chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer Dose 1 1/20/21 (EL0140) Pfizer Dose 2 2/10/21 (EL9261) Pfizer Dose 3 12/3/21 (FG3527) COVID Positive 1/20/22  1/22/22: 85-year-old female patient with a history of hypertension, CAD, hypothyroidism, Parkinson's disease, dementia, COPD, chronic constipation, adult failure to thrive lives at a local nursing home.  Patient was sent to the emergency room via paramedics as the patient was found to be not very responsive to the staff at the nursing home. The patient normally is able to perform a few of her activities of daily living and be herself in the wheelchair around the nursing home.  The patient also verbalizes her needs at the nursing home.  The patient was diagnosed with SARS-CoV-2 infection on 1/20/2022.  Since then, patient has been weak, fatigued with no oral intake and reaching state of not being very responsive.  When the paramedics reach the nursing home, the patient's pulse ox was at 78%. Patient was placed on non-rebreather mask with 15 L of oxygen and brought to the hospital.  Upon evaluation, patient is noted to have a urinary tract infection and was given IV antibiotics.  She is also noted to have elevated CK levels with acute renal failure, hypernatremia and hyperchloremia.  Patient's son does not wish for any aggressive treatment but reported treatment with IV fluids, antibiotics.  Patient is a DNR/DNI.  If the patient is not responsive in the next 48-72 hours, the son would like to proceed with hospice care for the emergency room provider.  1/24/22: 85-year-old female patient with a history of CAD, hypothyroidism, hypertension, COPD, dementia, Parkinson's disease, chronic constipation and failure to thrive was admitted on 1/22/2022 for altered mental status.  The patient was recent diagnosed with SARS-CoV-2 infection as of 1/20/2022.  The patient was noted to have fever on admission.  She was also diagnosed with E coli tract infection and requiring significant amount of oxygen at 15 L via OxyMask.  I discussed patient's case with the son on admission who wanted to wait for for clinical to 48 hours to see how the patient responded to treatment.  The but there was no significant improvement in the patient's clinical condition and he decided to proceed with comfort care.  The patient was made comfort care as of 1/23 and transferred to the nursing home this care.  The son did not want to proceed with any further aggressive treatment and with the patient to be comfortable.  The case manager also has spoken with the son prior to discharge.
Pain inside the lower-left rib cage After injection #2, pain expanded to upper left chest and lower-right rib area upon exhale. Extremely painful when sneezing Worsens with a cough or breathing deeply. Feeling fatigued and sleepy
2 days post vaccination the patient was experiencing arm pain and chest tightness. He has a history of heart failure and 2 bipass heart surgeries. He grew concerned so went to the ER. They cleared him of any cardiac issues. He continued to feel uncomfortable in his chest and arm for approximately 2 days. He is unsure what caused this
No additional adverse events reported.; Rotateq Improperly Stored, administered; This spontaneous report was received from a medical assistant who refers to a patient of unknown age or gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 18-MAY-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S040076, expiry date 15-JUN-2021, 2 milliliter orally, for prophylaxis (formulation, concentration, dose number, frequency were not reported).  Digital data logger was not involved. The vaccine underwent the temperature excursion above 47 degrees of Fahrenheit (F) (46.9 F) for 84 hours 30 minutes. It was not provided if there was a previous temperature excursion. No additional adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of the reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA001381:
7 seizures in two days. 12/3/09 Medical records and discharge summary received for DOS 9/8-9/11. Final DX:  Seizure like episodes  C/O 4 episodes eye rolling, back arching, arms stiff.  3 episodes unresponsive.  Immunizations 6 days prior.  Subjective fever. No definite post ictal state
Flu-like symptoms-- chills and aches.  lasted about 12 hours.  Started almost 24 hours exactly after I received the vaccine.
1 week after injection I developed well demarcated, red, hot, painful induration at the injection that traveled slightly down the arm
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, when the patient was 1 month of age received RECOMBIVAX HB (lot#, expiration date, dose unknown). The patient received second dose of RECOMBIVAX HB (lot#, expiration date, dose unknown) when was three months of age and third dose of RECOMBIVAX HB (lot#, expiration date, dose unknown) when was four months of age (on unspecified dates). No adverse effect was reported. Additional information has been requested.
TOOK THREE UNREFRIGERATED DOSES; This spontaneous case (PVX2019-1520) was received from a pharmacist on 12-Jun-2019. It describes a female consumer who "took three unrefrigerated doses", while being on Vivotif for an unknown indication.  Case report: The consumer took three doses of Vivotif which were kept at room temperature since 07-May-2019. She took the first dose on 07-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took three unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event  "took three unrefrigerated doses" was considered as not applicable.
Cramping and stomach pain; Still not herself and energy level is low; Just doesn't feel good, still not herself; IBS that flared up; Arthritis flared up in her knee; Fatigued; Headache; Fever; Nausea; muscle pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Cramping and stomach pain), ASTHENIA (Still not herself and energy level is low), FEELING ABNORMAL (Just doesn't feel good, still not herself), IRRITABLE BOWEL SYNDROME (IBS that flared up) and ARTHRITIS (Arthritis flared up in her knee) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attack on 25-Sep-1989. Concurrent medical conditions included Thyroid disorder NOS since 25-Sep-2010, Irritable bowel syndrome and Arthritis.   On 23-Mar-2021 at 5:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021 at 5:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced CHILLS (Chills). On 21-Apr-2021 at 2:00 AM, the patient experienced MYALGIA (muscle pain). On 21-Apr-2021 at 8:00 PM, the patient experienced ABDOMINAL PAIN UPPER (Cramping and stomach pain), ASTHENIA (Still not herself and energy level is low), FEELING ABNORMAL (Just doesn't feel good, still not herself), IRRITABLE BOWEL SYNDROME (IBS that flared up), ARTHRITIS (Arthritis flared up in her knee), FATIGUE (Fatigued), HEADACHE (Headache), PYREXIA (Fever) and NAUSEA (Nausea). At the time of the report, ABDOMINAL PAIN UPPER (Cramping and stomach pain), ASTHENIA (Still not herself and energy level is low), FEELING ABNORMAL (Just doesn't feel good, still not herself), IRRITABLE BOWEL SYNDROME (IBS that flared up), ARTHRITIS (Arthritis flared up in her knee), FATIGUE (Fatigued), HEADACHE (Headache), MYALGIA (muscle pain), PYREXIA (Fever) and NAUSEA (Nausea) had not resolved and CHILLS (Chills) outcome was unknown. Not Provided          No Treatment medications were provided.  No  Concomitant medications were provided.   This case was linked to MOD-2021-098146 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: patient demographic details, historical diseases, start date of event  and new events were updated. On 16-Jul-2021: follow-up received on 16-JUL-2021 and contains Non-significant information. On 12-Aug-2021: Follow up included no new Information
I had a healthy pregnancy before my Pfizer shot. After my Pfizer shot, I had a spontaneous miscarriage. The only different thing was this shot.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Error: Known Immunization Allergy Contraindication-
a red patch around my arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (a red patch around my arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (a red patch around my arm). At the time of the report, ERYTHEMA (a red patch around my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not reported. No Treatment information was provided. Patient reports that "this could also be a burn from hot water"   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: CROSSLINK CASE MOD21-018137
This case was reported by a consumer and described the occurrence of pertussis in a 2 month old male patient who received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined. The reporter is the mother of the patient. A physician or other healthcare professional has not verified this report. The patient's past medical history included prematurity. On an unspecified date in 2004, the patient received the first dose of Pediarix. On the same date, the patient received other vaccines, but the consumer was unsure of the names. At an unspecified time following the first dose of Pediarix, at two months of age, on an unspecified date in August 2004, the patient was coughing up blood and phlegm and was seen at a physician's office. The patient was diagnosed with pertussis and was hospitalized. The consumer reported that the patient received the second dose of Pediarix while in the hospital. The events had improved as of the time of initial reporting.
Pain, swelling and redness at injection site; Pain, swelling and redness at injection site.; Pain, swelling and redness at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 31Jul2021 at 10:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Aug2021 at 20:00, the patient experienced pain, swelling and redness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, 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 events pain, swelling and redness at injection site was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Approximately 2 weeks after receiving vaccine, pt c/o numbness and tingling from waist down. Went on vacation, after visiting E.d. Pt admitted x 5 days with work up - dx with Transverse myelitis.  11/16/16 DC Summary and Hospital records received service dates 10/30/09 to 11/3/09. Assessment: Thoracic and cervical myelitis, bilateral lower extremity weakness, rule out Gullain-Barre' syndrome. Patient presents with 2-3 week history of diffuse skin sensitivity, numbness beginning in feet and progressing up the leg to below the knees. Saddle sensory changes, difficulty stopping bowel movements and urination. Difficulty swallowing. Bilateral lower extremity weakness, loss of sensation forefoot, leg and in a saddle distribution. Overweight. Edema feet. Heel-to-shin ataxia, gait wide based and unsteady.  Gait ataxia, numbness, diagnosis of transverse myelitis (MRI (+))
Headache, Myalgia, Arthralgia, Fever, chills and shaking Narrative: missed one day of work due to s/s which onset day after injection
Pt turned pale and started with purple spots on head.  Pt was given .15 ml of epinephrine and observation. Within 10 min pt's color returned and spots started to disappear.
atrial fibrillation; BOTH WERE PAINFUL; diarrhea; nausea; This case was reported by a consumer via other manufacturer and described the occurrence of atrial fibrillation in a elderly male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Co-suspect products included ELASOMERAN (COVID-19 MRNA VACCINE MODERNA) for prophylaxis, COVID-19 MRNA VACCINE PFIZER for prophylaxis and ibrutinib (Imbruvica) for chronic lymphoid leukemia.   On an unknown date, the patient received Hz/su + AS01B, COVID-19 MRNA VACCINE MODERNA (intramuscular), COVID-19 MRNA VACCINE PFIZER (intramuscular) and Imbruvica (oral) at an unknown dose and frequency. On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced atrial fibrillation (serious criteria GSK medically significant), injection site pain, diarrhea and nausea. The action taken with Imbruvica was unknown. On an unknown date, the outcome of the atrial fibrillation, diarrhea and nausea were unknown and the outcome of the injection site pain was recovered/resolved.   The reporter considered the atrial fibrillation, injection site pain, diarrhea and nausea to be possibly related to Hz/su + AS01B.   Additional Information: GSK Receipt Date: 29-JUL-2022 Reporter's Comments: This was a solicited report by a consumer of an elderly male. The patient had moderna covid-19 vaccination and the shingles shot, one in each arm. The patient's both arms were painful, atrial fibrillation, diarrhea and nausea with imbruvica (ibrutinib).  There was no reported medical history. Concomitant drugs were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter did not have the lot number information, because the packaging was discarded.  On an unknown date, unknown after receiving COVID-19 MRNA VACCINE MODERNA and COVID-19 MRNA VACCINE PFIZER, the patient experienced atrial fibrillation, vaccination site pain, diarrhea and nausea. The reporter considered the atrial fibrillation, vaccination site pain, diarrhea and nausea to be possibly related to COVID-19 MRNA VACCINE MODERNA and COVID-19 MRNA VACCINE PFIZER. Causality for IMBRUVICA (IBRUTINIB) was not reported with respect to atrial fibrillation, vaccination site pain, diarrhea and nausea. Follow-up would not be possible as no contact details available.
Shingles from right mid back across right stomach  Evaluated by MD, treated with Valtrex 1 GM 3xs a day x 7 days, topical lidocaine and neosporin, Ibuprofen and Medrol dose pack. Shingles with blisters on back resolving, painful to touch continues.
Information was received from a nurse practitioner concerning a female patient. On 14-OCT-2013 the patient was vaccinated with her third dose of GARDASIL, intramuscular. The nurse reported that the patient had received her first two doses on a unspecified dates two years ago. No additional information available. No adverse effect was reported. Additional information is not expected.
This case was reported by a consumer via call center representative and described the occurrence of narcolepsy in a 60-year-old female patient who received Rabies NVS (Rabies Vaccine) for prophylaxis.  Concomitant products included Tetanus NVS (Tetanus vaccine). In June 2013, the patient received Rabies Vaccine. In June 2013, less than a month after receiving Rabies Vaccine, the patient experienced narcolepsy (serious criteria GSK medically significant) and fibromyalgia. On an unknown date, the outcome of the narcolepsy and fibromyalgia were not recovered/not resolved. It was unknown if the reporter considered the narcolepsy and fibromyalgia to be related to Rabies Vaccine. Additional details were provided as follows: Concomitant products included as immunoglobulin. The Rabies Vaccine (unknown manufacturer) was used for post-exposure prophylaxis. The patient planned to continue follow-up with her physician on an unknown date.
This vial was kept at room temperature for more than 2 hours.  At the time, I did not realize this vial is only good for 2 hours at room temperature.  I contacted the manufacturer and they did not have any stability data for me and said to use clinical discretion.  The vial was opened around 11AM and the patient was vaccinated around 330PM.  The patient was not contacted yet and I am awaiting further instruction on this as per a conversation with my immunization specialist.
While receiving vaccine some came out of shoulder; Vaccinator re administered the amount they thought came out; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (While receiving vaccine some came out of shoulder) and EXTRA DOSE ADMINISTERED (Vaccinator re administered the amount they thought came out) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a21b) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced ACCIDENTAL UNDERDOSE (While receiving vaccine some came out of shoulder) and EXTRA DOSE ADMINISTERED (Vaccinator re administered the amount they thought came out). On 24-Mar-2021, ACCIDENTAL UNDERDOSE (While receiving vaccine some came out of shoulder) and EXTRA DOSE ADMINISTERED (Vaccinator re administered the amount they thought came out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Triggered Alopecia Areata. No previous history of autoimmune.; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not reported), via an unspecified route of administration, administered in left arm on 29May2021 at 10:00 (at the age of 31 years old) as a single dose for COVID-19 immunisation. COVID-19 vaccine was administered in Pharmacy or Drug Store. Lot number was not known due to Unable to locate or read the details. Medical history and concomitant medications were not reported. No previous history of autoimmune. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: not reported) in left arm on 01May2021 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination. The patient was not COVID tested post vaccination. On an unspecified date in 2021, the patient experienced Triggered Alopecia Areata. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with Vestibular Steroid topical for the event. The reporter stating the events as non serious. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
joint pains; Constant headaches; tired; low energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 at 13:00 as dose 2, single (Lot number: ER8731) at the age of 48 years, in left arm for covid-19 immunisation at Pharmacy or Drug Store. The patient's relevant medical history included: "cilantro" (unspecified if ongoing), notes: known allergies: Cilantro. The patient's concomitant medications were not reported. Past drug history included: Ddoxycycline, reaction(s): "known allergies doxycycline", notes: known allergies: Doxycycline. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left at 01:00 PM), administration date: 17Mar2021, when the patient was 47-year-old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 15Apr2021 at 07:00, outcome "recovering", described as "Constant headaches"; ARTHRALGIA (non-serious) with onset 15Apr2021 at 07:00, outcome "recovering", described as "joint pains"; ASTHENIA (non-serious) with onset 15Apr2021 at 07:00, outcome "recovering", described as "low energy"; FATIGUE (non-serious) with onset 15Apr2021 at 07:00, outcome "recovering", described as "tired". The events "joint pains", "constant headaches", "tired" and "low energy" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of arthralgia, headache, fatigue, asthenia.  Additional information: If other vaccine in four weeks: No. If Covid prior vaccination: No. If Covid tested post vaccination: Yes.  No follow-up attempts are possible. No further information is expected.
tender; itchy; red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash), PRURITUS (itchy) and TENDERNESS (tender) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 immunisation.     Concomitant products included LEVOTHYROXINE and IBUPROFEN for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced RASH ERYTHEMATOUS (red rash). On 09-Feb-2021, the patient experienced PRURITUS (itchy). On 10-Feb-2021, the patient experienced TENDERNESS (tender). At the time of the report, RASH ERYTHEMATOUS (red rash), PRURITUS (itchy) and TENDERNESS (tender) 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 details included None.
I have had a metalic tatse in my mouth ever since the booster shot i got in june. and its constant. has not gone away at all.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for vitamin d deficiency, CAD, asthma, hyperlipidemia mixed, Atrial fibrillation, ckd stage 3, HTN. T2DM, gout, CHF, renal stenosis, cardiac pacemaker, advanced age (90 Years of age). Pt arrived at ED on 4/28/21 with a CC of leg swelling, redness, drainage and pain. Pt has worsening edema over the previous few months. In ED received vancomycin. Was transferred to another facility for vascular eval. on 5/8 readmited for generalized weakness and pain. Patient and family wished to be kept comfortable. Deceased 5/11