chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient wrote out a letter describing what happened to her.  She brought it to us at the pharmacy on 11/2/19.  Here's what she wrote: "Saturday, October 26th.  Normal day out and about running errands.  That evening took 1.5 hour ride to visit with family.  It was on the way home that I started to feel achy and tired.  Went to bed around 10pm. Around 3am, Sunday morning, I woke up and needed to go to the bathroom.  My hips ached and were tight - hard to move.  Rolled to my side and put my feet on the floor.  Once I stood up the pain was very bad.  The pain went up my entire body.  Tried to sit on the steps beside the bed.  Still very painful.  My husband woke up to help me.  Tried to turn and get back into bed and slid down the bed and hit my face on the bedside table.  It didn't bruise, but it hurt.  My husband got me up and I was in so much pain I started getting sweaty and clammy.  I couldn't explain what was going on.  He wanted to call an ambulance, but I didn't.  I told him I would get through this.  He helped me back in the bed.  I tried to stretch out the pain.  Finally able with his assistance was able to go to the bathroom.  Hard to sit down and then stand back up.  Finally able to go back to sleep. 9am Sunday morning (Oct 27th).  Tired, but able to move on my own.  Did stretches throughout the day to work it out.  Monday through Wednesday - ached some in the morning but throughout each day it would get better the more i moved.  Thursday and Friday I had little to no weird feelings.   Saturday November 2nd, 2019.  Woke up felt great.  Can't explain what caused this but scary."
Within 10 minutes of injection, nausea, vomiting and stool. Diaphoretic and flush, had to be cooled with cold washcloths, immediately put to stretcher, BP slightly elevated, Blood glucose normal at 105--returned to feeling better within 30-45 minutes, but was driven home as a precaution, within 12 hours after sleeping 6-7 hours resumed normal work activities.
Information has been received from a patient's daughter concerning a 60 year old female with no pertinent medical history who in "February or March 2007", was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck).  Concomitant therapy included LEXAPRO.  On 24-JUL-2007 the patient developed severe pain under her right shoulder that she describes as similar to "post herpetic neuralgia".  The patient never developed any type of rash.  Unspecified medical attention was sought.  X-rays and MRI studies were performed.  At the time of this report the patient had not recovered.  There was no further information provided.  There was no product quality complaint involved.  Additional information has been requested.
No adverse event reported. Patient was not eligible for a pfizer booster. Patient is 15 years old.
One week post vax, the pt developed a fever which lasted 4 days, sometimes high and sometimes low grade. On the third day, she developed spots on neck and upper torso. By the fifth day, the spots covered entire body even on face. Baby was cranky and did not sleep well.
Information has been received from a medical assistant concerning a 16 year old female who on an unspecified date, also reported as in August 2008, was vaccinated with GARDASIL in the arm (lot number and injection route not reported). Subsequently the patient developed unspecified arm pain at the injection site. Subsequently, the patient recovered from arm pain at the injection site without treatment. The patient did not sought any medical attention. Additional information has been requested.
Welts/shoulder to her elbow; product supply issue; This case was reported by a pharmacist via call center representative and described the occurrence of welts in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced welts and product supply issue. On an unknown date, the outcome of the welts and product supply issue were unknown.   It was unknown if the reporter considered the welts and product supply issue to be related to Shingrix and Shingrix.  Additional details were received as follows: After 1st vaccination, the patient experienced  welts from her shoulder to her elbow. Pharmacist states when it was time for the patient's second dose, the Shingrix was out of stock at the pharmacy. The reporter consented to follow up. Pharmacist states she did not have further information available at the time of this call, but she could get additional details from the patient. Pharmacist granted permission for follow up.
Patient was administered second dose Moderna vaccine early (Day 20).  Patient has experienced no s/sx of adverse effect. Patient is being monitored per caregiver and home health daily. Caregiver has been instructed to notify home health of any s/sx of adverse effects of vaccine.
Pt's 1st flu shot. Complains of "tightness" in throat about 10 mins after shot. Pt quite anxious abt. shot. Has clear breaths sounds, easy resp. effort given 1 tab of BENADRYL, vs stable.
11/15/2017  generalized fatigue and muscle aches. 12/9/2017 increased fatigue and starting pin and needles feeling in both feet. 12/15/17 pain in feet increasing, hard to ambulate, fatigue. 1/12/18 ER VISIT minimal ambulation, legs and arms weak, numbness noted, spreading from feet to arms. 1/19/18 Neurology visit with diagnosis of Guillian Barre ordered to recieve IVIG infusion. 2/19/18 EMG and nerve cobduction studies performed performed with demyelinating polyneuropathy- Guillian Barre.
Fever; Chills; Body aches; No energy; Vomiting; Nauseous; Just don't feel like sitting up; This is a spontaneous report from a contactable consumer (the patient). A 45-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, in left arm on 19May2021 17:00 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included iron deficiency anemia, migraines and pulmonary embolism (reported as PE's) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to 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. On 20May2021 03:00, the patient experienced fever, chills, body aches, no energy, vomiting, nauseous, just don't feel like sitting up. The consumer considered events as non-serious. The patient did not receive treatment for adverse events.  Information on the lot/batch number has been requested.
mouth tenderness; Lips feel sunburned and a little swollen; Lips feel sunburned and a little swollen; Gums are tender; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 13:00 as dose 1, single (Lot number: HH7595) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; ATORVASTATIN. Vaccination history included: pfizer covid- 19 vaccine (Dose Number: 6, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 11May2023, when the patient was 70-year-old, for Covid-19 immunization; pfizer covid- 19 vaccine (Dose Number: 5, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 11Sep2022, when the patient was 69-year-old, for Covid-19 immunization; pfizer covid- 19 vaccine (Dose Number: 4, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 07Apr2022, when the patient was 69-year-old, for Covid-19 immunization; pfizer covid- 19 vaccine (Dose Number: 3, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 21Oct2021, when the patient was 68-year-old, for Covid-19 immunization; pfizer covid- 19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 03Mar2021, when the patient was 68-year-old, for Covid-19 immunization; pfizer covid- 19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 09Feb2021, when the patient was 68-year-old, for Covid-19 immunization. The following information was reported: GINGIVAL PAIN (non-serious) with onset 20Sep2023, outcome "not recovered", described as "Gums are tender"; ORAL DISCOMFORT (non-serious), LIP SWELLING (non-serious) all with onset 20Sep2023, outcome "not recovered" and all described as "Lips feel sunburned and a little swollen"; ORAL PAIN (non-serious) with onset 20Sep2023, outcome "not recovered", described as "mouth tenderness". Therapeutic measures were not taken as a result of oral pain, oral discomfort, lip swelling, gingival pain. Additional information: Patient had no issues with first 6 covid vaccines. The 7th has caused mouth tenderness. Lips feel sunburned and a little swollen. Gums are tender. There was no covid prior vaccination. Patient was not tested for COVID post vaccination. There are no known allergies. Patient was on medicines for both high blood pressure and high cholesterol.
The evening after receiving MCV4 - had pain @site which progessed into neck,back and legs. Had headache, stiffness, in jaw and legs.  Chills , dizziness and sweating.  Very Pale. BP was 160/104. Lasted until 12/17/08.  Went to ER and they said she had influenza.  But symptoms went away in 2 days.
had heart palpitations with a fast heart beat; had heart palpitations with a fast heart beat; she doesn't feel good constantly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 13-year-old female patient received BNT162b2 (BNT162B2), on 02Jun2022 as dose 1, single (Lot number: FG4991) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious), HEART RATE INCREASED (non-serious), outcome "unknown" and all described as "had heart palpitations with a fast heart beat"; MALAISE (non-serious), outcome "unknown", described as "she doesn't feel good constantly".  Additional information: Caller is a grandmother, calling on behalf of her granddaughter. Caller reports her granddaughter received her first dose of the Pfizer covid 19 vaccine on 02Jun2022. Caller says her granddaughter has had heart palpitations with a fast heart beat that comes and goes since yesterday evening. The caller provided LOT FG4991. Caller declined transfer as she wants to prioritize medical care for patient at this time. Encouraged caller to contact granddaughter's primary doctor and if she were highly concerned could take the patient to the nearest emergency medical treatment center. Reporter stated, I am calling regarding my grand daughter. She got the COVID shot yesterday, the Pfizer and since she has got it, she feels like really fast palpitations and then it goes down and then she feels it again and she doesn't feel good constantly since yesterday.   Follow-up attempts are completed. No further information is expected.
DOSE ADMINISTERED FROM THE VIAL LEFT OUT FOR 4 HOURS AT ROOM TEMPERATURE; VIAL LEFT OUT FOR 4 HOURS AT ROOM TEMPERATURE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced dose administered from the vial left out for 4 hours at room temperature, and vial left out for 4 hours at room temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dose administered from the vial left out for 4 hours at room temperature and vial left out for 4 hours at room temperature was not reported. This report was non-serious.
Pt had tingling tongue and racing heart 15 min post vaccine O2 sat 98, HR 105 BP 140/90 Given 10 mg Zyrtec PO By min 30 post vaccine felt fully fine. HR 81, Os sat 99, BP 110/80 Pt to follow with PMD
1206 C/O nausea no emesis. Blood Preassure 124/70,HR 76, resp 17.sats 98%. 1220 nausea relieved left & went home with her sister.
Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) and SWELLING (Swelling) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness) and SWELLING (Swelling). At the time of the report, ERYTHEMA (Redness) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was  not reported.  Treatment information was not provided.
2" long & wide raised swollen area. Soreness TYLENOL, compresses.
Onset of Bell's palsy 1 hour after 1st dose of Pfizer vaccine received
Brief fainting episode. Flushing/sweating. Given water. BPs 97/59 (pulse 62), 108/61 (pulse 72). 100% O2 sat.
Severe menstrual cramps and GI distress during period, abnormally light flow.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that their facility was not able to download the digital data logger, they had been put on hold by the state at the moment. They would need to treat this issue as a temperature excursion. There had been no power outages that would have impacted the Moderna vaccine. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
erythema, tenderness, fever, induration @ DTP vax site; no response to ATB;
After injection pt began to swell at the site of injection only. Had patient wait for approx 30 minutes before leaving. She said that she felt fine no rash, itching on hives or difficulty breathing.
The Health Department was asked to vaccinate residents at the long term care facility, Health and Rehab.  Staff assisted this nurse by providing consents and vaccine cards for all that needed 2nd dose of Moderna vaccine. Patient, had a vaccine card marked with a Moderna dose given on 6-22-21.  The dose was given and the another facility at the facility denies any adverse reactions from the patient.  When documenting vaccines into Show Me Vax at the office afterward, I discovered that patient had received a dose of Moderna from pharmacy on 3-8-21, next dose of Moderna was given from another pharmacy on 6-22-21 and then again today 7-22-21 by our health department.  Pt was a poor historian.  I called to notify Manager at Health and Rehab of the error.  She was unaware of any previous dose given in March  stating the patient declined it before and this was documented in error.  Pt does not to appear to be having adverse reactions if this was her 3rd dose of Moderna vaccine.
A non-serious spontaneous report of administration of expired product has been received from a Registered Nurse concerning a seven-year-old male who received FLUMIST on 15-Nov-2008. FLUMIST expired on 12-Nov-2008. Medical history and concomitant medications were not reported. There was no adverse event reported with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. On 05-Jan-2009, the reporting nurse confirmed that there were no late-occurring adverse events reported.
1st dose given 05Feb2021; 2nd dose given 15Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given 05Feb2021; 2nd dose given 15Mar2021) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given 05Feb2021; 2nd dose given 15Mar2021). On 15-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given 05Feb2021; 2nd dose given 15Mar2021) had resolved.            No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-379996 (Patient Link).
Headache. Fever 100+, nausea, tiredness, dizziness,  chills
rash on both legs and arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on both legs and arms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MELOXICAM from 18-Feb-2021 to an unknown date for Pain.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (rash on both legs and arms). At the time of the report, RASH (rash on both legs and arms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not provided.  treatment medications included steroid cream for rash.  Company Comment: 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.   This case was linked to MOD-2021-286241 (Patient Link).; 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.
Site: Redness at Injection Site-Mild, Error: Wrong Dose of Vaccine - Too High-
Hands trembling; hand tremors/Parksinson's like tremors in her hands; I got the first shot and afterwards I got heart palpitations causing me to wear a heart monitor/heart palpitations; headaches; severe fatigue; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number: Unknown) via unspecified route of administration in the left arm, on 22Jan2021 (at the age of 75-years-old), as 1st dose, single for COVID-19 Immunization. Medical history and concomitant medications were not reported. On 22Jan2021, the patient experienced severe side effects: sever fatigue and headache. On 24Jan2021, heart palpitations and on 28Jan2021, Parkinson's like tremors in her hands. On an unspecified patient also experienced hands trembling. It was reported that on 05Feb2021, the patient had a Holter monitor on, attached for 24 hours to monitor her heart. The patient had called her neurologist to report Parkinson's like tremors in her hands and also stated after the vaccine that she had severe fatigue where she normally sleeps five hours slept for 14 hours. The patient wanted to know the recommendation for getting the second shot. Reporter seriousness: non-serious. On 31Jan2021 (reported as: 9 Day), the outcome of the event severe fatigue and headache was recovered. The outcome of the event heart palpitations, Parkinson's like tremors in her hands was not recovered. Outcome of the event hands trembling was unknown.  Information on the lot/batch number not available. Follow-up attempts have been completed and no further information is expected.
pt became blue, limp 1 1/2 hrs p/vax; adm to hosp for observation;
Extreme hives,welts,facial swelling and redness like a sunburn,injection site swelling(4 inches bigger than other arm), bone pain, tachycardia, wheezing,brain fog, muscle spasms, achey body, difficulty sleeping, headache, extreme fatigue, muscle/bone pain, nausea, chills,sweats broncho spasms, wheezing Started at Medrol Dose pak then increased steroids for 3 days, then tapering down every 3 days. Hydroxyzine, allegra, promethazine,tylenol,steroid sprays for skin, aveeno bath, ice albuterol inhaler, symbicort inhaler