chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unable to receive scheduled second dose of the vaccine (23Jun2021); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (unable to receive scheduled second dose of the vaccine (23Jun2021)) 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 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (unable to receive scheduled second dose of the vaccine (23Jun2021)). On 23-Jun-2021, PRODUCT DOSE OMISSION ISSUE (unable to receive scheduled second dose of the vaccine (23Jun2021)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Patient was not able to get her scheduled second dose of vaccination due to lack of transport and family problems. No treatment medication was reported.
Hours after vaccine given, right arm became painful, erythematous and edematous. Symptoms worsened overnight prompting patient to come to the Clinic for evaluation.
01/18/22 presents to ED for "cramping in both hands". PMHx of "cirrhosis of liver with recurrent ascites who undergoes weekly paracentesis"
The patient had a nose bleed; The patient experienced pain in her left axilla area; The patient experienced swelling in her left axilla; drug use for unapproved indication; The patient developed red streaks on her left arm; The patient developed red streaks on her left arm and into her chest area; This spontaneous report was received from a nurse practitioner concerning a 64-year-old female patient. The patient's pertinent medical history included auto-immune connective tissue disorder. The patient's drug reactions or allergies included sulfa, omeprazole (PRILOSEC) and esomeprazole magnesium (NEXIUM). No information was provided regarding the patient's concomitant medications.  On 22-JAN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection on the left arm, 1 dose, administrated via intramuscular, lot No. S029916 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent), expiration date reported as 20-DEC-2021, but upon internal validation established as 12-JUN-2021 for auto-immune disorder & over 60 years old (product use in unapproved indication). Following the injection, the patient developed red streaks on her left arm and into her chest area (vaccination site streaking and rash macular).  On 09-FEB-2020, the patient had a nosebleed (epistaxis).  On an unspecified date in February 2020, the patient experienced pain and swelling in her left axilla area (axillary pain and peripheral swelling) that had not resolved when the patient came back to see her healthcare professional on 20-FEB-2020. The healthcare professional directed the patient to get an ultrasound to check on the pain in her axilla. It was unknown by reporter if the patient had gotten the ultrasound to date.  The outcome of vaccination site streaking, rash macular, epistaxis, axillary pain and peripheral swelling and the causal relationship between all the aforementioned events and therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) were not reported.
Patient was given 2nd dose of Pfizer COVID-19 vaccine series on Day 14 which was earlier than the recommended minimum interval between the two dose series. Patient reports no major adverse effects
Myalgia, Fever, CoughWheeze, NauseaVomiting, chills Narrative:
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 27-NOV-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 144, and 120 hours, with the lowest recorded temperature of 33, and 34 degrees Fahrenheit (0.55, and 1.11 degrees Celsius) respectively. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
the Covid 19 Vaccine killed her Aunt; This is a spontaneous report received from a non-contactable reporter (Consumer-patient's niece) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "the Covid 19 Vaccine killed her Aunt". The patient date of death was unknown. The reported cause of death was "the Covid 19 Vaccine killed her Aunt". It was unknown if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: the Covid 19 Vaccine killed her Aunt
Tinnitis  Luts (severe urinary tract symptoms )  urinary retention, had to visit patient first then had to visit emergency department
Paper work (incident/near miss report)completed and sent to risk management.  Provider also informed and to contact patient.
Information has been received from a registered nurse, via a company representative, concerning a female patient who was vaccinated, IM, with a dose of Gardasil vaccine (yeast) (date not specified). Subsequently the patient fainted after the vaccination was administered. The patient sought unspecified medical attention. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Follow up information from a nursing manager confirmed the event of fainting as reported, however, she also confirmed that further identifying details for the patient or event could not be provided. The patient sought unspecified medical attention. No further information is expected.
WITHIN 24 HOURS HAD SOME REDNESS, SWELLING, AND LOW GRADE FEVER.   AFTER 24 HOURS, REDNESS SPREAD TO LARGER AREA.   WAS SEEN BY PROVIDER AND DX WITH CELLULITIS.  PRESCRIBED KEFLEX.
Achy; The last shot she got in Nov or 2022 same symptoms but also lost bladder control for roughly 4 hours; Chills; Exhaustion have had this happen with all doses; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), URINARY INCONTINENCE (The last shot she got in Nov or 2022 same symptoms but also lost bladder control for roughly 4 hours), CHILLS (Chills) and FATIGUE (Exhaustion have had this happen with all doses) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Achy), URINARY INCONTINENCE (The last shot she got in Nov or 2022 same symptoms but also lost bladder control for roughly 4 hours), CHILLS (Chills) and FATIGUE (Exhaustion have had this happen with all doses). At the time of the report, PAIN (Achy), CHILLS (Chills) and FATIGUE (Exhaustion have had this happen with all doses) outcome was unknown and URINARY INCONTINENCE (The last shot she got in Nov or 2022 same symptoms but also lost bladder control for roughly 4 hours) had resolved.        No concomitant medication information was provided. Patient had dose 3 of moderna vaccine on 30 Oct 2022, Lot No: 076C21A and Location of injection was left arm. Patient had dose 2 of moderna vaccine on 27 May 2022, Lot No: 004M21A and Location of injection was left arm. Patient had dose 1 of moderna vaccine on 02 Mar 2022, Location of injection was right arm. Patient had Paxlvoid for COVID-19 treatment from 30 Sep 2023 to 05 Oct 2023. Patient had medication drugs included Prednisone from 23 Sep 2023 to 28 Sep 2023, Rabeprazole on 24 Mar 2023, Clonazepam on an unknown date, DULOXETINE HCL DR 20 MG CAP CAPSULE, DELAYED RELEASE(DR/EC) on an unknown date. The reported event was achy, chills, exhaustion had that happened with all doses The last shot patient got was in Nov or 2022 same symptoms but also lost bladder control for roughly 4 hours. No treatment medication was provided by the reporter.   This case was linked to MOD-2023-745589 (Patient Link).
This spontaneous report as received from a 31 year old female registered nurse, reporting on herself, via company representative, who on 15-OCT-2013 was vaccinated with the first dose of VARIVAX (lot# reported as J003708, Expiration date 25-MAR-2015 subcutaneous in the right arm. Following the vaccination, in the last week, in October 2013, the nurse developed a couple of lesions including a blister. The outcome of couple of lesions including a blister was reported as not recovered/not resolved. The nurse sought medical attention at unspecified clinic physician. Relatedness between vaccination with the first dose of VARIVAX and couple of lesions including a blister was not reported. This is one of several reports received from the same source (MARRS# 1310USA013599). Additional information has been requested.
Fatigue; Headache; Unwell; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Apr2021 at 11:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any other medications within two weeks prior to the vaccination. The patient did not have a history of allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 13:15, the patient experienced fatigue, headache and unwell. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events fatigue, headache and unwell was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about the lot number cannot be obtained.
The patient had a period with bleeding and really bad abdominal cramping; irritating breakthrough bleeding/ Menstrual bleeding; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 36 year-old female patient (wife) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jun2021 (Lot number: EW0191) at the age of 36 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing); "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose: Received 28May2021, lot EW0191, NDC and expiration date unknown.), administration date: 28May2021, when the patient was 36 years old, for COVID-19 immunisation. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "The patient had a period with bleeding and really bad abdominal cramping"; INTERMENSTRUAL BLEEDING (non-serious) with onset 2021, outcome "recovered" (2021), described as "irritating breakthrough bleeding/ Menstrual bleeding".  Additional information includes The caller doesn't know what birth control the patient was on before that. Lot NDC and expiration date unknown for the birth control that the patient was on that experienced breakthrough bleeding. The caller didn't connect this until recently. The patient switched birth controls and it helped her side effects. The patient thought it may be the birth control she was originally on. The patient had a period with bleeding and really bad abdominal cramping, its not like the caller. The caller doesn't know what birth control the patient was on before that. Lot NDC and expiration date unknown for the birth control that the patient was on that experienced breakthrough bleeding.   No follow-up attempts are possible. No further information is expected.
85 recruits were vaxed w/Td & yellow fever @ the same time; pts exp swelling & erythema surrounding vax site to a greater extent than was prev experienced;
Sore arm; This is a spontaneous report received from a contactable consumer (patient).  A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in deltoid right on 19Feb2021 12:30 (Batch/Lot Number: EL9266) as single dose for covid-19 immunisation. Medical history included allergies: dogs, cats, pollen, dust, feathers, erythromycin. Historical vaccine included tetanus shot with flu like symptoms: fever. Concomitant medication included loratadine (CLARITINE) taken for allergies from an unspecified start date and ongoing. The patient experienced sore arm on 19Feb2021 14:00 with outcome of recovered.  Patient received treatment Ibuprofen for the event.  No follow-up attempts are needed. No further information is expected.
Pt received expired Sanofi Hib vaccine on 7/20/2022 Lot # UJ524AA Exp: 7/11/2022. Parents were made aware on 7/22/2022. Parents state pt is doing well. Parents brought pt to clinic on 7/22/2022 and was examined by Dr. Pt received Sanofi Hib vaccine Lot # UJ586AA Exp: 10/23/22 on 7/22/2022. IM RT. by. medical assistant.
Patient received Pfizer COVID vaccine on 4/27/21 (lot # ER8736), 5/24/21 (lot # EW0177), 9/5/21 (lot # 301308A), and 1/18/22 (lot # 33036BD). On 1/24/22 and 1/29/22, patient tested positive for COVID. On 1/29/22, patient admitted to our inpatient facility for COVID19 pneumonia with nausea/vomiting.  Patient stayed in the med/surg unit and discharged today (2/1/22).
Headache; Chills; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 41-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. Concomitant medications included testosterone (MANUFACTURER UNKNOWN), for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received morphine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and experienced drug allergy. On 24Mar2021 at 08:00, the patient experienced headache, chills, brain fog. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 26Mar2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the event headache, chills, brain fog was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Developed intense pruritis of left arm next day edema and erythema from shoulder to mid forearm. Pruritis and edema has persisted. No fever or respiratory problems. Pt will be sent to allergist after he recovers from this episode.
Pediarix given to 15 month old  patient instead of Infanrix.; 4th dose of Pediarix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9X3T5, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th August 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 20th August 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were 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: 12-JUL-2022  Reporter's Comments: The registered nurse reported that the patient received a dose of Pediarix as a fourth dose of Dtap series instead of Infanrix.  The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up. Additional Supportive Information: The patient received a dose of Pediarix as a fourth dose of Dtap series instead of Infanrix, which led to extra dose administered and wrong vaccine administered.
I woke and initially, I had a really hard time walking, I had a lot of body aches and pain. My face was extremely swollen, where I get cosmetic filler. My face continued to swell, so I called an online physician. They prescribed me a prednisone that taper and some Benadryl. 3 hours later the swelling went down.
Blinding Headache. Chills, low grade Fever.  Joint pain and body aches. Severe Fatigue. Severe pain in left wrist.  Unable to move left wrist or use fingers for 5 days. Pain subsiding now. Can use hand.
I had received my first shot of the Moderna vaccine on July 14, 2021 sometime in the afternoon. I woke up on July 15, 2021 and felt a sense of imbalance during the day along with some dizziness. I woke up on the morning of July 16, 2021 and I experienced complete hearing loss in my left ear. I was also experiencing a loud ringing noise in my left ear. I figured it was just allergies or some side effect from the vaccine since I heard that some people may experience COVID-related symptoms after receiving the first or second dose. Several days passed as I assumed my hearing would just come back in my left ear, but about a week later I went to the doctors to get it checked it. When I went there, the nurse practitioner told me that it was just allergies and I must have fluid in my ear. They told me I had tinnitus and they prescribed me Claritin-D and told me my hearing would come back in less than two weeks. They said if my hearing in my left ear didn't come back in two weeks or less that I should schedule another appointment. Two weeks went by and my hearing never came back. The ability to listen to others became exceptionally difficult since I am only able to hear from my right ear now. This started becoming serious to me and I became very worried. I realized that this might be something serious. I went back to the doctors and saw another nurse practitioner who told me to just wait for the "fluid in my ear" to clear out and continue taking the Claritin-D daily. A few weeks later I talked to a friend about my problem. She referred me to an ears nose and throat specialist, so I made an appointment with an ENT doctor. I went to this appointment two weeks later and the doctor performed some sound tests. She informed me that I had nerve damage in my left ear and that my ability to hear from my left ear again is impossible since my cochlea was somehow permanently damaged. She explained that the only way I could hear from my left ear again is by receiving cochlear implants. She also explained that this is a medical mystery to her since there are no possible causes of this happening. She explained that complete nerve damage in the cochlea only happens from a viral infection or trauma to the ear or head, none of which I had experienced leading up to this condition. I have no prior head or ear injuries that could have caused this. I never contracted COVID-19 or any other virus in the year of 2021 or during the weeks and months leading up to the date of losing the hearing in my left ear. I also have no health conditions that could have caused this.
I am being treated with doxycycline antibiotics by mouth And neomycin ear drops into infected left ear
Diagnosed with Guillain Barre 10-28-2010.  Hospitalized 10-20-2010, still at Rehab.  Symptoms began 10-18-2010 with numbness of her hands and lower lip, Oct. 20th had back pain and couldn't walk.  Complete paralysis on October 28th.
could not walk on her left foot; hot, painful patch on the inner left lower leg below the calf muscle; Left lower leg and foot bluer than right; vascular issue; pain and redness was present in the lower left calf/ a large red, hot, painful patch on the inner left lower leg below the calf muscle; pain and redness was present in the lower left calf/a large red, hot, painful patch on the inner left lower leg below the calf muscle/tenderness, pain on affected area; tightness, tenderness, pain on affected area; This is a spontaneous report from a contactable consumer (patient).   A non-pregnant 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6204), via an unspecified route of administration at the age of 43 years old, administered in arm right on 17Mar2021 19:45 at single dose for covid-19 immunisation.  Medical history included diabetes, Hashimoto's, PCOS (Polycystic ovarian syndrome), allergies to medications, food, or other products: contrast dye. The patient's concomitant medications were not reported, the patient had received medications within 2 weeks of vaccination, but the patient did not provide the specified drug. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Thursday morning, 18Mar2021 07:00, after vaccine, pain and redness was present in the lower left calf. This progressed to a large red, hot, painful patch on the inner left lower leg below the calf muscle. This has progressed over the past eight days and the patient had gone to Urgent Care (Sat 20Mar2021) where they were concerned about a clot and sent the patient to the ER. An ultrasound in Mar2021 confirmed there was no clot, but the Dr. did not know what the issue was. The doctor started the patient on an antibiotic. This still progressed and 25Mar2021 it spread bilaterally and could not walk on her left foot. Dr. believed it to be a vascular issue with how it presented at her office 26Mar2021 and was closely monitoring the situation. Left lower leg and foot bluer than right, redness, tightness, tenderness, pain on affected area. Subsides at various points during the day, but always returns at night.  The patient was told to keep elevated, try Benadryl, and Advil and keep doctor informed to determine referral vasc Dr. The outcome of the events was not recovered. Date of start of events was reported 18Mar2021 07:00. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Case was reported as non-serious by reporter: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Brief loss of consciousness followed by extremity weakness.  LOC recovered in ambulance. Weakness of extremities improved in ER, resolved in days.