chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 11-year-old male patient received BNT162b2 (BNT162B2), on 05Nov2021 as dose 1, single (Lot number: FK5127) and on 07Dec2021 as dose 2, single (Lot number: FK5618) at the age of 11 years, all intramuscular for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm hurts more than with previous doses.". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient had no known allergies. Patient was not allergic to latex. Prior to vaccination, the patient was not diagnosed with COVID -19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Post vaccination, the patient had not been tested for COVID-19.
Patient was below recommended age guidelines. Patient's Father was called to verify symptoms the next day. Patient was in good spirits and not experiencing  any symptoms.
Patient was administered a dose of the monovalent COVID-19 vaccines after they were no longer authorized. Patients' parents were notified and did not report any symptoms.
The child was accidently given 2 doses of Varicella. Proquad and a dose of Varicella was inadvertently administered to the patient during the well child visit. The error was discovered during a audit by pharmacy
currently asymptomatic but he tested positive on his polymerase chain reaction (PCR) shortly after received the BNT162b2; currently asymptomatic but he tested positive on his polymerase chain reaction (PCR) shortly after received the BNT162b2; This is a spontaneous report from a contactable pharmacist reporting on her son. A 22-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was currently asymptomatic but he tested positive on his polymerase chain reaction (PCR) shortly after received the BNT162b2 on an unspecified date in Apr2021. The patient underwent lab tests and procedures which included PCR test: positive in Apr2021. The outcome of event was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: The contribution of the suspect drug to the onset of event drug ineffective cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.
A mild fever noted by sweating and fatigue (had no thermometer therefore no confirmation), muscle fatigue noted by tenseness and pain. Took 600mg ibuprofen and felt better.
Within 24 hours, developed fever - 101.8 degree - Aching joints, headache. Treated with Ibuprofen. Duration - 12 hours.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; 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 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:25 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:25 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 34.48 years.  No concomitant medications were reported.  Batch number 031L20A  underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. The vial was initially moved to the fridge on 30-Mar-2021 and proposed beyond use date was 29-Apr-2021. Product moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. 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 traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Felt like she had acid reflux right away with the administration of the vaccine.  Monitored then released.  No signs of distress
This spontaneous report as received from a medical assistant refers to a 33 year old female patient. The patient's pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On an unknown date the patient was vaccinated with M-M-R II (lot, expiry date, dose, frequency and route of administration were not reported) for immunization (also reported as it was unsure if she received in the past or not). The patient had an "unspecified Serologic screening for measles, rubella, or mumps immunity, for pre- pregnancy planning. " The "unspecified serologic test was negative(measles antibody negative, rubella antibody negative and mumps antibody test negative). " On 16-OCT-2018, The patient received a dose of M-M-R II. Outcome and causality assessment were not provided by the reporter. No product quality complaint was filed.
Approximately after one minute of receiving vaccine, I had a burning sensation in my chest. This sensation started from left to right and once it spread across chest, it remained.  I brought it to the attention of my primary on Monday, 3/22 but late in the day and on Tuesday 3/22, I had a telemedicine visit with her in the morning. She then asked me to come in to see her that afternoon, which I  did and she did an EKG but wasn't sure if it was off due to the loop recorder. She then asked me to walk around the office while they monitored my oxygen and it went down to 95. She then scheduled me for blood work and a chest xray. A basic metabolic, CBC with Diffeerential came in normal but the D-Dimer, Quantitative came in high at 1.01. I was sent to the ER for further testing with concerns of potential blood clotting, however none found.
Mom states pt had immunizations and that pt "had a loss of memory for 12 hours."  Pt could not remember taking a driving test. Mom took pt to ER but left after being told wait would be about 4 hours. Pt recovered the next day but per mom pt still cannot remember the day of vaccines.
patient states she started having some trouble breathing and wheezing at 1330 & then tightness in her chest and her heart was racing & she felt hot and flushed.  She was told to call 911 as she was home alone, but she drove herself to the E.D.- they treated her with epinephrine, benadryl, solu-medrol and alubuterol inhaler.  At 1540, she called to say she was feeling much better.
Pt. had previously cancelled her appointments for her second dose of the Moderna Vaccine.  Pt. called on date noted and requested for vaccine to be given. Facility only gives Pfizer vaccinations of Wednesdays.  Upon My error, I mistakenly thought the pt. had previously taken the Pfizer vaccine and sent co-worker out with Pfizer vaccine for pt.  The patients second dose of vaccine was administered. Patient then presented her vaccination card notating that pt. had previously received the Moderna vaccine as her first dose.  No adverse reactions noted while with pt. or after administration.  Pt. has not contacted anyone about any adverse reactions.  Called pt. to check in with her, with no response back.  Patient is enrolled in Community program and has a history of being difficult to contact.  Patient is also known to reach out to the Community Program when she needs anything.  Will Continue to reach out to patient to see if she has any adverse side effects.
Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness). At the time of the report, VACCINATION SITE PAIN (Soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.   This case was linked to MOD-2021-008232 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: TCR - patient refused further follow up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
got paralyzed; This is a spontaneous report from a contactable consumer. A patient of unspecified gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The consumer reported that she had heard that the patient had reactions to the Covid-19 vaccine. The patient had a reaction where they literally got paralyzed. The consumer did not provide any details of the patient that was paralyzed after receiving the Covid-19 vaccine. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild
Information has been received from a pharmacist (PharmD) concerning a 54 year old male with possible pneumonia who on 03-OCT-2007 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 657042/1374U).  Concomitant vaccination included ZOSTAVAX (Oka/Merck) (MSD). Concomitant therapy included heparin, ROCEPHIN and ZITHROMAX.  Within 12-24 hours after PNEUMOVAX 23 was given, the patient experienced pain in the arm at the injection site and down to the elbow.  The patient also fainted 12-24 hours after PNEUMOVAX 23 was given.  It was noted that the patient complained to the nurse.  The patient was treated with TYLENOL.  At the time of this report, the patient was recovering.  This is one of three reports from the same source.  Additional information has been requested.
fell and hurt knee; fell; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of JOINT INJURY (fell and hurt knee) and FALL (fell) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced JOINT INJURY (fell and hurt knee) and FALL (fell). At the time of the report, JOINT INJURY (fell and hurt knee) and FALL (fell) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. the patient was suggested to take Tylenol on 23-feb-2021.    Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: NNI
cataracts, which was told by her doctor as very small and causing no problems prior, had progressed to the point she needed surgery; This is a spontaneous report from a non-contactable consumer (patient herself) via self-reporting portal. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 25Mar2021 at 10:00 at the age of 60 years old (Batch/Lot Number: ER8728, Expiration date: unknown) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was a public health clinic/administration facility. Relevant medical history included cataracts, which were very small and causing no problems from an unknown date. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately two weeks after the shot, on an unspecified date in Apr2021, the patient's vision became very blurry to the point that she made an appointment with her eye doctor. The cataracts, which was told by her doctor as very small and causing no problems prior, had progressed to the point she needed surgery. The adverse event did result in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event, which included cataract surgery. The patient was recovering from the event.  No follow-up attempts are possible. No further information is expected.
Shortness of breath, body ache, headache, diarrhea, runny nose,chills , fatigue
Error occurred in a private office where a 1 year old came to Clinic to get first H1N1 injection. Was given full 0.5 ml dose instead of a 0.25 ml dose. LPN who gave the shot gave full dose before checking proper dose. Read the packet insert after and then reported error to Management. Didn't check on proper dose before administering med, therefore a full dose administered. H1N1 0.5 ml reached the patient. There was an increased chance of local reaction and side effects. Fortunately when patients mother was called the next day, there was no local reaction or fever noted, child was fine per mother. Products involved were H1N1 multidose vial, Sanofi/Pasteur and Multi dose vial 10ml vial. Nurse double checked the package insert after giving the vaccine, discovered error on her own and truthfully reported the error. Clear posting of dosing was already in the med room, reviewed with this LPN.
A non-serious spontaneous report of flu-like symptoms has been received from a physician concerning a 15-year-old female patient, subsequent to receiving FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 22-Oct-2009. On 23-Oct-2009, the patient got sick and experienced classic flu-like symptoms. On 27-Oct-2009, she tested positive for Influenza A. The outcome of the event was not reported.
Muscle aches for the next month slept for three days straight unable to wake him not even to eat very groggy flu like symptoms headache muscle aches fever.
within one hour of vaccine developed difficulty concentrating, described as brain fog.  She also developed tinnitus. Both symptoms were transient and resolved without intervention
3/13/21 03:00 am, chills, shakes 3/13/21 04:00 am, fever 102, threw up 3/13/21 07:00 am, dizziness, cold sweats, nausea
Headache, Myalgia, fatigue, stuffy nose Narrative: N/A
Complains of very sore arm for 4 days after shot. States that she has had a constant headache since. Notes also been dizzy sporadically off and on since then.
Call from pt's mother (visit 12/28/11) 01/06/12. Concern: 6 yr old "bump and redness" at the injection site post 24 hrs still has hardness and rash appointment for 1/06/12.
Small amount of redness at injection site noticed last night (>24hr from injection). Patient scratched at it last night. Redness area became larger this morning (>36hrs from vaccine) and there was some swelling superficial to injection site. No pain/discomfort. No fevers. No breathing issues or wheezing, no hives, no facial swelling, no anaphylaxis. Patient.
Began developing a rash about 4 inches in length, 2 inches across at the injection site of the vaccine. This occurred 10 days after receiving vaccine. The rash is hot to the touch, slightly itchy, and skin underneath is a bit hard.
2d post PCV13 - low grade temperature, erythema, induration, swelling over deltoid to mid humerus.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 19-OCT-2017, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot number were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. Approximately one day after receiving the ZOSTAVAX vaccine, the patient suffered sharp, stabbing, tingling pain on the right side of her head. The very next day, the patient developed a rash on her scalp and was diagnosed with herpes zoster. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable 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 the use of the ZOSTAVAX vaccine, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. As a direct and proximate consequence, patient sustained serious personal injuries and related losses including, but not limited to, the following: patient required and will continue to require healthcare and services; patient incurred and will continue to incur medical and related expenses, and patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The event herpes zoster was considered disabling. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 02-MAY-2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2014, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Just looks like vaccine given a little lower than normal.  Warm/welt, I'm not concerned with anything,  but was told to report it.
t>104 x several hr w/no relief p/administering antipyretics; vomiting; intense crying/shrill x several hr; taken to Er w/blood work & urine check done all neg; hyper/hypotonic response
Patient was given the Pfizer monovalent adult vaccine instead of the Pfizer Bivalent booster
Sore arm for one day, Extreme headache starting two days after vaccination. Started in the afternoon and increasingly got worse in the evening. At 7 pm it was so bad a I took Tylenol (500mg) . The pain was excruciating, never felt anything like it before. Sitting and laying down felt horrible so I went outside and started walking. That helped. The intense pain lasted for about 1 hour.  Today, Saturday 4/10/2021, I can feel a bit of a headache but I?ve been taking Tylenol twice today to avoid the same thing happening again.
The pt experienced pallor, lethargy, 1-2 hours post vax. The pt also experienced a fever.
Soreness at injection site; soreness at injection site and into theback of arm; Headache; Weak; Extreme Fatigue; Nausea; Vomitting; This is a spontaneous report from a contactable healthcare professional. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the right arm on 30Mar2021 at 16:45 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history included thyroidectomy, asthma, COVID-19, sulfonamide allergy and penicillin allergy. Concomitant medications included levothyroxine (LEVOTHYROXINE) and unspecified birth control pills; both from unknown dates for unknown indications. 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 31Mar2021 at 06:00, the patient experienced soreness at injection site and into the back of arm, headache, weak, extreme fatigue, nausea and vomiting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events soreness at injection site and into the back of arm, headache, weak, extreme fatigue, nausea and vomiting were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
This case was reported by a pharmacist and described the occurrence of injection site soreness in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (unknown deltoid) and experienced vaccine administered at inappropriate site. It was relayed to the pharmacist that an RN gave the BOOSTRIX "too high up on the deltoid". At an unspecified time after vaccination with BOOSTRIX, the subject experienced local site injection soreness. At the time of reporting the outcome of injection site soreness was unknown.  The pharmacist did not have any further details.