chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Knee pain that went away in a week, shoulder pain beyond normal injection site tenderness.  I could not lift my arm and the pain traveled down to fingers, up across neck and into other shoulder and under arm and into chest.  After a month and a half the pain started to subside however now at 2 months and one week it has started back up and I have severe tenderness in back ribs, breasts, under arm and shoulder again as if I did hundreds of push ups.  My finger joints hurt very much and almost seem to lock up.  Doctor initially said I had frozen shoulder syndrome gave me exercised and 800mg Advil.  Advil bearly touches the muscle soreness and like I said with time and exercise the shoulder pain seemed to be getting better only to now return.
Redness, swelling and warm to the touch. Shot given Oct. 15, 2013.
Patient reported vaccine coming out of arm 3 days post vaccination.  Patient was working out and noticed white substance coming out of injection site.
SKIN left deltoid region with oval shaped non raised rash, pen mark drawn yesterday reportedly by a nurse in the family continues to encircle the rash. It's warm to touch, no discharge, slightly itchy. BENADRYL Allergy Tablet, 25 MG, 1 tablet as needed, Orally, every 8 hrs.
Patient had syncopal episode within 15 minutes of vaccination.  Patient felt better after resting and drinking some juice and was released to home.
Swelling below (distally) injection site; Lump below (distally) injection site (2 inch by 2 inch lump); Mild itching on swollen area; Redness on swollen area/mild redness over area of lump; Mild fever x 2 days.; Pain below (distally) injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 64-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 01Mar2021 at 09:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, complex regional pain disorder and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Apr2021 at 09:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 01May2021, the patient experienced pain and swelling/lump below (distally) injection site, (2 inch by 2 inch lump) that started immediately. There was mild itching and redness on swollen area and mild redness over the area of the lump. Swelling was still there for 8 days and mild fever for 2 days. 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 and swelling/lump below (distally) injection site, (2 inch by 2 inch lump) started immediately, mild itching and redness on swollen area, mild redness over area of lump and swelling still there  for 8 days and mild fever  for 2 days were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
hearing loss; vision loss; post herpetic neuralgia; multiple outbreaks of herpes zoster; Information has been received from a lawyer, regarding a case in litigation concerning a patient of an unknown age and gender. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster, post herpetic neuralgia, hearing loss and vision loss. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. As a result of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) conduct, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.The outcome of the events was considered to be not recovered. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was determined to be related.  Upon internal review, the events of hearing loss and vision loss were considered to be medically significant. All events were considered to be disabling by a reporter.
VERY LETHARGIC; ACHES; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the subject experienced very lethargic. On 03-APR-2021, the subject experienced aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very lethargic on 06-APR-2021, and the outcome of aches was not reported. This report was non-serious.
Patient presented to the ED on 4/10/2021 for a fall. Patient hospitalized on 5/7/2021 for fluid overload. Patient hospitalized on 5/8/2021 for acute diastolic heart failure. These visits are within 6 weeks of receiving COVID vaccination.
Diaphoretic, trembled, stated, "vision spotty". Did not lose consciousness.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: 1252) at the age of 70 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Jan2021 at 11:00 as dose 1, single (Lot number: 9261), in left arm, on 12Feb2021 at 11:00 as dose 2, single (Lot number: 9265), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: 1623), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Apr2022 as dose 4 (booster), single (Lot number: 1606), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "chronic gastritis" (unspecified if ongoing); "Ankylosing Spondilitis" (unspecified if ongoing); "Known allergies: peanut" (unspecified if ongoing), notes: Known allergies: peanut; "Known allergies: pollen" (unspecified if ongoing), notes: Known allergies: pollen; "Known allergies: dust" (unspecified if ongoing), notes: Known allergies: dust; "Known allergies: IV Iodine" (unspecified if ongoing), notes: Known allergies: IV Iodine. Concomitant medication(s) included: ALLERTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jan2018; CARAFATE, start date: 01Jan2010; LIPITOR, start date: 01Jan2010; NORVASC, start date: 01Jan2016; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE], start date: 01Jan2018; ZOLOFT, start date: 01Jan2010. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Sep2022, outcome "unknown", described as "vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
she's not feeling well today; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "she's not feeling well today". Additional information: Patient's age was 36. Patient's mother called and stated, "my daughter got a covid shot on Friday and she's not feeling well today. I'm wondering if she took a covid test because of the shot on Friday would it give it an automatic like she has it like a false positive."
covid 19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (covid 19) in a 78-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication not reported.  Patient was on IV cancer medication. He was tested positive for COVID in APR or MAY 2022, about 6 months after receiving the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-746863, US-MODERNATX, INC.-MOD-2023-746968 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746863:grandson case US-MODERNATX, INC.-MOD-2023-746968:Wife case
No AE, patient was given dose 8 days too early from primary series. No sx noted after injection.
Suspected vaccination failure/Had both shots, got shingles both times; Got shingles both times; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 22-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both shots and stated that shots did not work, got shingles both times. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Left eye infection(itchy, red, puffy, swollen) above on eyelid and underneath eye/Allergic Reaction/Covid-19 Vaccine Diagnosis: Adverse effect of other viral vaccines Prescribed: H. Cortisone 1oz - 1% cream, apply lightly and use cold compress 3x daily
CHEST PAIN, LOW BLOOD PRESSURE, COLD SWEATS, DIZZINESS, BLURRY VISION, SEIZURE
4:45pm later that same day began having numbness in left arm and foot and Cramp in left jawline. Contacted left message. Symptoms continued, I took three baby aspirin and called primary care doctor on duty. She called back and explained that the Pfizer wasn't the same as J&J vaccine and to take a Tylenol for discomfort. I took a Tylenol and went to bed. The next morning when I woke up, I had pain behind neck into right leading up to right side of my head. I took some water and meditated until time to go to work. I called primary care Dr. and left message. Pressure continued and numbness in left extremities continued. Friday when I woke up my lower right leg and foot were numb. I drank a bottle of water and ate a banana. I stayed awake until time for work. I called my primary care and left message with nurse. Primary care called back around 3:35pm. she discussed steroid and meds or ER. I suggested both, go to ER to see what outcome is and then steroid possibly. Numbness and pressure continued while at work. I took two baby aspirin when I got off work. Saturday morning, I went to ER. Ct Scan with and without contrast done on head and neck. Doppler was done and no clotting was detected at that time. I was told by Dr. to see my Primary care physician or come back to see ER if symptoms worsened. I contacted my primary care on Monday and left message. They called back and made appointment to see me in office for Tuesday. Dr. suggested to use steroid and I asked to do therapy. Wednesday night excessive pressure, numbness, tightness in jaw and front of neck. Contacted primary care Dr. and called Clinic to learn for Stroke Neurology. Thursday, saw fire stars twice throughout the day. Called Poison control and put in report. This is second VAERS report that I have made.
A consumer report has been received. The report concerns a 10 year old, Male consumer, who had been receiving Nasal FLUMIST .2 Millilitres, Once/Single administration. FLUMIST started on 13-Oct-2012. The patient experienced RED CHEEKS, HEADACHE and RED SPOTS which 14-Oct-2012. The patient recovered from the event of RED CHEEKS, HEADACHE and RED SPOTS on 20-Oct-2012. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 09-Nov-2012 from consumer: Events stop date added and Outcome changed from not recovered to recovered.
Heart started to beat really hard and fast.  Pulse was so fast, it was very hard to count.  About 130.  Slowed to 120.  Several minutes later Had pain in the jaw area.  Heart rate slowed then speeded up.  Cycle repeated several times.  Went to emergency room where I was admitted over night for observation.  Did a stress test and all was negative.  Sent home the next day, 2/14/10.
left upper and lower lip swelling.   no rashes, intraoral swelling, difficulty breathing or swallowing
Had Side Effects; Having a hard time urinating; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had Side Effects) and DYSURIA (Having a hard time urinating) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DYSURIA (Having a hard time urinating). On an unknown date, the patient experienced VACCINATION COMPLICATION (Had Side Effects). At the time of the report, VACCINATION COMPLICATION (Had Side Effects) and DYSURIA (Having a hard time urinating) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: No specific follow-up information recorded.
Employee reports h/a 1 hr p/vax; devel nausea & severe flu like sx over next 2 days;
Sore throat; Cough; Loss of appetite; Body aches; Brain fog; Fever of 100.8; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 62-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 30Mar2021 at 13:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 27Apr2021 at 12:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unspecified date, prior to vaccination. Concomitant medications included calcium (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and loratadine (MANUFACTURER UNKNOWN) all from an unspecified date, for unknown indication. Prior to the vaccination, the patient was 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 an unknown date in 2021, after the first dose of vaccine, the patient experienced sore throat, cough, body aches, fever of 100.8, chills, fatigue, loss of appetite and brain fog. On 27Apr2021 at 12:00 after the second dose, the patient experienced sore throat, cough, body aches, fever of 100.8, chills, fatigue, loss of appetite and brain fog. Body temperature was found to be 100.8 (unit not specified) on an unknown date in 2021 after first dose and on 27Apr2021 at 12:00, found to be 100.8 (unit not specified). The clinical outcome of the events sore throat, cough, body aches, fever of 100.8, chills, fatigue, loss of appetite and brain fog was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
When the registered nurse injected me, blood squirted out my arm in a stream.  I thought that was strange.  She asked me if I took blood thinners, I said "No,"  She put gauze on the injection site, held it there and then put a bandage on it.  I told her this has never happened to me before ever when I took any shots in my arm.  She said I would be alright and told me to wait 15 minutes in the parking lot which I did.  That night, I had a slight fever, my arm felt like it was on fire and I had hot and cold chills and couldn't eat anything or I  felt I would vomit.  I felt the same way the entire next day and just felt  miserable.  I also had problems breathing all day.   I had to use my inhaler every two hours with 3 or 4 puffs.  This went all ALL day and in the evening.  The second day (5th), I felt slightly dizzy and my arm still hurt and noticed a red rash but I could BREATHE finally with no problem!
Presented with AMS/fever; admit for Covid PNA; fully vaccinated;  tx with Vit C, Zithromax, Maxipime, doxycycline, merrem; steroids, Zinc; resp status worsened; made comfort care; pt died
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. No medical history or concurrent conditions were reported. The patient was vaccinated with an expired dose of live, oral ROTATEQ on 24-OCT-2012. It was the patient's first dose of live, oral ROTATEQ. The reported lot number was 1457AA with an expiration date of 07-OCT-2012. No adverse event was reported. No further information was provided. Additional information has been requested.
On 09Feb2021 she felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist; On 09Feb2021 she felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist; On 09Feb2021 she felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist; On 09Feb2021 she felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist; On 09Feb2021 she felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist; On 09Feb2021 she felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist; This is a spontaneous report from a contactable consumer(patient). A female patient of unspecified age received bnt162b2(BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 05Feb2021 at 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 09Feb2021, the patient felt dizzy which resulted in her being disoriented enough to fall and stroke her head in a metal furniture, she didn't have a concussion but a head bump, also she broke her wrist. The patient reported that she had never felt dizzy before and she would like to report the AE and to know if there's information on if this two things could be connected and also reported that doctor told her that she should report this also to the place where she received the first dose of the vaccine and she would like to know if she should do this. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient received an expired dose of DAPTACEL with no adverse event; Initial information was received on 10-May-2021 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 1 years old female patient who received a 0.5 mL expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5611BA and expiry date: 03-Apr-2021) via intramuscular route in the left thigh (expired product administered) for prophylactic vaccination on 10-May-2021.  The patient's medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  The reporter asked whether dose needs repeating.  At the time of reporting, the patient experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. 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.
On 9/25/01, pt developed a temperature of 39.4C and had a seizure at home. He was taken to ER, observed and released.