chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the second dose patient had a very intense leg pain for seven day, had to sit under and electric blanket for a week.; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (After the second dose patient had a very intense leg pain for seven day, had to sit under and electric blanket for a week.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 040a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure, Drug allergy (47 medicines), Latex allergy, Drug allergy (sulfa drugs), Polyethylene glycol allergy (polyethylene glycol) and Liver disorder. Concomitant products included ATENOLOL for Blood pressure.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (After the second dose patient had a very intense leg pain for seven day, had to sit under and electric blanket for a week.). At the time of the report, PAIN IN EXTREMITY (After the second dose patient had a very intense leg pain for seven day, had to sit under and electric blanket for a week.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported the patient had to sit under a electric blanket for a week. No treatment drug details was reported. There were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The AE did not cause patient to seek medical care. The patient did not experienced a similar event in the past.   This case was linked to MOD-2022-609287 (Patient Link).
Venous thromboembolism; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EMBOLISM VENOUS (Venous thromboembolism) in a 49-year-old female patient who received mRNA-1273 for COVID-19 vaccination.    Co-suspect product included non-company product ORAL CONTRACEPTIVE NOS for Birth control.    No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273  (Intramuscular) 1 dosage form. On an unknown date, the patient started ORAL CONTRACEPTIVE NOS (Oral) at an unspecified dose. On 08-Apr-2021, the patient experienced EMBOLISM VENOUS (Venous thromboembolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 08-Apr-2021 to 12-Apr-2021 due to EMBOLISM VENOUS. At the time of the report, EMBOLISM VENOUS (Venous thromboembolism) outcome was unknown. The action taken with mRNA-1273 (Intramuscular) was unknown.  For mRNA-1273 (Intramuscular), the reporter considered EMBOLISM VENOUS (Venous thromboembolism) to be unlikely related. Treatment medications included anticoagulant therapy.  Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.  Assessment is confounded by the reported use of oral contraceptive.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.  Assessment is confounded by the reported use of oral contraceptive.
Injection site: red, raised, hot: treated with ice packs and Tylenol.  3-4 days after injection: Malaise, headache, particularly upon excertion.  Feels like my brain is bouncing.  Fever 101 treatment: Tylenol and rest.
Miscommunication between provider and MA.  Vaccine not dangerous to patient but wanted to report and be honest
I broke out in a rash all over. I was treated with a Steroid shot and steroid medicine. My skin was very itchy and now peeling all over.
Within 12 hours of receiving vaccination my left arm became red, hot to the touch, itchy, and sore to the touch from the injection site to approximately 4 inches down my arm and approximately 2-3 inches wide.  Today is February 10th and there is only limited improvement (5 days since date of injection).
This is a spontaneous report from a contactable consumer. A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Apr2021 (at the age of 62-year-old) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 62-year-old) as single dose for Covid-19 immunization. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient been tested for COVID-19. On an unspecified date in Apr2021, the reporter stated that the patient experienced sore sensations in his joints after dose 2 of the Pfizer Covid 19 vaccine. The event assessed as serious (medically significant). The reporter stated the event result Doctor or other healthcare professional office/clinic visit. It was unknown if patient receive any treatment for the event. Outcome of the event was not recovered.  Information about lot/batch number requested.
Aside from the expected soreness in the arm and short lived fevers, I started to develop painful swelling and hard lumps in my lymph of the same armpit as my injection site. It was quite painful and broke out into a puss-tipped rash and continued to get worse. It has been over 20 days now and instead of getting better, it has spread to my other armpit now. I went to the local advanced urgent care clinic who ran some bloodwork and said my white cell count is normal and non-indicative of lymphoma, so I was put on prednisone and doxycycline. The medication has done next to nothing and I was told that there was nothing else they could do. The pain in the arm varies per day but there are some days where it is too painful to use my arms at all.
Fever, sweating, chills/body aches (upper and lower body). Symptoms started around 3 am (woke me from sleep). Fever broke after taking 2 Advil liquid gels. Chills/aches contributed through out today.
face and upper body itching; face and upper body burning; she has a 4 inch long red patch; 4 inch long patch that is really red and itchy; soreness at injection site; redness at injection site; itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (face and upper body itching), BURNING SENSATION (face and upper body burning), RASH (she has a 4 inch long red patch), PRURITUS (4 inch long patch that is really red and itchy) and VACCINATION SITE PAIN (soreness at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM, VITAMIN D3, MULTIVITAMIN & MINERAL, PROGESTERONE and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PRURITUS (itching at injection site). On 09-Jan-2021, the patient experienced RASH (she has a 4 inch long red patch) and PRURITUS (4 inch long patch that is really red and itchy). On 12-Jan-2021, the patient experienced PRURITUS (face and upper body itching) and BURNING SENSATION (face and upper body burning). At the time of the report, PRURITUS (face and upper body itching), BURNING SENSATION (face and upper body burning), RASH (she has a 4 inch long red patch), PRURITUS (4 inch long patch that is really red and itchy), VACCINATION SITE PAIN (soreness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PRURITUS (itching at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included cortisone cream.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: No specific follow-up information recorded.
"COVID-19 arm" (red rash from injection sight, halfway down bicep); large lump at injection site; pounding headache.
Patient mentioned redness / discoloration still remains at the vaccine injection site; Patient mentioned redness / discoloration still remains at the vaccine injection site; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE DISCOLOURATION (non-serious) all with onset Oct2023, outcome "not recovered" and all described as "Patient mentioned redness / discoloration still remains at the vaccine injection site". It was unknown if therapeutic measures were taken as a result of vaccination site erythema, vaccination site discolouration.  Additional information: Patient stated the reaction looks like a cupping therapy mark and that the same thing happened after their last booster (date unknown).  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
symptoms: nazel congestion, running nose, temp elevated by 1 degree, cough, tired,  3Positive covid tests over 2 days.  Treatment: bedrest, fluids, Isolated from family outcomes: on day 5 felt better, 3 negitive covid test, will isolate till day 10.
LOUD HEARING; BARELY GET OUT OF BED; SENSATION OF PRESSURE IN EAR; TIREDNESS; HEADACHE; SKIN HURTS TO TOUCH; PAIN IN SPINE; EAR RINGING; ITCHING TOE AND LEFT EAR; DISCOMFORT; DIARRHEA; IRRITABLE; COUGH; JOINT PAIN; EXHAUSTION; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included experienced rare side effects for past medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced skin hurts to touch. On APR-2021, the subject experienced pain in spine. On APR-2021, the subject experienced ear ringing. On APR-2021, the subject experienced itching toe and left ear. On APR-2021, the subject experienced discomfort. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced irritable. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced exhaustion. On APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced sensation of pressure in ear. On 09-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced barely get out of bed. On 10-APR-2021, the subject experienced loud hearing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sensation of pressure in ear, tiredness, skin hurts to touch, pain in spine, discomfort, ear ringing, irritable, headache, cough, joint pain, diarrhea, itching toe and left ear, exhaustion, barely get out of bed and loud hearing was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Chills, Nausea, Migraine, Heaviness in Chest, Cough, Fever, Redness and Rash on vaccinated area of arm, Tight Muscles in Shoulder and Upper Back.
Diarrhea 6-8 times for 2-3 hours. Very tired, chills, stomach ache and mild headache all day. Normal the next day, except for a mild headache.
Patient was administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB37AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 03-Aug-2022 Reporter comment: The nurse reported that the patient was administered a dose of Bexsero, which had an expiration date of 31st July 2022. This was the patient's second dose in the series.  At the time of reporting, the dose had not been repeated. The reporter consented to follow up. Additional Supportive Information: The patient was administered an expired dose of Bexsero, which led to expired vaccine used.
continues cough, visited or office for flu test and X-ray: Result was mild Pneumonia/viral pneumonia; This is a spontaneous report from a contactable consumer (patient). This is second dose report of two reports. A 75-year-old male patient received the second dose of bnt162b2 (lot: EL 9264), via an unspecified route of administration in left arm on 03Feb2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot: EL3249), at the age of 75-year-old, via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization and experienced COVID-19 (Tested positive 22Jan2021. Jan 24-25 experienced Fever, Diarrhea, Dizzy, Hot/cold periods, Headache, weakness and tiredness). The patient experienced continues cough, visited or office for flu test and x-ray: result was mild pneumonia/viral pneumonia on 05Feb2021. On 05Feb2021 patient was tested for flu. Test was negative, however, an X-ray showed some Pneumonia. Dr. indicated No treatment required. The event required a visit to Physician office. The patient underwent lab tests and procedures which included flu test: negative on 05Feb2021, Pneumonia: positive (viral pneumonia) on 05Feb2021, x-ray: mild pneumonia on 05Feb2021, COVID-19 virus test: positive on 22Jan2021. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106774 Same patient, reporter, drug and different event and dose
Information has been received from a registered nurse (RN) concerning a 16-week-old male who on 01-MAY-2006 was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). It was unknown if medical attention was sought and no symptoms were reported. Additional information has been requested.
monovalent given instead of bivalent.  manufacturer sent wrong one and they both have gray caps
Patient received the updated version of COVID-19 - Spikevax 10/2/23. He states at approximately 10PM the same day he found he had a fever and loss of balance leading to falls. He was transported to the hospital via ambulance and held for 2 days (discharged 10/4/23). He states they ran tests and determined that he had an adverse reaction to the vaccine. Patient informed the pharmacy shortly after discharge. As of follow up call 10/8/23, pt states he is feeling significantly better.
Patient received a Moderna COVID-19 vaccine booster dose (0.25mL) on 11-10-21 at about 2:00pm intramuscularly in the left arm. About 24 hours later, Patient reports she developed left sided numbness to her lips -- but only on the left side of her face and only her lips. This numbness lasted for about 4 hours and then abated without return.  The patient also reported significant fatigue 48 hours after the booster dose, which then prevented her from from performing her work duties on 11/12/21 and lead to her leaving work early to go home.
I had my vaccination on 10/07/2022. I woke up on 02/10/2023 with flu like symptoms and extreme fatigue. I went to the walk in clinic and had a COVID-19 test. I was COVID-19 positive and prescribed PAXLOVID. On 02/17/2023 I contracted Shingles. I stayed in quarantine until 02/23/2023. I still presently have the fatigue on 04/11/2023.
pt recvd vax 23AUG95 & pregnancy tests @ time of vax were neg, according to  pt; LMP 3AUG95; pt found to be pregnant; etimated date of delivery was 25APR96; ultrasound on 3OCT95 revealed a non-viable pregnancy
first Moderna booster dose each time after the injection she experienced a red left arm; first Moderna booster dose each time after the injection she experienced a swollen left arm; first Moderna booster dose each time after the injection she experienced a sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (first Moderna booster dose each time after the injection she experienced a red left arm), VACCINATION SITE SWELLING (first Moderna booster dose each time after the injection she experienced a swollen left arm) and VACCINATION SITE PAIN (first Moderna booster dose each time after the injection she experienced a sore left arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 024M20A and 008B21A) for COVID-19 vaccination.     Previously administered products included for Flu: Flu Vaccine (Right deltoid) on 24-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu Vaccine. Concurrent medical conditions included Hypertension (25 years ago) and Thyroid disorder (15 to 20 years ago).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (first Moderna booster dose each time after the injection she experienced a red left arm), VACCINATION SITE SWELLING (first Moderna booster dose each time after the injection she experienced a swollen left arm) and VACCINATION SITE PAIN (first Moderna booster dose each time after the injection she experienced a sore left arm). At the time of the report, VACCINATION SITE ERYTHEMA (first Moderna booster dose each time after the injection she experienced a red left arm), VACCINATION SITE SWELLING (first Moderna booster dose each time after the injection she experienced a swollen left arm) and VACCINATION SITE PAIN (first Moderna booster dose each time after the injection she experienced a sore left arm) had resolved.            Concurrent medication included medication for high blood pressure. It was reported that patient's HCP changed her blood pressure medication a year ago. Treatment medication not reported.   This case was linked to MOD-2022-577887, MOD-2022-577895, MOD-2022-577806 (Patient Link).
No adverse event.  HPV was administer per patient request. Then was able to pull in vaccine record from registry . patient  had already received all 3 HPV vaccines
Patient was accidentally given a higher than intended dose of vaccine.  Approximately 0.75 to 1 ml was administered to the patient instead of the intended 0.5 ml by certified pharmacy technician.  After it was confirmed that the incorrect dosage had been administered, Pharmacist contacted Janssen to discuss the matter. Representative from Janssen recommended continual monitoring of patient based on available data of incorrect dosage administered. Patient was contacted to assess for adverse effects and none had been observed as of yet. Pharmacist will continue to follow up with patient to monitor for adverse effects.
Since December 24- I keep getting extremely itchy skin and hives. The reaction goes away after taking Zyrtec or Allegra but comes back next day. I hope this reaction goes away soon!
Pt complains of sore arm with no redness or swelling at injection site. Injection was given on 9-21-09. Pt reported to pharmacy on 10-12-09 (date this form was completed).
Narrative: Pt is a 81y.o. male who died on 02/12/2021 w/ h/o ESRD on chronic HD, HTN, CAD h/o pci and stents, CHF EF 26%, tachycardia s/p ppm, aortic stenosis s/p TAVR 2019, T2DM, HTN, HLD. Pt received Moderna Covid-19 Vaccination 2/2 on 02/05/2021. Unlikely that Moderna Covid-19 Vaccine caused/contributed to pt death.
Pt recvd Engerix-B vax on 6NOV90 & 11DEC90 & in MAY91 & 13DEC90 donated blood & on 18MAR91 red cross sent ltr stating pt was Hep B antigen positive;
Pfizer vaccine was administered outside of facility - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------- J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/7/2021 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/12/2021 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/7/2021 RESPIRATORY DISTRESS J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/12/2021 RESPIRATORY DISTRESS
Administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported.   It was reported that the vaccine was stored in freezer, one of two vials were taken out and placed in fridge each day as needed.  No treatment given to the patient.