chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right arm hurt; Itchy; Bumpy and hard; Arm red; Arm felt hard; Swollen; Arm really hot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Right arm hurt), INJECTION SITE PRURITUS (Itchy), INDURATION (Bumpy and hard), INJECTION SITE ERYTHEMA (Arm red) and INJECTION SITE REACTION (Arm felt hard) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included No adverse event (No reported medical history).   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Right arm hurt), INJECTION SITE PRURITUS (Itchy), INDURATION (Bumpy and hard), INJECTION SITE ERYTHEMA (Arm red), INJECTION SITE REACTION (Arm felt hard), INJECTION SITE SWELLING (Swollen) and INJECTION SITE WARMTH (Arm really hot). At the time of the report, PAIN IN EXTREMITY (Right arm hurt), INJECTION SITE PRURITUS (Itchy), INDURATION (Bumpy and hard), INJECTION SITE ERYTHEMA (Arm red), INJECTION SITE REACTION (Arm felt hard), INJECTION SITE SWELLING (Swollen) and INJECTION SITE WARMTH (Arm really hot) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
8/29/14 Mother reports that infant had adverse reaction to second DTaP on 4-09-14. Screaming all afternoon and throughout the night. Also noted tremors, staring episode, hands turned blue while giving bath; tired? Seizure?? No further activity since.
Myositis of (R) arm. Warm, tender and red at injection site. Clindamycin 450 mg IV Q 6 hrs.
Information has been received from a Doctor of Pharmacy concerning a 15 year old female who on 25-JUN-2007 was vaccinated with a second dose of Gardasil. On 25-JUN-2007 the patient developed seizure like activity shortly after the injection. The physician was summoned to the room, but upon arrival the patient's symptoms stopped. The patient looked confused but her color remained good. Her blood pressure was 104/60 mm/Hg. She stayed at the office for 35 minutes for observation. Her blood pressure was taken again was 110/60 m/Hg. The patient recovered and was sent home. Upon internal review, the patient's seizure like activity was considered an other important medical event. Additional information has been requested. This is in follow-up to report (s) submitted on 8/8/2007; 8/17/2007. Additional information has been received from the Pharm D who reported that the patient with no history of seizures was not diagnosed with seizures. The patient did not have a true seizure. The patient's experience was described as "seizure like" activity. The patient was sitting upright when she received GARDASIL. Within 1 - 2 minutes following adiministration, she leaned back against the chair, her head went against her arm on the side, her eyes rolled back in her head and arms and torso shook. It was reported that the patient was very lucid after the "seizure". The Pharm D. reported that the patient was to have unspecified test and an EEG performed (details unknown). The Pharm D had no additional information regarding the patient's experience. The nurse reported that the patient was contacted on 26-Jun-2007 and 28-Jun-2007 and was doing fine. The nurse stated that she did not think that the patient would be back for the third vaccination. No additinal information is expected.
The day after receiving the H1N1 vaccine, developed red rash, hives and itching to upper arm - more enhanced than after seasonal vaccine. Saw MD and treated with methylprednisolone.
11/30/2021: Pt admitted due to generalized body aches, cough, n/v/d, loss of taste and smell, and fever since 11/21. continue o2, wean as tolerated. placed on decadron, will check procal if elev then begin abx.  12/01: weaned off of o2. o2 sats 92% on room air. continue current meds and treatment plan. pt discharged with decadron and albuterol
On 1/27/01 the pt experienced a sudden onset of severe abdominal pain, cramping with nausea, dizziness, weakness and headache, unable to sleep at night. On 1/28/02, the pt experienced a headache, weakness, nausea vomiting, with confusion. The pt also experienced a fast heart rate, felt like I was going into coma. The pt took Motrin for the headache. The headache continues with weakness, joint pain.
Pt. states that after receiving the 1st dose of J&J 11/20/2021, started experiencing symptoms 11/21/2021 of fever (101.0), "flash" in the right eye, and pain throughout the left leg (lasting 2 days). No noted Primary visit/communications.
Both of our second toe feels numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: HYPOAESTHESIA (non-serious), outcome "unknown", described as "Both of our second toe feels numb".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a healthcare professional and described the occurrence of hive in a 49-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 20 October 2013 at 06:00 the subject received unspecified dose of FLUARIX (unknown details). On 20 October 2013, 2 hours after vaccination with FLUARIX, the subject experienced hive and elevated heart rate. The reporter documented that the events occurred "about 2 hours after receiving the vaccine." The subject sought medical attention at the emergency room and was treated for hives and elevated heart rate." The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events were unspecified.
This is an initial spontaneous report from a contactable consumer. The mother reported that her 12-month-old son accidently received a fifth dose of PREVENAR 13 on 27APR2011 (one and half months after the fourth dose was given). It was thought that the fourth dose was not given. Relevant concomitant vaccines administered on unspecified dates included a (reported as) BCG vaccine; MMR; DTaP duration, dose, frequency and indication for all concomitant vaccines was unknown. Relevant medical history included sickness since 22APR2011. On 27Apr2011, the patient was diagnosed with bronchiolitis and conjunctivitis and was hospitalized (for little less than 24 hrs). The mother also mentioned that her son was cranky and had a cough for an unknown duration in APR2011 (exact date not provided). Therapeutic measures taken in response to the bronchiolitis included albuterol sulfate (dose and frequency unknown), ciprofloxacin eye drops for conjunctivitis (unknown duration in 2011, unknown dose four times a day), and MOTRIN (unknown duration, unknown dose as needed orally). (It was also reported that), the consumer was also put on oxygen hold for about four days after he was discharged from the hospital. The outcome of accidently given a fifth dose was unknown. The outcome of conjunctivitis was recovered on 01MAY2011. The outcome of bronchiolitis and cough was recovered on 6MAY2011. The outcome of cranky was not recovered at the time of this report.
Site of injection was sore to the touch, feverish at site lasted more than 1 week.
This is a spontaneous report from a contactable consumer (patient).   A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12Apr2021 11:00 AM (Batch/Lot Number: ER8737) as DOSE 2, SINGLE for covid-19 immunisation.  Facility type vaccine was in hospital. Medical history included arthritis, high cholesterol and known allergies to shellfish. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm right on 22Mar2021 10:45 AM (Batch/Lot Number: EP7534) as DOSE 1, SINGLE for covid-19 immunisation. Concomitant medication(s) included nebivolol hydrochloride (BYSTOLIC); metformin; hydrochlorothiazide; finasteride (FINASTERIDE), all taken for an unspecified indication, start and stop date were not reported.  There is other unspecified vaccine on 12Apr2021. 24 hours after 2nd shot on 13Apr2021, patient had 90 straight hours of high fever and constant bad chills. Next 2 weeks mostly severe aches and pains, next 2 weeks mostly difficult breathing, and 6 weeks of heavy night sweats. All events onset date was on 13Apr2021, with latency 24 hours. The patient underwent lab tests and procedures which included sars-cov-2 test (Blood test): negative in May2021.  The outcome of events was recovered in 2021 without treatment. Events was results in physician office visit. Follow-up attempts are completed. No further information is expected.
The patient had a scaring at the site of injection. Then a couple weeks after the injection, he developed hair loss in clumps. Over the next couple of months significant alopecia areata of the scalp from a near full head of hair a couple months prior. He currently has been referred to dermatology for treatment.
Tinnitus in left ear since 3/16/2021. Was told it should go away but never has!!
This medically confirmed spontaneous report (initial receipt 17-JUL-2014) concerns a female patient. The patient had a medical history of an unspecified neurologic condition, diabetes, hypothyroid (Hashimoto's disease) and an unspecified autoimmune disease. She had drug reactions/allergies to Metformin (reaction-facial swelling), Carbamazepine (reaction-facial swelling), Losartan (reactions-facial swelling and blisters), penicillin and sulfa drugs.  On an unspecified date, the patient receive unspecified flu vaccine (manufacturer and batch number not reported) and pneumonia vaccine.  On an unspecified date, the patient experienced arm swelling, rash and fever. Outcome was not reported.
Reports of : Fatigue/Diarrhea/Nausea/Vomiting  up to 7 days post vaccination.
sore left arm; also had diarrhea from Saturday to Tuesday and my stool was bright yellow.; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via unspecified route of administration in the left arm on 13Mar2021 (at the age of 27-year-old) at 15:00 as a single dose for COVID-19 immunization. Medical history included asthma and COVID-19. The patient had no known allergies. Concomitant medication was not reported. The patient did not receive any other vaccine within four weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021 at 21:00, the patient experienced a sore left arm, diarrhoea from Saturday to Tuesday and his stool was bright yellow, which was not too serious. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of sore left arm was recovered on 15Mar2021, while that of diarrhoea was recovered on 16Mar2021 at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Prior to vaccination, was the patient diagnosed with COVID-19? Yes, added as Relevant Med History and vaccination Facility Country added.
Had flu shot last year 2009 no reactions. Did not get H1N1. This year same flu shot had hives around immunization site and face. Resolved with BENADRYL.
Right anterolateral thigh 7.5cm local cellulitis at site of injection developed day after immunization mom sought treatment 2 days after immunization. Treatment with Keflex 500mg po qid x10 days
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 08-SEP-2015, the patient was vaccinated intramuscularly with an expired 0.5 ml dose of PNEUMOVAX23 injection (lot # J013344, expiry date 22-JAN-2015). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
I woke up with mostly gastrointestinal pains and runny nose. I started vomiting seeming to be mostly mucus. I noticed I was napping with my CPAP machine for my sleep apnea machine. I had severe aches and pains and became restless. My sleep cycle had been disturbed. I became aware that my pulse had changed as if my heart had been skipping a beat. I have a device that can detect any irregularities, but it didn't pick up on any irregular rhythms. I went to my doctor where they performed an EKG and discovered a premature atrial contractions. However, two weeks later, another EKG was performed, and they newly determined I was having premature ventricular contractions onset by my bradycardia according to the cardiologist. No new medication was prescribed, but I was told to monitor my blood pressure consistently as well. I was told contracting COVID-19 from my earlier symptoms could've impacted this as well.
1:16 Pt. c/o that she feels faint, also has nausea and vomiting.  1:25 Pt. report feeling better. 1:45 left site.  BP 133/66, 81hr, O2Sat 100%1.  1:47 Patient reported feeling better.  Mom was advised that if patient (daughter) still experiencing symptoms to consult 911 or family physician.   Understanding verbalized.
Diluent given without antigen compotent in error. Contacted patient in regards to error, patient returned for correct dosage.  Correct dose given without any adverse reactions.
Pt recvd vax & exp nausea, diarrhea, fatigue, abdo cramping; sx were not so severe that missed any work; pt exp photophobia, diarrhea, abdo cramping, fatigue & rash of the lt knee & inner thigh; dx w/shingles; raw, weeping blister;
Eyes are closed with pain; Unable to sleep; Body aches; Shaking chills; Fever; Headache; Cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Cold), EYE PAIN (Eyes are closed with pain), INSOMNIA (Unable to sleep), MYALGIA (Body aches) and CHILLS (Shaking chills) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FEELING COLD (Cold), INSOMNIA (Unable to sleep), MYALGIA (Body aches), CHILLS (Shaking chills), PYREXIA (Fever) and HEADACHE (Headache). On 15-Jan-2021, the patient experienced EYE PAIN (Eyes are closed with pain). At the time of the report, FEELING COLD (Cold), EYE PAIN (Eyes are closed with pain), INSOMNIA (Unable to sleep), MYALGIA (Body aches), CHILLS (Shaking chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Reporter's Comments: Based on the current available information and temporal association between the product and the start date of the events a causal relational cannot be excluded.
Developed fever on 12/02/03, but normal behavior.  On 12/03/03 maintained fever--measured at 101.3 F, developed extreme lethargy, loss of appetite, and weakness.  Evaluation demonstrated hypoglycemia.  Subsequent evaluation demonstrated metabolic results consistent with Probable Medium Chain Acyl-CoA Dehydrog. Defic.
expired menactra administered to a patient with no reported adverse event; Initial information received on 12-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics and is reported expired meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose 0.5 ml of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine Solution for injection strength, lot number not reported expiry date: feb-2023 via unknown route in unknown administration site for prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient developed a non-serious expired menactra administered to a patient with no reported adverse event (expired product administered) on the same day following the administration of Meningococcal A-C-Y-W135 (D CONJ) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired menactra administered to a patient with no reported adverse event.  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 the guidelines. 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.
patient "lost a little bit of balance" after receiving the first shingrix dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of loss of balance in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included parkinson's disease.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced loss of balance (Verbatim: patient "lost a little bit of balance" after receiving the first shingrix dose). The outcome of the loss of balance was unknown.   It was unknown if the reporter considered the loss of balance to be related to Shingrix.     It was unknown if the company considered the loss of balance to be related to Shingrix.   Additional Information: GSK receipt date: 17-Jul-2023 Pharmacy technician reported that a patient lost a little bit of balance after receiving the 1st dose of Shingrix. No further information reported by the pharmacy technician to the agent. The reporter did not consent to follow up.
father called hlth dept 20JUL98 & reported pt was taken to hosp ER 18JUL98 for temp 106R;given motrin q 4hr & APAP q 4hr;
Pt states that she was itching and showed some type of rash on both arms and anterior thighs, and some in the flank area.
VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8° (10 mins); This non-serious spontaneous report with reference numbers 02197725 / 02197588, was received by partner on 05-JUL-2022 and forwarded on 06-JUL-2022.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 01-AUG-2022 and forwarded on 03-AUG-2022, from a HCP. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins)" and Vaxelis remained not applicable.  For reference purposes this case is linked to MCM-003724, MCM-003725, MCM-003726, MCM-003724, MCM-003734, MCM-003735, MCM-003737, MCM-003738, MCM-003739, MCM-003740, MCM-003741, MCM-003742, MCM-003743, MCM-003744, MCM-003747, MCM-003749, MCM-003751, MCM-003752, MCM-003753, MCM-003757, MCM-003759, MCM-003760, MCM-003763, MCM-003766, MCM-003761, MCM-003769, MCM-003767, and MCM-003772, due to same reporter.  No further information is expected.
Patient reported, who declined to provide demographics, reports that he received ZOSTAVAX on an unspecified date described as approximately three weeks ago, and subsequently developed a disseminated upper body rash as well as worsening of an arm tremor he has had since birth. Patient reports that the rash spontaneously resolved approximately two weeks after it started, but that the worsened arm tremor remains. Patient declined to provide his physician's identity and disconnected the call before all questions could be asked. Patient reports that he has been allergic to all antibiotics since experiencing a bout of Stevens-Johnson Syndrome in 2003. Patient also reports that following administration of an unspecified antibiotic, during an unspecified surgery on an unspecified date in 2011, he experienced a disseminated and severe rash over the entire body that persisted for weeks before resolving. No further information is available.
74 yr old rec'd Pfizer-BioNTech covid vaccines on 4/11/2021 and 5/21/2021, w/o issue. Received his booster dose in left arm on 11/21/2021.  Visited this clinic on 1/30/22 w/ a friend, at which time he informed RN of adverse event occurring 2 weeks after the booster.  Described waking w/ "tightness," muscle weakness and numbness in forearm, wrist and lateral 3 digits of hand.  Symptoms persist to present. Saw pcp and a "specialist" (ruled out vascular etiology, suggested possible ulnar nerve involvement).  Has been scheduled w/ neurologist in 2 wk's  for further workup