chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got neurologic symptoms feeling like she got electrified and her joints were swollen and painful. She couldn't even grab a phone. Starting the next morning and getting better over 3 days but she still feels pain and her joints were swollen. She called her PCP and explained how she was feeling and her MD said those symptoms were idiosyncratic effects from vaccine not related to fibromyalgia.
Severe muscle pain. Severe joint pain. Inflammation of joints relieved by Ibuprofen 800mg.
Pt experienced facial swelling, throat closing and rash to face and arms. This took place later in the day after vaccine. Also pt had been playing and holding a cat. (Which mom states pt has played with cats before). BENADRYL was given and pt fine next day
After the vaccine, my period got heavier and come with larger blood clot.   As today, my periods are still very heavy.
she has ear problems; This is a spontaneous report from a contactable consumer (patient) reporting herself.  A 71-years-old female patient BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: Unknown), via an unspecified route of administration on 29Sep2021, as dose 3 (booster), single (at the age of 71-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient historical vaccine included BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: Unknown), via an unspecified route of administration on unspecified date, as dose 2, single for COVID-19 immunization and BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: Unknown), via an unspecified route of administration on unspecified date, as dose 1, single for COVID-19 immunization. On 29Sep2021 patient received the third dose of the COVID-19 vaccine from Pfizer. In 2021 the patient reported that she has ear problems. Patient wanted to know how to get the "global code" on her card with her vaccination certificate. The clinical outcome of the event was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.  .
PATIENT RECEIVED FIRST DOSE OF MODERNA COVID VACCINE ON1JUL2021. RECEIVED SECOND DOSE BEFORE RECOMMENDED TIME FRAME ON 09JUL2021.
Information has been received from a registered pharmacist concerning a 16month old male who on 06Nov03 was vaccinated with varicella virus vaccine live and measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) , inadvertently via the IM route of administration instead of the recommended SC route. Concomitant therapy that day included influenza virus vaccine and respiratory syncytial virus vaccine. Subsequently, on 06Nov03, the pt developed a fever and increased heart rate. It was noted that the pt was not hospitalized. There was no product quality complaint involved. The pt sought unspecified medical attention. Additional information has been requested.
Pt reports chills and nausea a few hrs after vaccination of dose #2 - abrupt onset and cessation lasted 1 hr. Also mild fever. Sx less severe with dose #2. Arm sore for 3 days.
Pt received first two doses as Pfizer  on 01/29/21 and 02/20/21 at another facility Pt received Moderna today as third dose
Red, painful, bump at injection site; Red, painful, bump at injection site; Red, painful, bump at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red, painful, bump at injection site), VACCINATION SITE PAIN (Red, painful, bump at injection site) and VACCINATION SITE SWELLING (Red, painful, bump at injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red, painful, bump at injection site), VACCINATION SITE PAIN (Red, painful, bump at injection site) and VACCINATION SITE SWELLING (Red, painful, bump at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red, painful, bump at injection site), VACCINATION SITE PAIN (Red, painful, bump at injection site) and VACCINATION SITE SWELLING (Red, painful, bump at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
On Saturday after vaccination, the Patient states he had a temp of 98.1 F as well as back and lung pressure.  Those symptoms resolved by Sunday.  On Monday, he developed a temp of 100 F.  On Tuesday, he had bloodwork done and his platelets were a 7.  The doctor's office rechecked his bloodwork on 11/9/21 and his platelets were 108.  Patient is/was a bladder cancer / chemo patient.
4-4-21 Awoke in morning and had no balance.  I could stand but could NOT walk.    4-6-21 After this condition did not improve in 48 hrs, I contacted my Primary Care Physician (PCP).  They had no available appointments & advised that I go to our local Urgent Care. The doctor at the Urgent Care noted I had high blood pressure and also noted that he didn't believe the balance issue was associated with the inner ear.  He advised me to monitor my condition, take a 2nd blood pressure pill as well as an antihistamine and follow up with my PCP or ER if condition worsened.  4-7-21 Condition had no improved.  Called PCP @ 0900 and left message for nurse to return our call.  By 1 pm, with no return call, decided to go to Hospital ER.  The ER physician initially suspected I had experienced a stroke.  They took blood, performed a neuro exam, EKG, a head CT scan, and MRI.  None of these tests showed signs of a stroke.  At that point, they ruled out a stroke and believed I had some unique form of Vertigo.  They prescribed Valium to help with my sense of Unbalance and recommended I follow up with Epely Manuevers Physical Therapy Department.  4-7-21 / 4-18-21 Continued to take Valium pills for 48 hrs.  Condition somewhat improved.  I could walk without assistance but still had serious unbalance.     4-19-21 Physical Therapy Consult.  Director evaluated my condition and stated that I had no inner ear issue.  Rather, a left-sided delay in motor skills.  Epely Maneuvers were not warranted.  Recommended follow up PT sessions & a Neurologist appointment.  4-20-21 Saw my PCP.  He agreed with everything suggested previously by Hospital physicians.  4-21, 4-27, 4-29, 5-3, & on-going  PT sessions.  Slow but continuous improvement of my condition.  5-3-21 Appointment with Neurologist. The doctor evaluated all previous tests & documents from previous  ER & PT visits.  She consulted with the doctor (head Neurologist) who also had been consulted during my earlier ER visit.  They believe at this point that my condition is likely an adverse reaction to my first Moderna covid-19 vaccination.   A follow up  with Neurologist is sheduled for 9-3-21.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 19-DEC-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II, lot # L049314, expiry date 03-DEC-2017 (dose, route and site of administration were not reported). Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effects reported. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0034214) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced TINNITUS (Ringing in ears). At the time of the report, TINNITUS (Ringing in ears) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received which included no new information as reporter  was unable to edit Adverse event reporting form sent in the follow up letter.
Information has been received from an 18 year old female patient with allergic to codeine and not medical history who on 20-JUL-2009 was vaccinated with her first dose of GARDASIL. There was no concomitant medication. After getting the vaccine, the patient experienced dizziness and nausea that went away after the first couple of days. However recently she started experiencing pain in her side and muscle twitching/spasms throughout her body. The patient also lost weight and was very stressed. The patient stated that she was very nervous to receive the vaccine in the first place and had been nervous about possible side effects since. Her physician did not think it was due to the vaccine but rather from stress and prescribed LEXAPRO (manufacturer unspecified) on 10-AUG-2009. The physician also prescribed magnesium oxide (manufacturer unknown). Blood work test had been performed and everything came back normal. At the time of reporting, the patient had not recovered. Additional information has been received from the patient's friend who reported the patient experienced nausea after receiving GARDASIL and a week later she felt better. After recovering from the nausea, she started experiencing muscle spasms, shaking, pain in her "sides". The patient herself came on the line and stated that she went to see her doctor on 11-AUG-2009. Urine test had been performed, and everything was normal. No further information is available.
Information has been received from a medical assistant concerning a 14 year old female with allergies (unspecified) and a penicillin allergy who on 09-JUL-2007 was vaccinated with a 0.5 ml first dose of Gardasil (657868/0523U).  Concomitant therapy included montelukast sodium MSD, LORATIDINE D and vitamins (unspecified).  On 09-JUL-2007 the patient passed out within 10 seconds of receiving Gardasil and there was jerking of the body noted.  The patient awoke and mentioned that she had a "weird dream" when she passed out.  Again the patient passed out and jerking was noted for 5-10 seconds.  There were no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  On 09-JUL-2007 the patient recovered.  Additional information has been requested.
Red bumpy rash covering trunk, back, and pubic area.  Hot and itchy.
right after, shaking hands and unsteady feeling overall.  Next day, slight fever, broke next day in am.
101 fever; lymph node swelling in my arm; full body aches and chills; full body aches and chills; headache; This 27- year-old female patient contactable consumer (reported for herself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 16Feb2021 (at the age of 27-years-old) as a single dose for COVID-19 immunization. The facility where COVID-19 vaccine was administered was at a Workplace clinic. She has had no other vaccines on the same day or in the past 4 weeks. The patient is not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical Vaccine included first dose of BNT162B2. Medical history and concomitant medications not reported. On 16Feb2021, the patient experienced a 101 fever, lymph node swelling in my arm, full body aches and chills, headache. The patient did not receive treatment for the events. The clinical outcome of the events 101 fever, lymph node swelling in my arm, full body aches and chills, headache was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
My arm was very painful after my injection. That lasted several days. The pain felt somewhat like a band around half my arm. I still have some discomfort even to waking up with pain in my arm if I have been on my left side too long. Also a bulge formed on my left side near my armpit. It is not painful.
Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a 15 year old female patient who was vaccinated IM in the gluteus with a first dose of Gardasil in another practice. On 12-FEB-2007, she was vaccinated IM in the gluteus with a second dose of Gardasil, lot #653978/0955F. Concomitant therapy included Ortho-Tri-Cyclen Lo. Within minutes of the vaccination, the patient developed dizziness, blurred vision and severe headache. The patient visited the emergency room and was diagnosed with migraines. The patient recovered. Additional information has been requested.
I started experiencing a headache around 6 pm the evening of the 2nd shot (May 28). I took 2 Tylenol and felt much better. I started feeling achy and took 1 more Tylenol around 11:45 pm before going to bed. I woke up around 2 AM (May 29) with extreme shakes, fever of 100.4. I tried to drink some tea / water and I began having uncontrollable vomiting / diarrhea for about 3 hours. At that point I was lightheaded, and my arms and legs both became numb / tingling. My husband drove me to the ER and I was given 2 bags of IV fluids, nausea medication and pain meds. I am also on the tail end of my period and began having cramping. The doctors were very concerned about an elevated heart rate and believe I was possibly also having a panic attack
I started having pelvic area pressure and a little pain at the end of urinating. They diagnosed it as left lower quadrant abdominal pain, infective urethritis, cystitis, and urethritis. They believed that I had a bladder infection and they would know more when the culture sample comes back. They prescribed an antibiotic.
STARTED EXPERIENCING NUMBNESS, TINGLING AND ACHINESS IN THE LEFT ARM THE DAY AFTER SHE RECEIVED THE INJECTION, DAY 2 STARTED WITH SWELLING AT NECK ABOVE CLAVICLE, CONTINUES WITH NUMBNESS, TINGLING, SHOOTING PAIN AND DECREASED FUNCTION IN LEFT ARM, SWELLING IN NECK PROGRESSIVELY WORSE
Patient administered flu shot.  Kept under observation because of history of latex allergy.  After 10 minutes, concern of tightness in throat and was seen by doctor.
Wife was having a shortness of breath and feeling ill for three days prior going to the emergency room and was admitted for pnemonia for 3 days observation. She was doing fine and showed no signs of worsening. The next day around 12:00 pm a nurse administerd the PNEUMOVAX 23 VACCINE. Around 4:00 pm she begane to experience ringing of the ears, a bloody nose and was put on oxygen by nose apparatus and soreness of the arm. By the next morning her breathing was becoming more shallow and more difficult. By late evening in a consultation with d.o. heart and a lung specialist they were informed by us that she had received the inoculation. They said they didn't order it and that the hospital has a policy that they give the vaccination prior to leaving the hospital. With in a couple of hours they moved her to ICU for closer observation. Her condition continued to get worse. The very next day she was ordered transferred to another hospital by me. She was there for three weeks in a drug induced coma under severe condition. She was in the hospital for a total of 6 weeks. 5/6/08-records received for DOS 9/24-10/20/06. DC DX: Lupus pneumonitis. Hypoxic respiratory failure secondary to pneumonia. ARDS. Pneumonia. DM.  Trach placed. Developed acute renal insufficiency which resolved.  4/30/08-records received for DOS 9/20-9/24/06-DC DX: Viral pneumonia. Unspecificed organism pneumonia. Hypoxemia. Acute respiratory failure. Fluid overload disorder.  Fever and sweating. Non productive cough. Chest pain.  Transferred to another facility.
Patient was fully vaccinated. 8/07/21 sinus congestion. 8/09/21 tested positive. returned to work on 8/18-still tested positive.
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were provided.
resulted in her arm looking like cartoon character but she felt like this was related to the size of the needle instead of the vaccine itself; resulted in her arm looking like cartoon character but she felt like this was related to the size of the needle instead of the vaccine itself; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein) (Solution for injection in pre-filled syringe, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date, at single dose for Immunization. The patient's medical history and concomitant medications were not reported. Patient stated that she had a bad reaction to a pneumonia vaccine which resulted in her arm looking like cartoon character but she felt like this was related to the size of the needle instead of the vaccine itself. Outcome of the events was unknown.  Pfizer is a marketing authorization holder of Pneumococcal 13-Valent Conjugated Vaccine (Diphtheria CRM197 Protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Valent Conjugated Vaccine (Diphtheria CRM197 Protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial information received on 07-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2019SA066981 (same reporter). This case involves a 9 years old female patient who received a 0.25 mL dose of vaccine FLUZONE QUADRIVALENT (lot number, expiry date, dose in series and route was not reported) in the left arm on 05-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any concomitant vaccines. It was a case of actual medication error due to vaccine underdose. It was unknown whether the adverse event occurred or not after the injection. 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. List of documents held by sender: none.
It was reported post vaccine's pt developed a fever of 104F, also experienced joint swelling of the knees and ankles.
2 days p/vax pt devel a generalized case of chickenpox. then 20june pt presented w/uveitis. treated w/topical steroids
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: ear ache both sides
Client was ordered the Shingrix vaccine on 11/9/21 by APRN.  The instructions entered were to administer 2 doses, 12 weeks apart.  The first dose was administered 11/10/21.  Due to an unforeseen error with our eMAR system, the order came up to administer the dose again on 11/17/21 which was done.  Therefore, the client received 2-0.5ml doses of Shingrix vaccine within 7 days.  Client has reported no adverse effects.  Discussed with our contracted pharmacist who recommended the final dose be given 5-6 months from 11/17/21.  This is scheduled to be administered 4/20/22.
dry cough; congestion; breathing hard; lack of energy; mild fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough), NASAL CONGESTION (congestion), DYSPNOEA (breathing hard), ASTHENIA (lack of energy) and PYREXIA (mild fever) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070L21A, 002C21A and 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (dry cough), NASAL CONGESTION (congestion), DYSPNOEA (breathing hard), ASTHENIA (lack of energy) and PYREXIA (mild fever). At the time of the report, COUGH (dry cough), NASAL CONGESTION (congestion), DYSPNOEA (breathing hard), ASTHENIA (lack of energy) and PYREXIA (mild fever) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment medications were provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.