chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 14Feb2021 as dose 2, single (Lot number: EM9810, Expiration Date: 30Jun2021) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Comments: Breast cancer had breast cancer like 7 years ago. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9262, Expiry date: 31May2021), administration date: 24Jan2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "tenderness", "Chills". The following information was reported: TENDERNESS (non-serious), outcome "unknown".  Additional information: Patient did not have any significant reaction to any of her Pfizer covid vaccines and stated that she had no reactions just some local arm tenderness and one time that she can't tell when it was she had some chills but no fever at night. She thinks the tenderness of the arm she had that from all of the Pfizer Covid vaccines and the chills might have been from the first dose but she cannot remember.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271774 Same reporter/patient, same drug/different dose, different AE.;
rash covers 90% of her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash covers 90% of her body) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blood pressure (High) on 04-Dec-1998, Cholesterol (High) on 04-Dec-1998 and Hypothyroidism on 16-Aug-2009. Concomitant products included ATORVASTATIN from 04-Dec-1998 to 20-Apr-2021 for Cholesterol, LISINOPRIL from 04-Dec-1998 to 16-Apr-2021 for Hypertension, LEVOTHYROXINE from 16-Aug-2009 to an unknown date for Hypothyroidism, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) from 16-Aug-2009 to 20-Apr-2021 for Prevention.   On 19-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced RASH (rash covers 90% of her body). The patient was treated with HISTAMINE at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. At the time of the report, RASH (rash covers 90% of her body) outcome was unknown.            Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-052403.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Report document added Reporter email On 24-May-2021: Initial Additional-1 : VAERS, patients initials, DOB, med history, AE details, Date of Vaccination
She wants to get the second booster shot but she got COVID in March; She wants to get the second booster shot but she got COVID in March; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Mar2022, outcome "unknown" and all described as "She wants to get the second booster shot but she got COVID in March". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Consumer stated, she had COVID from like 19Mar but she was diagnosed officially on the 21Mar, she think she had the monoclonal antibodies (Treatment) either 22Mar or 23Mar and so they were going to go in a few weeks and she was hoping to be able to get second booster to make sure she was safe or safe as possible going over. So she was scheduling the second booster with here for 11Jun but its not quite 90 days. Its gonna be short by about 10 or 12 days and so she was wondering if its going to be safe for her to get that booster on 11Jun.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a physician via call center representative and described the occurrence of myalgia in a 41-year-old patient who received a BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, less than a week after receiving BOOSTRIX, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was unknown. It was unknown if the reporter considered the myalgia to be related to BOOSTRIX. Additional details were provided as follows: The patient who received BOOSTRIX couple days ago, was experiencing at the time of reporting severe myalgia of the neck, back, and shoulder area.
Muscle pain, headache, tired, fever for about 24 hours. 4" X 5" warm, itchy spot on my arm for 8 days.
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 female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years, 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing), notes: celiac; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Gluten" (unspecified if ongoing), notes: Known allergies: Gluten. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously receive a COVID-19 Vaccine. Patient did not receive other medication in 2 weeks.  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.
Information has been received from a certified medical assistant referring to an unspecified number of unspecified patients. On unspecified dates the patients were vaccinated with doses of improperly stored ROTATEQ orally (dose, frequency and lot# were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Description of Error: Patient presented at vaccination table after having documents and appointment reviewed by non-clinical staff, and identity was confirmed by RN Vaccinator using two unique identifiers (including DOB). Nurse vaccinator reviewed patient's responses to screening form completed and screened patient to confirm she was feeling well, had no history of anaphylaxis, does not carry an epi-pen for allergies, and had not received COVID vaccine previously. Nurse vaccinator educated patient on possible side effects of Moderna product. Patient indicated she wished to be immunized, received Moderna vaccine, and proceeded to observation area where she waited for fifteen minutes before departing from clinic without reporting any adverse event. Patient was later found to be 12 months (dose received on 17th birthday) under the minimum age of 18 years for receiving Moderna COVID-19 vaccine, thereby rendering the medication as administered outside the age limit of the applicable order.   Immediate Action/Intervention: Patient was under observation for CDC-mandated 15-minute period following vaccine administration. Upon review of records and discovery that dose was administered to patient who was 12 months too young to be eligible. Director of Nursing was informed of error and tasked with completing required documentation and performed root cause analysis.  Corrective Action by Individual & Program: RN vaccinator has identified need for including review of patient?s age during screening performed prior to every vaccine administration as necessary redundancy in the interest of patient safety in case ineligible patient is not correctly identified during clinic check-in process.  Director of Nursing/Chief Planning, COVID will ensure that signage is available throughout the clinic stating minimum age for vaccine and ensure that there is an announcement at each trainings prior to the start of each clinic.
"tickle in throat" - 2:41pm 25mg oral benadryl - 2:47 pm Sx resolved - 3:15pm monitored 45min - went home 4pm
Rash on chest and arms.; Dose received: 3/ Dose number= 3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 14Dec2021 at 14:30 (batch number: FD0809) at the age of 57 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: ER8731; Anatomical location: Left Arm), administration date: 14Apr2021, when the patient was 57 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0165; Anatomical location: Left Arm), administration date: 06May2021, when the patient was 57 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 at 14:30, outcome "unknown", described as "Dose received: 3/ Dose number= 3"; RASH (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Rash on chest and arms". Therapeutic measures were taken as a result of rash.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures for RASH included treatment with Benadryl.
2-3 hrs after flulaval injection, client broke out in itchy, red rash with welts abdomen and back. Speads to face. MD called. Benadrl 50 mg IM given/LD. Symptoms worsening.To ER, private car driven by school nurse. No throat or breathing difficulties. DC'd home at 6 PM. Rash cleared by AM Sat 10/11/08.
pt recv vax 1NOV95 & 28FEB98 pt exp widely scattered chickenpox described as vesicles on an erythematous base;devel one on back, one on the lt foot, two on the chin;visit to a MD was required;
Nausea/vomiting for 24 hours after shot, muscle/joint pain for 3 days after shot, bilateral hand neuropathy (continuing) since 2 hours after first shot.
Patient states that reaction happened within the first 2 minutes after injection and subsided within 30 minutes.  States that the top half of her middle finer became white with numbness and tingling.  Denies any hx of Reynauds.  Patient was monitored by provider on site during incident.    Note  Patient also reported incident through VAERS
Developed fever & urticaria 1-2 hrs post vax; Temp not taken @ home but 102.8 @ clinic;Also had prolonged crying/screaming for several hrs beginning 1 hrs post vax; Tx APAP & DPH;
About ten hours after the inoculation I developed a fever of 100.4 along with muscle aches/cramps. My fever broke the next morning, but I still felt very weak and sick. This morning I feel much better.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug allergies/reactions were not provided. On an unspecified date, the patient was vaccinated with an improperly stored doses of PEDVAXHIB lot# reported as: M047666, expiration date: 24-OCT-2019 for prophylaxis (dose, frequency, route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion 32 degree Fahrenheit to 35 degree Fahrenheit for 6 hours. There were no adverse effects reported. There was no previous temperature excursion. Data logger was involved. The outcome were unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
Broke the bone of my eye socket (bottom part); Broke my right-hand wrist; Broke my right-hand wrist; I slipped outside while given food to birds; A spontaneous report was received from a consumer who was a 50- year-old female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, slipped outside while giving food to birds(fall), broke her right-hand wrist (hand fracture; wrist fracture) and broke the bone of her eye (facial bone fracture).   The patient's medical history was not provided. Concomitant medications reported included lisinopril and vitamins.  On 30-JAN-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot: 010M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 20-FEB-2021, patient reported that she slipped outside while giving food to birds.  She stated that she broke her right hand and wrist as well as the bottom part of her eye socket.  The patient was scheduled to receive the second dose of mRNA-1273 on 27-FEB-2021 and was unsure as to whether or not to get it due to the fact that she had recently received a Tetanus vaccine.  Treatment for the events  included a cast to the right upper extremity and a tetanus shot to the right arm on 20-FEB-2021.  Action taken with mRNA-1273 in response to the events was unknown.  At the time of this report, the events, slipped outside while giving food to birds(fall), broke her right-hand wrist (hand fracture; wrist fracture) and broke the bone of her eye (facial bone fracture), were considered recovering/resolving.; Reporter's Comments: This case concerns a 50 year old, female patient, who experienced a serious unexpected event of Facial bones fracture, hand fracture, wrist fracture, and fall, 22 day after receiving 1st dose of mRNA- 1273 (Lot# 010M20A). Based on the mechanism of action of mRNA-1273, the events are assessed as unlikely related to mRNA-1273. Further information has been requested.
COVID-19 vaccine induced thrombocytopenia; This literature-non-study case was reported in a literature article and describes the occurrence of THROMBOCYTOPENIA (COVID-19 vaccine induced thrombocytopenia) in a 25-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.      No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOCYTOPENIA (COVID-19 vaccine induced thrombocytopenia) (seriousness criterion medically significant). At the time of the report, THROMBOCYTOPENIA (COVID-19 vaccine induced thrombocytopenia) outcome was unknown. Related      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered THROMBOCYTOPENIA (COVID-19 vaccine induced thrombocytopenia) to be related.    No concomitant and treatment medications were reported  Company Comment: This spontaneous case concerns a 25-year-old, female patient with no reported medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest Thrombocytopenia. The event occurred on an unspecified date after receiving a dose of mRNA-1273 vaccine. Clinical course, including presenting symptoms and etiologic investigations, and treatment details were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 25-year-old, female patient with no reported medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest Thrombocytopenia. The event occurred on an unspecified date after receiving a dose of mRNA-1273 vaccine. Clinical course, including presenting symptoms and etiologic investigations, and treatment details were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pfizer was given 10-12-2021.   The resident had received Moderna  1-2-2021 and 1-30-2021. It was requested that he  recieve a first dose of Pfizer, Vaccine administration form was completed with inaccurate data at the facility.
shingles came back; non-stop heavy bleeding since 13 days; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (non-stop heavy bleeding since 13 days), HERPES ZOSTER (shingles came back) and PALPITATIONS (Palpitations) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced PALPITATIONS (Palpitations). On 05-Jun-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (non-stop heavy bleeding since 13 days). On 13-Jun-2021, the patient experienced HERPES ZOSTER (shingles came back). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Shingles, at a dose of 1 dosage form. At the time of the report, HEAVY MENSTRUAL BLEEDING (non-stop heavy bleeding since 13 days), HERPES ZOSTER (shingles came back) and PALPITATIONS (Palpitations) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jun-2021, Heart rate increased: abnormal (abnormal) Fast Heartbeat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
I have developed Brachioradial pruritus which has caused severe inflamation of the nervous system
pt recvd vax 8NOV89 IV instead of SQ; @ time of the report, there were no noted problems;
shingles lesion on her waist; Headache; Vertigo; Fever; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 24th July 2021, 1 days after receiving Shingrix, the patient experienced headache, vertigo and fever. On 26th July 2021, the patient experienced shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On 27th July 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the shingles, headache and vertigo were not recovered/not resolved.   It was unknown if the reporter considered the shingles, headache, vertigo and fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received her second dose of Shingrix and experienced headache, vertigo, and a fever the next day. And the day after that she developed shingles lesion on her waist. She saw her dermatologist and was prescribed an antiviral medication. The fever was resolved till the time of reporting but other symptoms were still unresolved. Lot number for vaccine was unknown. The reporter declined to provide HCP information. The reporter did not consent to follow up.
Chills (possibly before I realized I was having side-effects) Extreme Fatigue Extreme Muscle Soreness (hurt to touch my own body, to sit, to lay) Extreme Joint Pain (swollen hands from trying to use computer)
7/27/2021: 76 year old male with PMH of CAD, CKD stage 3, HLD, PVD, hypothyroidism, bipolar, parkinson's disease, and HTN who presented to the ED due to worsening COVID symptoms. Patient states that he was at a family party on the 18th which he feels is his possible exposure to Covid as his sister, brother-in-law, and niece were all diagnosed with Covid afterward. Patient states that his symptoms started on the 21st, which consisted of nausea, diarrhea, productive cough, wheezing, and fever.  He presented to the ED on the 23rd and at that time was diagnosed with Covid.  Patient was discharged home at that time with an inhaled steroid and decongestant and advised to hydrate and quarantine for 2 weeks.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 55-year-old female patient who received SHINGRIX (batch number 9277N, expiry date 27th June 2021) for prophylaxis. On 3rd February 2019, the patient received SHINGRIX (intramuscular) .5 ml. On 3rd February 2019, less than a day after receiving SHINGRIX, the patient experienced injection site erythema. The patient was treated with CLARITIN. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported a patient had severe redness at the injection site following SHINGRIX. Within hours of the injection the redness was the size of a quarter. The redness had been growing by the hour since and was now 3 by 5 inch. The patient took some CLARITIN the day before reporting, but the redness was still growing.
Had COVID shot March 2, got headache right away, lasted 4 days, resolved.  Then on March 8 she had a stroke affecting R side of the body.  It was not severe, and it is already partially recovering.
Information has been received from a nurse concerning a 24 year old female, who on 05-MAR-2008, was administered her first dose of GARDASIL. Subsequently, the patient experienced hair loss "since she was given the first dose of " GARDASIL.  The patient was administered second dose of GARDASIL on 06-MAY-2008, and third dose on 08-SEP-2008. The patient's hair loss persisted. Additional information has been requested.