chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; She got a little sick/Following the second dose she was a little sick for a few days; A little nauseous/ Nausea lasted for 2 days; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ILLNESS (She got a little sick/Following the second dose she was a little sick for a few days) and NAUSEA (A little nauseous/ Nausea lasted for 2 days) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Blood pressure high, Diabetes and Obesity.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), ILLNESS (She got a little sick/Following the second dose she was a little sick for a few days) and NAUSEA (A little nauseous/ Nausea lasted for 2 days). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and ILLNESS (She got a little sick/Following the second dose she was a little sick for a few days) and NAUSEA (A little nauseous/ Nausea lasted for 2 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2022-494417, MOD-2022-494503 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Reporter's type and Outcome of event Illness were updated.
Two weeks later my arm at the injection site is hot, red, and blotchy over a large area. I am occasionally also having pain in the other arm.
Injection site turned red, hard, warm to touch and itchy. Symptoms improving on Day 5
Symptoms of chills, shaking, headache, nauseous, unable to get warm.  Got out of bed 2:30am due to nausea. When I stood up I took about four steps then  passed out and fell down.  My husband found me lying on my back in our closet.
pt recv vax 18JAN96 & devel break-through varicella on 23MAR98;
This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hidradenitis suppurativa. Concomitant products included ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa. On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) outcome was unknown. It was unknown if patient was enrolled in a COVID-19 vaccine trial. No treatment medication was provided. This case was linked to MOD-2022-575209 (Patient Link).
AFTER THREE WEEKS PATIENT STARTED TO COMPLAIN ABOUT ITCHY SCALP AND RASH ON THE LOWER BACK NECK.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild
Low-grade fever between 99.6 and 100.6.  Rash at injection site on 2/3/2011.  Rashes and bumps on head, neck, chest and legs.  Diagnosis on 2/4/2011 was chickenpox.
This is a spontaneous report from a contactable Physician via Pfizer sales representative. A male patient of an unspecified age (16, Unit: unknown) and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose in the left arm for immunisation, MENACTRA, via an unspecified route of administration on an unspecified date at an unspecified dose in the left arm for immunisation and HPV9, via an unspecified route of administration on an unspecified date at an unspecified dose in the right arm for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe headache, severe fatigue, severe pain, redness, and swelling at the injection site on an unspecified date with outcome of unknown. Follow-up (09OCT2016): Follow-up attempts are completed. No further information is expected.
Individual RNA PCR at Clinic, a pharmacy within a Pharmacy. Case investigation has not been completed  at the time of this note.
ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE ACUTE ST ELEVATION MI, UNSPECIFIED HYPOTENSION HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA 11/12/2022,  11/15/2022,  3/17/2023,  3/10/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient passed out after a few minutes of injected the vaccine in the left arm. Patient was unresponsive for about 5 seconds but regain consciousness. Blood pressure was taking 163/95 and heart rate: 92. Called 911 for medical response team and firefighter team came to check out the patient. Patient said that he is ok and declined to be taking to the hospital for check up. Patient sat in the waiting room until 1pm for further observation and evaulated. Patient left the pharmacy with family membe
The patient they experienced fever, muscle pain, migraine headache, shivering, and that he couldn't up the whole day on Saturday.
Information has been received from a nurse at a physician's office that a "12 month old" patient with no medical history, received a dose of MMR II, injection (dose and lot number not provided) on approximately 03-OCT-2008 ("2 weeks ago"). The patient broke out in a rash "yesterday" on approximately 16-OCT-2008. The mother of the patient stated that it looks like measles, however did not come to the office for a check up. No fever reported. No laboratory diagnostic tests were performed. There was no product quality complaint. Additional information has been requested.
PATIENT ADMINISTERED VACCINE 1 DAY AFTER THE BEYOND USE DATE. NO KNOWN ADVERSE REACTIONS AFTER ADMINISTRATON.
Chills, fever, headache, muscle aches and restless leg one day after vaccinations.
Pt with completed primary DTaP's administered an alternate schedule at parents request. Pt with confirmed pertussis 6/15/12.*
After the vaccine there was some soreness in my left shoulder and headaches.  After about 4 to 5 days, my joints started aching.  Then I started to hear and feel my joints cracking.  This continues when I move  around.
No adverse event; lower than authorized dose of Moderna bivalent vaccine administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients).    No concomitant medications were provided. It was reported that 18 elderly patients received 0.25 mL dose instead of 0.5 mL dose. The patients had not reported any adverse reactions at that time.  No treatment medication was provided. This case contains information for the 5th of 18 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-666277, US-MODERNATX, INC.-MOD-2022-666284, US-MODERNATX, INC.-MOD-2022-666280, US-MODERNATX, INC.-MOD-2022-666278, US-MODERNATX, INC.-MOD-2022-666063, US-MODERNATX, INC.-MOD-2022-666249, US-MODERNATX, INC.-MOD-2022-666248, US-MODERNATX, INC.-MOD-2022-666250, US-MODERNATX, INC.-MOD-2022-666252, US-MODERNATX, INC.-MOD-2022-666255, US-MODERNATX, INC.-MOD-2022-666279, US-MODERNATX, INC.-MOD-2022-666281, US-MODERNATX, INC.-MOD-2022-666282, US-MODERNATX, INC.-MOD-2022-666283, US-MODERNATX, INC.-MOD-2022-666286, US-MODERNATX, INC.-MOD-2022-666290, US-MODERNATX, INC.-MOD-2022-666295 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666277: US-MODERNATX, INC.-MOD-2022-666280: US-MODERNATX, INC.-MOD-2022-666063: US-MODERNATX, INC.-MOD-2022-666284: US-MODERNATX, INC.-MOD-2022-666278: US-MODERNATX, INC.-MOD-2022-666249: US-MODERNATX, INC.-MOD-2022-666248: US-MODERNATX, INC.-MOD-2022-666250: US-MODERNATX, INC.-MOD-2022-666252: US-MODERNATX, INC.-MOD-2022-666255: US-MODERNATX, INC.-MOD-2022-666279: US-MODERNATX, INC.-MOD-2022-666281: US-MODERNATX, INC.-MOD-2022-666282: US-MODERNATX, INC.-MOD-2022-666283: US-MODERNATX, INC.-MOD-2022-666286: US-MODERNATX, INC.-MOD-2022-666290: US-MODERNATX, INC.-MOD-2022-666295:
The day after vaccination I had chest pain and tightness, which was bad for at least three months and still continues to bother me, but has lessened in severity.  It was accompanied by extreme fatigue and shortness of breath during exertion.  I also suffered from dizzy spells for about a month after vaccination.
Fainted approximately 5.5 hours (12:00am) after vaccine followed by diarrhea 30 minutes afterwards. I am still experiencing chills and fatigue.
Mild papular erythematous rash on chest, upper back, started 7-22-07, without pharyngitis or productive cough or fever.
Itchy welt-like rash. Oval- 3 inches by 2 inches
Bad headache/migraine the next night with vomit and diarrhea. Took  Excedrin. Felt groggy with mild headache the next two days.
Patient came into the store today 3 days after vaccination and had a red band along the top part of this arm. It was about 5 inches long red and warm to the touch, it was located approximately 3 inches beneath where the vaccine was administered
Patient vaccinated x3 (02/09/2021, 03/02/2021, 11/05/2021). Patient admitted to hospital 09/22/22 and tested COVID positive 09/23/2022.
Woke up with body aches, headache, low grade temperature.  Stayed in bed most of day(thu)  That evening finally took a couple tylenol because the aching was preventing me from sleeping.  Fri I felt better maybe a little tired.  Friday evening I started vomiting, and had diarrhea.  Fever was at 202 at highest.  Brain fog. Had severe chills for a couple hours.  Fever hung around 100 most of Saturday.   Have slight tightness in upper chest.  Occassional dry cough.  Occassional diarrhea.  Weak.  Sunday.  Still have occassional diarrhea.   Temp has been around 99.5.  Weak. But a little more energy.  Still have tightness in chest.
Next day my face was swollen- no treatment 3 days after vaccination my left shoulder ligament tear during normal use of my arm. - Pain medications Symptoms - joint pain.
The patient has a history of vasovagal response to needles sticks, injections, and perhaps to the sight of a needle.  In the recovery/observation area, he became pale and lightheaded.  His companion asked for help from EMTs stationed in the room.  After I spoke with the patient and at my suggestion, the EMTs helped the patient onto a gurney so he could recline and recover.  The patient was fine after 15 minutes, declined further care, and walked out of the room in the company of his companion.
Began experiencing shortness of breath and shaking within 6 hours of receiving vaccine. Patient was admitted to hospital due to severe symptoms. Patient start feeling better and was released from hospital within 2 days.
6 x 4cm area warm to touch not fluctuant; no fever poss secondary skin inf (cellulitis); rx w/Keflex
Information has been received from a physician concerning male patient of unknown age. The patient was vaccinated with the first dose of VAQTA, 0.5 ml, on 05JUL2006 and the second dose of VAQTA, 0.5 ml, was administered on 16AUG2006. No adverse effects were reported. No further information was provided. The outcome of the event was not specified. Additional information is not expected.
Within a few hours from getting the vaccine I was very tired. But the severe reactions started around 9 hours after I received the shot. I had the chills and then a fever. I had nausea so bad I couldn?t hardly eat all day. I was dizzy, short of breath, exhausted, and had a sore throat. I was so tired and so dizzy I couldn?t get out of bed all day. These symptoms lasted at least 24 hours. I am still slightly tired today and dealing with a mild sore throat and headache. The adverse effects I had from the moderna vaccine were awful. I couldn?t take care of my kid or do anything all day. I didn?t even have the energy to look for a thermometer.
Chills; Muscle pain; Joint pain; Nausea; Arm pain; Fever; Headaches; This is a spontaneous report from a contactable other hcp, the patient. A 39-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in Arm Left on 27May2021 17:45 (at the age of 39-years-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines in four weeks. The patient did not receive any concomitant medications in two weeks. On an unknown date in May2021, the patient experienced chills, muscle pain, joint pain, nausea, arm pain, fever, and headaches. It was unknown whether any therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of chills, muscle pain, joint pain, nausea, arm pain, fever and headaches were unknown at the time of this report.  Follow-up attempts completed. No further information is expected.
vaccines that expired on Saturday; This is a spontaneous report from a contactable consumer. This case is linked with AER #2021466018. A 69-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization on unspecified date on Saturday at 5:00PM. The patient's medical history and concomitant medications were not reported.  The caller is an assistant/manger of an urgent care and stated that one of her staff members administered two of the Pfizer BioNTech COVID-19 vaccines that expired on Saturday at 5:00PM to two different patients. Clarified with caller that this expiration date was contingent upon the undiluted vaccines being in the fridge at 2C to 8C, so this meant that the 5 days labeled time ended on Saturday at 5:00PM. She stated that the vaccines were in the fridge up until that morning which is when they were administered. Caller would like to know if there is any guidance on how to proceed.   E-transmitting AE due to long hold times.Response: Spoke from the attached document to let caller know about the 48 hours excursion time for undiluted vaccines at 2C to 8C in addition to the 120 hours labeled time. According to the caller, the vaccines were in the fridge at this temperature for less than the additional 48 hours excursion time. Sent document via email for caller's review. Of note, the attached "Revaccination after Administration of Invalid Dose" was also reviewed for further guidance, but not sent via email. The outcome of event was unknown.  No follow up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021466018 same reporter/product/event, different patient
Became diaphoretic, unresponsive for 20 seconds twice, nauseated, pale, cyanotic on forehead and fingertips.  Pt was slid to floor and elevated legs, cold compress to head and chest.  BP  90/50 pulse 76 after 5 minutes at 10 minutes BP 108/70, Pulse 78, Respirations were unlabored.  Pt talking stating feeling better at 13 minutes, at 20 minutes sat pt up and feeling better, redness coming back in cheeks, not dizzy,  talking,  BP at 25 minutes was 100/70.  Sat pt in a chair until 30 minutes past, stated he was fine to walk out with mom and brother.  Mom stated pt has a hx of passing out when getting shots after I had given the shot.
patient received second dose of IMOVAX RABIES on day 02 instead of 03/ NO AE; Initial information received on 14-Jun-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who received second dose RABIES (HDC) VACCINE [IMOVAX RABIES] (batch number and expiry date not reported) instead third day (inappropriate schedule of product administration) on 09-Jun-2021 for post exposure immunization.  The patient's past medical history included animal bite.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to drug dose administration interval too short.  Patient had never been vaccinated for rabies. Patient asking what is the recommended schedule. She was referred to the Hospital Outpatient Department for scheduling the remaining doses of vaccine. She was told she would need 4 total doses on days 0, 3, 7, and 14. The facility for the remainder of the vaccines is not open on weekends, so they scheduled her second vaccine dose on day 2 instead of day 3. She is concerned that her doses will be adequate for protection. She says that it seems schedule deviations are common for this facility since it is never open on weekends. The caller was reluctant to provide details.  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  There will be no information available on the batch number for this case.
Difficulty breathing 30 minutes after injection with dizziness, Symptoms subsided but reoccurred at 3 hrs and 6hrs. Dizziness continued sporadically  for the next 3 days.
Numbness and tingling through both shoulders and down back.  Every major muscle in body hurts.  In the morning, started getting very dizzy
Patient received the Pfizer monovalent covid vaccine instead of the Pfizer bivalent covid vaccine.
Body aches and fatigue started at 12pm and continued, in conjunction with temperature that got up to 101.0 by 4:00 pm. Sore arm at injection site. Body aches and fatigue increased and peaked at 5pm. Tylenol was taken at 5 pm, fever broke and body aches dissipated at 6pm. At 11pm, both symptoms including fever returned until another dose of Tylenol. Tylenol was taken around the clock for 24 hours until all symptoms were gone without treatment.   Additionally, chest pain and SOB started 1/16/21, lost of taste 1/17/21, tested POSITIVE for Covid on 1/18/21.
DEVELOPED PAIN IN THE BACK BELOW LEFT SHOULDER   WENT TO URGENT CARE ON A SUNDAY . XRAY TAKEN SHOWED PLEURISY  WAS GIVEN A PRESCRIPTION PREDNISONERGENR VCARE AND A BACTERIA FIGHTER. I WENT TO MY PRIMARY  DR. HE GAVE A PAIN MEDICINE  IT HELPED,  BUT THE PAIN RETURNED  AND THAT HELPED   BUT AS OF TODAY MAY 29TH THE PAIN IS COMING BACK
Case number PHEH2015US002934, is an initial spontaneous report received from a nurse on 06 Feb 2015. This report refers to a 38 year old male patient. Medical history and concomitant medication was not reported. On 14 Jan 2015, he received FLUVIRIN (batch number: 146525) 0.5 ml intramuscular that reached 48 degree Fahrenheit for 9 hours. Event outcome, seriousness and causality assessment was not reported. No further information was provided.
2 month female was accidentally injected with Menactra instead of ActHIB/ no AE; Initial information received on 24-Apr-2019 regarding an unsolicited valid non-serious case received from a Nurse via phone.  This case involves a two-months-old female patient who was vaccinated with 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] instead of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: U6153AA and expiry date: 20-Mar-2021) via intramuscular route in the left thigh on 03-Apr-2019.  Information on the batch number was requested for ACT-HIB.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX), PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) on an unknown date.  It was a case of actual medication error due to wrong vaccine administered. Patient was accidentally injected with Menactra instead of ActHIB.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.   Documents held by the sender: none.