chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 11th September 2018, refer case US2018208355). On 9th November 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 9th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, fever, sweating, muscle soreness and intramuscular formulation administered by other route. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site erythema and muscle soreness were not recovered/not resolved and the outcome of the fever and sweating were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, fever, sweating and muscle soreness to be related to SHINGRIX. Additional details were reported as follows: The patient experienced the same symptoms as 1st dose. However, the second time she experienced fever, sweating, muscle soreness. The patient experienced these symptoms the same day she had the vaccine and they were gone by the next morning. However, the patient said that she still had some redness and soreness at the injection site. The patient received SHINGRIX subcutaneously instead of intramuscularly, which led to incorrect route of vaccine administration. The reporter did not give consent to follow up.
Redness, Swelling, itchy, bruising, hard lump, tender to the touch, Upper arm feels tight when trying to raise up, throbbing. Going on 5 days since getting  vaccine. No signs of improvement, very itchy on day 5. Spoke with local pharmacist for advice. She recommended this website and to  go get  it looked at by a doctor.
Pt recv vax on 11/11/98; on 11/18/98 pt exp red circumscribed area w/ induration
This case was reported by a consumer (subject) and described the occurrence of difficulty breathing in a 66-year-old female subject who was vaccinated with influenza vaccine (unspecified) (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to formaldehyde. The subject experienced second-hand smoke exposure. Concurrent medications included trazodone and XANAX. In October 2010 the subject received a dose of influenza vaccine (unspecified) (unknown details, left arm). In October 2010, less than one day ("within 24 hours") after vaccination with influenza vaccine (unspecified), the subject experienced difficulty breathing. The subject was told the difficulty breathing "may have happened due to the vaccine having formaldehyde." In September 2012, the subject was diagnosed with chronic obstructive pulmonary disease. The subject "was not sure if this was related to the flu vaccine but she said it might be." At the time of reporting the event of difficulty breathing was resolved. Per the subject, the "difficulty breathing only lasted for less than one day." The subject reported that chronic obstructive pulmonary disorder were unresolved. The subject did consult a healthcare professional regarding the event(s); however, she reported that medical attention was not required. The subject reported 2 other cases with influenza vaccine (unspecified). See cases A1044321A and A1044322A for details on the other cases.
This spontaneous report as received from a physician refers to a 7 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-APR-2016, the patient was vaccinated with the first dose of ROTATEQ (orally, expiration date 23-OCT-2017, lot # reported as M004885; dose was not reported). No adverse effect was reported. Additional information has been requested.
chronic cardio-resp disease; between shortages and my health- on prednisone twice, never got 2nd shot; This case was reported by a consumer via call center representative and described the occurrence of chronic pulmonary heart disease in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Approximately 4.5 years after receiving Shingrix). Previously administered products included Shingles vaccine (received shot 6 years ago) and Prednisone (received twice).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced chronic pulmonary heart disease (serious criteria GSK medically significant) and product supply issue. On an unknown date, the outcome of the chronic pulmonary heart disease and product supply issue were unknown.   It was unknown if the reporter considered the chronic pulmonary heart disease to be related to Shingrix. It was unknown if the reporter considered the product supply issue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had 1st dose of Shingrix approximately 14 months ago from the time of reporting. Then between shortages and health- On Prednisolone twice, the patient never got 2nd shot. Finally the patient was diagnosed with chronic cardio-respiratory disease.  The patient asked, It was likely that, the patient had any protection from 1st dose alone? Would he/she need to start over or could just get 2nd shot? The patient asked 3 physician who said didn't know.
Swelling in bottom lip in corner occurred 3 hours after Moderna Vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of LIP SWELLING (Swelling in bottom lip in corner occurred 3 hours after Moderna Vaccination) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE for an unknown indication.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced LIP SWELLING (Swelling in bottom lip in corner occurred 3 hours after Moderna Vaccination). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swelling in bottom lip in corner occurred 3 hours after Moderna Vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Reaction started out with a localized 3-4 inch inflamed reaction. It looked very similar to hives. This was on Friday, March 19th, 2021 around 9 PM. I went to sleep and woke up the next morning and it was still there. I took benadryl and one ibuprofen to help the inflammation and the reaction, but it only got worse following this. I then had intense tactile and mechanical allodynia, which is often associated with my diagnosis of fibromyalgia, but this has been very intense. The allodynia had been occurring across my left hand up to my elbow, but has now moved to both of my arms, my neck, my entire back (more severely around the ribs), my chest, and my feet. I am very fatigued and feel feverish. My current temperature is only 99.2, but the pain is still active. Today is Sunday, March 21st, 2021. I got the vaccine on Saturday, March 13th, 2021 and this reaction is following the vaccine about a week after.
This case was reported by a healthcare professional and described the occurrence of fever in a 2-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  The subject had no pre-existing medical conditions.  There were no concurrent medications.  On 28 November 2006 the subject received 1st dose of Pediarix.  On 28 November 2006 the subject also received PedvaxHIB (Merck) and Prevnar (Lederle Labs).  On 29 November 2006, 1 day after vaccination with Pediarix, the subject experienced a "high" fever, pain and "uncontrolled" crying.  The subject was seen at a physician's office.  The healthcare professional considered the events were clinically significant (or requiring intervention).  The fever resolved on 30 November 2006.  At the time of initial reporting, 18 December 2006, the crying and pain were ongoing.  The healthcare professional considered the events were probably related to vaccination with Pediarix.  Follow-up information was received on 13 April 2007.  The subject received PedvaxHIB and Prevnar intramuscularly.  The reporting healthcare professional indicated the events improved on 16 January 2007.  At the time of reporting, the Pediarix had not been re-introduced to the subject and the immunization series with Pediarix had been delayed.  In addition, the subject had not received vaccination with subsequent DTaP doses.  The healthcare professional considered the events were possibly related to vaccination with Pediarix and believed that the DTaP components of Pediarix caused the events.
Tired; Nausea has been coming and going; Extreme vertigo/ vertigo is worse with bending over, and lying on her back; Broke out in a sweat; Pain extending from her finger tips to her shoulder blades; Headaches which will start in the back of her head, move along the left side of her head and into the front; Pain in every extremity at once; A sequence of numbness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in every extremity at once), HYPOAESTHESIA (A sequence of numbness), VERTIGO (Extreme vertigo/ vertigo is worse with bending over, and lying on her back), HYPERHIDROSIS (Broke out in a sweat) and PAIN (Pain extending from her finger tips to her shoulder blades) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteoarthritis.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in every extremity at once), HYPOAESTHESIA (A sequence of numbness), PAIN (Pain extending from her finger tips to her shoulder blades) and HEADACHE (Headaches which will start in the back of her head, move along the left side of her head and into the front). On 02-Mar-2021, the patient experienced VERTIGO (Extreme vertigo/ vertigo is worse with bending over, and lying on her back), HYPERHIDROSIS (Broke out in a sweat) and NAUSEA (Nausea has been coming and going). On 09-Mar-2021, the patient experienced FATIGUE (Tired). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 02-Mar-2021, HYPERHIDROSIS (Broke out in a sweat) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in every extremity at once), HYPOAESTHESIA (A sequence of numbness), VERTIGO (Extreme vertigo/ vertigo is worse with bending over, and lying on her back), PAIN (Pain extending from her finger tips to her shoulder blades), NAUSEA (Nausea has been coming and going) and FATIGUE (Tired) outcome was unknown and HEADACHE (Headaches which will start in the back of her head, move along the left side of her head and into the front) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   This case was linked to MOD-2021-061028 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received and contains No New Information
No Adverse Event; HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4 APR 2023 after the expiration date of 01 APR 2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4 APR 2023 after the expiration date of 01 APR 2023.) and NO ADVERSE EVENT (No Adverse Event) in a 33-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     Patient had no allergies and no medical history conditions. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 04-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4 APR 2023 after the expiration date of 01 APR 2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4 APR 2023 after the expiration date of 01 APR 2023.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4 APR 2023 after the expiration date of 01 APR 2023.).    No concomitant medication details was reported. No adverse events were reported. No treatment medication details was reported.
Had COVID in November 2020.  Received vaccine on 1/7/2021.  Side effects: Headache, fatigue, and muscle aches for 3 days. Fourth day I was fine.
I had a case of Strep later in the evening it worsened stayed in bed rested was better the following evening.
Back of throat started to get small pimple-like bumps.  As time passed, the back of my throat started to swell.  I took 2 benadryl capsules which seemed to stop the swelling.  By the following morning, the symptoms resolved.
24 hours after vaccination, he was unusually tired, and napped.  9 hours later, he went to bed with a 101 degree fever.  2 hours later, he woke crying loudly and acting strangely.  He would not open his eyes when asked, nor say what was wrong.  When asked what hurt, no response.  Head?  Yes.  Stomach?  Yes.  Eventually calmed in 10 minutes.  Temperature 102 degrees.  Slept fitfully the rest of the night, continued fever.
Initial report received from medical assistant on 27 Apr 2010: This child patient was inadvertently vaccinated with S-OIV FLUVIRIN, (batch no: 102046P1, exp date: 31 Mar 2010), 0.5 ml intramuscular on 26 Apr 2010. No adverse events were noted after vaccination.
slept on and off; Felt dizzy; Felt unbalanced; No appetite; Knocked me down; fever; Body Aches; Major fatigue; Nausea; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Felt dizzy), BALANCE DISORDER (Felt unbalanced), DECREASED APPETITE (No appetite), VACCINATION COMPLICATION (Knocked me down) and PYREXIA (fever) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 30-Apr-2021, the patient experienced DECREASED APPETITE (No appetite), VACCINATION COMPLICATION (Knocked me down), PYREXIA (fever), MYALGIA (Body Aches), FATIGUE (Major fatigue) and NAUSEA (Nausea). On 01-May-2021, the patient experienced DIZZINESS (Felt dizzy) and BALANCE DISORDER (Felt unbalanced). On an unknown date, the patient experienced SOMNOLENCE (slept on and off). On 02-May-2021, DIZZINESS (Felt dizzy), BALANCE DISORDER (Felt unbalanced), DECREASED APPETITE (No appetite), VACCINATION COMPLICATION (Knocked me down), PYREXIA (fever), MYALGIA (Body Aches), FATIGUE (Major fatigue) and NAUSEA (Nausea) had resolved. At the time of the report, SOMNOLENCE (slept on and off) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Body temperature: 99 (High) 99 and 101.9 (High) 101.9. On 01-May-2021, Body temperature: 99.9 (High) 99.9.         Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Non significant follow up received on 01-JUN-2021, no new information
RASH ON FACE AND NECK; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. On an unspecified date, she then felt her face and neck were sore (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 05-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-NOV-2021, the patient experienced rash on her whole face down to the chin, and neck (dose number in series 2). Patient consulted her MD (doctor of medicine) who said that this rash would go, but as per the patient it was still there. Patient also consulted a dermatologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on face and neck. This report was non-serious. This case, involving the same patient is linked to 20220238207.
the temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event; vaccines being administered post-excursion with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Adult (patient-7) and unknown gender patient who was administered post temperature excursion at 29.0 Fahrenheit for 45 minutes due to unknown cause with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the INFLUENZA QUADRIVAL A-B VACCINE was exposed to a temperature excursion at 29.0 Fahrenheit for 45 minutes due to unknown cause with no reported adverse event (product storage error).  On 23-Sep-22, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (lot UT7689LA) (formulation, strength, dose not reported) via unknown route in unknown administration site for prophylactic immunization.  On 23-Sep-22, the patient was administered vaccine post excursion with no reported adverse event (poor quality product administered)  following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  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 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.
Mother states she noticed right arm swollen, red, warm to touch on Tues night. She brought child to clinic Fri, 2/7/03 15:15 p.m.
Under my eyes swelled up on both eyes.  My face was red....it felt sunburned.   I had welts on my inner tighs and private area.  Normal symptoms were sore arm and ache body.  Bad headache
Rash started approximately 08:00 on 4/16/2003. Stated fever began during late evening/night. Rash primarily located on legs and trunk. Also few on the face and arms. Very red around injection/needle sites. Small papular rash. Was going to see physician. 4/22/03 PC to check status. Never sent to see PMD. Used OTC Benadryl ct rash subsided.
Shortness of breath started 48 hours post vaccine. Ended up in the ER at hospital on 4/4 with sever shortness of breath and pain in back between shoulder blades. CT and blood work revealed massive Pulmonary Embolism in both lungs and enlarged right ventricle of heart.  Pulmonary angiogram was completed, bed rest, ICU and EKOS catheter. Released from hospital on 4/6.
On May 8, 2021, I woke up with a large red and inflamed rash on my injection site right arm! It was itching, and a raised puffy rash