chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received an expired vaccine, no AE; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown demographic patient who was vaccinated with an expired dose of TYPHOID VACCINE [TYPHIM VI] (lot number N1K901, expiration date 24 Oct 2019) on 28 Oct 2019 (Other dosing details not reported).  Medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  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 set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
By the following evening my rings on my fingers were extremely tight then I noticed Increased joint swelling in both hands, both wrist, both feet, both ankles, both knees, stiff neck on left with shoulder blade stiffness on left .  Sunday cont to get worse but I could still manage to do life and by Monday at 7am I had to go to ER as the swelling continued and the pain intensified from trying to walk and move. I explain to the ER that I had received a Covid booster vaccine on Friday and did not see any immediate changes until Saturday night when I couldn?t get my rings off my fingers at bedtime. I continue to experience swelling throughout Sunday and by Monday I couldn?t walk without pain or move without pain. The ER monitored my blood pressure which was extremely high 250/112 ( exact measure  avail on ER report). They ran a blood lab and EEG which our normal gave me a starting dose of prednisone and sent me home with a prescription for four additional doses of prednisone. They told me it was going to take at least three days before the swelling went down. I have had to call out for work as I am a physical therapist assistant and cannot return to work until I can safely manage patients in my nursing home. I have a follow up appointment with my PCP on Tuesday, November 30 to address the concerns with the high blood pressure and to continue to monitor the swelling .
very dizzy/lightheaded; weak; I got blood drawn today because it may be anemia; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 19; Units; Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER2613), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was very dizzy, weak, lightheaded and reported that she got blood drawn today (on the day reporting) because it may be anemia. Patient further reported that she got the first dose Covid vaccine on Monday and she was still exhibiting some symptoms from this. She was experiencing this prior to the vaccine but then got worse afterwards. The patient was wondering if this was normal or she should see a doctor. Outcome of the event got blood drawn today because it may be anemia was unknown while for the other events was not recovered.  No follow-up attempts are possible. No further information is expected.
pt took her blood pressure medicine 1 hour prior to getting the vaccine. Pt was feeling okay at the time of the vaccination. Pt states that she passed out after leaving the pharmacy and came to her son's place. Pt didn't experienced this before with her primary series and first booster dose of Pfizer covid19 vaccine.
pt recvd vax & exp pain in right arm; swollen; red; hot to touch; 4-5 inches; most of pain went to joint & shoulder; could not raise arm; throbbing;
(R) leg swollen with multiple wells, red, and hot to touch. Received BENADRYL, and ORAPRED from PCP.
Initial and follow-up information has been received from a registered nurse concerning an 11 year old male with no known allergies or pertinent medical history who on 08-APR-1997 was vaccinated SQ with a first dose of varicella virus vaccine live (Oka/Merck) (Lot #621073/0083E). Concomitant vaccination included a first SC dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot #618887/1244D). On 19-OCT-2007, the patient experienced breakthrough chicken pox. The patient had 25-30 scabbed lesions on the neck, trunk and face. The patient also had seven new lesions on the right plantar area. The patient was seen in the office (also reported as medical attention was not sought). There were no lab studies performed. On an unspecified date the patient recovered. Additional information is not expected.
Subsequently post vax, the pt developed a rash. The pt sought unspecified medical attention.
had been exp less than 5 sz per month;on 26JUL95 started having marked inc in sz activity,lasted for 6 days, had 37 sz during the 6 days time period;has had no sz since 1AUG95
SYNCOPE ONCE VACCINE ADMINISTERED/FAINTED; FALLING OUT OF CHAIR; This spontaneous report received from a pharmacist concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. Patient was not pregnant at the time of reporting.  On 01-APR-2021, the patient experienced syncope once vaccine administered/fainted and falling out of chair.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope once vaccine administered/fainted, and falling out of chair on 01-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210404291-covid-19 vaccine ad26.cov2.s-Syncope once vaccine administered/Fainted. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
About 4 hrs later a headache set in.  18hrs after first shot, lethargic, whole body sore, massive headache, could hardly get out of bed.  4-5 days after this second injection... i was almost back to normal with the exception that my right shoulder still hurt a lot when lifting, putting pressure on my arm (example, lifting myself out of bed), etc.  I am NOT referring to injection site.  Never had a problem with the injection site.  I'm referring to the actual shoulder joint.    To this day... and the reason I'm doing this report... I'm still having serious issues with my right shoulder.  I still do not have full range/motion.  Lifting objects, trying to reach behind my back, trying to lift myself when sliding down under the covers when going to bed... all hurt.  Shoulder joint also hurts randomly throughout the day for no apparent reason and simple things like Tylenol, Aleve and Ibuprofen do not help.  Left hip is also an issue... but less than the shoulder at this time.     I have also started to have "memory" issues which is new.  Randomly over the past 4 weeks i have found myself driving to work or the store or somewhere else and for no apparent reason, i have this sense of being lost and it takes a minute, maybe 2 before i realize exactly where i am.  Today, i had a strange issue where i was on my cellphone at work and i made a comment to the person i was talking to, that i lost my work phone.  It was not until i hung up the phone that i realized i was on the phone!    That is not right!  That is not normal!  And that takes being a bit absent minded at times since the first shot, to a whole new level!  Prior to vaccinations... i never ever had a problem with my right shoulder or left hip.  No memory or cognizant issues either.
Patient received two Moderna COVID-19 vaccines on 2/19/2021 and 3/16/2021, respectively, and was admitted to our hospital on 11/23/2021 and was tested positive with COVID-19 on 11/23/2021
have developed pityriasis rosea on my entire body; rash started gradually on my face but has been getting worse while spreading down the rest of my body; It is extremely itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), on 14Mar2022 at 19:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 25 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot unknown: True, prev dose lot unknown reason: Not, available/provided to reporter at the time of report completion, prev dose administration date: 13May2021, prev dose administration time: 12:00 PM prev dose dose number: 2, prev dose vaccine location: Left arm), administration date: 13May2021, when the patient was 24-year-old, for Covid-19 immunization; BNT162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot unknown: True, prev dose lot unknown reason: Not, available/provided to reporter at the time of report completion, prev dose administration date: 13Apr2021, prev dose administration time: 12:00 PM prev dose dose number: 1, prev dose vaccine location: Left arm), administration date: 13Apr2021, when the patient was 24-year-old, for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 03Apr2022 at 12:00, outcome "recovering", described as "It is extremely itchy"; PITYRIASIS ROSEA (non-serious) with onset 03Apr2022 at 12:00, outcome "recovering", described as "have developed pityriasis rosea on my entire body"; RASH (non-serious) with onset 03Apr2022 at 12:00, outcome "recovering", described as "rash started gradually on my face but has been getting worse while spreading down the rest of my body". The events "have developed pityriasis rosea on my entire body", "rash started gradually on my face but has been getting worse while spreading down the rest of my body" and "it is extremely itchy" required physician office visit. Therapeutic measures were taken as a result of pityriasis rosea, rash, pruritus.  Additional information: I have developed pityriasis rosea on my entire body, this has been confirmed by 4 separate doctors. The rash started gradually on my face but has been getting worse while spreading down the rest of my body. It is extremely itchy. Patient has covid prior to vaccination and no covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 03Oct2022 as dose 1, single (Lot number: 028A21A) at the age of 33 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (03Dec2022) Positive, notes: Tested positive again on day 11 (4 days after end of paxlovid course). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient was treated with PAXLOVID from 23Nov2022 to 28Nov2022 for Covid-19.    No follow-up attempts are possible. No further information is expected.
Dizziness; Pounding heart; Chest pain; Generally feeling ill; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 17Sep2021 at 14:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medication included atenolol (ATENOL) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 18Sep2021, the patient experienced dizziness, pounding heart, chest pain, generally feeling ill and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were 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 dizziness, pounding heart, chest pain, generally feeling ill and tiredness was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment drug was Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
lightheadedness, dizziness, lip tingling. Evaluated by EMS-Refusal to transport.
Arm pain with injection and immediate swelling.  Sever body ached and fever.  Shaking chills nausea headache
March 23 about 7pm I started with stomach upset, then had body aches and then had a migraine start about 10pm.   Went to the ER the next day to be treated for the stomach upset and migraine. Found out I had a fever of 101 degrees. Was treated with a few medications. Migraine subsided a little bit and then I was sent home. It is now almost 48 hours post-covid vaccine and I still have a headache.
multiple outbreaks of herpes zoster, postherpetic neuralgia and vision issues; multiple outbreaks of herpes zoster, postherpetic neuralgia and vision issues; multiple outbreaks of herpes zoster, postherpetic neuralgia and vision issues; Information had been received on 08-MAR-2021 from a lawyer regarding a case in litigation. This case is regarding a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified date, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage information was not provided) for routine health maintenance and the prevention of shingles. On unspecified date after vaccination, the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, and vision issues. As a result of these symptoms the patient was seen and treated by medical providers and was still under their care. As a result of the receipt of Zoster Vaccine Live (ZOSTAVAX) the patient sustained severe and permanent personal injuries, also reported as serious, progressive, permanent, and incurable injuries. At the time of the report, the patient had not recovered from the events, and the reporter considered the adverse events to be related to suspect therapy. According to the reporter, the events of herpes zoster, post herpetic neuralgia and vision impairment were considered disabling.
knee cap pain/the pain is also around the back of the knee; it's so hard to walk; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. Medical history included diabetes mellitus, hypertension, arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Patient stated, she received the second dose of the vaccine 6 weeks ago and experienced some knee cap pain. Patient had arthritis in the knee, but she never experienced anything like that. The pain was also around the back of the knee and it's so hard to walk on an unspecified date. Patient tried putting arthritis medications, but it didn't help. Therapeutic measures were taken for the events. The clinical outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Parents report pt wheezing, post vax, on 5/12/00 and 10/28/99. Mom gave prelone on 5/12/00. Pt developed a croup-like illness but condition resolved in 3 days.
Patient noted that her arm felt tingly upon administration, the tingling continued into her face including tightness in the cheeks.  She felt a slight difficulty breathing.  Benadryl (liquid) was given to patient and by the time she left she no longer felt the tingling in arm/face and breathing was back to normal.
On or about 10/2/15 the pneumonia shot was administered. On 10/11/15 he began to have difficulty breathing and spiked a fever. He was transported to the hospital and treated with antibiotics and oxygen.
diffuse rash that looked like urticaria, in face and arms; diffuse rash that looked like urticaria, in face and arms; This is a spontaneous report from a contactable physician. This physician reported for a 23-years-old female patient who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced diffuse rash that looked like urticaria, in face and arms. Reported that 3 or 4 days later after vaccination had experienced event but not like contact dermatitis. It didn't have that appearance, maybe a little bit. It wasn't like poison ivy. She wasn't outside or anything. She wasn't exposed to anything else. She lived with it 2 or 3 weeks. Is wondering if she should have the second one. Had issues with other vaccines as well. It was reported that reporter seriousness for event was not serious. Event relatedness with Pfizer Covid 19 vaccine was reported as related. It was reported that this reaction was not life threatening. It was not a serious reaction, like this lady was going to die. Therapeutic measures were taken as a result of diffuse rash that looked like urticaria, in face and arms, she didn't try any soaps or anything right after the shot. Presumes that the shot did it. Does not have any reason to suspect anything else. He gave her meds, gave her a steroid. The outcomes of events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Patient fainted after receiving the vaccine.  She was seated at the time and immediately the chair was reclined.  She did NOT hit her head and regained consciousness within a minute.  Felt nauseated and dizzy.  She remained laying down for ~15 minutes until feeling better.  She left later feeling fine.
Pt received booster on 1/14/22 when due for booster 2/2/22.  Pt left and signed paperwork immediately post vaccination and did not complete observation.
Pt developed an injection site rash (blotchy-red, non-itchy) which occurred 10 minutes, post vax.
body aches; headache; shivering; fever; Flu like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received the 1st dose of Shingrix. In MAR-2023, 6 hrs after receiving Shingrix, the patient experienced general body pain (Verbatim: body aches), headache (Verbatim: headache), shivering (Verbatim: shivering), fever (Verbatim: fever) and influenza-like symptoms (Verbatim: Flu like symptoms). The outcome of the general body pain, headache, shivering, fever and influenza-like symptoms were resolved.   It was unknown if the reporter considered the general body pain, headache, shivering, fever and influenza-like symptoms to be related to Shingrix.  It was unknown if the company considered the general body pain, headache, shivering, fever and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter asked if there was a smaller dose of Shingrix available for her 2nd dose, as she experienced flu-like symptoms of headache, fever, shivering and body aches that began about 6 hours after her first dose of Shingrix, approximately 3 months ago. The reporter consented to follow up.
I got the shingles vaccine and 2 weeks later I got shingles??; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received the shingles vaccine and 2 weeks later got shingles. The follow up would not be possible as no contact details were available.
After receiving the covid vax, I had shoulder soreness the first couple of days. That night, the vein , was a different color than the rest of my veins in my bicep. The discoloration of the vein was at the top of my bicep.  Now, the vein is visually fine now.