chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was red, wealty, rasied, feverish and very sore.; I had a spot that was the size of a silver dollar.  It felt and looked like a bruise; I had a spot that was the size of a silver dollar. It was sore.; It was red, wealty, rasied, feverish and very sore.; It was red, wealty, rasied, feverish and very sore.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (It was red, wealty, rasied, feverish and very sore.), VACCINATION SITE BRUISING (I had a spot that was the size of a silver dollar.  It felt and looked like a bruise), VACCINATION SITE PAIN (I had a spot that was the size of a silver dollar. It was sore.), VACCINATION SITE ERYTHEMA (It was red, wealty, rasied, feverish and very sore.) and VACCINATION SITE URTICARIA (It was red, wealty, rasied, feverish and very sore.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (It was red, wealty, rasied, feverish and very sore.), VACCINATION SITE BRUISING (I had a spot that was the size of a silver dollar.  It felt and looked like a bruise), VACCINATION SITE PAIN (I had a spot that was the size of a silver dollar. It was sore.), VACCINATION SITE ERYTHEMA (It was red, wealty, rasied, feverish and very sore.) and VACCINATION SITE URTICARIA (It was red, wealty, rasied, feverish and very sore.). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (It was red, wealty, rasied, feverish and very sore.), VACCINATION SITE BRUISING (I had a spot that was the size of a silver dollar.  It felt and looked like a bruise), VACCINATION SITE PAIN (I had a spot that was the size of a silver dollar. It was sore.), VACCINATION SITE ERYTHEMA (It was red, wealty, rasied, feverish and very sore.) and VACCINATION SITE URTICARIA (It was red, wealty, rasied, feverish and very sore.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.  Further information have been request.
Extreme joint pain and muscle aches. Unable to hold items or stand up straight, difficulty walking. Headache and pain at injection site. Pain by left armpit and breast. Pain in left thigh when sitting.  Fever (100.1) and chills. Abdominal cramping. Heart palpitations. Nerve pain all over. Intermittent chest pain.   Five months later, still having mild-moderate joint pain. Saw PCP. Bloodwork showed change in thyroid-hypo. Referred to Rheumatologist.
Hallucinations; Lethargic; Dizziness; Headache; Muscle aches; Vaccination site pain; A spontaneous report was received from a consumer concerning herself, a 66-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain, headache, lethargic, muscle ache, dizziness, and hallucinations.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On 14 Jan 2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch#: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the same day as the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch#: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient became lethargic and experienced headache, muscle ache, dizziness, and hallucinations. Treatment for the events included acetaminophen (one a day), warm cloth and cold compress.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events were not applicable.  The outcome of the events, headache, lethargy, muscle ache, dizziness and hallucinations were 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 event, a causal relationship cannot be excluded.  Further information has been requested.
- arm pain, throbbing stabbing pain from fingers to shoulders - cannot lift arms - No redness or swelling Advised pt to contact MD in morning
She got her vaccine, it hurt really bad getting it.  Then getting around dinner time she started getting a fever, her arm swelled up, red and she felt like her whole body was in a flu-like state.  She was this way for a week.  Due to her allergies and having a stroke that she can only take Tylenol arthritis.  This medicine does not help much for her.  She is in a lot of pain, has been tried on Gabapentin and was drugged up on it.  She did call her doctor and they said to ice it, rest, fluids, and if it got worse to come in.
Fever; Cold symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, 1 day after receiving Meningococcal B vaccine, the patient experienced fever and cold symptoms. On an unknown date, the outcome of the fever and cold symptoms were unknown.   It was unknown if the reporter considered the fever and cold symptoms to be related to Meningococcal B vaccine.  Additional information was provided as follows: The case was reported by the parent who reported for son. The age at vaccination was not reported. The patient received Meningococcal B vaccine and experienced terrible fever and cold symptoms the very next day.
had rashes on both arms but not on the injection site; This is a spontaneous report from a contactable consumer (patient's husband) from a Pfizer sponsored program COVAX US Support. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration on 07May2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 07May2021, the patient received the second dose of Pfizer Covid-19 vaccine and had rashes on both arms but not on the injection site. They enquired how long the rashes will last. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Swelling thigh (diffuse) fever 100.7, vomited X1.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. At the time of patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced patient to be vaccinated. Alternatively, in 2013, the patient's healthcare providers, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The event was considered related to zoster vaccine live (ZOSTAVAX).
Painful, blistering rash developing right (opposite) arm and hand. Causing difficulty to perform job. Dr. called in methylprednisolone pack and valacyclovir on 8/23/20. Treatment ongoing.
Large local reaction in area of injection left thigh 5" x 7" : started within 24 hours of injection.
No additional AE.; an improperly stored vaccine was administered to a patient; This spontaneous report was received from a registered nurse and refers to a 4-year-old male patient. The patient's concurrent conditions or medical history was not provided.  On 18-OCT-2022 the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA) (lot # U029319, expiration date: 19-MAR-2023),0.5 milliliter, subcutaneous in the right vastus lateralis for prophylaxis. The same day the patient was also vaccinated with improperly stored diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) and influenza vaccine. Patient also received COVID 19 vaccine on 26-SEP-2022.  Administered dose of vaccine experienced the temperature excursion of 10.8 degrees Fahrenheit (F) for 18 hours 30 minutes. There was no previous temperature excursion.  There was no adverse event reported.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 2:21 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 63.37. Concomitant products were not provided.  On 27-Oct-2021, Excursion time was 09 AM,10 AM temperature was 29, 32, total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021, 05-Oct-2021 vial was moved to clinic on 27-Oct-2021. 2,4 vials were sent to clinic. Vaccine BUD date was 29- Oct -2021, 04-Nov-2021. On 27-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM: 46, 3 PM: 46, 4 PM: 46 and 5 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
No Adverse Event; 10-year-old patient received a booster dose of Moderna COVID-19 vaccine from a Bivalent vial dark pink cap and yellow label on 12-Jan-2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (10-year-old patient received a booster dose of Moderna COVID-19 vaccine from a Bivalent vial dark pink cap and yellow label on 12-Jan-2023.) and NO ADVERSE EVENT (No Adverse Event) in a 10-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (10-year-old patient received a booster dose of Moderna COVID-19 vaccine from a Bivalent vial dark pink cap and yellow label on 12-Jan-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (10-year-old patient received a booster dose of Moderna COVID-19 vaccine from a Bivalent vial dark pink cap and yellow label on 12-Jan-2023.) 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 WRONG PRODUCT ADMINISTERED (10-year-old patient received a booster dose of Moderna COVID-19 vaccine from a Bivalent vial dark pink cap and yellow label on 12-Jan-2023.).    No relevant concomitant medications were reported.  No treatment information was provided.
I administered KINRIX to a 15 month old and that immunization is suggested for ages 4-6 years of age.
symptoms of myocarditis include chest pains, heart palpitations and shortness of breath; Difficulty lifting my left arm higher than my shoulder.; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9809), via an unspecified route of administration on 11Feb2021 at 15:00 (at the age of 65-year-old), as dose 2, single in left arm for COVID-19 immunisation in other facility. The patient's medical history was reported as none. The patient had no known allergies. Concomitant medications within 2 weeks of vaccination included acyclovir taken for an unspecified indication, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9263), via an unspecified route of administration on 21Jan2021 (at the age of 65-year-old) as single dose in left arm for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021, 12 days after the administration of second dose of vaccine, the patient experienced difficulty in lifting her left arm higher than her shoulder; which lasted over a week and got worse before she went to the hospital. On 23Mar2021, 1 month and 12 days after the administration of the second dose of vaccine, the patient experienced symptoms of myocarditis include chest pains, heart palpitations and shortness of breath. The adverse events resulted in visit of emergency room. Treatment medications included anti-inflammatory and muscle relaxer. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal swab): negative; on 04Jun2021. The patient had no COVID prior vaccination and was tested COVID post vaccination. The clinical outcome of all the events was resolved on unspecified dates in 2021.  Follow-up attempts are completed. No further information is expected.
patient received PENTACEL and DAPTACEL on the same day with no reported adverse event; Initial information received on 25-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15 months old and unknown gender patient who received pentacel and diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] on the same day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Prophylactic vaccination.  On an unknown date, the patient received unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  On an unknown date the patient developed a non-serious event "patient received pentacel and daptacel on the same day with no reported adverse event (contraindicated product administered)" (unknown latency) following the administration of diphtheria-15/tetanus/5 AC pertussis vaccine.  Action taken: not applicable.  Outcome: Unknown   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.
Staff member checked on her at 3am and patient stated that she felt like she couldn't breathe.  911 was called and taken to the hospital.  While in the ambulance, patient coded.  Patient was given CPR and "brought back".  Once at the hospital, patient was placed on a ventilator and efforts were made to contact the guardian for end of life decisions.  Two EEGs were given to determine that patient had no brain activity.  Guardian, made the decision to end all life saving measures.  Patient was taken off the ventilator on 1/9/2021 and passed away at 1:30am on 1/10/2021.  The initial indication from the ICU doctor was the patient had a mucus plug that she couldn't clear.
Narrative:  COVID infection following COVID vaccine series 08/05 COVID vaccine dose #1 of 1 09/29 reports sore throat, cough, dyspnea 10/02 COVID positive, seen in ED due to  productive cough x 2 weeks, no nausea/vomiting but spits up when coughing, fever 1 week ago w/ chills, body aches; rx'd albuterol, Tessalon, guaifenesin DM, discharged home 10/05 COVID positive (re-tested due to work), no symptoms 10/06 clinically resolved
Red and swollen down arm thru elbow with pain. Fever on Tuesday 11/7.
Shoulder pain in joint (rather than normal muscle pain) within 1 hr of shot, pain lessened but did not disappear after several days. Pain increased with activity. Primary care provider treated with 5 day course of oral steroids (prednisone) starting ~3 weeks after onset of pain, which lessened pain but did not eliminate it. Pain later increased again with use in the workplace (lifting ~10-20lbs) and did not go away, currently six days into physical therapy with mild improvement in pain. The shoulder pain requires adjustment/limitation of normal activities (driving, opening doors, lifting/carrying >10lbs).
Had significant leakage from the sight of injection; A spontaneous report was received from a pharmacist concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and had significant leakage from the sight of injection.  No relevant medical history and concomitant medications were reported.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient received the vaccine and had significant leakage at the sight of the injection. No treatment information was provided.  Action taken with mRNA-1273 in response to the event were not reported.   The outcome of the event had significant leakage from the sight of injection was considered to be resolved on an unspecified date.; Reporter's Comments: This concerns a patient of unknown age who received their first of two planned doses of mRNA-1273 (lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection and had significant leakage at the sight of the injection. There were no reported adverse events associated with the event of injection site leaking.