chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm is already sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 08-MAR-2023, the patient received Shingles vaccine. On 08-MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm is already sore). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine just today and his/her arm was already sore. The patient stated that what he/she have seen it was better than the shingles. Follow-up would not possible as no contact details were available.
Mom describes golf ball size lump L deltoid noted 4 days post Dapt IM and IPV sc given L arm on 5/24/01. No streaks, hives or airway problems. Used caladryl for itching. Lump decreased to flat by 5/29/01.
PAIN ON LEFT BREAST; This spontaneous report received from a patient concerned a 45 year old female. 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: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced pain on left breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain on left breast. This report was non-serious.
Flu like symptoms - sneezing, running nose - weakness, & slight cough low grade temperature.
Patient given monovalent dose after date of authorization. Authorization expiration  date was 8/31/22. Provider unaware of expiration date at the time of administration. Notified of expiration date on 9/14/22, at which time the regulatory authority directed the provider to complete an event report. Shipment of bivalent booster doses was not received until 9/12/22.
Janssen COVID-19 Vaccine EUA - fatigue, body aches, fever (100.6), headache, chills
Acute onset of crying and screaming change in stools with development of sprasmodic abdominal pain and bloody stools that resolved over 3-4 days.
Client reported pain to the arm that he states has increased in the six months since receiving his second dose.  The client describes the pain as in his bone and in the last week is keeping him up at night.
Two hours after receiving the first doze, I started to get dizzy (the room started to spin). I contacted the pharmacy to ask if it was a common side effect, and the pharmacist told me to lie down on my side to see if the dizziness goes away in about 30 minutes. It didn't. I contacted the office of my primary care physician, and the nurse told me that it was not a common side effect, that I should go into the urgent care or ER. I did not take myself in, as I was feeling extremely dizzy. After 8 hours from getting the shot, I started to feel better and went to sleep. I felt better the next morning; however, I continued to have on and off dizziness/vertigo for the next 10 days, to the point that I chose not to drive my children around. In addition to dizziness/vertigo, during the first 10 days, I also experienced sensitivity to sounds and a feeling of a band around my head, squeezing. From day 11 to day 14, I experienced extreme fatigue. I was out of breath and my heart was racing from doing basic activities, such as cooking, cleaning the floor, and walking from one room to another.
8 days after receiving the vaccine, I was walking and had to go to the bathroom with terrible pain and I was bleeding excessively from my rectum. I went to the ER and was diagnosed with Colitis. No medication was administered. I was given fluids and pain meds an released from the hospital. The took an X-ray of my abdomen and said my intestines were swollen. I have completely recovered.
Full body itchy painful hives/welts; Full body itchy painful hives/welts; fatigue; light-headedness/dizziness; nausea; unable to stand for more than a few minutes at a time continuing on Day 6 after second dose; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program Pfizer RXPathways.   A 31-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Jul2021 at age of 31 years old (Batch/Lot Number: EW0198) as DOSE 2, SINGLE for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store.  None Medical history.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications the patient received within 2 weeks of vaccination. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jul2021 at age of 31 years old (Batch/Lot Number: EW0217) as DOSE 1, SINGLE for covid-19 immunisation.  The patient experienced Full body itchy painful hives/welts, fatigue, light-headedness, dizziness, nausea, unable to stand for more than a few minutes at a time continuing Day 6 after second dose (this report is written on Day 6 and these symptoms are still ongoing even with prescription steroids (a steroid shot).  Started date of events was on 31Jul2021. The events resulting Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient claimed a severe adverse reaction to COVID vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test (Rapid Test, Nasal Swab): negative on 01Aug2021, sars-cov-2 test (Nasal Swab, PCR): negative  on 01Aug2021.  Therapeutic measures were taken as a result of all events. The outcome of all events was not recovered.
Note: I have had 4 Moderna Covid 19 vaccines previously at the same location. All have been fine. The only unusual incident with any of those was 1 year ago, a very swollen lymph gland  (opposite side from the injection site), lasting 5 days, then subsiding fully.  This time, 2 days after the Moderna Bivalent Covid 19 shot, I had a sudden onset of abdominal cramping and constipation lasting two days, with low fever on the first day. I've been on a clear liquid diet for two days, now on day three I am consuming some soft low fiber foods but am having liquid diarrhea. This may or may not be a result of the vaccine, but no other obvious cause comes to mind.
Patient has been experiencing "excruciating pain" "waking up most nights in agony". Patient not able to fully use his left arm. Patient has been seen primary care physician and was prescribed prednisone and cephalexin.
Chills, fatigue, fever, congestion, rhinorrhea, sore throat, cough and myalgias.
Pains in my lower right side of my stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN LOWER (Pains in my lower right side of my stomach) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN LOWER (Pains in my lower right side of my stomach). At the time of the report, ABDOMINAL PAIN LOWER (Pains in my lower right side of my stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.
10 days post vaccination, injection site became itchy.  Patient noticed the site to be red and swollen.
Client collapsed while exiting vaccine room after vaccine administration. Client hit forehead against door handle as she fell forward and sideways against a staff member. Client landed on the floor on bilateral knees. Client was placed in supine position on the floor. Client lost consciousness for approximately 5 seconds. Client regained consciousness and answered questions appropriately . Client complained of feeling dizzy after regaining consciousness. Client denied nausea or vomiting. Cold compress was applied to forehead. Client's skin color was noted pale and non diaphoretic. A soft swelling 1inch by 1 inch  to right side of forehead was noted. Syncope symptoms resolved and client was discharged with instruction to have client evaluated by doctor.
Encephalitis; Sudden onset altered mental statues; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team and a sales representative.  An 82-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: ENCEPHALITIS (medically significant), outcome "unknown"; MENTAL STATUS CHANGES (non-serious), outcome "unknown", described as "Sudden onset altered mental statues".  Clinical course: Age 82 otherwise fully functioning. Event took place after use of product.  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.; Sender's Comments: Based on the temporal relation, the association between the event of encephalitis and the suspect product cannot be completely ruled out.  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.
Had shots yesteday, both in left leg, HIB and pneumococcal.  Last night noted area of redness and swelling, increased today.  Remains active, playful, no pain or restriction of movement.  Eating well.
After 5 minutes my arm started burning. Then I got cold sweats. After 20 minutes I was struggling to breathe. It felt like something was sitting on my chest. My lips and throat also got very itchy. I went over to a paramedic who gave me IV benadryl and something for nausea. My blood pressure and HR were initially high but lowered. My O2 was fine. Then I got really light headed and my tongue, throat, and whole face got more itchy. I then went to the ER and got epipen intramusclarly in the ambulance. At the hospital I got steroids and an IV bag. Around 3:30 I started to feel normal again. I stayed under observation for 4 hours. THen got discharged with a prescription of steroids.
Breakthrough case admission after three vaccines ; Moderna 1/30/21 Lot# 007M20A ; Moderna 2/27/21 Lot# 031L20A;  Moderna 11/11/21 LOt# 005C21A
Hives, rash around mouth and face after shot and lollipop, swollen eyes, red ears and neck, vomited clear, sleepy.
Aching at injection site, then throat began swelling and was dry, tightness in the chest, slight dry cough, fever and chills, vomited once, weakness, achy - went to bed and did not seek treatment.  The next day I awoke with a headache but, was better.  I did require more sleep that mid-morning.  The following day (on 9/4/10) felt fine.
shoulder pain; flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced shoulder pain and influenza-like symptoms. On an unknown date, the outcome of the shoulder pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the shoulder pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient came in to the store to get the second Shingrix vaccine. In the evening after getting the first Shingrix vaccine, the patient experienced shoulder pain and flu like symptoms. The reporter consented to follow up. The pharmacist stated she was filling in at this store, and was not the regular pharmacist.  The reporter did not get patient's name at time of discussion with patient, and is unable to provide details, other than what is provided at time of initial report. The reporter was agreeable to follow up via email.
Nausea for one day, decreased ability to use arm for two days, headaches for a week
My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-340460 (Patient Link).   Reporter did not allow further contact
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021 at 9:41 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        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.
Same day PM her Body rash, persistent crying for hours, crossing of eyes, diarrhea, 105F fever.
administered PENTACEL to a pediatric patient that expired with no reported AE; Initial information received on 16-May-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 3 months old female patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] that expired with no reported ae (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 23-Mar-2023 the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot: UJ668AA; expiry date: 13-May-2023) via intramuscular route in unknown administration site for immunisation.  On 15-May-2023, the patient received an unknown expired 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot: UJ668AA; expiry date: 13-May-2023) via intramuscular route in unknown administration site for immunisation with no reported ae (expired product administered) (same day latency).   It was reported that The patient did not experience anything and is still under the care and monitoring of the said physician. 3 vaccines were administered prior to PENTACEL but the reporter did not disclose the information about this.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered pentacel to a pediatric patient that expired with no reported ae.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Headache, low grade fever, joint pain, muscle aches, onset 14 hours post shot, resolved 12 hours after start, Advil taken orally
The rash on chest, it was like the dots were connecting & starting to fill in on my chest/ rash all over his body; It went from dots to blotches.; This spontaneous case was reported by a patient and describes the occurrence of RASH (The rash on chest, it was like the dots were connecting & starting to fill in on my chest/ rash all over his body) and RASH MACULAR (It went from dots to blotches.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     Patient had no allergies. Patient has never had Covid positive test or diagnosis. Patient did not receive other vaccines one month prior to Moderna Covid-19 vaccine.  Concurrent medical conditions included Thyroid function decreased (for the past 2 yrs) and Cardiac arrhythmia.   On 26-Jun-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2022, the patient experienced RASH (The rash on chest, it was like the dots were connecting & starting to fill in on my chest/ rash all over his body) and RASH MACULAR (It went from dots to blotches.). The patient was treated with PRAMOCAINE HYDROCHLORIDE (CERAVE ITCH RELIEF) at an unspecified dose and frequency; MAGNESIUM SULFATE (EPSOM SALT) at a dose of baths; OATMEAL at a dose of baths; BAKING SODA at a dose of baths; ALOE VERA at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, RASH (The rash on chest, it was like the dots were connecting & starting to fill in on my chest/ rash all over his body) and RASH MACULAR (It went from dots to blotches.) had not resolved.            No concomitant medications were reported. Patient received first booster and second booster dose. On 02-Jun-2022, patient saw a cardiologist and patent wore a cardiac monitor for 3 days. Patient sought medical care for the adverse event. The patient symptoms worsened.   This case was linked to MOD-2022-606692 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2022: Follow up contains updated narrative. On 11-Jul-2022: Follow up contains information on second booster dose (lot number) and updated event verbatim.
Headache, Myalgia, Arthralgia, Fever, fatigue Narrative:  date of vaccination 1/11/21 symptoms/complaints: a fever, headache, general body/ bone pain and fatigue
I received my second Varivax dose less than 28 days after the initial vaccination; worried; nervous; This spontaneous report as received from a 57 year old female patient referring to herself. The patient's concurrent conditions, medical history and concomitant medications were not provided.     On 24-APR-2019, she was vaccinated with her first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and on 09-JUN-2019, the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) for vaccination (before travel) (strength, dose, route, frequency, lot# and expiration date were not provided for both vaccines).  On 07-JUL-2019, she called in, and was nervous and worried about having received the varicella virus vaccine live (Oka/Merck) (VARIVAX) initial vaccination and second vaccination less that 4 weeks apart. She was worried and nervous that she also was receiving the second Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccination less than 1 month after her initial varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccination; and that the vaccinations she received on 05-JUL-2019 would not be effective and she would need to be re-vaccinated (inappropriate schedule of product administration). She stated she was feeling fine after receiving both varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) on 05-JUL-2019, but was just nervous and worried there would be a problem since she received the vaccinations outside of the recommended dosing schedule. She had already consulted the pharmacy who administered the vaccinations on 05-JUN-2019 (conflicting information, other vaccinations dates provided), regarding her concern and was informed by the pharmacy she would be fine. Despite the pharmacy telling her she would be fine, she was still nervous and worried about the situation. No laboratory data was provided. As of 07-JUL-2019, it was unknown if she would continue varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) and the outcome of the early vaccination was unknown. She continued to be worried and nervous.   The  causal relationship between the events and the varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) vaccines was not provided.
This spontaneous report as received from a pharmacy technician refers to a 37 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 15-MAY-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
PT REPORTED OF NUMBNESS AND TINGLING OF THE LEFT ARM AFTER VACCINATION, DENIES SOB, DYSPNEA, HIVES OR ITCHINESS, PT INSTRUCTED TO KEEPMOVING THE ARM TO HELP WITH THE SYMPTOMS AND EDUCATED THAT MAY EXPANDE MORE SIDE EFFECTS AS THE IMMUNE SYSTEM IS MORE RESPONCE TO 2ND DOSE. ALSO EDUCATED TO STAY HYDRATED, PT INSTRUCTED TO FINISH OUT 30 MIN OF OBSERVATION TIME AND TO NOTIFY TEAM IF SYMPTOMS WORSEN.