chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient had a tactile temperature and the mother gave her ibuprofen. Hours later, patient started to cry and then she had an episode described as "body jerking/shaking/tense" movements, eye rolling that lasted a few seconds.
Information has been received from a pharmacist concerning an adult patient who on 16-JUL-2007 was inadvertently vaccinated intramuscularly with a 0.5 milliliter dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). Subsequently, the patient experienced no adverse experience. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from the pharmacist indicates that he was informed of the experience from the personnel health department. His understanding of what occurred was that the physician wrote that the patient should receive "varicella zoster" or "herpes zoster," which ever the correct vaccine was, and the other person grabbed the wrong product. The date of birth, age and lot number were unknown. Additional information has been requested.
Patient developed large raised area at site of injection. Tender, red, mild itching. Swelling resolved over the next 5 days.
Began as "hot muscle aches" moving around to various parts of the body. Several days later, she developed hives on her torso.
neuropathy in his lower leg from the knee down; Neuropathic pain; tingling; This is a spontaneous report from a contactable physician, the patient. This report was received via a Pfizer sales representative.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 23Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  On 06Jan2021, the patient experienced neuropathic pain in his leg below the knee. It felt like "daggers in his foot". On 06Jan2021, the patient also had neuropathy in his lower leg from the knee down that persisted.  The patient received the second dose of BNT162B2 on 06Jan2020 and did not experience any worsening "tingling" after it. The clinical outcomes of the neuropathic pain and neuropathy and tingling were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the onset of neuropathy peripheral with neuropathic pain and tingling cannot be excluded due to temporal relationship.  The case will be reassessed should additional information become available.  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.
immunocompromised; remember things can't remember much of next 2 weeks; it affects ability to concentrate and remember things; Potassium low; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (immunocompromised), MEMORY IMPAIRMENT (remember things can't remember much of next 2 weeks), DISTURBANCE IN ATTENTION (it affects ability to concentrate and remember things) and BLOOD POTASSIUM DECREASED (Potassium low) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced BLOOD POTASSIUM DECREASED (Potassium low). On an unknown date, the patient experienced IMMUNODEFICIENCY (immunocompromised), MEMORY IMPAIRMENT (remember things can't remember much of next 2 weeks) and DISTURBANCE IN ATTENTION (it affects ability to concentrate and remember things). At the time of the report, IMMUNODEFICIENCY (immunocompromised), MEMORY IMPAIRMENT (remember things can't remember much of next 2 weeks), DISTURBANCE IN ATTENTION (it affects ability to concentrate and remember things) and BLOOD POTASSIUM DECREASED (Potassium low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: positive for anti-double strand dna antibodies (Positive) positive for anti-double strand DNA antibodies. On 27-Jul-2021, Blood potassium: low (Low) low. On an unknown date, Monoclonal immunoglobulin present: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications information was not reported. Treatment information was not provided. The patient did many blood tests, the first one after a month of getting second dose, it showed that patient had anti-nuclear antibodies. The second test was positive for anti-double strand DNA antibodies, while the third test was positive for M Spike. Patient went to the ER on 27Jul2021 for low potassium levels. Patient stated to be immunocompromised; Sender's Comments: This case concerns a 59 year-old female patient with no reported medical history, who experienced the unexpected non-serious event of Immunodeficiency. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Manual override done to remove seriousness criteria of Medically significant from event Immunodeficiency based on medical judgement and review of source document that did not include information supporting seriousness criteria.
Left upper arm sore: 1/07/2021 resolved on 1/09/2021 Myalgias: 1/8/2021 took Tylenol with some relief resolved 1/12/2021 Severe headache: 1/08/2021: some relief with Tylenol around the clock. Resolved 1/13/2021 Left eye swelling: 1/13/2021 took Zyrtec with resolution
Information has been received from a licensed practical nurse concerning a 13 year old female with no medical history and no drug allergies, who on 27-NOV-2007 was vaccinated intramuscularly with a 0.5mL first dose of GARDASIL. Concomitant therapy included a second dose of HAVARIX. On 27-NOV-2007, within 5-10 minutes of leaving the office, the patient stated that her throat was "on fire" and raw feeling. The patient had a cold drink and the feeling lasted for 1.5 hours and then subsided. The patient contacted the office by phone. No laboratory diagnostics were performed. The patient recovered on 27-NOV-2007. No product quality complaint was involved. Additional information has been requested. Follow-up received 04/16/2008. Additional information is not expected.
Patient was given a dose from a vial that been opened for 22 hours/12 hours beyond stability.  Recommendation from CDC/Health Dept is to revaccinate asap.  Outreach has been placed to inform patient of error and have him return for repeat vaccine.
low white blood cell count; a 13 year old male patient received PROQUAD; hallucinations (like dreams but not dreaming); HEADACHE; Fever to 101 degrees fahrenheit (constant then intermittent); unspecified number of Bloody noses; lethargy; epigastric pain; chest pain; decreased appetite; dizziness with standing; This spontaneous report was received from a nurse, referring to a 13 year old male patient. The patient's concurrent conditions were not reported. The patient did not have any concomitant therapies, significant medical history or drug allergies/reactions. The patient's historical drugs included behind on vaccination.  On 25-MAR-2019, the patient was vaccinated with albumin status rHA (recombinant Human albumin) Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot# N035172, expiration date 09-JUN-2019, for prophylaxis (strength, dose, route and frequency were not reported), hepatitis A virus vaccine inactivated (HAVRIX) (strength, dose, route, frequency, lot#, expiration date and indication were not reported) and poliovirus vaccine inactivated (Vero) (IPOL) (strength, dose, route, frequency, lot#, expiration date and indication were not reported).  Between 28-MAR-2019 and 01-APR-2019, the patient developed headache, hallucinations described like dreams but not dreaming, fever to 101 degrees Fahrenheit, constant then intermittent (pyrexia), unspecified number of bloody noses (epistaxis), lethargy, epigastric and chest pain (abdominal pain upper and chest pain) with decreased appetite, and dizziness with standing (dizziness postural).  The patient did stay home from school and did not go to an emergency room or urgent care center, but sought medical attention and was seen by the physician assistant on 02-APR-2019.   On an unknown date in April 2019, a complete blood count with a electrolytes test was performed with normal results, except for a low white blood cell count. It was stated that the patient did not have a previous immunization reaction.  On 05-APR-2019, the physician assistant spoke with the parent and stated that the patient was back in school with no further symptoms (recovered). The patient did not receive any treatment.  The causality assessment was not provided.
Fever (103.7), chills, flu like symptoms still persisting 6/8, injection site hard, swollen, hot, painful.
Severe vertigo requiring an ambulance to the ER Could not walk, stand or sit up Was given IV Valium and meclizine orally Back to normal after 5 days
Pt recvd 3 doses of Engerix-B vax, 3rd dose given 27AUg90 & pt did not seroconvert;
Pts mother calling ER stating that she "is worried patient is having an  allergic reaction to the PNEUMOVAX injection he got on Friday." Pts arm is sore, swollen, painful to move per mother, pt able to raise both arms above head, temp 100.4 at this time, mother has been alternating tylenol and ibuprofen, highest temp 104 yesterday. This author placed caller on hold to look up chart, two identifiers used, and caller hung up, plans to see health aide tomorrow.
Symptoms: headache, stomach ache, muscle pains, joint pains, she had troubles walking, diarrhea, dizziness, sore throat, numbness and tingling in hands and feet, pain in left side of stomach, neck and back pain, fatigue, insomnia, hyper sensitive to senses, memory loss, brain fog, tics, vibrations in body, hard time breathing, lymph nodes hurt, and ringing in ears. Treatment: This vaccine injury activated Lyme disease, Mycoplasma, and Bartonella. She had 16 months of antibiotics, supplements, and probiotics, Then patient had 90 silver, UVI, ozone, Vitamin C, and Meyer's cocktail IVs to kill the organisms and boost her immune system. Now she is on an herbal protocol. Patient has been in treatment for over 2 years. She is still in treatment recovering from the HPV vaccine.
Patient received Vaccine Booster (Dose 3) which had hindsight was expired past 10 weeks in refrigerator temperatures.  (16 days Past date Expired 4/11/22) Called Patient 5/13/22 Appreciated the call, decided she will not revaccinate. May consider revaccination after speaking with her doctor. Appreciated the transparency.
Systemic: racing heart reported by pt via phone -Severe, Systemic: Tachycardia-Severe
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; BITTER TASTE; BITTER SMELL; VOMITING; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 42 year old adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sea food and shell fish allergy, and asthma, and other pre-existing medical conditions included: The patient was not pregnant at the time of report. The patient was other health care professional. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: Unknown) dose was not reported, 1 total administered to left arm on 10-SEP-2021 11:00 for prophylactic vaccination. Age at time of vaccination 41 years old.  The non-company co-suspect drug Paxlovid (nirmatrelvir, ritonavir) (form of admin, route of admin not reported, batch number: FY7031, expiry: Unknown) dose was not reported, administered on 20-MAY-2022 for Covid-19 treatment. No concomitant medications were reported.  On an unspecified date, the patient had covid-19 infection (suspected clinical vaccination failure). On 20-MAY-2022, the patient started treatment with Paxlovid. At 19:00 the patient experienced bitter taste, bitter smell, and vomiting.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, bitter taste, and bitter smell, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: 20220562698 -Covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Piercing chest pains on left side in heart muscle/chest still sore/felt like a icepick; Fever; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Piercing chest pains on left side in heart muscle/chest still sore/felt like a icepick), PYREXIA (Fever) and FATIGUE (extremely tired) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included Hodgkin's lymphoma. Concurrent medical conditions included Diaphragmatic paralysis (Diaphragm paralyzed on left side).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Piercing chest pains on left side in heart muscle/chest still sore/felt like a icepick), PYREXIA (Fever) and FATIGUE (extremely tired). At the time of the report, CHEST PAIN (Piercing chest pains on left side in heart muscle/chest still sore/felt like a icepick), PYREXIA (Fever) and FATIGUE (extremely tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter. Treatment medications were not provided by reporter.   This case was linked to MOD-2021-117903 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Significant follow up on 27 Jul 2021 : Events outcome resolved.
Dizzy; Joint pain; Weak; Shaky; Fever; Headache; This is a spontaneous report from a non-contactable other hcp. A 66-year-old female non pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, age at vaccination 66-year-old) via an unspecified route of administration on unspecified date in Jan2021 (Lot Number and expiry date was not reported) as single dose for COVID-19 immunisation. Medical history included keratitis and known allergies to Plaster, Sanitizer from an unknown date and unknown if ongoing. Concomitant medications included fish oil; probiotics; calcium; colecalciferol (VITAMIN D) taken for an unspecified indication start and stop date were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration on unspecified date in Jan2021 (Lot Number and expiry date was not reported) as single dose for COVID-19 immunization. No COVID prior to vaccination. On 26Jan2021, the patient was dizzy, weak, shaky and had joint pain, fever, headache. The patient experienced dizzy symptoms a month after taking it, never got dizzy. She still had joint pain over a month after taking it. She was weak, shaky, fever, headache, and joint pain the night after taking second dose and latest three days. The patient underwent lab tests and procedures which included sars-cov-2 test via nasal swab as negative post vaccination on 26Feb2021. She did not receive treatment for adverse event. The outcome of all the events was recovering.  No follow-up attempts are possible. No further information is expected.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Additional Details: pt went unresponsive soon after vaccine like within 30 seconds, couldnt not feel a pulse, called 911. patient came with it less than 30 sec. EMS came and eventually patient left with mom.
MARKS ON BOTH ARMS; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the subject experienced marks on both arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of marks on both arms was not reported. This report was non-serious.
Stinging upon administration 11/10 - Husband returns stating Pt. developed bruise at injection site. Continues to have muscle tightness in shoulder and neck, headache + Vertigo.
This spontaneous report as received from a pharmacist via Field Representative refers to a male patient of unkonwn age. On an unknown date (within the last week), a pharmacist was somehow exposed to the ZOSTAVAX vaccine, while administering it to a patient (exact route of exposure and dose was unspecified). The Field representative was speaking to his brother who is a pharmacist, the pharmacist, reported to the field representative that another pharmacist, experienced a rash while administering ZOSTAVAX to a patient. On an unknown date (within the last week), a pharmacist, administered ZOSTAVAX to a patient and has experienced shingles himself. The pharmacist got a rash on his elbow. The pharmacist was somehow exposed to the ZOSTAVAX vaccine while administering it to a patient (exact route of exposure was unspecified). The pharmacist then developed a shingles like rash afterwards. The field representative was unable to clarify the exact date or time frame in which that rash was noticed by the Pharmacist nor did he clarify if the rash was diagnosed as shingles specifically. No further AE information was provided. The outcome of the pharmacist then developed a shingles like rash afterwards and the pharmacist was somehow exposed to the ZOSTAVAX vaccine while administering it to a patient (exact route of exposure was unspecified) was unknown. Relatedness between adverse events and ZOSTAVAX was unknown. Additional information has been requested.
Patient got Fluzone HD Friday evening.  By the next morning, her upper arm was red, swollen, warm and itchy around the injection site.  Patient came into pharmacy 48 hours later to have pharmacist look at redness.  Pharmacist recommended applying ice to area, taking tylenol, and allergy medication for itching.  Pharmacist called to follow up 9/20 and patient was doing better but asked pharmacist to complete this form so the event could be documented since she has never had a similar reaction post immunization.
Soreness on injection resolved within 24 hours. Itchiness began approximately 5 days after vaccine. Large swollen warm rash developed on day 7.
Fainted X 3 lasting about 5 min total. Bilateral extremity weakness. Pt is being monitored by PA by phone.
After 24 hours whole body itching, headache, within 48 hours rash on trunk & arms and local reaction at site of injection, also very tired and body aches. Feeling little better by day 3.
This case was reported by a medical assistant and described the occurrence of dizziness in a 50 year old female subject who was vaccinated with Twinrix for prophylaxis. Concurrent vaccination included Typhim VI given on 7/31/06. There were no concurrent medications. On 7/31/06, immediately following vaccination with Twinrix, the subject experienced dizziness, lightheadness and low blood pressure. The pt presented to the ER and it was unk if the pt was hospitalized. The reporter considered the events were clinically significant intervention required (OMIC). The events had improved before the subject left the physicians office. The reporter considered that the events were unrelated to the use of Twinrix. On 7/31/06 the subject received 1st dose of Twinrix IM, right deltoid.
Severe vertigo for 16 hours , vomiting 12 times through the time, chills, couldn't get out of bed without assistance (never happened to me before), slept for 20 hours
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding medical history, concurrent condition and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored PEDVAXHIB (lot # L051125 with expire date 14-OCT-2018, lot # M006710 with expire date 06-DEC-2018, dose and route unknown). No adverse effects were reported. This is one of the several reports received from the same reporter. Lot# L051125 is an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate). Additional information has been requested.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose04/02/21 2nd dose04/23/21 Diagnosed covid positive:08/3021 Symptom onset:08/31/21 Exposure:travel Symptoms:muscle aches, chills.
herpes zoster; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 11-MAy-2016, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and/or zoster-related conditions.   On an unspecified date, subsequent to patient's dose zoster vaccine live (ZOSTAVAX) inoculation, the patient presented shingles. As a direct and proximate result, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).