was not possible to contact the physician.
Body aches, fever, chills, headache, and heart palpitations that started approximately 12 hours administration of vaccine.  Fever, chills and body aches subsided within 36 hours.  Heart palpitations reduced but continue to occur periodically
A non-serious spontaneous report of administration to six month-old was received from a healthcare professional concerning a seven-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 28-Oct-2010, the patient received second dose of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Information has been received from a physician concerning a 16 year old female, who in May 2007, was vaccinated with a first dose of Gardasil. On 26-JUL-2007 the patient received a second dose of Gardasil at 09:50. Subsequently, the patient fainted for 30 seconds. The patient was sitting in a chair in the lobby when she fainted. She did not fall off the chair. The patient left the office around 10:05. The physician reported that the patient did not eat anything before receiving the vaccination and it was also reported that the patient may have been nervous about getting the vaccination. The patient sought unspecified medical attention. On 26-JUL-2007 the patient recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a physician concerning a 16 year old whhite female student with no drug allergies, who in May 2007, was vaccinated with a first dose of GARDASIL. On 26-JUL-2007 the patient was vaccinated intramuscularly in the right deltoid with a second dose of GARDASIL (lot# 658094/0524U) at 10:10 (previously reported as 09:50). Subsequently, the patient fainted for 30 seconds. The patient was sitting in a chair in the lobby when she fainted. She did not fall off the chair. The patient left the office around 10:05. The physician reported that the patient did not eat anything before receiving the vaccination and it was also reported that the patient did may have been nervous about getting the vaccination. The patient sought unspecified medical attention. On 26-JUL-2007 the patient recovered. No product quality complaint was involved. Additional information is not expected.
stiff neck, muscle flaccid, unable to void or defecate;dx transverse myelitis (CMV virus in spinal fluid);MD reports fever, muscles aches, back pain, hyperactive reflexes;
20 year old male patient administered expired dose of Menactra, no AE; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 20 year old male patient who was vaccinated with an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  Patient did not received other vaccines.  On 03-Dec-2020, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6346AA and expiry date: 30-Aug-2020) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  Reporter relationship: HCP (health care professional), product used: used, first time product used: yes and still using product: no  At the time of report, 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 holder's 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.
Child was seen for initial Obstetrics visit onn 3/27/2023 after being referred by PCP for positive pregnancy test during initial medical exam on 3/20/2023. Sonogram performed on child noted gestational age to be 6 weeks with due date noted as 11/15/23. Child is doing well and has no complains. Child has prescribed Prenatal tablets once daily.
COULD NOT STAND UP FROM A KNEELING POSITION WITHOUT A DEVICE PATIENT CAN LEAN ON TO STAND UP; LEGS WERE WEAK; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced could not stand up from a kneeling position without a device patient can lean on to stand up. On APR-2021, the patient experienced legs were weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the legs were weak and could not stand up from a kneeling position without a device patient can lean on to stand up was not reported. This report was non-serious. This case, from the same reporter is linked to 20211107590.
arm got sore 10 hours after shot,,,,,,,,bad headache at back of my head , check bone real sore, ,teeth hurt,  tightmess  in chest, felt like throat was closing up. That lasted for 4 hours, I took an asperin finally, and it started to subside,
On Wednesday,  we accidently gave a 5 and 7 year old 0.2 of the adult Pfizer vaccine instead of the children Pfizer vaccine,  It was a misunderstanding with the new bottles of the Pfizer vaccine.   Parents have been contacted by staff and provider, parents were informed and told to monitor symptoms.  Children were experiencing no signs or symptoms post vaccine.
generalized erythema on rt buttock, pruritic on 27DEC95;erythema spread down outer aspect of rt leg w/bruising @ site;dx as cellulitis & prescribed ATB;
Headache, Shoulder pain and fatigue 2 days following vaccine.  Adomilnal pain 6 days after vaccine
Left arm became completely red; Its been more than 42 days after the first shot and she has not taken the second shot; Tired; rash in left arm; left arm swollen up; itching; i felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm swollen up), PRURITUS (itching), DIZZINESS (i felt dizzy), ERYTHEMA (Left arm became completely red) and PRODUCT DOSE OMISSION ISSUE (Its been more than 42 days after the first shot and she has not taken the second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PERIPHERAL SWELLING (left arm swollen up), PRURITUS (itching), DIZZINESS (i felt dizzy) and VACCINATION SITE RASH (rash in left arm). On an unknown date, the patient experienced ERYTHEMA (Left arm became completely red), PRODUCT DOSE OMISSION ISSUE (Its been more than 42 days after the first shot and she has not taken the second shot) and FATIGUE (Tired). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 07-May-2021, PERIPHERAL SWELLING (left arm swollen up), PRURITUS (itching), DIZZINESS (i felt dizzy) and VACCINATION SITE RASH (rash in left arm) had resolved. At the time of the report, ERYTHEMA (Left arm became completely red), PRODUCT DOSE OMISSION ISSUE (Its been more than 42 days after the first shot and she has not taken the second shot) and FATIGUE (Tired) 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.   Treatment medication Benadryl  for rash.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Significant follow up appended
High fever for 2 night in a row (in excess of 103), nausea, headache, sore muscles and joints, sore teeth, red inflamed area of vaccination about the size of an orange lasting 5 days., dizziness, unproductive cough, extreme tiredness for 3 days and lingering for 5 days.
89 year old was in bed for 2 days after receiving moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (89 year old was in bed for 2 days after receiving moderna vaccine) in an 89-year-old patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced MALAISE (89 year old was in bed for 2 days after receiving moderna vaccine). At the time of the report, MALAISE (89 year old was in bed for 2 days after receiving moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment information were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-068360, MOD21-070439, US-MODERNATX, INC.-MOD-2021-068645 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068360: MOD21-070439: US-MODERNATX, INC.-MOD-2021-068645:
Significant pain in vaccinated arm, severe fatigue/weakness, tingling in both hands and feet, sweating with cold feet. Pain in arm was within 5 minutes of vaccine (more pain than the tetanus shot), tingling in both hands and fee started about 2 hrs after the shot, followed quickly by severe fatigue/weakness (similar to flu response). Pain meds resolve most of the pain, but cannot get rid of other symptoms. People reporting online the tingling in hands and feet was followed by tremors and nerve issues. Very concerned about this reaction.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was administered with a dose of ZOSTAVAX post supported temperature excursion (0.65ml, subcutaneously, lot # L000450, expiration date: 09-MAR-2016). No adverse effects were reported. Follow up information has been received on 14-MAY-2015 and on 15-MAY-2015, from a pharmacist who was able to provide the patient's initials and dates of vaccination for the ZOSTAVAX that experienced a temperature excursion; it was stated that the patient of unknown age and gender was vaccinated on 15-APR-2015. The pharmacist had no additional information to provide at the time of the call. This is one of several reports from the same reporter. Additional information has been requested.
Patient received Janssen vaccine at age of 17.  The patient did not experience any adverse reactions to the vaccine.
Seizure activity described as "rapid eye blinking and dragging her right foot" was seen approx 3 hours post administration of Tdap. Family stated she had generalized tonic-clonic seizures with previous (>10 yrs ago) administration of DPT.
On left thigh at site of KINRIX - Mom noticed some localized redness on 4/15/10 but on 4/16/10 it became much larger and hotter to touch. 14x20 cm area of raised well documented erythema. We called to check on pt on 4/19/10. Mom states leg is better - swelling decrease, leg no longer hard.
Injection site very red, inflamed, hot, and large wheal. Pt having pain behind left eye and under left breast (like when she has had shingles previously). NO rash yet, but called pt on 10-9-15 and stated having rash under breast at that time.
Patient received 2nd dose of Moderna covid vaccine on 05/05/2021.  He reports that he felt weak the day after this 2nd dose.  Patient states that within a week after the 2nd dose both of his shoulders' muscles got to pain level of 8-9 on a pain scale of 1-10.  He states he could not do anything or lift his shoulders.  He states that he did have a pre-existing rotator cuff injury, but had never experienced pain like this before and that it was very debilitating.  He states he went months in pain and the pain has now subsided to a 3 on a pain scale 1-10.  He reports that he is not able to do push-ups.  Patient contacted pharmacy 10/21/2021 and reported his adverse effects.
During her 15 minute waiting period after the injection, the patient began to experience lightheadedness.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat; This is a spontaneous report received from a contactable other health care professional. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6205) via an unspecified route of administration on 16Mar2021 as single first dose for COVID-19 vaccination. Medical history, concomitant medication and past drug were not reported and no known allergies. On 16March2021 the patient experienced light-headedness after 15 minutes vaccination during the waiting period, the patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. The patient did not undergo lab tests and procedures. It was unknown the patient received any other vaccine within 4 weeks prior to the covid-19. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19, Since having the vaccination. Therapeutic measures were taken as a result of Event and included treatment with water, snacks and Tylenol on an unknown date. The outcome of the event light-headedness was recovering. It was reported that the patient was stable to go home and follow up with primary care providers (pcp). No follow-up attempts are possible. No further information is expected.
This non-serious spontaneous case was initially received on 14-Sep-2017 from other Health Professional and concerns a female patient of unspecified age. Patient's medical history and concomitant medications were not reported. On an unspecified date in Sep-2017, the vaccine stored FLUCELVAX QIV in a new fridge that reached 29-degree F and  later it was displaced to the fridge after it reached 63.96-degree F for less than 24 hours in the previous one. On 14-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). It was reported that four administrations took place after second excursion, recommended the vaccines be discarded. It was reported that, the patient had not experienced adverse event, after the second excursion of vaccine administered. The outcome of the events was not reported. The reporter assessed the report as non-serious. Non-significant case correction received on 14-Sep-2017: Batch number was added in the screen and updated expiry date. The narrative was amended accordingly. Follow-up report received on 20-Sep-2017: It was reported that, the patient had not experienced any adverse event following the administration of the vaccine, amended narrative accordingly. Non-significant case correction received with IRD 14-Sep-2017: Batch number was added in the screen and updated expiry date. The narrative was amended accordingly.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patient's medical history or concurrent condition were not provided. On unknown dates between 01-JUN-2015 and 15-JUL-2015, the patients received improperly stored M-M-R II 0.5 ml, (lot # J014876, expiration date 21-NOV-2015, therapy type rHA) subcutaneously. Concomitant drug was not reported. No adverse effects were reported. It was unknown whether the patients sought medical attention. This is one of several reprots received from the same reporter. Additional information has been requested.
Received the J&J Shot the morning on 4/9. By dinner time, I was feeling nauseous and my body ached. That night was flu like symptoms (chills, sweating, body aches, food tastes funny, etc.). On 4/12 I got a terrible headache, blurry vision, and stomach pains. On 4/13, started to feel better, but stomach still had pains and food tastes funny.  Today is 4/14 and I'm am still more tired than usual and still have some stomach pains.