chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right occipital nerve inflammation; Unilateral radiating pain from base of neck to tip of ear for 3 days; This is a spontaneous report received from a contactable other healthcare professional (patient). A 40-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Batch/Lot Number: EN6199) as dose 1, single for covid-19 immunisation. Medical history included seasonal allergies and sciatica like pain last experienced during pregnancy over 5 years ago. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included ibuprofen (ADVIL) and multivitamin [vitamins nos] (MULTIVITAMIN) both taken for an unspecified indication, start and stop date were not reported. On 17Mar2021, approximately 7 days after first dose, the patient experienced right occipital nerve inflammation and unilateral radiating pain from base of neck to tip of ear for 3 days. The patient received ibuprofen and gabapentin as treatment for the event however non-responsive to pain medications and resolved on its own. The event required physician office visit. The outcome of the events was recovered on unspecified date in 2021.  Follow-up (27Jul2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Shot (Flu) admin. LA on 10/17/11. Client state injection was not painful at all - started having pain shoot down left arm. This A.M. 10-19-11 got up, could hardly move arm, is feverish at injection site.
Skin itchy and has a rash and she was diagnosed with Dermatographism; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Skin itchy and has a rash and she was diagnosed with Dermatographism) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00SM21A, 019A21A and 038A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 25-Jan-2022. Previously administered products included for Product used for unknown indication: Flu shot (given within 1 month prior to Moderna COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Flu shot.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MECHANICAL URTICARIA (Skin itchy and has a rash and she was diagnosed with Dermatographism). At the time of the report, MECHANICAL URTICARIA (Skin itchy and has a rash and she was diagnosed with Dermatographism) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         The symptoms started after the patient received the second booster. The symptoms reported are rash and skin itchiness. On the day of reporting she was diagnosed with dermatographism and her doctor said that the second booster might be the cause.  The patient had no allergies.   The patient was not on concomitant or regular medication. She was waiting for her prescription.   This case was linked to MOD-2022-557013 (Patient Link).
This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Nov2021 at 09:45 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included calcium (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D), ascorbic acid (VITAMIN C) and biotin (MANUFACTURER UNKNOWN); all for unspecified indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 09:30 (at the age of 45-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Apr2021 at 10:00 (at the age of 45-years-old); both as single dose for COVID-19 immunisation. On 23Nov2021 at 17:00, the patient experienced swelling and soreness of lymph node in left arm pit toward the front of body. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling and soreness of lymph node in left arm pit toward the front of body was not resolved at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.
No adverse medical reaction.  The patient is 17 years old, too young for the Moderna vaccine We have contacted the health department and moderna
Presented to ED on 3/20/21 with shortness of breath and was admitted for treatment for COVID-19 infection and COPD exacerbation.
Patient was given PROQUAD vaccine instead of MMR. At this time no side effects have occurred.
PT REPORTS THE FOLLOWING MORNING SHE FELT MILD BODY ACHES AND FATIGUE, PT REPORTS BY THE EARLY AFTERNOON SHE HAD FEVER, WORSENING BODY ACHES, FATIGUE, HEADACHE. PT REPORTS SHE COULD BARELY FUNCTION YESTERDAY AFTERNOON AND EVENING SHE FELT SO POORLY.
Redness at the injection site; Throat felt thick; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Throat felt thick) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced PHARYNGEAL SWELLING (Throat felt thick). On 17-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site). On 18-Jan-2021, PHARYNGEAL SWELLING (Throat felt thick) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No new information received.
a 7 year old femal patient was given a 0.5ml dose of Quadracel vaccine on 31-Jul-19; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a seven years old female patient was given a 0.5ml dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL]vaccine on 31-Jul-19 lot C5500CA, expiry date: 16-Aug-2020 via unknown route in the left deltoid 31 July 2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   The patient was also given Progard vaccine.  It was an actual medication error due to inappropriate age at vaccine administration.  Adverse event was not 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.  List of documents held by sender: none.
Pt. reported sever abdominal cramping and diarrhea in the evening of 06/17/23.  Pt. also reported she had vomiting, low grade fever and  approximately a 2 inch oval of redness around the injection site.  Pt. had called an after hours triage. Pt. did not seek medical attention other than triage call.  Today 06/19/23, pt. reports diarrhea, vomiting , fever, and abdominal pain are absent.
(translated from Spanish by FV) mom reported that @6PM 07OCT94 began an eruption, spread from chest to arms, legs & whole body; T 39.8; cried 5PM to 11PM; to sleep @11PM; woke & slept during night; to ER; Rx: DPH & Solu-Cortef;
Patient was placed in my home as a foster child in July 2007 (I'm also his maternal aunt).  I was told by the social worker that patient's mother had neglected his medical care, and we had 90 days to bring him up to date on his vaccines.  I took patient to the local Health Department sometime around the beginning of the school year, but I'm unsure of date/time of vaccines.  He was given the first dose of EVERY vaccine he had missed as a baby (it was 6 or 7 shots all at once!).  I was concerned about his safety receiving so many at once, but the nurses assured me it was ok, so I allowed it.  It was almost exactly 24 hours later when patient spiked a high fever of 105.9 and went into a "frozen" like state; he was totally unresponsive, and just staring blankly into space. Nothing I did would get the fever down, so I took him to the ER where I was told he was having a seizure from the high fever.  He was given IV fluids, given a urinary catheter, and other treatments to lower his fever and stop the seizure. We were allowed to take him home within 12 hours. I told the doctors that he had received vaccines the day before, and thought for sure this was a reaction, but all the medical professionals denied the link to the shots. (I never realized I personally could report a reaction, which is why I am now reporting this event years later.) Patient continued to have seizures after this event...he would have brief "stop and stare" seizures almost everyday, and began having behavioral and learning issues--his personality changed.  I took him to see countless specialists (pediatricians, several neurologists, and several brain scans and other tests were done)--and we received in home counseling services for him.  His behavior became so bad that he was put on Risperdone, an anti-psychotic medication.  He got kicked out of daycare, had constant issues in pre-school, and became nearly impossible to handle at home.  This poor child was suffering and no one could tell me why, or how to fix it.  Patient is now almost 7 years old, and still has symptoms...I suspect he will have life long issues.
Nausea, vomiting, rash on site arm, rash, fever, hallucinating, loss of appetite, fatigue, migraines, body aches, chills, dehydrated, and joint pain.
started with headache and sore throat, then high fever (103) a few hours after first symptoms. body aches, chills and vomiting.
Pain at the injection site and arm; Pain at the injection site and arm; body chills and aches; body chills and aches; Mild headache; Mild nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 26 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Graves' Disease" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE, on 21Sep2023 as dose number unknown, single; ALTAVERA; ESCITALOPRAM; BUSPIRONE. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin; Ibuprofen, reaction(s): "known allergies: Ibuprofen", notes: known allergies: Ibuprofen; Lamb, reaction(s): "known allergies: lamb", notes: known allergies: lamb. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, Manufacturer unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 18Oct2023 at 18:00, outcome "recovering", described as "Mild headache"; NAUSEA (non-serious) with onset 18Oct2023 at 18:00, outcome "recovering", described as "Mild nausea"; VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 18Oct2023 at 18:00, outcome "recovering" and all described as "Pain at the injection site and arm"; CHILLS (non-serious), PAIN (non-serious) all with onset 18Oct2023 at 18:00, outcome "recovering" and all described as "body chills and aches". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, chills, pain, headache, nausea. Additional information: Patient did not have COVID prior vaccination and was not COVID tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt describes pain in left shoulder that kept her up the night after the vaccination. Has limited range of motion in left arm. On follow up as of 02/28/19 pt pain is markedly decreased, and range of motion is improving but not back at 100% Pt is concerned of bursitis in the left shoulder as a result of vaccine administration. The immunization site was inspected as she still had the bandage on from the administration. The site appears to be at the upper limit of the normal immunization site.
dizziness; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 13Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "autoimmune disease" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DIZZINESS (non-serious) with onset 13Mar2021, outcome "unknown", described as "dizziness"; PAIN IN EXTREMITY (non-serious) with onset 13Mar2021, outcome "recovered" (14Mar2021), described as "sore arm".  Additional information: Since the vaccination, the patient had developed dizziness. It has gone to the point where she could not use computer because of her dizziness. The patient could only work if she had sunglasses in front of her computer monitor. The patient thought it was vertigo since she had experienced it before, but her HCPs had tested her for it and told her she had no vertigo. The patient also mentioned that she had a sore arm on the day of her vaccination until the next day. The patient wanted to know if her adverse events were common and should she be concerned about it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Breakthrough case admission after three vaccines Moderna 3/3/21 Lot# 010A21A;  Moderna 3/31/21 Lot# 025B21A  Moderna 11/6/21 Lot# 058F21A
Large, hard, red, and hot to the touch at injection site. 3 inches in diameter.
headache that night, slight nausea the next day, fatigue for about 48 hrs after injection
Red rash over chest and torso (not hives, not a pinprick rash); Splotchy rash; Rash has a tender sensation similar to a sunburn.; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 13Apr2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) from an unknown date for an unspecified indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 over 24 hours after receiving the second dose, the patient developed a red rash over chest and torso (not hives, not a pinprick rash). The rash was not raised and was a splotchy rash. The rash was not painful or itchy but had a tender sensation similar to a sunburn. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of events red rash over chest and torso (not hives, not a pinprick rash), splotchy rash and rash had a tender sensation similar to a sunburn was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pain increased over the next few days instead of diminishing and lasted for weeks.  It started to restrict the movement of the arm.  Today 11/9/2022 I saw Dr. via telemedicine and described what was happening.  He said that it was akin to frozen shoulder and would prescribe steroids.  if that did not work I would have to see an orthopedist for an injection in the joint and pt.  I can not raise my left arm in from of me or to the side and my upper arm is tender to touch.  I've had flue shots for 46 years and never a problem.  He said the shot may have been placed too high.  You will have to call the office to get the correct lot number and manufacture.  It was a Quadrivalent,.5 influenza injectable
Within 6 hours of vaccine developed headache, 8 hours of vaccine had myalgia. And by 12 hours severe pain throughout body, chills, stiffness, dizziness, nausea, headache for 48 hours.
Member states severe red bumps appearing on chest.  Also pain in the arm that received vaccination.  Member was evaluated by Dr on 09/226/2011 and determined to have mild generalized vaccinia.  No treatment was given at this time.
Low oxygen level/low oxygen saturation level; This spontaneous case was reported by a consumer and describes the occurrence of OXYGEN SATURATION DECREASED (Low oxygen level/low oxygen saturation level) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Interstitial lung disease.    On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OXYGEN SATURATION DECREASED (Low oxygen level/low oxygen saturation level) (seriousness criterion medically significant). At the time of the report, OXYGEN SATURATION DECREASED (Low oxygen level/low oxygen saturation level) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: low (Low) Low.         The patient had experienced the event after the booster dose. No relevant concomitant medications were reported. No treatment information was reported.  Company comment: This case concerns a patient of an unknown age, unknown gender with a relevant medical history of rheumatoid arthritis and interstitial lung disease, who experienced the unexpected serious event of oxygen concentration decreased. The latency for the event is unknown (date of onset of the event was not reported) after receiving the third dose of mRNA-1273 vaccine. The rechallenge is not applicable. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine in not affected by this report. Further information has been requested.; Sender's Comments: This case concerns a patient of an unknown age, unknown gender with a relevant medical history of rheumatoid arthritis and interstitial lung disease, who experienced the unexpected serious event of oxygen concentration decreased. The latency for the event is unknown (date of onset of the event was not reported) after receiving the third dose of mRNA-1273 vaccine. The rechallenge is not applicable. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine in not affected by this report. Further information has been requested.
Pt received her first dose of Pfizer vaccine and at 1148 started to c/o tongue and throat "beginning to swell". Pt states hx of the same with penicillan. Pt is with mother. Pt was given 25mg Benedryl PO at 1200. EMTs called to evaluate Pt and released by medics home with mom.    VS per medics at 1215 BP 114/68 HR 70 RR 16 O2 sat 98% RA
1st vaccine 6/23/2022 and 2nd dose 2 weeks later; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO).   On 11th July 2022, the patient received the 2nd dose of Bexsero .5 ml and Bexsero Pre-Filled Syringe Device. On 11th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 11-July-2022. Reporter's Comments: The patient's mother stated that patient got his first Bexsero vaccine on 23rd June 2022 and second dose 2 weeks later versus the one month as stated in the prescribing information. No side effects were reported.  The reporter consented to follow-up. Additional Supportive Information: The patient received Bexsero vaccine before the recommended one month interval, which led to drug dose administration interval too short.