chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rapid heart rate; feverish; body aches; chills; could not eat drink; brain fog; shaky; breathing issues; could not walk to his truck; Could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (could not eat drink), FEELING ABNORMAL (brain fog), TREMOR (shaky), DYSPNOEA (breathing issues) and GAIT DISTURBANCE (could not walk to his truck) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced EATING DISORDER (could not eat drink), FEELING ABNORMAL (brain fog), TREMOR (shaky), DYSPNOEA (breathing issues), GAIT DISTURBANCE (could not walk to his truck), INSOMNIA (Could not sleep), PYREXIA (feverish), MYALGIA (body aches) and CHILLS (chills). On an unknown date, the patient experienced TACHYCARDIA (rapid heart rate). On 17-May-2021, EATING DISORDER (could not eat drink), FEELING ABNORMAL (brain fog), TREMOR (shaky), DYSPNOEA (breathing issues), GAIT DISTURBANCE (could not walk to his truck), INSOMNIA (Could not sleep), PYREXIA (feverish), MYALGIA (body aches) and CHILLS (chills) had resolved. At the time of the report, TACHYCARDIA (rapid heart rate) outcome was unknown.            No concomitant medications are  provided.  No treatment drug details was included. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.
t100 2OCT96 PM;t101 AM 3OCT96;t100 PM noon 3OCT96;inner ear infec & sore throat;pt to ER 330PM t106.5; pt stayed at hosp overnoc;
lg red area around inject site (approx 2.5x6 cm); hot to touch; painful to touch;
Muscle Spasms in the left arm (injection arm), Jittery/Anxious 3 consecutive days post vaccination
(Agency Flu Nurse) administered adult Pfizer Bivalent COVID Booster dose 0.3 ml to member.
Only some pain in the shoulder for 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Oct2021 18:00 (Lot number: 301558A) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA. The following information was reported: ARTHRALGIA (non-serious) with onset 25Oct2021 20:00, outcome "recovered" (2021), described as "Only some pain in the shoulder for 2 days". Therapeutic measures were taken as a result of arthralgia. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility type Vaccine was Pharmacy or perfume shop. Other medications in two weeks included Humira 15 days before. The patient did not have Known allergies. The patient received Tylenol as treatment for the event.  No follow-up attempts are possible. No further information is expected.
2nd dose caused some symptoms 48 hours fever with body aches and Fatigue; 2nd dose caused some symptoms 48 hours fever with body aches and Fatigue; 2nd dose caused some symptoms 48 hours fever with body aches and Fatigue; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 intramuscular on 25Jan2021 09:30 (Batch/Lot Number: EK5730) at Arm Right as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), intramuscular, administered in Arm Right on 05Jan2021 as SINGLE DOSE for covid-19 immunisation and causes hours fever with body aches and fatigue. On 06Jan2021 02:00, The patient reported 2nd dose caused some symptoms 48 hours fever with body aches and fatigue. The action taken in response to the event for bnt162b2 was not applicable. The outcome of events was recovered.
Rash - on left - arm - swollen - 2nd day flu like symptoms - chills - fever - sweating - 10/20/11 - visit to urgent care -- allergic reaction. Treatment - BENADRYL - Prednisone.
Pressure in head, dizziness shortly after receiving vaccine. By evening, rash appeared on arm and leg. Next morning eye paid and swelling, nausea. Chills, fatigue and nosebleeds. Symptoms are still present as of 11/03/2014.
No additional AE; Patient did not wait and received V ARlV AX on Jan 27, 2022, which was four days earlier than it was suppose to be.; This spontaneous report was received from pharmacist and refers to a 33-year-old patent (gender not reported). No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On 03-JAN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis, then on 27-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) Once (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). The patient did not wait and received varicella virus vaccine live (oka/merck) (VARIVAX) four days earlier than it was suppose to (Inappropriate schedule of product administration). No additional adverse events.
Information has been received from the mother of a female who was vaccinated with the second dose of Gardasil. Subsequently the patient experienced pain. The mother reported that her daughter will receive the third vaccination "late". Additional information has been requested. It was also reported that another daughter was vaccinated with Gardasil and experienced pain (WAES 0703USA02877).
tested positive on a covid-19; tested positive on a covid-19; body is aching / terrible body ache / Pain; vomiting / throwing up; she has lack of appetite; she started to feel like she has a virus infection; Temperature of 101 degrees Fahrenheit / fever like 101 at least; This is a spontaneous report from a contactable nurse (patient herself). A 65-years-old female patient received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration on 02Sep2021 as dose 1, single for covid-19 immunization (age at vaccination 65-years-old). Medical history included urinary tract infection from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient was tested positive on a covid-19. On 15Sep2021, the patient experienced body is aching / terrible body ache / pain, vomiting / throwing up, she has lack of appetite, she started to feel like she has a virus infection, temperature of 101 degrees fahrenheit / fever like 101 at least. Patient was feeling okay at the moment when she got her injection. She also stated that she has been very healthy, works out regularly, had low weight and no pre-existing conditions aside from UTI that she developed somewhere else. She mentioned that within the last 3 days, she started to feel like she has a virus infection, her body was aching, she had been throwing up (vomiting), and she had lack of appetite. Patient was tested positive on a covid-19 nasal swab test a few days ago. She wanted to know if she can postpone the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine for 5 more days after the recommended 21 days interval from the 1st dose. Clinical outcome of the events was reported as unknown.  The lot number for the vaccine was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2.   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.
Next day after first dose of Moderna vaccine patient noticed that things would fall out of his hands for now reason, for example the phone while talking on it.  Lasted for 2 days then resolved.  Had 2nd dose of vaccine and then the next day noticed numbness in hands and tingling in hands and feet that began the next day and has not resolved since . Symptoms are worse when washes hands with hot water.  Symptoms as of 5/19/2021 are either the same or worsening, no improvement.
Approx 3 min p/inject pt fell to ground, had generalized sz 2 to 3 minutes, then generalized tonic posturing w/grunting addtl 3 to 4 mins; agitated & lethargic next 8-10hrs;
I have had tinnitus for about 20 years. It was really terrible in the beginning and gradually calmed down and I have been able to control it with diet. After the vaccination, the buzz in my left year became louder, constant, and didn't respond to diet as it has in the past.
About 7:00 pm, on June 5, 2022, I was not feeling well and I went to bed.  I woke at 3:00 am and my temperature was 99.5.  Immediately thought I should do a home COVID-19 test and it was positive. I messaged my doctor and asked if I needed a PCR and he said no. I tested myself every day until I was negative, on June 8, 2022. He prescribed Paxlovid.
I noticed pins and needles and numbness in the lower right side of my body. I took Benadryl and had an extreme reaction to Benadryl. It was like a heart attack symptoms and that worsened the pins and needles feeling on my right side of my body. This lasted 6-8 weeks. I went to my PCP for a blood test and general exam. I got an ultrasound on my neck due to swollen lymph nodes which was inflamed.
Patient reports tongue swelling pain and sores on his tongue later in the day of the vaccination.  There was no difficulty breathing so he did not call for medical treatment.  Symptoms resolved after 3 days.
Fibromyalgia pain at all joints flared up to severe (level 10 of 10) pain for approximately 24 hours. Use of Cyclobenzaprine (muscle relaxer) had no affect in the first 12 hours. Aggressively treated with Tylenol and continued use of daily medications. Attempted to call doctor's office but was unable to receive further help. Resorted to attempting to sleep until pain levels decreased.
EE presents to medical with c/o aches/chills sxs (R) thumb/index finger numb.
Mom gave pt APAP @ 4PM pt recvd immun about 430PM started high pitched, shrill crying about 8PM still crying @ 930PM mom took pt to ER continously crying till 10PM in ER;
This is an unconfirmed spontaneous report from a lawyer referring to a 42 year old male who claims to have experienced pain and tightness in his heels, knees, hips and elbows, after his 2nd dose of Lymerix. The pt has no history of Lyme disease or arthritis nor any arthritic-type symptoms. In April, 1999, the pt received his 1st injection of Lymerix with no reported events. In May, 1999, the pt received his 2nd dose of Lymerix and approximately a week later (May, 1999), experienced pain and tightness in his heels, knees, hips and elbows. The most recent information received on 2/17/2000, reports that the pain continues on an intermittent basis. Additional information has been requested.
Patient's Mom stated patient has a history of vasal syncope and any sharp pain can trigger the event. The event lasted approximately 5 minutes while in the counseling room. Patient then was seated at the waiting area for another 10 minutes before walking through the store. Mom confirmed at 5:50pm patient was feeling ok and then left the store.
Patient developed rash spots on belly and legs in the evening. The rash spots are almost gone by the next day in the morning
Shortly after receiving vax, the pt experienced a rash and a swollen arm. The most recent information received reports the condition of the pt is unknown.
The booster dose was administered too early.  The second dose was given on 9/2/21.  The booster dose should have been given 3/2/22 or later.  I explained the error to the patient immediately after it was discovered.  The patient waited 15 minutes after the vaccination without having any issue.  I referred to the CDC Covid-19 Vaccine Administration Errors Revaccination Guidance updated 12/1/21 and per their guidance, the dose should NOT be repeated.  I also explained this to the patient.  The patient had no questions or concerns at that time.
24 hours after injection: dizziness; lethargy; nausea; pain at injection sight.; swelling at injection sight; This is a spontaneous report from a contactable consumer or other non hcp  (patient) reporting for herself. A 38-years-old female non-pregnant patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0182, expiry date: unknown) via an unspecified route of administration in Arm Left on 10Jun2021 at 08:30 (at the age of 38-year-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported no known allergies. Historical vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EWO175, expiry date: unknown) via an unspecified route of administration in Arm Left on 21May2021 at 03:45 PM at the age of 38-year-old) as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient did not have Covid prior to vaccination and was not tested for it post vaccination. 24 hours after injection, on 11Jun2021 at 06:00 AM patient experienced dizziness, lethargy, nausea, pain and swelling at injection site. No treatment was received by the patient for AEs. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Within one hour of all of these shots, pt developed cough, wheezing,and mild urticaria. The shot was given on 03/21/2002.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, shingles and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the shingles and shingles were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix. Additional details were provided as follows: The patient was self-reported this case. The age at vaccination was not reported. The patient got shingles within a week after 1st and 2nd shot. The patient discussed with pharmacist and he ok'd 2nd shot. The patient continued to get shingles about every 6 weeks. The patient asked that it would help to get another round of Shingrix. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding the laboratory test confirming shingles were unknown at the time of reporting. Note: As the follow up was not possible for the case, the shingles experienced within a week after 1st and 2nd dose was considered as recovered and case was conservatively considered as SVF for shingles occurred after every 6 weeks.
Onset of fever 1NOV90 peaked @ 103 on 2NOV90. Seen @ MD on 2NOV90; Started on antibiotics & Ventolin syrup. Hospitalized 1 day 12OCT90.
Redness, swelling of the injection site 5*2.5 inch. muscle pain. Neck pain.
Had some light flu-light symptoms the day after injection.  On second day after injection, was getting a haircut when began sweating profusely.  When stood, became very dizzy and had to sit down and immediately passed out.  Upon returning to consciousness became very nauseated and had to vomit.  Was transported by ambulance to emergency room.  All vitals were fine.  Could find no cause of loss of consciousness.  As a precaution, was given a heart monitor to continue for several days and made an appointment with cardiologist.  Still experiencing some dizziness on day three.
SYNCOPE, unresponsive for 5 minutes, gave fluids, snacks, VS taken, VS stable.
Onset papulovesicular rash on 10/26/10 (-) pruritic. 1 lesion (L) thigh (admin site) + 2 vesicles (L) upper arm; papules to trunk only initially; 2nd office visit 11/01/10 with diffuse rash like prickly heat increased pruritic.
Consumer has not menstruated in the 3 months since having comirnaty shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) received bnt162b2 (COMIRNATY) (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: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "Consumer has not menstruated in the 3 months since having comirnaty shots".  Additional information: Patient not on birth control and definitely not pregnant. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg Cramps) and MYALGIA (Body Aches) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (no adverse event reported). On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MUSCLE SPASMS (Leg Cramps) and MYALGIA (Body Aches). At the time of the report, MUSCLE SPASMS (Leg Cramps) had resolved and MYALGIA (Body Aches) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication include potassium capsules . Concomitant product was not provided by the repoerter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves male patient (age unknown) who received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ036AA, expiry date 09-May-2019 via unknown route in unknown administration site. It was an actual medication error due to vaccine underdose and syringe leak. It was reported that Prefilled syringe leaking is at neck. The doctor pushed the plunger and there is drop or 2 of liquid coming out of the neck. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender- none.
Body aches, rash, no energy, sore muscles, feel weak, pain in legs, some numbness.
had the shot, still got shingles/Suspected Vaccination failure; shingles; chicken pox's; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and chickenpox. On an unknown date, the outcome of the vaccination failure, shingles and chickenpox were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and chickenpox to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's sister. The age at vaccination was not reported. The patient had the shingles shot but still got the shingles and chickenpox. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation was not reported.
POSITIVE COVID ANTIGEN TEST AFTER BEING FULLY VACCINATED- SYMPTOMS INCLUDE COUGH, CHILLS, HEADACHE, MUSCLE ACHES, COUGH.
Approximately 40 minute after receiving the  Moderna COVID-19 Vaccine EAU in my left upper arm , I experienced a thickening of my tongue and a tingling feeling   It felt as though it was  in the forward part of my tongue.  It felt very odd and was very scary. I had no tingling  in my lips or in my throat. I could speak, drink water and eat. The sensation lasted approximately 5 hours until it felt somewhat back to normal.  I have my second doze of the Moderna vaccine scheduled for March 5. I am worried about getting it after having this reaction.  Please advise me.
Got the shot on a Saturday, a little sore and dizzy on Sunday, improving Monday and Tuesday, woke up Wednesday totally dizzy.  It has improved, but that was over 12 days ago now and it's still happening. It's gotten progressively better since that initial Wednesday but with increased activity I cleaned the house, vacuumed, etc. yesterday and it made it very bad again. Today, it's very mild. But I'm scheduled for my 2nd shot Thursday.