chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 9-week-old white female with a probable mix protein allergy who on 28-NOV-2006, at 1700, was vaccinated PO with the first dose of rotavirus vaccine.  Concomitant vaccines administered on that same day and time included the first IM dose of Pediarix, the first dose IM dose of ActHib (lot#VE965AA) and the first IM dose of Prevnar. There was no illness at the time of vaccination. The physician reported that on 30-NOV-2006, the patient developed vomiting and diarrhea.  No laboratory/diagnostic tests were performed as medical attention was not sought. No adverse consequences, hospitalization or IV fluids were required.  Subsequently, the patient recovered from the vomiting and diarrhea.  No further information is available.
After being exposed to sunlight on 3/27, over 8 days after vaccination, hot red rash appeared for the first time on left arm near injection site.  Overnight, in just one night, the rash has lessened.
had diarrhea after the booster and continue to have it now; very sick 12 hrs after very sick 12 hrs after that lasted for about 72 hrs; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (very sick 12 hrs after very sick 12 hrs after that lasted for about 72 hrs) and DIARRHOEA (had diarrhea after the booster and continue to have it now) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (J and J vaccine) in March 2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.   On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (very sick 12 hrs after very sick 12 hrs after that lasted for about 72 hrs). On an unknown date, the patient experienced DIARRHOEA (had diarrhea after the booster and continue to have it now). In November 2021, ILLNESS (very sick 12 hrs after very sick 12 hrs after that lasted for about 72 hrs) had resolved. At the time of the report, DIARRHOEA (had diarrhea after the booster and continue to have it now) had not resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.
Severe headache, lethargy, elevated temperature, nausea, loss of appetite, Fever>103.  Symptoms progressed over 72 hours and dissipated over 7 days.
Nausea; Upset stomach; Body aches; Fever; Sore throat; Head ache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 14Sep2021 03:45 (at the age of 33-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient received no other vaccine in 4 weeks. The patient was not diagnosed with COVID-19 prior vaccination. On 14Sep2021 05:00 the patient experienced nausea, upset stomach, body aches, fever, sore throat, and head ache. The patient received no treatment for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Rapid Nasal Swab): negative on 15Sep2021. The outcome of the events was reported as not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
lymph nodes swollen under her neck, arm pits, and the back of arms; problems breathing; a lot of headaches; tenderness around the shot site; A lot of joint pains especially in the hips; The first one from January has not healed. It makes a scab and it comes off. It is not healing.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN5318, expiration date not reported) via an unspecified route of administration, in left arm, on 30Jan2021 16:00 (at the age of 71-years-old), at dose 1, single for covid-19 immunization from convention center. Medical history included asthma, arthritis, diabetes, cholesterol, reflux (as reported), allergies, vitamin d (as reported). Concomitant medications included glipizide for diabetes; liraglutide (VICTOZA); lisinopril taken for diabetes to keep her kidneys healthy; rosuvastatin calcium (ROSUVASTIN) taken for cholesterol; fenofibric acid taken for reflux; montelukast sodium (MONTELUKAST) taken for allergy; cyanocobalamin (VITAMIN B12) taken for vitamin d; meloxicam taken for arthritis, mometasone furoate (NASONEX); ergocalciferol (VITAMIN D) taken for unspecific indication. Historical vaccine included flu shot (FLU) administered on 11Sep2020 (Fluad quad 2020 2021 syringe. HARX: 120345300 (as reported), lot number, expiry date: unknown) from pharmacy. No additional vaccines administered on the same date of vaccination. On an unspecified date after vaccination in 2021, the patient experienced lymph nodes swollen under her neck, arm pits, and the back of arms, a lot of headaches, a lot of joint pains especially in the hips, tenderness around the shot site and the vaccination site has not healed. It made a scab and came off. After 2 to 2.5 hours of vaccination, the patient also had problems of breathing. The patient had her second dose of vaccination on 05Mar2021 for COVID-19 immunization. The patient had no investigation assessments. Therapeutic measures were taken for problems breathing included nebulizer and albuterol emergency inhaler. The outcome of the event vaccination site has not healed/ a scab was not recovered and outcome of other events was unknown.   No follow up attempts are possible. No further information is expected.
sore arm; slight temperature; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (slight temperature) and CHILLS (chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history wsa reported.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (slight temperature) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (slight temperature) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Action taken with mRNA-1273 in response to the events was not applicable.
Woke from sleep at ~1:00 am with anxiety and the sensation that I could not breathe. It progressed to a panic attack with uncontrollable crying and breathing issues for ~5-10 minutes. I was able to calm down, but continued to feel horrible all night. I threw up twice about an hour later. Muscle aches in both my shoulders (far worse in the one I got the injection in), back, buttocks, hips, and feet all night that kept me from being able to sleep. Ongoing nausea, headache, and fatigue all morning. Mostly has resolved now (2 pm) aside from fatigue.
I was fine for the first four days then I noticed my knee started swelling. I reached out to my rheumatologist and was prescribed prednisone, and that kept the swelling down. I took the prednisone through Dec and I decreased the medication. Then in January I stopped the prednisone. Then a week later the swelling started again so I went to see my family doctor and they really didn't know what the cause was.
Fever, night sweats, fatigue, aching, weight loss, dizziness, loss appetite, high blood pressure.
A nurse described the occurrence of limb swelling in a 15 month old female who was vaccinated with Infanrix for prophylaxis. The subject had no relevant medical history and was described as a "well child" with no known drug allergies. Concurrent medications were not reported. The subject received her fourth injection of Infanrix on 9/9/02 (557A2). On 9/11/02, the subject developed an injection site reaction characterized by redness, pain and swelling from the knee to the groin. The injection site reaction was treated with Ibuprofen or paracetamol on 9/11/02. As of 12/17/02, the injection site reaction had resolved. This report has been linked to reports A0389650A, A0389653A, and A0389649A due to same reporter.
No adverse effects, there was a vaccine error. Pt was supposed to receive adult Hep B (Energix) and was given pediatric vaccine (Recombivax HB)
did not feel right; did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (did not feel right) and MALAISE (did not feel well) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DOXYCYCLINE HYCLATE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced FEELING ABNORMAL (did not feel right) and MALAISE (did not feel well). At the time of the report, FEELING ABNORMAL (did not feel right) and MALAISE (did not feel well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.    Reporter did not allow further contact
Hives primarily on left side of face/cheek.  Just observed, about 4 hours after it diminished 75%,  I took one Benadryl at bedtime just in case, next morning it was gone.
Patient she felt fine the day after her 1st dose, she went her usual brisk walk with her friend and was chatting incessantly as usual (according to her) and suddenly stopped making sense and was speaking gibberish. She said this has happened before, she has a history of stroke but was not concerned about herself. Someone encouraged her to call PCP, who said call 911, she went to ER (said it was awful, never going back again) they did a bunch of tests and determined she was fine. She told ED that she had recently gotten her COVID shot, but cleared her to go home as her coherence returned and they couldn?t find anything wrong with her.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, not applicable after receiving SHINGRIX and an unknown time after starting VALTREX, the patient experienced shingles and incomplete course of vaccination. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The pharmacist on the line with the patient who was at the 7 month mark for receiving the 2nd dose and the patient did not receive second dose till the time of reporting, which led incomplete course of vaccination. The patient had Shingles and she went to the doctor on the previous day before the time of reporting and they filled VALTREX for her. The information regarding the vaccine administered filed away. The caller stated that he did not know when the patient developed Shingles. The batch number and expiry date was unknown.
arrhythmia; the arrhythmia got worse; feel bad; This case was reported by a pharmacist via call center representative and described the occurrence of arrhythmia in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 592DX, expiry date 6th December 2021) for prophylaxis.   Concurrent medical conditions included arrhythmia.   On an unknown date, the patient received Shingrix. On 13th November 2019, less than a day after receiving Shingrix, the patient experienced arrhythmia (serious criteria GSK medically significant), condition aggravated and feeling unwell. On an unknown date, the outcome of the arrhythmia was not recovered/not resolved and the outcome of the condition aggravated and feeling unwell were unknown.   It was unknown if the reporter considered the arrhythmia, condition aggravated and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient with heart condition, arrhythmia, received a dose of Shingrix and after the administration started to feel bad and the arrhythmia got worse. The reporter did not consent to follow-up.
Rash on forearms bilaterally. Started 24-36 hours after he received 1st Hep B immunization.
tongue became thick roof of mouth itching and throat became thick and felt like something stuck in throat.  Person was administered 50 mg Benadryl and within 20 minutes symptoms subsided .  No symptoms noted 60 minutes after injection.  Individual instructed to repeat Benadryl in 6 hours then again and another 6 hours
Given. 10 minutes after the shots grandmother noticed red rash. 4yr old with a red rash on both cheeks, uppers arms, and upper chest and ears. Throat without redness, lungs without wheezing. Denies itching. BENADRYL 20 mg orally given and monitoring. Instructed to go to the ER if the rash gets worse, SOB and difficulty breathing. Grandmother verbalized good understanding. Dismissed home alert OX3 and ambulating with grandmother and mother. No SOB, Respiratory distress, rash cleared, lungs without wheezing and clear in all lobes, throat without redness or swelling. Followed-up with mother on 07/30/18 at 0930 and per mother "she is fine" she did not need any other medical attention. Reinstructed to follow up with her PCP within 2 weeks.
Client became lethargic and diaphoretic about 1-2 min after receiving vaccine. He stated "This is normal for me when I get injections, I always faint." Client was placed in a wheel chair and given fluids until stabilized after about 1-2 min. 911 called and EMT arrived to evaluate client.
bell's palsy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (bell's palsy) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.   No Medical History information was reported.  On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced FACIAL PARALYSIS (bell's palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (bell's palsy) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medications reported. The patient was treated with prednisone.  Company comment: 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.; Sender'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.
mom called states lt upper arm is swollen, red & feverish;states has a knot in it the size of a baseball;
This spontaneous report was received from a consumer (patient's mother) and refers to a 16 year old male patient. Information on medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 intramuscularly. On an unknown date, the patient developed swollen lymph node near his collar bone. The physician was contacted for treatment, however he did not believe that the event was a side effect of the vaccine. No treatment was given for the event. The outcome of the event was reported as not recovered/not resolved. The reporter did not assess the causality of the event with GARDASIL 9. Additional information is not expected as no physician or reporter contact details were provided.
This non-serious medically confirmed spontaneous report (initial receipt 07-Jan-2015) concerns a 68 year-old male patient. On 17-Oct-2014, the patient received intramuscular AFLURIA (batch number T52008). The patient inadvertently received a second intramuscular AFLURIA (batch number T54009) on 07-Jan-2015, hence administered two doses during the flu season. The AFLURIA vaccine was given for the prevention of influenza. The patient has no reaction noted. The outcome was not reported.
Cough; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.
Started with itching. After approx. 2 days, area was red, inflamed, and warm to the touch.
redness/erythema local; itching/pruritus local; local rash; Hypersensitivity reaction; Eye itching; wrong route of administration; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), EYE PRURITUS (Eye itching), ERYTHEMA (redness/erythema local), PRURITUS (itching/pruritus local) and RASH (local rash) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis and Bee sting (Lips,face started swelling, rash on chest, throat was getting tight) on 08-Jan-2012. Concurrent medical conditions included Gluten sensitivity, Food allergy (strawberries), Food allergy (vanilla), Allergy to chemicals (sulfur), Drug allergy (codine), Drug allergy (triamcinolone), Allergy to antibiotic (tetracycline) and Allergy to antibiotic (cipro).    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 06-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (wrong route of administration). On 08-Jun-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction) and EYE PRURITUS (Eye itching). On an unknown date, the patient experienced ERYTHEMA (redness/erythema local), PRURITUS (itching/pruritus local) and RASH (local rash). On 11-Jun-2021, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. At the time of the report, EYE PRURITUS (Eye itching) had not resolved and ERYTHEMA (redness/erythema local), PRURITUS (itching/pruritus local), RASH (local rash) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (wrong route of administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown.       This felt just like my reaction to steroid shots with the ingredient of triamcinolone in them. It wasn't as serious of reaction though. I took Benadryl every 4-6 hours until the itching stopped. My eye did not swell up very much, but it did have little bumps on the eyelid that were itching. My eye itself was fine.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Additional information included reporter details and vaccination details On 30-Jun-2021: Follow up received includes new events and Medical history
Pain in the right costovertebral angle area initially then similar pain on the left which has worsened and radiates around to the left side of abdomen. Skin over painful area is sensitive to touch and has a burning sensation. The distribution of the pain is dermatomal in nature.
Syncopal episode after MMR vaccine and TB skin test.  While checking out of clinic with parent struck tile floor resulting in laceration to head and 10 to 15 seconds of tonic seizure activity.
Patient after a week of receiving the vaccine, was admitted through the emergency room for abdominal pain and admitted for colitis. Patient was treated and discharged with ciprofloxacin and metronidazole. While on antibiotics patient developed diplopia that remained unresolved until 10/7/2021.  Patient returned to ER 9/28/2021 for left sided Otalgia leading to Bells palsy of the left side of face. Symptoms of bells palsy has improved but has not resolved.
Patient states that she had received the vaccine on May 25, 2021 at approximately 12pm.  Soon after around 3pm, she developed chills headaches, sore arm , body aches, and cough.  As of date, 5/27/2021, symptoms have mostly reseolved except for sore arm and localized redness and swelling to injection site.
No adverse effect; The patient received one dose each of PROQUAD and VARIVAX on 06-AUG-2019; Information has been received from a nurse referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 06-AUG-2019, the patient received one dose each of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (therapy type: rHA, lot # S005880, expiration date reported as 31-AUG-2020, but upon internal validation established as 25-AUG-2020, strength, dose and route were unknown) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # R029519, expiration date reported as 31-OCT-2020, but upon internal validation established as 14-OCT-2020, strength, dose and route were unknown) (overdose) for prophylaxis. No adverse effects were reported.
They are noticing some strange reactions to Shingrix; This case was reported by a consumer and described the occurrence of adverse drug reaction in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. The reporter mentioned that physician was noticing some strange reactions to Shingrix. This case is linked to the case US2020AMR059714 and US2020AMR059707 reported by the reporter for herself.