chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red rash on hand covering 1/5th of left hand between index and middle finger and hand, Still see signs of the healing today; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 39-year-old male patient received BNT162b2 (BNT162B2), on 16Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; METFORMIN. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for covid-19 immunisation. The following information was reported: RASH ERYTHEMATOUS (non-serious) with onset 19Jun2022, outcome "recovering", described as "Red rash on hand covering 1/5th of left hand between index and middle finger and hand, Still see signs of the healing today" (as reported). Therapeutic measures were not taken as a result of rash erythematous.  Additional information: It was reported that if other vaccine in four weeks: unknown; If covid prior vaccination: no; If covid tested post vaccination: unknown and known allergies: unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sedation, Myalgia, Immediate post vaccine, employee reported feeling "funny" almost like she was intoxicated.  this passed after a few hours.  Narrative:  Employee missed greater than >1 days of work second to symptoms (aches and extreme fatigue)
PATIENT RECEIVED FLU SHOT IN RIGHT ARM & PNEUMOVAX IN LEFT ARM.  LEFT ARM HAD REACTION AND HAD ABNORMAL SWELLING, PAIN, INCREASED HEART RATE, & DIZZINESS.  PATIENT WAS HOSPITALIZED AND IT WAS CONCLUDED POSSIBLE DEHYDRATION, CELLULITIS, & REACTION TO IMMUNIZATION.
Pt experienced a 3 inch diameter rash on left arm. Pt also had a light rash across his chest and fever.
Developed ITP (Platelets of 6000) on 2/21/05.
On Friday the 26th, About 18 hours after I received my first shot which was 9pm ET on March 25th, I started to feel low energy and spacey, and began to feel muscle aches and felt feverish (I didn't take my temperature) - in addition to a very sore arm.   The muscle aches improved Saturday but the fatigue and feverishness has continued through the weekend (Saturday and Sunday).
This spontaneous report was received from a health care professional refers to unspecified number patients of unknown demographics. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX (lot # L000454; expiry date: 06-JAN-2017) (dose, route and frequency unspecified). Concomitant therapy was not reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Several minutes after patient was administered both vaccinations, patient complained that her tongue felt funny like it was tingling. Patient stated it also felt like her tongue was getting thick. I notified Dr. and repeated patients vitals. Dr. examined patient and ordered Diphenhydramine 50 mg IM. Patient was administered diphenhydramine 50 mg IM 10:10 am. Patient reassessed by provider after 15 minutes and patient was feeling much better. Patient was discharged from office and advised to call 911 or go to emergency room if symptoms returned or had any difficulty breathing, swelling, or trouble swallowing.
Developed baseball sized hive and swelling about an inch or more below the injection site along with lymph node swelling on the right side only. Ibuprofen and Benadryl were taken and hot and cold compresses were used to help alleviate the pain and swelling.
Hives on neck, chest, shoulder.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 04Apr2021 at 17:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer, pre-diabetic from an unspecified date. It was unknown if the patient had any allergy. Concomitant medications included amlodipine besilate (AMLODIPINE BESYLATE) 10 mg from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 22:00 the patient experienced hives on neck, chest, shoulder. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event hives was resolving.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions or allergies reported. On unspecified dates, since 14-AUG-2015, the patients were vaccinated with doses of RECOMBIVAX HB (lot# J000722, expiration date 17-SEP-2015; lot# K024036, expiration date 26-NOV-2016, doses, frequency, site and route of administration were not reported), which were exposed to temperatures outside of the recommended range. No adverse experiences had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Dose given 2 hours after the 6 hour vial puncture expiration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given 2 hours after the 6 hour vial puncture expiration) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given 2 hours after the 6 hour vial puncture expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given 2 hours after the 6 hour vial puncture expiration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.
mom recv vax & child devel a rash;MD was concerned w/poss measles transmission;
Itching; several open sores on scalp; Large inflamed lymphnode in arm pit same side asvaccination; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: Er8729) via an unspecified route of administration in the left arm on 09Apr2021 at 12:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic dehydration, gastroparesis, malabsorption, mastectomy and hysterectomy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient previously took Ativan and Zosyn and experienced allergy to it. Concomitant medications included sodium lactate; potassium chloride; calcium chloride (LACTATED RINGER'S), promethazine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), clonazepam (clon) (MANUFACTURER UNKNOWN), diphenhydramine; paracetamol; phenylpropanolamine hydrochloride (BENADRYL), dicycloverine (dicyclomine) (MANUFACTURER UNKNOWN), hyoscyamine (MANUFACTURER UNKNOWN) and oxycodone (MANUFACTURER UNKNOWN), all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: Er2613) via an unspecified route of administration in the left arm on 19Mar2021 at 12:45 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, the patient experienced itching, several open sores on scalp and large inflamed lymph node in arm pit same side as vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of itching, several open sores on scalp and large inflamed lymph node in arm pit same side as vaccination was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt received vaccine, next day reported heat/redness at site. Advised that this was not uncommon, use ibuprofen/acetaminophen and/or cold compresses, alert pharmacist if continued. Pt followed up 2 days later with initial complaint resolved but heat/swelling/redness lower on same arm (forearm and wrist). Advised at this time to follow up with physician for possible cellulitis.
Severe left arm muscle and joint pain. Painful with movement and extension. Some minor aches in all extremities that does not go away unless I take ibuprofen or tylenol.
"Janssen COVID-19 Vaccine EUA" Mild nausea began within one hour of injection.  Within six hours developed severe nausea, headache, and chills, fever, generalized body aches, swollen glands in neck and groin, fatigue, dizziness, debilitating weakness in legs, racing heart, and bruising and pain at injection site.  Symptoms were severe for 48 hours, then moderate for another 48 hours.  Pain at injection site prevented lifting arm for 6 days.
Redness, soreness, Burning sensation down the arm at the site of Injection Lasting More Than ~ 2 weeks. Weakness causing difficulty to walk, pain Radiates to elBow.
have a little fever with aches and pains; lots of pressure by my hand; looks like I have hives; rash that burns like fire; swollen arm; Numbness by her hand; On Tuesday complete sick with fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (On Tuesday complete sick with fever), PAIN IN EXTREMITY (lots of pressure by my hand), URTICARIA (looks like I have hives), INJECTION SITE RASH (rash that burns like fire) and PERIPHERAL SWELLING (swollen arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (On Tuesday complete sick with fever), URTICARIA (looks like I have hives), INJECTION SITE RASH (rash that burns like fire), PERIPHERAL SWELLING (swollen arm) and HYPOAESTHESIA (Numbness by her hand). On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (lots of pressure by my hand). On an unknown date, the patient experienced MYALGIA (have a little fever with aches and pains). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PYREXIA (On Tuesday complete sick with fever), PAIN IN EXTREMITY (lots of pressure by my hand), URTICARIA (looks like I have hives), INJECTION SITE RASH (rash that burns like fire), PERIPHERAL SWELLING (swollen arm) and HYPOAESTHESIA (Numbness by her hand) had not resolved and MYALGIA (have a little fever with aches and pains) outcome was unknown. Not Provided
Pt received vaccinations and about 15 minutes later fainted and had brief seizure like activity characterized by eye rolling, vocalizations & bladder incontinence. Was observed in clinic for 2-3 hours with complete resolution of symptoms and back to baseline. Bloodwork including CBC & Chem 10 were normal.
Pain in left arm. Stiffness. Can not lift heavy items. Having to stretch arm in the morning upon waking up in order to work out the pain and stiffness
11/24/2021 11:23 am Pt. reports she felt hot, she had visible facial redness, with generalized redness/flushing of skin, and reported that she was breathing funny. Pt. stated, "my skin feels so hot and my breathing  feels funny and I taste saline in my mouth like after I do my infusions."  Symptoms occurred within 2-3 minutes after receiving Pneumovax 23 vaccine. Provider checked Pt. and had staff monitor vitals as well as glucose level which were all within normal parameters, kept Pt. in office longer to monitor for any problematic reactions to vaccination from Pneumovax 23 as per providers orders. She denies any previous history of syncope with blood draws, vaccine issues. VS were good with BP 139/79, HR 81, T 98.1 R 20 and O2 96 on RA @ 11:23 am, 11:30 am B/P 127/80 HR 70, R20, O2 98 on RA, 11:55 am B/P 112/75, HR 70, R 18 O2 98 on RA. Laid down on exam table, bs checked 118 fasting, vitals remained normal with improved BP , given cold water to drink She was monitored and felt at baseline at time she left office @ 11:55 am.11/24 2021 called Pt. @ 1:44 pm to inquire if she was still doing ok once she got home, she reported she was doing fine, she felt tired but reports this is not an unusual symptom for her to have otherwise, she was doing ok.
Localized redness/swelling at site. Flu-like symptoms with fever, headache, muscle aches, nausea.  Follow up 02/25/2003: "Information not available to me.  She received vaccine from military."
patient presented to ED with COVID symptoms and positive test. Treated with Regeneron antibodies. Fully vaccinated in April 2021.
Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old female patient who accidently received an expired dose of 0.5 ml of vaccine MENACTRA (batch number: U5751AB, expiry date: 12-Nov-2018) via intramuscular route in the right deltoid on 16-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication were FLULAVAL and TDAP. It was case of actual medication error due to Expired vaccine used. No adverse event was experienced. 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 Directive EC and Module VI of the 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. List of documents held by sender: none.
Eight days after vaccine, foot drop ("dropped foot") in right foot; bilateral numbness and tingling in hands with eight hand more severe; bilateral numbness and tingling in hands with eight hand more severe; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 09:15 (Lot number: ER8729) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MIRTAZAPINE; NORTRIPTYLINE.  The following information was reported: PERONEAL NERVE PALSY (non-serious) with onset 22Apr2021, outcome "not recovered", described as "Eight days after vaccine, foot drop ("dropped foot") in right foot"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 17Apr2021, outcome "not recovered" and all described as "bilateral numbness and tingling in hands with eight hand more severe". The events "eight days after vaccine, foot drop ("dropped foot") in right foot", "bilateral numbness and tingling in hands with eight hand more severe" and "bilateral numbness and tingling in hands with eight hand more severe" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of peroneal nerve palsy, hypoaesthesia, paraesthesia.
No adverse effects; expired vaccine administered; This spontaneous report was received from a medical assistant and refers to a 32-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 09-JUL-2020, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S012250, expiry date 07-JUL-2020) (strength, route and site of administration were not provided) for prophylaxis. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012250; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Pt recv vax on 4/13/98; on 4/14/98 pt exp sore arm, body aches, shivering, fever (100.9), diaphoresis, felt sick, vax site red/ tender; tx=ice pack & Ibuprofen
Patient came by the pharmacy 3 days after Shingrix and Fluzone HD were given Saturday. States the redness and slight swelling and warmth was spreading from injection site in her upper right arm down to her elbow.  She said she has no other symptoms. I recommended she use ice and Benadryl if needed and contact her doctor. She said she feels fine and that she is just visiting for a couple weeks and it is too difficult to contact her doctor. I told her to at least monitor and seek medical attention if it gets worse even after doing the above. She did not seem too concerned, just showing us her reaction.
dose 1 in August 2019, and dose 2 June 11, 2020; side effect listed for two weeks after the injection; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On 11th June 2020, the patient received the 2nd dose of Shingrix. On 11th June 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, On August 2019, received 1st dose of Shingrix and 2nd dose on 11th June 2020 and experienced every side effects listed for 2 weeks after the injection. Less than 2 years after vaccination with 1st dose of Shingrix, the patient experienced side effects, listed for 2 weeks after vaccination.  The patient received 2nd dose late than the recommended schedule, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Initially about 10 mins after receiving the vaccine, I got a little flushed and then I got a low-grade fever. Then it resolved. The following Sunday I woke up with really bad pressure and pain in my right ear. I went to the urgent care at Dignity Health in state. They treated me with an antibiotic, an auditory antibiotic, and a steroid. It did not resolve in the seven-day course, so I was reissued an auditory antibiotic on August 16th. The initial culture showed no signs of infection although I did have drainage and everything else.
Head cold; 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 NASOPHARYNGITIS (Head cold) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included GUAIFENESIN (MUCINEX) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Apr-2021, the patient experienced NASOPHARYNGITIS (Head cold). At the time of the report, NASOPHARYNGITIS (Head cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included  guaifenesin (Mucinex).   This case was linked to MOD21-072032 (E2B Linked Report).; Sender's Comments:  MOD21-072032:
bumps and itching across his body; major cluster on his ankle on the same side of his shot; fairly severe allergy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (bumps and itching across his body), JOINT SWELLING (major cluster on his ankle on the same side of his shot) and HYPERSENSITIVITY (fairly severe allergy) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (bumps and itching across his body), JOINT SWELLING (major cluster on his ankle on the same side of his shot) and HYPERSENSITIVITY (fairly severe allergy). At the time of the report, PRURITUS (bumps and itching across his body), JOINT SWELLING (major cluster on his ankle on the same side of his shot) and HYPERSENSITIVITY (fairly severe allergy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Swelling and redness around the site of the vaccine.  Measured 2 in. x 2.5 in. First noticed at 7:30 PM day after vaccination.  No behavioral changes.  Indication of scratch marks.  Noticeable radiating heat from site of vaccine.
one week after injection, developed itchy rash which grew into 5" diameter red swelling. Sensitive but not intolerable, still have after one week. Did not take pain relief or use salvlel
DTaP and MMR given (both in left thigh) on 7/13. Fever to 104.3 degrees max (7/13-7/15) 7/16 woke up at 1:30 am screaming inconsolably until 5:00am. Went to ER. Normal exam. 7/16 AM came to office. Exam normal. Except teething molars. Baby seen in office later on 7/16/04: normal exam except appears tired.