chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DVT was twice as bad; death/natural process; This is a spontaneous report from a contactable Nurse reporting for reporter's husband. A 78-year-old male patient received bnt162b2 (reported as COVID vaccine), dose 2 via an unspecified route of administration on 20Mar2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as 2nd dose, single (at the age of 78-year-old) for COVID-19 immunisation. Medical history included diabetes, Liver cirrhosis, thrombocytopenia, Kidney stone, sarcoidosis, blood pressure abnormal, high cholesterol, pacemaker and they putted the IVC filter for blood clot. Concomitant medications included insulin, simvastatin, hydrochlorothiazide and omeprazole (PROTONIX), all taken for an unspecified indication, start and stop date were not reported; and carvedilol (COREG) taken for blood pressure, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (Lot Number: EN6201; Expiration Date: 30Jun2021) on 27Feb2021 at the age of 78-year-old for COVID-19 immunization and experienced pulmonary embolism and deep vein thrombosis (DVT) on 12Mar2021, and went into the hospital 12Mar2021. Then the patient had the second COVID shot on 20Mar2021 and the reporter had taken him right back into the hospital couple days later because the DVT got twice as worst. The patient experienced DVT was twice as bad on an unspecified date in Mar2021, which required hospitalization on 22Mar2021. The patient underwent lab tests, he had lab tests on 22Mar2021 when he went in and he probably had them on 23rd and 24th of Mar2021. The reporter didn't know what all the lab tests were done in the hospital. The patient died on 12Apr2021. The reporter stated they put Reason of death as natural process because she sent him in the Hospice. An autopsy was not performed. The outcome of event DVT was unknown. The reporter considered there was a causal relationship, when he got his second COVID shot on 20Mar2021 and then he went back in the hospital on 22Mar2021 and the DVT was twice as bad.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported DVT. 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.; Reported Cause(s) of Death: death/natural process
Woke up the following day after receiving the flu shot with headache, muscle aches and chills.  I continue with a fever all day and now into the 2nd day.  My fever reached as high as 102.  I am now on day number two, with a fever as high as 101 today.
Very Strong Metallic taste in mouth. Effected taste sensation, made food undesirable, made food taste bad and metallic. Notified Doctor but he did not respond.
Just fatigue; Headache for a head; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Just fatigue) and HEADACHE (Headache for a head) in a  patient of an unknown age and gender 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) (unknown route) 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 FATIGUE (Just fatigue) and HEADACHE (Headache for a head). At the time of the report, FATIGUE (Just fatigue) and HEADACHE (Headache for a head) outcome was unknown.            No concomitant drug information was provided. The patient had reported did not have major side effects related to the Moderna vaccine. The first two were just fatigue and a headache for a head. Patient received booster dose on 03-Nov-2021 No treatment drug information was provided.   This case was linked to MOD-2022-579137, MOD-2022-583093 (Patient Link).
I have fluid in my right ear, my ear is completely clogged and I have difficulty hearing out of my right ear and there is a constant thumping sound and at times ringing.
This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis and Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix .5 ml, dTpa vaccine and Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a month after receiving SHINGRIX and less than a year after receiving dTpa vaccine and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. The reporter considered the pain in arm to be related to SHINGRIX, dTpa vaccine and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: This case was reported by the other healthcare professional (HCP) for herself. The age at vaccination was not reported. In 2018, the patient received dose 1 of SHINGRIX in the left arm, approximately one month before the reporting date. The patient also received Tdap in the right arm prior week as well as flu shot in the left arm prior week. The patient's arm hurt significantly for a couple of weeks. The patient reported that her arm hurts almost one month later although she was unsure if it was related. The patient was not sure if the sore arm or arm hurt was full resolved or unrelated issue in arm. The patient did feel the sore arm or arm hurt was related to vaccines. No other obvious symptoms according to patient were reported. The patient did not agree to follow up.
lymph nodes were enlarged and still are; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: was not reported/ Caller unwilling to complete the report, Expiry date: Not provided) via an unspecified route of administration on 17Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date patient lymph nodes were enlarged and still are. Additional Context: Caller just received her first dose on Saturday afternoon and by sunday afternoon her lymph nodes were enlarged and still are. She wanted to know, she has been reading different things that swollen lymph nodes aren't in the category of severe allergic reaction. Should she take the second dose vaccine or should she wait until her lymph nodes go down. Patient declined to provide- address, alternative telephone, email address. The clinical outcome of lymph node was unknown.  Information about Lot/Batch number has been requested.
Approx. 18 hours after vaccine, chills, fever, muscle aches, headache actually worse than when I'd had Covid. Lasted about 8-9 hours then cleared up. Went to bed that night around 9:00 pm and woke again at 1:30 am once more with chills, fever, and headache. 4 Hours later woke up and have been okay since.
36 hours post vax pt experienced a varicella like rash with 6-7 lesions on his trunk.
I received the 2nd dose of the pfizer vaccine in the morning. I developed a fever in the evening and by the time I was trying to fall asleep my heart began pounding for a period of time. My fever had started going away by morning and about the same time I developed chest pain and shortness of breath. My finger nail beds and lips became discolored (blueish).
Neuropathy, chills, fever, tremors - started day 1 and continues through day 3.
This spontaneous report was received from an office manager concerning a patient of unknown age and gender. Medical history was not reported. Patient was administered a dose of ZOSTAVAX, subcutaneous injection (dose, lot number and expiry date not provided) on an unspecified date in 2008 at a pharmacy. On 31-OCT-2014 the patient was inadvertently administered with a second dose of ZOSTAVAX subcutaneous injection (dose, lot number and expiry date not provided). No adverse effects were reported. Additional information has been requested.
Flu like symptoms; Body ache; My left arm upper left arm in muscle stacks, It is still hurts, when I am lift up my arm is painful.; Sweaty and hot like a fever; Sweaty and hot like a fever; Sweaty and hot like a fever; muscle ache; i can't get out of bed; In my mouth started feeling numb, my cheek on my face is feeling numb.; In my mouth started feeling numb, my cheek on my face is feeling numb.; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EW0168; Expiration Date: Aug2021), dose 1 via an unspecified route of administration in arm left on 11May2021 at 11:05(age at the vaccination 56-years-old) as single dose for COVID-19 immunisation. Medical history included anxiety, ongoing cardiac disorder (heart condition), diabetes mellitus patient reported she was earlier diagnosed with diabetes but her not any more diabetic. Concomitant medications included clonazepam (MANUFACTIURER UNKNOWN) taken for anxiety, calcium carbonate, cholecalciferol (VITAMIN D 2000). The consumer stated that after the vaccine was administered to her then after three or five minutes, her mouth started feeling numb, she cheek on her face started feeling numb. So, she had to wait to be observed and she need to see her physician for follow up primary but, also the side effects like the next day almost like she had a flu like symptoms these are side effects. Consumer also stated that sweaty and hot like a fever and body ache and she can't get up of bed, a body ache, that's not giant like a muscle ache, and it hurts, and then her arm was like; she can't move it, but that was last night but she okay, she walking around, she alive and alright, it's just that she had to follow what doctor told her at the clinic, where they, not the clinic, IOG, where they gave me the shot, the vaccine, that she have to follow up with her primary doctor and today was second date, second date of vaccine. She had not feeling like before so that's why she here at the doctor clinic waiting for it to open. She just sharing that with you because she was told to by the physician. She primary doctor told her to take Vitamins long ago and Vitamin D taken once a day Vitamin that's all she takes and wanted to take Clonazepam if she really needs it. Therapeutic measures were taken as a result of events included treatment with Only took Tylenol. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
9 x 8 cm, red, warm red area (L) upper arm at site of injection.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jun-2021 at 10:10 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 10:10 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 55.84. No concomitant medications were reported. On 22-Jun-2021 at 08:00 A.M., the temperature recorded was 35 degree Fahrenheit, and vial was initially moved to the fridge on 27-May-2021 and beyond use date was 26-Jun-2021. Product moved to clinic on 22-Jun-2021. Vial was stored on cooler 1, on 22-Jun-2021, Excursion duration At 8 AM: 35, 9 AM: 39, 10 AM: 47, 11 AM: 36, 12 AM: 42, 1PM: 43, 2 PM: 43, 3 PM: 43, and 4 PM: 43. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported.
About 24 hours from vaccine, began running a fever.  Took acetaminophen to break fever and got rest.  Felt fine next morning
A pharmacist reported that an 11 year old female received Pnu-Imune 23, MMRII and Hep-B vaccines on 8/25/00 and subsequently, developed a fever and an injection site reaction characterized by redness and tenderness. She recovered. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23 (lot 463729).
Patient presented to clinic for COVID-19 booster following receipt of J&J for primary series. Full-dose Moderna was administered by mistake. Patient was notified of dosing error via phone.
A health professional reported the occurrence of injection site cellulitis in a 10-month-old female who was vaccinated with dephtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were not provided.  On 09/24/2002, the subject received an injection of Infanrix (lot DTPA572A2) into the left thigh.  On 09/25/2002, the subject developed limb swelling and redness at the injection site.  The subject was seen by a physician, who made a diagnosis of injection site cellulitis and prescribed azithromycin (Zithromax) and cool compresses.  The reporter stated that the injection site cellulitis was possibly related to Infanrix administration.  Comment:  This report has been linked to report A0381793A due to the same reporter.
Headache, bodyaches, chills, fever, hives/rash, pain at injection site.
Severe joint inflammation; Ligament stiffness in fingers, knees, elbows and shoulders; Ligament stiffness in fingers, knees, elbows and shoulders; Ligament stiffness in fingers, knees, elbows and shoulders; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 28Mar2021 at 12:30 in the left arm (at an age of 66-years-old), as single dose for COVID-19 immunisation. Medical history included atrial fibrillation, thyroid underactive, high cholesterol and known allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included apixaban (ELIQUIS), montelukast sodium (SINGULAIR), levothyroxine sodium (SYNTHROID) and atorvastatin calcium (LIPITOR); all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Apr2021, within one week of second shot, the patient developed severe joint inflammation and ligament stiffness in fingers, knees, elbows and shoulders lasting 4 weeks and beyond. The events resulted in doctor or other healthcare professional office/clinic visit. 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 of severe joint inflammation and ligament stiffness in fingers, knees, elbows and shoulders was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
22 Sept 2009 received reg nasal flu. About 6 hrs later developed rash and breathing problems. Seen in ER that night. Inhaler and observation.
Took vaccine at around 10:30am. Around 12 (noon) I started to not feel myself I had a headache, chest pain and burning in my chest, muscle aches, dizziness and fever 100 degrees F. Chest pain lasted 12 hours. I took 1 tablet MOTRIN.
The first symptoms was a headache - it was not a migraine but it was persistent and it continued into Friday, the 17th. I usually take Acetaminophen but it didn't go away. On the 17th, I got dizzy going up the stairs. I had to lay down for an hour or so. Dizziness was sporadic and lessened but it persisted along with the headache. I experienced a visual event - an optical migraine - the doctor called it. I took my blood pressure and I had higher readings then I had ever seen before. However, my blood pressure had been creeping up the last 12-18 months and had been a topic of concern with my doctor -  but this time it was high enough to go to an Urgent Care, I believe - Friday, the 17th. I am doing fine with  my symptoms now. They completely abated on the 18th - no headache and felt fine that morning and have felt fine since then.
A few hours after 2nd Covid vaccination (Pfizer), experienced left inner ear spasming lasting approx. 1 minute, followed by daily tinnitus for 4 months.   Some mild hearing loss is also suspected to present.  Also began experiencing chronic migraines 8 days after - lasting until present time (October 2022).   Chronic migraines are often noise induced, or begin upon waking, with light and sound sensitivity.  Frequency was generally 5-12 days per month, treated with Imitrex or Nurtec, until July 2022, when frequency began to reduce significantly.  Notably, first Covid infection occurred May 2022, with a complicated course followed by post-Covid secondary infections.   Also, heavy menstrual bleeding ceased after 2nd Covid shot, with a prior history of uterine fibroids.   All subsequent menstrual periods were light through September 2022.  First "normal" heavy menstruation returned October 2022.
Symptoms began as sore throat around noon the following day.  By 4pm, had most of the same symptoms when  diagnosed with covid.  Fatigue,  cough, sneezing, runny & stuffy nose, fever, abdominal pain, shortness of breath, and body aches.
Patient describes swelling in left arm at site of injection as well as redness and pain, this was at the time of return call at 13:45 hours. Advised patient to come to the clinic to be evaluated. Patient's daughter returned call at 14:36 stating that patient was not going to be coming in to our clinic and was in such a state that they called 911 to have her transported to the local ER. Spoke with patient the next day and she informed me that in addition to to the pain and swelling she had difficulty "getting up" as well as loss of function of the left arm to the extent that she was unable to move that arm under it's own power. Hospital in question is Hospital.
72yoM presented to the ED on 10/10 with acute painless L monocular blindness. Prior day prior, he reported having L eye pain but without vision loss and has no eye pain on day of presentation to ER. Neurology evaluated the patient and believes the left eye vision loss is related to retinal ischemia. Patient left prior to completion of MRI or optho evaluation.
Large, raised, red area on leg where DTap was given measuring 4" x 2". Mother noticed about 5 hours after vaccines were given. Slept well, eating and drinking well but fussy. RTC or ER if fussiness does not improve with Ibuprofen and cool compressor or worsing symptoms.
felt warm on my neck and face; skin was red; similar to a sunburn and likely an allergic reaction; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Jan2022 15:45 (Lot number: FJ8757) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: contrast dye" (unspecified if ongoing). Concomitant medication(s) included: QUERCETIN in two weeks. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 07May2021, when the patient was 42 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0169, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 16Apr2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: FEELING HOT (medically significant) with onset 03Jan2022 16:00, outcome "unknown", described as "felt warm on my neck and face"; ERYTHEMA (medically significant) with onset 03Jan2022 16:00, outcome "unknown", described as "skin was red"; HYPERSENSITIVITY (medically significant) with onset 03Jan2022 16:00, outcome "unknown", described as "similar to a sunburn and likely an allergic reaction"; IMMUNISATION (non-serious) with onset 03Jan2022 15:45, outcome "unknown", described as "booster". Therapeutic measures were taken as a result of feeling hot, erythema, hypersensitivity with Prilosec and Benadryl. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and did not test for covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Administered a booster dose of the Moderna Covid-19 vaccine from a vial which was first punctured on 24Nov2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a booster dose of the Moderna Covid-19 vaccine from a vial which was first punctured on 24Nov2021) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021 at 8:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a booster dose of the Moderna Covid-19 vaccine from a vial which was first punctured on 24Nov2021). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered a booster dose of the Moderna Covid-19 vaccine from a vial which was first punctured on 24Nov2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Non-Significant follow up appended