chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received the second dose of vaccine 6 days early based on 28 days intervals; A spontaneous report was received from a nurse concerning a 53-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was involved in inappropriate schedule of product administration.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29-Dec-2020, the patient received his first dose of two planned doses of mRNA-1273 and on 20-Jan-2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 041L20A) in the deltoid muscle of the left arm for prophylaxis of COVID-19 infection.   On 20-Jan-2021, the patient received his second dose of Moderna COVID-19 vaccine 6 days early based on the 28-day internals. Reporter provided consent to follow up. No treatment information was provided for the event.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The event inappropriate schedule of product administration was reported as resolved on 20 Jan 2021.; Reporter's Comments: This report refers to a case of a 53-year-old patient who experienced non-serious event of received the second dose of vaccine 6 days early based on 28 days intervals (inappropriate schedule of vaccine administered) for mRNA-1273 (lot # 041L20A, Exp date-unknown). There were no reported AEs associated with the event of received the second dose of vaccine 6 days early based on 28 days intervals.
typical flu like symptoms; fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, administration date: Mar2021, for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "typical flu like symptoms"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; HEADACHE (non-serious), outcome "unknown", described as "headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101655010 same patient/drug, different dose/event
A nurse reported the occurrence of an injection site reaction in an 18-month-old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The medical history and concurrent medications were not specified.  On 05/28/2002, the vaccinee received her fourth injection of Infanrix (lot DTPA542A2; expiration date 09/24/2003).  On the same date, she also received an injection of inactivated poliomyelitis virus vaccine (IPOL) in the opposite arm.  That evening, she began to develop an injection site reaction characterized by redness and swelling that progressively got worse.  The swelling eventually extended to include half her forearm.  the vaccinee was seen by a physician.  The reporter stated that the events were probably related to Infanrix administration.  As of 05/30/2002, the events were unresolved; the limb swelling was "worse".
This is a spontaneous report from a contactable nurse. An 89-year-old female patient received the  PREVNAR 13, intramuscularly in the right deltoid on 03Oct2017 at 0.5 ml, single for immunization. The patient medical history was not reported. There were no concomitant medications. On 11Oct2017, the patient experienced cellulitis and from the cellulitis she had altered mental status. Therapeutic measures were taken as a result of cellulitis and from the cellulitis she had altered mental status, and included treatment with ceftriaxone (ROCEPHIN) injection. The clinical outcome of the events, cellulitis and from the cellulitis she had altered mental status, was unknown.; Sender's Comments: The vaccination with PREVENAR 13 might play a contributory role in triggering the occurrence of cellulitis requiring antibiotic therapies in the patient considering the plausible time association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
6 hrs after vaccine: Cool, pale, hypotonic, hyporesponsive eyes up in head. No tonic or clonic activ. Duration: 20 min.
Became dizzy, with a headache, cloudy thinking within the hour of injection. Injection site became itchy and before 24 hours entire body was itchy, skin felt like it was crawling.
Information has been received from a health professional concerning a 10 year old male who on 1/15/99 was vaccinated with a dose of varicella virus vaccine live. On 7/23/05 the patient developed severe shingles on his right eyelid and forehead resulting in iritis and eye droop. The patient was referred to an ophthalmologist and he is being treated with a steroid. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. The reporter considered the experiences to be other important medical events (OMIC). The patient's brother experienced breakthrough chicken pox following vaccination with varicella virus vaccine live (WAES0508USA02170).
24MAR acquired chicken pox-2 wk p/sibling;pt sibling had breakthrough chicken pox;not sick 15-20 pox;w/in 3-4 days scabbed over missed 1 day of school;
mild sore arm/mild sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild sore arm/mild sore injection site arm) in an 85-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 060F22A and 020H224) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-May-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (mild sore arm/mild sore injection site arm). At the time of the report, VACCINATION SITE PAIN (mild sore arm/mild sore injection site arm) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  The patient received the vaccine in his left arm and had mild sore arm after fifth and sixth doses of vaccine.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746996, US-MODERNATX, INC.-MOD-2023-747010 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746996:Dose 7 US-MODERNATX, INC.-MOD-2023-747010:Monovalent case
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022; Vaccine received post its 30 days Expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2022 at 4:46 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Feb-2022 at 4:46 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 03-FEB-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Vaccine administration time was given as 03-Feb-2022 16:46:34.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Fever, chills, nausea, vomiting, diarrhea, chest tightness, pain at site of injection as well as alone injection arm & axulliary pain.
Fever FATIGUE, NAUSEA, GENERALIZED SKIN PAIN, INJECTION SITE REACTION Narrative: EMPLOYEE STATES: INJECTION SITE REACTION OF REDNESS, SWELLING, RASH, ARM PAIN
Fever started 7/29/16 in the evening, started with rash 7/31/16 on cheek, increased to body 8/1/16.
About 2 hours after vaccination became pale and dizzy. Approximately around 4-6hrs after vaccination that arm was incredibly sore and the evening of 10/31/2017 felt lymphadenopathy near collarbone and axillary region on left side.
Fever 101.1 Iz's were given a couple wks before reaction occurred. Pt was fussy, no running nose, no cough. A circular lesion localized (L) thigh 15 x 20 mm with redness.
She got her vaccine, initially she had bruising on her forearm that was blue/yellow with a swollen vein connected running down to her hand.  She had tingling and numbness in her fingers in a select few on the left hand.  She also had drooping of her left eye for a short period and a sensation on her left leg, swelling and pain.  She went to the urgent care on 4/15/21, they told her to go home and monitor it.  She knew that somewhat was not right and called a nurse at Hospital and went to the ER shortly thereafter and confirmed that she had a blood clot in her jugular vein IJ-DVT.  In the ER they gave her a shot of Lovenox in the ER into her stomach and run several tests.  They also gave her an anti-inflammatory in her right arm.   She was sent home with Eliquis for the next 3 months.  She has extreme exhaustion, and in addition to that she has had a lot of swelling on the left side of her leg, and visited the ER again on 4/17/21.  Her left foot became blue, very swollen, so they ran a number of tests which all came back negative.  She thinks these are side effects in relation to the previous.  She is still continuing with stiffness in her neck as well.   She also has a severe headache, fever of about 100, and severe achiness.   She has not been able to work due to these symptoms since 4/15/21.  The ER told her to have a lot of rest, no heavy listing/straining due to the clot.
No adverse event; the patient received monovalent Moderna Covid-19 vaccine instead of the Moderna Bivalent vaccine for the booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (the patient received monovalent Moderna Covid-19 vaccine instead of the Moderna Bivalent vaccine for the booster dose) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (the patient received monovalent Moderna Covid-19 vaccine instead of the Moderna Bivalent vaccine for the booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (the patient received monovalent Moderna Covid-19 vaccine instead of the Moderna Bivalent vaccine for the booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (the patient received monovalent Moderna Covid-19 vaccine instead of the Moderna Bivalent vaccine for the booster dose).    No concomitant medication information provided.  It was reported that the patient had received monovalent Moderna Covid-19 vaccine instead of the Moderna Bivalent vaccine for the booster dose. Bivalent Lot 057A22A expiration date 06-Feb-2023.  No treatment information provided.
Patient received shot around 7:30 PM       plus or minus . Shot hurt more than others I already had taken.  Left arm in the muscle.  Achy arm within hours. Maintained and got worse since the event. Presently after many hours of PT over the months the patient can not get a pull over shirt on of off by himself, as well as a heavy jacket.  Patient will be seeing his 2nd Orthopedic Specialist in 3 weeks.  The pain is severe and the arm is too weak to pick up a 1/2 gallon of milk.
Patient became sweaty, unresponsive, and felt dizzy. Patient was given orange juice and had her place her head between her legs to increase blood flow. EMS was called.
The morning after my shot (received around 3-3:30p on Saturday 4/3/21), I woke up to a partially swollen right eye and pressure pain across the sinuses. Vision slightly obscured, but I could still see. Applied a cold compress throughout the day and monitored for additional concerns. By the end of the day, the swelling subsided. By Monday, both eyes still felt pressure pain, but the swelling was significantly improved. Other side effects included the expected muscle soreness/aches, fatigue, and a mild rash around the vaccination spot. No additional adverse effects observed.
This case was reported by a nurse via call center representative and described the occurrence of pain in a adult patient who received 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 pain and myalgia. On an unknown date, the outcome of the pain and myalgia were unknown. It was unknown if the reporter considered the pain and myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The nurse reported that after receiving SHINGRIX, several patients experienced myalgia and soreness. The nurse did not have specific patient or vaccine information.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (expired vaccine given to patient) and product storage error (vial initially stored in the refrigerator on April 1, 2022; administered April 20, 2022) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 016J212A) for COVID-19 immunization. No medical history reported. On Apr 20, 2022, patient received the fourth dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 20, 2022, patient administered expired product (expired vaccine given to patient). On an unknown date, patient experienced product storage error (vial initially stored in the refrigerator on April 1, 2022; administered April 20, 2022). At the time of the report, administered expired product (expired vaccine given to patient) and product storage error (vial initially stored in the refrigerator on April 1, 2022; administered April 20, 2022) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. On April 1, 2022, vial was initially stored in the refrigerator. Vial did not undergo any temperature excursions.
Once covid vaccine was administered, patient stated she could taste the vaccine as the pharmacist was giving the shot. Once the shot was completed, patient had a pulsating feeling all throughout her chest that traveled down her body and into her lower body. Patient stated that she had a pain all over and after about 15-20 minutes this feeling went away. We checked the patient's blood pressure to make sure she would be okay before leaving and her blood pressure was elevated with readings of 168/90, 168/93, and 175/95. The patient felt okay to drive home after the pain subsided. We will follow up with the patient to make sure her blood pressure goes back to normal and to check in and make sure she doesn't have any further reactions.
lightheaded, nausea, tingly improved with fluids and in recliner BP 100/62 HR 60 O2 97
This case was reported by a consumer via sales rep and described the occurrence of cluster headache in a 64-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included cluster headache. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 1 day after receiving SHINGIRX, the patient experienced cluster headache. On an unknown date, the patient experienced fever and chills. On an unknown date, the outcome of the cluster headache was not recovered/not resolved and the outcome of the fever and chills were recovered/resolved. It was unknown if the reporter considered the cluster headache, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient had a history of cluster headaches but did not have a cluster headache in about 9 years since it was controlled last. The patient reported that the day after having the first injection of SHINGRIX he experienced cluster headaches and had been experiencing 3 to 4 headaches per day since then.  In 2018, less than a year after receiving 1st dose of SHINGRIX, the patient experienced chills and fever as well. The patient had the second dose of SHINGRIX in late June.
has Covid 19; has Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Aug2022, outcome "unknown" and all described as "has Covid 19". The event "has covid 19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Aug2022) Positive, notes: he started with Covid yesterday His doctor this morning prescribed him the medication Paxlovid pills. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller has a question. He has Covid 19 and was being treated and he was vaccinated already. His doctor this morning prescribed him the medication Paxlovid pills. He started it now in the afternoon after he picked it up at the pharmacy. He was feeling pain since he started with Covid yesterday before he started the Paxlovid pills. His concern was can he take ibuprofen or Advil; would that make any trouble with Paxlovid. Caller declined to report as he was feeling pain in his joints and would like to ask about ibuprofen or Advil. Clarified that he had 2 Pfizer Covid vaccines and the Pfizer Covid booster.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 7 year old female who on 03-NOV-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot no. 661662/1137X) (route and site not reported). Concomitant therapy included influenza virus vaccine (unspecified). On 04-NOV-2008 the patient experienced cellulitis. Additional information has been requested.
Got covid shot and my arm hurt later as common after vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, start date: 14Oct2023, stop date: 14Oct2023; QULIPTA. Vaccination history included: Covid 19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for Covid-19 immunization; Covid 19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for Covid-19 immunization; Covid 19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Oct2023 at 21:00, outcome "recovering", described as "Got covid shot and my arm hurt later as common after vaccines". Therapeutic measures were not taken as a result of pain in extremity. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Slight Abdominal pain 0400 2/2/21. Loss of appetite. Severe abdominal pain 1400. Went to ER. Surgery and ruptured appendix 2/2/21 at 2130. Resulting in peritonitis, seven day hospital stay, multiple antibiotics, elevated abnormal labs including LFT and platelets. ,
approx 30min p/immun, pt became irritable; persisting inconsolable screaming for @ least 5-6hrs;
Fussy, restless. Local reaction at DTaP site. Change in affect. Not cooing or vocalizing, not smiling. Autonomic dysfunction likely with abnormal pupillary responses.
Erysipelas was diagnosed at ED.  Rash at injection site, swelling, tender to touch, redness at injection site.
Patient had a loss consciousness for some few seconds and after regain of consciousness he was confused. Follow up to ED reports Non hemorrhagic CVA.
On 3rd day after vaccination, pain began in left pectoral region on left side. Pain heals settled in intercostals of left rib cage.  This has caused difficulty in taking a deep breath.  No congestion, coughing, or vomiting. Just pain with inhalation.  Pain can be palpated in ribs, level 6 and 7.  Somewhat better today, March 17.
This spontaneous report as received from a Doctor of pharmacy refers to 2 patients of unknown gender and age. On an unspecified date in 2013, "last year", the patients were vaccinated with a ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported that on an unspecified date in 2013, after being administered ZOSTAVAX, the patients experienced injection site rashes. The outcome of injection site rashes was unknown. Additional information has been requested.
Information has been received from a physician's assistant (PA) concerning a 9-year-old female who was vaccinated SC with a 0.5 mL dose of Varivax. The PA reported that a few years after being vaccinated with Varivax, the patient developed breakthrough chickenpox. The PA also reported that in 2006, the patient developed shingles. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.