chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy; Hot to touch; Vaccination site discoloration; Rash; Hurt to touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), PRURITUS (Itchy), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and VACCINATION SITE PAIN (Hurt to touch) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported.).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash), PRURITUS (Itchy), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and VACCINATION SITE PAIN (Hurt to touch). At the time of the report, RASH (Rash), PRURITUS (Itchy), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and VACCINATION SITE PAIN (Hurt to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Received Dtap, Ipv, Hib, Prevnar 8-29-01 Developed fever to 103.6 R w/in 24 hrs some irritablility
Fever 101.8, Sore throat, HA, Vomiting, Pulse 110, rash on chest.  Feels ok on 11-10-2009.
I had a severe reaction to the flu shot.  In addition to feeling like I have the flu, I have hives on most every part of my body-solid raised and large hives on the inside and outside of my legs, behind, arms and chest.  My nose is runny.  I continue to have major hives and swelling of the legs, feet and hands and it is 5 days later.  I still feel very ill.  My hives burn and itch.    There have been no changes in diet, creams or my environment.  I am not allergic to eggs.
Information has been received from a physician concerning an 8 year old (also reported as 18 year old) female patient who on an unspecified date was vaccinated with a dose of MMR II (dose, route and lot number not reported). The physician reported that the patient developed mumps on 15-DEC-2009. The patient was diagnosed with mumps on the same date. Laboratory test performed on 15-DEC-2009 included IgM (<1:10), IgG (4.47) and amylase (71). The patient had left parotitis and she was afebrile. The final outcome for mumps was not reported. This is one of several reports from the same source. No further information is available.
pain in the last shoulder and it makes lift the left arm very hurtfull, it is going away with time or pain medication
Severe eye redness and irritation, extreme sensitivity to bright light.  Diagnosed as Ocular Rosacea. Doctor prescribed 50mg /day of Doxycycline.  I may have to be on this antibiotic for the rest of my life.
Fast heart rate (113 - possibly higher before I checked it): began about 24 hours after injection and continued for about 8 hours before gradually reducing to a less elevated (but still a bit high) level.  Slightly elevated systolic blood pressure (138 - about 20 higher than my usual - may have been higher before I checked it): began about 24 hours after injection  Weakness: began intensely about 24 hours after injection; has improved but continues to be noticeable four days after injection Chest tightness: began about 24 hours after injection; has improved but continues to be noticeable four days after injection Lip tingling: became noticeable four days after injection
12 on 16MAR92 & on 23MAR92, had emesis x 2-3 w/probable syncopal period-eyes rolled back for few moments w/no seizure or convuls; no rash or diarrhea; noted temp x 1 day 1 wk ago;
After injection, patient stated he experienced some burning sensation but nothing extreme. The next morning, the burning sensation had increased and he saw that the injection site was inflamed in a circular area around it about the size of a pear. The patient stated it was painful but not unbearable and no systemic symptoms. All symptoms were limited to localized side effects. On day 2, the area seemed to have improved a little but came in for a consultation with the pharmacist on staff and they chose to continue to monitor the condition. It has improved each day.
Patient reported having difficulty breathing starting May 23rd, and shortness of breath on May 24th.  Patient has not sought any medical attention.  Recommended she call her primary care physician to see if she should still get second shot and to get to urgent care if symptoms do not improve or get worse.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: Kiwi fruit" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2023) positive, notes: tested positive for covid again; (Jan2023) negative, notes: testing negative for covid 19 twice; (Jan2023) negative, notes: testing negative for covid 19 twice. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: 4 days after finishing Paxlovid and testing negative for covid 19 twice, I started feeling sick on 13Jan2023 and tested positive for covid again.
Fever, chills; Fever, chills; right arm, subcutaneous; Fever, chills; chills; This spontaneous case was reported by a non-health professional and describes the occurrence of the first episode of PYREXIA (Fever, chills), CHILLS (chills), the second episode of PYREXIA (Fever, chills), CHILLS (Fever, chills) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (right arm, subcutaneous) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A, 042B21A and Unknown) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. In September 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced the first episode of PYREXIA (Fever, chills) and CHILLS (chills). On 01-May-2021, the patient experienced the second episode of PYREXIA (Fever, chills), CHILLS (Fever, chills) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (right arm, subcutaneous). On 06-Apr-2021, CHILLS (chills) had resolved. On 03-May-2021, last episode of PYREXIA (Fever, chills) and CHILLS (Fever, chills) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (right arm, subcutaneous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       No treatment medications were reported. No concomitant medications were reported.  Vaccine 1 (orignal series) received April 3, 2021 from Vaccine event in right arm: experienced fever and chills, bed rest, recovered without medical attention in 3 days.  Vaccine 2 (original series) received May 1, 2021 in right arm, subcutaneous: patient experienced fever and chills, recovered without medical attention in 1.5 days.
Beginning approximately 12 hours after vaccine administration I developed pain, conjunctivitis, and the sensation of a foreign body in my right eye under the upper eyelid. Visual examination revealed a fairly bloodshot sclera and a mildly swollen upper eyelid but otherwise normal appearing eye. No foreign body was able to be seen nor flushed out. The left eye had more mild conjunctivitis without pain or foreign body sensation.  I took acetaminophen, ibuprofen, and cetirizine. By about 24 hours after vaccine administration the redness and foreign body sensation had largely resolved. No other adverse effects from the vaccine were noted.
Fever/Elevated temperature; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (Fever/Elevated temperature) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever/Elevated temperature). At the time of the report, PYREXIA (Fever/Elevated temperature) 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.   No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: The patient name and dose number were provided.; Sender's Comments: This case concerns a female patient of unknown age. The medical history is not provided. The patient experienced an expected non-serious event of Pyrexia approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Patient received her first dose of the Moderna Covid-19 vaccine at the age of 17.43 years.
Stomach bloating, rumbling, slight nausea. Nighttime diarrhea Thurs night and next day.  Sat. Nov 28 - rash on both lower arms.
pt recv vax & initially following vax pt exp redness & local pain @ site;@ time of report 12JUN95 pt entire arm hurts when moves it;describes sx as discomfort;according to reporting pt MD suspects nerve damage;
Had an Ischemic Stroke.  Hospitalized via ambulance 4/23-4/29/2021.
This spontaneous report was received from an Administrator referring to a 6 month old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ per oral (dose, dose number, frequency and anatomical location were unknown) the lot #s reported were N003984 with expiration date 19-NOV-2018 and M044397 with 20-JUN-2018, the lot number administered to the patient was unknown for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 32 F up to 35 F (35.4F) degrees Fahrenheit for 45 minutes. There was Digital Data logger involved. There were no previous excursions reported. It was reported that this case was 2 of 7.
Blood pressure was 180/101; numbness on whole left side of body; tingling; A spontaneous report was received from a consumer concerning a 68 years-old, female patient who received Modern's COVID-19 vaccine (mRNA-1273) and  hospitalized for blood pressure that was 180/101 and experienced numbness on whole left side of body, and tingling.  The patient's medical history included hypertension, allergies to penicillin, IV contrast (highly allergic, has to be pre-medicated if uses it 2-3 days before), and sulfa, and unspecified issues with sodium. Concomitant product use included blood pressure medication.    On 24 Feb 2021 at 09:45 am, prior to the onset of the events, the patient received the first dose of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Feb 2021, approximately 2 hours after receiving the dose at 11:00 am, the patient's left side started going numb. The patient went home at 02:30 pm and took some Motrin, but still had numbness and tingling. At around 07:00 pm same day, the patient reported blood pressure was 180/101 beats per minute. Patient reported taking prescribed blood pressure medicine prior to getting the vaccine on 24 Feb 2021 and Motrin after the vaccination on 24 Feb 2021 in order to stop the numbness.   In the morning of 25 Feb 2021, patient's blood pressure was very high until 04:00 am; therefore, patient went to the emergency room (ER).  At the hospital, they were very concerned about patient's blood pressure because it remained high. The patient thought the numbness and tingling would stop but they didn't. Patient denied numbness in arms; but felt it in legs and all up left side. Due to prior "issues with sodium", patient had to be treated for sodium levels at the hospital. Patient was discharged out of the hospital on 26 Feb 2021. All tests came back normal. Numbness on side and tingling went away. The patient believed reaction was due to the vaccine even though it was temporary.   Treatment information included Motrin.   Action taken with mRNA-1273 in response to the events is not reported.   The events blood pressure was 180/101, numbness on whole left side of body, and tingling were considered resolved.; 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 approximately 2 hours after receiving the dose, a causal relationship cannot be excluded. However, patient's hx of hypertension, allergies to penicillin, IV contrast and sulfa, and issues with sodium are confounding factors that may play a possible contributory role providing an alternative explanation.
13 days after vaccine I began to have spontaneous itching which would migrate all over my body, my ears would burn, itching on my scalp, thighs, buttocks, sides, back, neck, hands would burn, usually in the evenings.  I tried different lotions with a little relief, and then on 2/5/22 began to take Zyrtec and the symptoms went away and I could sleep without being woken up with itching.
felt very sick; lymph nodes in right arm pit very sore; chills; terrible nausea; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt very sick), LYMPH NODE PAIN (lymph nodes in right arm pit very sore), CHILLS (chills), NAUSEA (terrible nausea) and HEADACHE (bad headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt very sick), LYMPH NODE PAIN (lymph nodes in right arm pit very sore), CHILLS (chills), NAUSEA (terrible nausea) and HEADACHE (bad headache). At the time of the report, MALAISE (felt very sick), LYMPH NODE PAIN (lymph nodes in right arm pit very sore), CHILLS (chills), NAUSEA (terrible nausea) and HEADACHE (bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
within 10' of injection , developed Wheezing, flushing and lip/ facial swelling. Transferred to ED and treated with epinephrine, Benadryl and albuterol. Po Benadryl and Pepcid. Sx resolved and remined in ED for 6 hrs observation. D/c'd to home
Refridgeration excursions identified; No adverse event; Poor quality vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022 at 1:51 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 21-Sep-2022 at 1:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No concomitant medications were reported.   Dose 4 vaccine administered through deltoid.   The Nurse reports a temperature excursion that has occurred in a refrigerator at her clinic containing both monovalent and bivalent Moderna Covid-19 vaccines. The Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients.     No information was available on that patients at this time.   It was unknown that the patient ever been diagnosed with/ tested positive for COVID-19.  The patient had received moderna vaccine doses 1, 2, and 3 intramuscularly and at the deltoid site of the body.  No treatment medications were reported.
This spontaneous report as received from a healthcare worker refers to a 24 year old patient. On 28-JAN-2014, the patient was vaccinated with expired GARDASIL, .5 ml, 0636AA as lot number and expiry date was 11-AUG-2013 intramuscular in the left deltoid. No adverse effect was reported. Additional information has been requested.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 at 07:30 as dose 1, single (Lot number: ER5730), on 20Jan2021 at 09:30 as dose 2, single (Lot number: Tl8982) and on 22Oct2021 at 09:30 as dose 3 (booster), single (Lot number: 30155BA), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Graves disease" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: RASUVO; COSENTYX; OMEPRAZOLE; LEVOTHYROXINE; FOLIFAST. Past drug history included: Gadolinium, reaction(s): "known allergies; Gadolinium". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 19Jan2022, outcome "not recovered" and all described as "Covid test result Positive". The event "Covid test result positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jan2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of Covid-19, vaccination failure. No follow-up attempts are possible. No further information is expected.
Child received 2nd dose of Pediarix, Prevnar13, hib & Rotateq 3 weeks after first dose.
Narrative:  covid pneumonia, dypnea, b cell lymphoma on chemo, ALS, SOB, malaise, dec appetite, cough, Moderna x 2, d/c home, then readmit, then rehab
pt had fever 102.8; had tachycardia x 2 days; nausea, back pain, swollen glands, dec lt arm into shoulder, pain @ site; also had diarrhea; pt phoned MD;
The patient's representative came up to the counter, and said the patient was getting the "second dose Moderna." The tech wrote down on the form and told the pharmacist the patient was getting the second dose Moderna. The pharmacist drew-up and administered the 0.5mL dose of Moderna. However, when asked again what dose the patient wanted, it was then disclosed the patient's first dose was J&J and this was a booster. The pharmacist then told both parties about the dose discrepancy and to expect more severe side effects.
Patient developed rash (0.5mm maculopapular bumps)  on bilateral inner forearms.
FLU-LIKE SYMPTOMS; TENDERNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced flu-like symptoms, and tenderness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms and tenderness was not reported. This report was non-serious.
Patient started experiencing chest pain about 5 minutes after vaccination. She was still in the store waiting her 15 minutes post-vaccination. She stated she had pain in her central chest under her breast bone and pressure in her face/ upper jaw.. She took two doses of nitroglycerin and the pain subsided after her second dose.
Shortness of breath started 1/16 in the AM, worse when lying down. .Also had diarrhea and a rash on right lower extremity. Discharged from ED to home. No significant findings found on work up.
Patient reported to client for second vaccine of series stating that after receiving vaccine she begun itching 1 hour after the vaccine was administered. Patient reports feeling ill and fatigue. The morning after she woke up with Lichenification on her right and left middle arm running down to her lower arm. Patient has been advised to seek medical care to check on her skin condition. Patient stated she did seek medical care in hopes the lichenification would clear on it's own.
This case was reported by a pharmacist via call center representative and described the occurrence of Bell's palsy in a 70-year-old female patient who received SHINGRIX (batch number 7M2KB, expiry date 30th March 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown. It was unknown if the reporter considered the Bell's palsy to be related to SHINGRIX. Additional details were provided as follows: In 2019, the patient received SHINGRIX. In 2019, the patient experienced Bell's palsy.
Low grade fever started night after getting vaccine and then had fever again 08/04 and 08/05 and again 08/08. Complained of flu-like symptoms, muscle soreness and aching in back and left arm. Started night of 07/30 and had continued. Dry cough started 08/08/04. Had macular rash on left forearm for 1 day.
on 1-13-21 I woke up with pain on my right deltoid muscle.  I was unable to lift my arm or even pick up a coffee cup, it completely resolved on 1-15-21.  Starting on 1-17-21 I developed severe muscle pain on my left pectoral muscle.  On 1-19-21 the pain is an 8 on the pain scale, I am unable to go to work and unable to do any ADL's.  I have not sustained any injury to these areas, the pain just appeared and pain relievers and muscle relaxers are not helping.