chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Loss of voice within 2 days of getting the booster; Laryngitis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administered in arm right, administration date 21Jan2022 (Lot number: F55683) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraines (one and off)" (unspecified if ongoing), notes: Migraines (one and off); "COVID-19" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Right), administration date: 27Feb2021, when the patient was 37 years old, for COVID-19 immunization, reaction(s): "Since the vaccination, the patient has been tested for COVID-19", "Since the vaccination, the patient has been tested for COVID-19"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9265, Location of injection: Arm Right), administration date: 01Feb2021, when the patient was 37 years old, for COVID-19 immunization, reaction(s): "Since the vaccination, the patient has been tested for COVID-19", "Since the vaccination, the patient has been tested for COVID-19". The following information was reported: APHONIA (non-serious) with onset 23Jan2022, outcome "not recovered", described as "Loss of voice within 2 days of getting the booster"; LARYNGITIS (non-serious) with onset 23Jan2022, outcome "not recovered", described as "Laryngitis". The events "loss of voice within 2 days of getting the booster" and "laryngitis" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of aphonia, laryngitis.  Additional information: This case was reported as non serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has been tested for COVID-19. The patient received (doctor believed cause at the time was laryngitis) treatment for the adverse event Prednisone.  Follow-up attempts are completed. No further information is expected.
Patient developed a 3-4" red, swollen rash on right thigh that was warm to the touch.
Slight swelling of tongue (sensation that tongue is suddenly too big for mouth) about 20 minutes following the shot and continuing over the next 22 hours and currently.
Ischemic Stroke, Hospitalization, Ambulance, arterial blood clot, loss of balance, atrial fibrillation , emergency room
This spontaneous report as received from a registered nurse refers to a 12 month old patient of unknown gender. On 29-APR-2014 the patient who was vaccinated with a dose of MMR II (strength, dose, route, lot # not reported) additionally received a dose PROQUAD (Merck) (strength, dose, route, lot # not reported) inadvertently instead of dose of VARIVAX (Merck) (strength, dose, route, lot # not reported) due to product confusion. No adverse effects were reported. Additional information has been requested.
Case number PHEH2014US025053, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 77 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
Escitalopram began to stop working for dark/depressive thoughts during the evening, no treatment was given.
"Covid Arm"  Raised, hard red and painful area surrounding injection site. Became apparent within 9 hours of 2nd vaccination.  Painful on day one, became itchy on day 2. No increase in size, but definite increase in redness and discomfort over 2 days.
pt devel lymph node swelling & days post vax then devel t101 & rash; MD contacted med given;
When the patient went to get up he felt light headed. We observed him and took blood pressure at 11:37 - Heart rate 78, o2 97 and BP 156/83, took again at 11:42 am heart rate 74, o2 97, BP 141/78, and took again at 11:47 heart rate 69, o2 97, and BP 137/78. I had the patient stand up to see how he was feeling. Patient stated that he was feeling better and we released him home with family at 11:50 am  and he stated that family member would drive home.
Diagnosed it to have allergy; Neck pain all her shoulder; Feeling pain on left side of body; Little bit pain on her right arm; Left shoulder/arm feels like she got shot in left arm; Pain behind her left ear going down her neck; Neck was kind of stiff and cant move neck easily; A spontaneous report was received from a 51-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced pain on the left side of the body, behind her left ear going down her neck, neck pain all her shoulder and little bit on her right arm, neck little stiff and can't move the neck easily, left shoulder/arm feels like she got shot in the left arm and allergy.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, after receiving the vaccine, the patient experienced pain on the left side of the body, behind her left ear going down her neck, neck pain all her shoulder and little bit on her right arm, neck little stiff and can't move the neck easily, left shoulder/arm feels like she got shot in the left arm. Went to a clinic and saw a Nurse and was treated with Methyl Prednisone, Benadryl and Cetirizine. Nurse diagnosed the events as allergy.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events is Unknown.; Reporter'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.
Severe elbow joint pain to the arm of injection site. Last shot in opposite arm same effect lasted 4 months.
Infant brought to ER 04/08/2003 in cardio-pulmonary arrest at 0039. Resuscitation attempted per DR but was unsuccessful. The autopsy report received on 1/28/04 states cardiomyopathy, and subendocardial fibroelastisis. The hospital discharge summary received on 1/28/04 states cranky and eye deviation.
Pt began crying loudly w/1st immun cont to cry w/2nd immun; lower extremities were cyanotic in spots-inside of thighs, inside legs below knees medially, both feet, buttocks none noted above waist; legs flushed no cyanotic;
Facial swelling; Redness and hot to touch on left side of face only.; Hot to touch on left side of face only.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 13Apr2021 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history included bipolar disorder and penicillin allergy. 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 vaccine. Concomitant medications included lithium (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN) and fluoxetine hydrochloride (PROZAC); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 23mar2021 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. On 18Apr2021 at 04:00, the patient experienced facial swelling accompanied with redness and hot to touch on left side of face only. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events facial swelling accompanied with redness and hot to touch on left side of face only were not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Eyes have gotten very bad where I can?t focus on anything 10 feet away. Extreme pain from shoulder blades through to chest unable to breathe because the pain was so bad
Case number PHEH2013US024641, is an initial spontaneous report received from a physician on 21 Nov 2013. This report refers to a 39-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13372P) intramuscularly on 18 Nov 2013. On the same day, immediately after vaccination she developed bad skin reaction and itching. After 10 minutes, her arm became hot and started swelling and within 15 minutes she developed facial swelling. The final outcome of the events was reported as completely recovered. The causality and seriousness of the event were not reported.
Patient experienced redness, hardness/swelling, and pain around injection site beginning the evening immediately after the vaccine. As of 11/23/2020 the diameter of red area was approximately 5 inches.
Received vaccines within 5min after became nausea's, dizzy, diaphoretic and vomited once. Symptoms resolved with 15 minutes rest supine and fluids.
This spontaneous report as received from a medical assistant refers to a 7 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 25-SEP-2018, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868 US-009507513-1902USA009324:Original Case : 1902USA009323 US-009507513-1902USA009323:Original Case : 1902USA009323 US-009507513-1902USA009326:Original Case : 1902USA009323.
This initial non-serious spontaneous case, received on 01-Sep-2017, reported by a pharmacist, concerning a 51 year-old male patient. Patient's medical history was not reported. On 01-Sep-2017, the patient received FLUVIRIN THIOMERSAL (dose: 0.5ml, route of administration: intramuscular, anatomical location was not reported, batch number: 1720801 as reported, expiry date: unspecified date in Apr-2018). It was reported that, the administered multi dose vial was opened and exposed to 51F for 13 hours, temp excursion above 46F (explicitly captured as incorrect product storage, drug administration error). However, no adverse effect was noted after administration. The outcome of the events was not reported.
1/20/21 underarm/armpit pain, swelling - lymph nodes  Day 7 post vaccine 1/21/21 same pain, continuing - Day 8 post vaccine
No adverse event; reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 069H21A, 030L20A and 025L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master Case
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent and historical conditions were not reported. The nurse reported that on or after 14-OCT-2015 the patients were vaccinated with improperly stored (at 34 Fahrenheit for 8 hours and 47 Fahrenheit for 14 hours, 45 minutes) doses of ROTATEQ (lot # L010844, expiration date 16-NOV-2016, dose unknown) orally. There were no temperature excursion issues previously. Concomitant therapies were not reported. No adverse effect was reported. Additional information has been requested.
After my flu shot my arm really hurt at the site of injection; much more than other years and lasted for days. It seemed to be given higher than in the past. About 2-3 weeks later I noticed pain when raising my arm about my head. By September 19th I really noticed the pain as I had a hard time taking off my clothes over my head and needed assistance. It continues to be painful when raised above my head to this day.
Case number PHEH2013US022485 is an initial spontaneous report from pharmacist received on 24 OCT 2013 with a follow up information received from a pharmacist on 19 NOV 2013. This case refers to an 81-years-old female patient. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1303501) intramuscularly on 18 SEP 2013. While FLUVIRIN administration , some of the vaccine oozed out at the injection site. The patient claimed that she felt liquid droplet came out of injection site. No adverse event was reported following this administration error.  Follow up information received from a pharmacist on 19 NOV 2013: Batch number, dose and date of vaccination updated.
weakness generalized; .                  This is a spontaneous report from a non contactable other health care professional, the patient. A 40 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration, and anatomical site as 2nd dose, single, on 16MAR2021 (at the age of 40-years-old) for COVID-19 immunization. Patient past drug history include BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not known) via an unspecified route of administration, anatomical site as 1st dose, single, on unspecified date for COVID-19 immunization. On 16MAR2021 after vaccination, during her 15 minute waiting period after the injection, the patient began to experience generalized weakness, need for a quick snack. She denied rash, shortness of breath, difficulty swallowing or syncope treatment included: snacks. It was reported that follow up response to treatment was good. Patient discharge: stable to go home. Clinical outcome of the event generalized weakness was reported as recovered .No follow-up attempts are possible. No further information is expected.
Patient describes hives over anterior neck and chest approximately 1-2 hours after receiving the injection. The rash lasted about 3-4 days and then resolved.
THROAT SWOLLEN BUT SPEAK AND  SWALLOW  Narrative:  Other Relevant History:
Patient has not had an adverse event. Based on the guidance provided by local authority stating monovalent vaccine is no longer recommended and to administer bivalent vaccine only, we administered the pink vial bivalent covid vaccine as a first primary dose. We were not made aware until days later that there would be a different vial and dose recommended to administer as a primary dose.
Patient experienced Dizziness and hypotension within fifteen minutes after vaccination. She  received supportive care while 911 was called until the arrival of paramedics.
(R) shoulder shrugging started approx 5 PM increased in freq intermittent and irregular. Gave BENADRYL at 9PM continued during sleep with decreased in freq has happened approx 2-3 times this morning.
unknown, patient tested positive for Covid-19 on 8/30/2022 at Hospital then admitted to facility unit
Initiated with extreme itching, redness that progressed to a raised rash--started on my L shoulder extended into my mid chest and down my arm to the  area above the AC. My arm looked like it was excoriated--and covered my bicep area---when the rash faded it left a tan/brown shading when it faded--my arm and chest looked like I had a tan.
Lethargic, headache, slight nausea. Chills and sensitive skin. Low grade fever lasting for about 24 hours.
abdominal pains fatigue unable to walk legs were weak shooting pains up and down back and legs headache fever, sore in mouth and muscle pain
post injection, c/o pain and tingling bilateral arms, chest tightness, and tongue "feels strange", difficulty breathing
Felt funny, dizzy took a bath around 2:00pm and then really started feeling bad and realized tht I had broke out in Hives all over.  Took Benadryl every 4 hours (4-25 mg tablests) Having trouble catching my breath, pulse was very fast.  Felt a little better on 10-18-09.  Went to work 10-19-09 can't take as much Benadryl at work feeling bad again. ears itch, eyes itch and toungue feels prickly.  Will be going to the doctor after work.
Information has been received from a physician concerning a 4-year-old female who on 06-SEP-2006 was vaccinate  subcutaneously with a 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  Concomitant vaccinations included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine.  On 08-SEP-2006 the patient experienced a large local reaction in the right arm (injection site arm).  It was noted that it had the look of red cellulitis.  Unspecified medical attention was sought and the patient was treated with cephalexin (KEFLEX).  Subsequently, the patient recovered on 11-SEP-2006.  No product quality complaint was involved.  The reporting physician considered the patient's experience to be an other important medical event.  Additional information has been requested. (OMIC)
This child received vax and the following day the pt experienced a fever of 101 F and vomiting.
BODY ACHES; LIGHT HEADEDNESS; GAS; TEMPERATURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: 25-MAY-2021) dose was not reported, administered on 19-MAR-2021 14:00 in the left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced body aches. On 20-MAR-2021, the subject experienced light headedness. On 20-MAR-2021, the subject experienced gas. On 20-MAR-2021, the subject experienced temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, light headedness, gas, and temperature. This report was non-serious.
Stomach pains on left side, especially under the last rib, down into hip area and sometimes across abdomen to right side, about two months after being on Rosuvastatin.. Doctor stopped Rosuvastatin. I also stopped Omeprazole.  Gastroenterologist PA put me back on Omeprazole on September 21, 2021 (Zoom appointment), 2X a day, and severe pain stopped although there are a few twinges. No mention was made of possible connection to the Moderna vaccine, only that the Rosuvastatin probably was irritating my stomach lining and intestines. I mentioned the stomach pains on my V-Safe Check-in just in case there was a connection.
25-year-old female administrative assistant received the flu shot on September 28th in her right deltoid. She points to just below her axial line in the mid deltoid as the injections site. Since the injection she reports progressive pain in the right shoulder which has been worsening. She rates her pain as an 8/10 constant, sharp and radiating distally from her anterior shoulder made worse with flexion and abduction, and reaching.  She denies pain around her injections site.  She denies numbness or tingling, and denies loss of power. She has been using Ibuprofen OTC for pain.
Sick in bed; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick in bed) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (Sick in bed). At the time of the report, ILLNESS (Sick in bed) had resolved.            The patient had no known allergies.  No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality with Humira for the event of sick in bed was not provided.  No treatment medications were reported.
PNEUMOVAX 23 administered on 11/20/14 - pt reports swelling and pain on 11/21/14 - says pain and soreness along with stiffness into shoulder - has rash on 11/22/14. ER visit. MD prescribes prednisone/ULTRAM/CLEOCIN.
Infectious colitis, 2 nights hospitalized with IV fluids and antibiotics.  Post discharge prescription dicyclomine