chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rotator cuff tendonitis; torn cartilage in shoulder; This is a spontaneous report from a contactable consumer (patient). This 33-year-old non-pregnant female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number ER8737) on 06Apr2021 at 09:30, at the age of 33 years, as the second single dose, for COVID-19 immunisation. Medical history included epilepsy. Known allergies: no. COVID prior vaccination: no. The patient received the first dose of BNT162B2 vaccine on 16Mar2021 at 09:00 AM, lot EN6208, in left arm, at the age of 33 years. Concomitant medication included lamotrigine. No other vaccine was administered in 4 weeks. The patient experienced rotator cuff tendonitis and torn cartilage in shoulder on 06Apr2021 at 10:00 AM. The events resulted in Doctor or other healthcare professional office/clinic visit and required treatment with steroid shot, physical therapy and Aleve for 2 weeks. The patient had not recovered. COVID was tested post vaccination with nasal swab: negative on 18Aug2021.   Follow-up attempts are completed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was patient's wife and declined to provide date of birth of the patient. The age at vaccination was not reported. The patient's wife reported that her husband experienced soreness after receiving the SHINGRIX. This case was linked with US2018GSK115151, US2018109093 and US2018109097, reported by the same reporter.
Developed a case of pink eye; This spontaneous case was reported by a nurse and describes the occurrence of CONJUNCTIVITIS (Developed a case of pink eye) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20a) for COVID-19 vaccination.     Concurrent medical conditions included Immunosuppression and Hidradenitis. Concomitant products included  for Hidradenitis.    On 29-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced CONJUNCTIVITIS (Developed a case of pink eye). At the time of the report, CONJUNCTIVITIS (Developed a case of pink eye) 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. This spontaneous case was reported by a nurse and describes the occurrence of CONJUNCTIVITIS (Developed a case of pink eye) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20a) for COVID-19 vaccination.     Concurrent medical conditions included Immunosuppression and Hidradenitis. Concomitant products included  for Hidradenitis.    On 29-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced CONJUNCTIVITIS (Developed a case of pink eye). At the time of the report, CONJUNCTIVITIS (Developed a case of pink eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Company comment: Very limited information regarding this event/s has been provided at this time.  Critical details such as the patient's medical history, clinical evaluation of the eye is lacking. Further information has been requested.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Critical details such as the patient's medical history, clinical evaluation of the eye is lacking. Further information has been requested.
Patient was immunized with Varivax at 13 months of age. At 5 years of age, she developed a case of chicken pox with > 200 pox noted. She is being treated with acyclovir topical cream and Bactroban cream.
Heart problem; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart problem) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Heart problem) (seriousness criterion hospitalization). At the time of the report, CARDIAC DISORDER (Heart problem) outcome was unknown.            No concomitant medication were reported. Treatment information was unknown.  Very limited information regarding this event  has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event  has been provided at this time.  Further information has been requested.
Severe brain fog  panic attacks  elevated BPM flu like systems  also inflamed right foot with shooting pains
Information has been received from a consumer concerning her 5 year old son who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was reported that the patient was diagnosed with autism after he was vaccinated. Unspecified medical attention was sought the patient's outcome was unknown. OMIC
Immunizations received on 04/02/2003. Developed red area at site of injection (right thigh) that has grown. Seen on 04/04/2003 with softball sized mild swelling, erythematous with some cleaning to right thigh.
Swollen anterior fontanelle; Febrile; Unresponsive to sounds, lights, social cues, lethargic
received the 1st dose of the vaccine on 02Apr2021 and after 2 days she was tested positive; This is a spontaneous report received from a contactable consumer (reporting on herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiry date was not reported), via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient ask if she can reschedule her 2nd dose appointment. She received the 1st dose of the vaccine on 02Apr2021 and after 2 days (on 04Apr2021) she was tested positive. Irish 2nd dose schedule was on 23Apr2021. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Injection site reaction. Medications received during ER visit. Diphenhydramine injectable and ketorolac injectable.
Headache  Body aches Fever  Chills Sick stomach Diarrhea  Fatigue Loss of appetite
cut her right index finger on PedVax vial which was broken at the neck of vial and broken at the bottom of vial.; cut her right index finger on PedVax vial which was broken at the neck of vial and broken at the bottom of vial.; cut her right index finger on PedVax vial which was broken at the neck of vial and broken at the bottom of vial.; This spontaneous report was received from an other health professional referring to a 30-year-old female patient who is also a healthcare worker. Her concurrent condition included immunisation. She did not have any pertinent medical history, concomitant medications and drug reactions/allergies.  On 04-APR-2019, it was reported that the patient cut her right index finger on haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) vial which was broken at the neck and bottom of the vial (skin laceration, accidental exposure to product, product container issue). The patient sought medical attention and was treated by physician. Her wound was cleaned and band aid was applied. No lab diagnostics/studies were performed. The outcome of skin laceration was reported to be recovered/resolved. Outcome of accidental exposure to product and product container issue was unknown. Causality of the events skin laceration and product container issue  were not reported. Product quality complaint (PQC) was involved.
ITP; Petechial rash around injection site and mouth; Petechial rash around injection site and mouth; Extreme headaches; Fatigue; A spontaneous report was received from a pharmacist concerning a patient of an unknown age and gender who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed immune thrombocytopenic purpura (ITP) (Immune thrombocytopenia), petechial rash around injection site and mouth (Petechiae), petechial rash around injection site and mouth (Vaccination site rash), extreme headaches (Headache) and fatigue (Fatigue).    The patient's medication history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the events, the patient received their planned dose (unknown dose number) of mRNA-1273 (Batch number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date the patient experienced ITP, petechial rash around injection site and mouth, extreme headaches and fatigue. On an unknown date, patient found to have platelet count of 2000.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of ITP, petechial rash around injection site and mouth, extreme headaches and fatigue was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested
Around 10pm on the day i received the vaccine i began to experience a headache. I was unable to sleep due to the pain and around 2am it became severe to the point of being unbearable. Standing would relieve the pressure enough so i attempted to remain standing as tolerable. I also had severe lower back pain that made it difficult to walk. These symptoms remained until apx 3pm the day following the vaccine (4/8/21).
Had symptoms of ulcerative colitis by 9/05. Diagnosed with ulcerative colitis in 1/06.
9/27/14 Administer vaccine about 5 pm. 9/30/14 Pt called - area is red -underarm/sore breast and fever 102. 10/1/14 Pt called - arm still tender - redness decreased. 10/3/14 Pt came to pharmacy - redness +- 3 x 4". 10/6/14 Pt called - redness and tenderness gone.
1.5 days post vax pt developed a low grade fever and felt tired. The next morning he had a temperature of 104 and chills. By Friday evening he had swollen glands, sore throat, painful to swallow.
Immediate stinging which did not diminish over 2 days.  My arm is swollen, red and has bruising above and below the injection site.  I have a headache and muscle aches.  Exhausted, took two naps yesterday, totaling 4 hours.  Slept 10 hours last night, Woke up today with the same headache; 48 hours ago.  I had zero reaction to the first dose.
6JUL97 noticed glands in neck are swollen maybe harder to swallow rt side worse than lt c/o joints in knees very sore-better now;whelps on hands itch, hands swollen & red;no fever;
Muscle contractions and SVT heart palpitations B/P up and down tightness in throat. Treatment with IV fluids and steroids and BENADRYL can't remember what else.
Patient did not suffer from an adverse event to our knowledge.  This is an administration error. Patient was too young for the moderna vaccine (18 and up) and this was not seen until after administration and the patient left. We tried to notify patient, but the phone number given to us is disconnected. Plan to notify patient when they arrive for their next dose.  Per CDC guidelines, we will offer the second dose of the vaccine to the patient and guardian at that time.
8.15.2021  congestion in her sinuses and a sore throat for 3 days.
patient called pharmacy at 10am 3/23/21 stated she is returning a missed call. spoke to all personnel in pharmacy and no one called.. she further went into discussing the reaction she received from the moderna covid shot she received on 3/8/21. imz was given on right arm but a severe itch, rash, and painful patches of blisters that are sensitive to the touch was developed on the left arm. she stated she developed asthma from the shot. i checked her questionnaire and asthma is listed as a chronic health condition. she stated she already notified her pcp, the pharmacy, and reported her reactions to the cdc. she received care from an urgent care on 3/11/21 and was prescribed zyrtec and hydrocortisone cream for her rash. spoke to patient in regards to her second dose. shes afraid of how she will react to it, but stated her pcp told her to proceed with it. stayed on the phone with patient for over an hour regarding matter
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with ZOSTAVAX at a medical office as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated at the same medical office for the onset of a severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
After receiving the vaccine. My daughter developed Tourettes and Tics.  Vocal noises and shaking of arms. She has never had anything happen to her after any injection.
Loss or developmental regression in expressive speech and increase in inability to regulate emotions by self soothing or accepting caregivers soothing comforts. Increased sensitivity and insensitive to environmental input. Lack of pain response and increase in sensitivity to soft touch and oral stimuli subsequentally diagnosed as Autism.
Rash and fever 7 days after MMR given 12/20/13. Fever 12/28 - 12/30. Rash 12/29 - current temp max 102.9. Cervical, occipital odeospaty.
Mouth and throat swelling treated with prednisone started 10/2/19 - gradual improvement Fatigue., Headache, lightheadedness -- resolving with time redness and swelling at injection site -- resolving with time
- lots of pain at injection sight, hard to move arm, especially the next day after shot - whole body fatigue - chills
the night of the 29th  got a head ache  was very chilled. when I went to be I was so cold ,had to put 2 extra blanks on me to try and stay warm. had the sakes like i was having a seizure. finally went to sleep. woke up 4 time had to go pee. In the morning on Sunday I got up and had some breakfast then went bad to bed, slept till 4pm. felt much better. Today Monday still feel shaky and have headache, not much pep.
Had TIA and recently diagnosed with A-Fib; Had TIA and recently diagnosed with A-Fib; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 (Lot number: FF2590) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "mild copd" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 28Mar2021, when the patient was 58 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6199), administration date: 03Mar2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), TRANSIENT ISCHAEMIC ATTACK (medically significant) all with onset Nov2021, outcome "not recovered" and all described as "Had TIA and recently diagnosed with A-Fib". The event "had tia and recently diagnosed with a-fib" and "had tia and recently diagnosed with a-fib" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: unknown results; computerised tomogram: unknown results; electrocardiogram: unknown results; magnetic resonance imaging: unknown results. Therapeutic measures were taken as a result of atrial fibrillation, transient ischaemic attack.  Follow-up attempts are completed. No further information is expected.
02/14/2007 @ 0934: Had an induration measuring 1.00 cm long, 1.25 cm wide, and erythema measuring 4 cm in width. This lasted approximately 30 minutes with no decrease or increase in size.
Adult patient received a primary series vaccine ( Lot 055A22A) that had an expiration date of 02/02/2023. Question: Does the patient need to be revaccinated?; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Adult patient received a primary series vaccine ( Lot 055A22A) that had an expiration date of 02/02/2023. Question: Does the patient need to be revaccinated?) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Adult patient received a primary series vaccine ( Lot 055A22A) that had an expiration date of 02/02/2023. Question: Does the patient need to be revaccinated?) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Adult patient received a primary series vaccine ( Lot 055A22A) that had an expiration date of 02/02/2023. Question: Does the patient need to be revaccinated?) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Adult patient received a primary series vaccine ( Lot 055A22A) that had an expiration date of 02/02/2023. Question: Does the patient need to be revaccinated?).    No concomitant medications were provided. No treatment information provided.
administered an expired dose of Menactra with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from consumer /non-health professional via Medical Information (Reference number- 00617311) and transmitted to Sanofi on 26-Apr-2021.  This case involves a 24-year old female patient who administered an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered) on 26-May-2021 (lot number: U6576AA and expiration date: 04-Apr-2021] at an 0.5 ml once (total) dose via intramuscular route in the left deltoid for prophylactic vaccination.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination was not reported.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  It was not reported if the patient received a corrective treatment.  Disclaimer: 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.
Patient complains of major "itchiness" as well as severe body pain 4 hours after receiving the vaccination on 11/29. On 12/4, Patient called the pharmacy and complained of those symptoms. Advised patient to take BENADRYL to help with body itchiness as well as TYLENOL to help patient with the pain. Advised patient to contact their PCP if symptoms don't improve.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 27-APR-2016, the patient was inadvertently administered a dose of expired ZOSTAVAX (lot number# L002424, expiration date 23-APR-2016, dose and route not provided) (expired drug administered). Concomitant therapies were not provided. No adverse effects were reported. There was no product quality (PQC) involved. Additional information has been requested.
Pt recv vax on 11/16/98; on 11/18/98 pt exp red emesis; 11/19/98 pt exp dark stool w/ black specks
Can the new Shingles vaccine cause diarrhea? I got the 2nd dose of the new Shingles vaccine last night and this morning I have diarrhea. I know stomach issues are one of the side effects but does that include diarrhea too?  Thank you....
PATIENT COMPLAINED OF BEING TIRED, HAVING ENTIRE BODY ACHE, AND CHILLS AFTER GETTING SHOT ON 3/24/10. SHE HAD TAKEN IBUPROFEN AND FELT TEMPORORAY RELIEF. SHE CONTINUES TO EXPERIENCE SYMPTOMS WHEN SHE CALLED PHARMACY ON 3/25/19. HER DR WAS CONTACTED AND WILL CALL PATIENT TO FOLLOW UP AND POSSIBLY SCHEDULE CHECK UP.