chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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 (No reported medical history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Per patient, states received Moderna vaccine on 4/30/22 and started experiencing itching and hives on legs and experiencing swelling in throat, tongue and ears.
40 min after shot experienced dizziness, feeling like was going to pass out, not coherent, BP high, fast heart rate, light headed. Got chills, freezing cold, shivering, and later in the day my ears were ringing. Extremely fatigued.
Swelling at injection site. Pain & discomfort night of injection given; patient went to ER nearby hosp for treatment. Sent home with pain med and ice pack(cold compress). Diagnosis of hematosis.
In our office, administered DTaP IM right thigh and IPV IM left thigh on 10/03/02. Phone call call reporting right thigh very swollen, red & warm to touch on 10/04/02. Patient seen in office 10/05/02 presented with local reaction right thigh vs cellulitis
Pt developed very sore, swollen and hot joints after Lymerix vaccination. I couldn't walk for quite some time. (Pt had 3 Lymerix injections over a 1 year period).
Swelling of the site of injection, redness & induration. I gave Rx for prednisone and BENADRYL. No other symptoms.
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Lot number: GH9694), in left arm and on 08Apr2023 at 15:00 as dose 5 (booster), single (Lot number: GS3268) at the age of 40 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER2613), in right arm, on 08Apr2021 as dose 2, single (Lot number: EW0150), in left arm and on 23Oct2021 as dose 3 (booster), single (Lot number: FF2593), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing); "fibroids" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "Cipro allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300186692 same patient, different drug and event.;
patient received fluzone hd flu vaccine in left arm at 1:15 pm after filling paper work and going over all questions and health check with the patient. after 30-45 minutes, patient returened to pharmacy with complaining from swallen area under left ear, no difficulty breathing, rash, dizziness, itching or hypotension. only swallen small area under left ear down to the neck. pt received 2 tablet sof 25 mg benadryl and water, sat and I checked her bood pressure (140/90). patient remained seated for about 20 minutes for observation, pt was alert and talkative, no further compalins or pther symptoms. after 20 minutes patient wanted to leave, i counceled her for emergency symptoms she should monitor and call 911 if needed, otherwise she should follow up with her physician. patient agreed and left pharmacy accompanied by her freind.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown. It was unknown if the reporter considered the fever and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced fever and aches after the first dose of the SHINGRIX series. The healthcare professional did not had all the details because she was working in a different location.
PENTACEL that was administered to a patient after the expiration date with no adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a patient of an unknown age and gender to whom administered diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib(PRP/T) Vaccine [Pentacel (Vero)] to a patient after the expiration date with no 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 unknown expired dose of suspect diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib(PRP/T) Vaccine Suspension for injection (strength, lot number not reported and expiry date: 09-Sep-2023) via unknown route in unknown administration site as Immunization and (expired product administered) (latency: same day). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
After administration of vaccine at 1:00 pm, I looked up and saw patient had fainted in chair, that time was maybe around 1:01 pm. When I rushed over to her, she regained consciousness, noticed she was not able to speak well, nurses removed her mask and we noticed her lips were swollen and was having an anaphylactic reaction, I then administered one dose of Epi-pen at 1:04 pm and called 911. We took her BP but it was high due to the Epipen injection, we tested her blood sugar. When the EMT arrived, they took over and took her to the ER.
Got the vaccine, had shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the vaccine, had shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 04-Mar-2023. This serious case was reported by a consumer via interactive digital media.  The patient had shingles after receiving the vaccine. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
After 1st dose, no issue other than mild sore shoulder muscle. For this (reported) dose,. > 6 month after 1st dose. Shoulder pain more pronounced, and is lasting to this date. For 24 hours after dose, to 72 hours after dose (yesterday relative to this report) Unusual tiredness requiring work stoppage and naps. Muscle pain, whole body (No jaundice), Ibuprofen not effective. Severe headache not mitigated with regular 2x regular ibuprofen doses. No fever, No night sweats, No Jaundice. After 72 hours only symptom that have continued is shoulder pain. The only reason I am reporting this is that on 1st dose, I only experienced injection site (shoulder) pain for 24 hours, starting 12 hours after injection.
Approximately 2 hours after the second dose of the Moderna COVID vaccine, fatigue and chills began. Over the course of the evening and through the next 30 hours, fever (100.6), sweats, chills, fatigue, and severe arm pain were experienced. Arm pain remained moderate after three days post vaccination.
Narrative:  76 year old male with a PMH of HTN, HLD, A fib, Sleep Apnea, obesity, CLL, SCC, DM2 and prostate cancer metastatic to bladder presented to the ED on 2/22/22 complaining of about 10 days of generalized weakness, mildly productive cough, nausea/vomiting and diarrhea. Pt reported he tested positive for COVID on 2/12/22. Minimal shortness of breath is also mentioned though mostly with activity. Following nausea medication and IVFs given in the ED Pt reports feeling better. Pt tested positive for COVID on 2/22/22. Admitted to hospital on 2/22/22 with COVID PNA and AKI. Pt treated with ceftriaxone and azithromycin on 2/22/22 only. Pt received supportive care including antiemetics. Pt improved and was discharged to home on 2/25/22.
Approximately 15 minutes after the vaccines were administered the child's mouth started shaking and the child started wheezing.
Elevated  blood pressure of 191/110 Heart rate 101 Saturation of peripheral Oxygen Room air 95 at 11:28 am BP 184/136 HR 97 SpO2 RA 99 at 11:35 am; BP 186/113 HR 105 SpO2  RA 100 at 11:38 am; Patient was experiencing anxiety, she reports that her blood pressure medicine was changed a week ago. She also informed that she did not eat before coming to get her shot. Patient was informed to call 911 or report to doctor if symptoms get worse.
Mild fever 100F next morning; This is a spontaneous report from a contactable consumer (patient) reported that a 31-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number EL3248 and Expiration Date unknown) via an unspecified route of administration (right arm) on 13Jan2021 at single dose for covid-19 immunisation. There is no covid prior vaccination, no covid tested post vaccination, no known allergies and other medical history. The patient's concomitant medications were not reported. Patient have mild fever 100 F next morning (14Jan2021). No treatment was received. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 01Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraines, but not other chronic conditions" (unspecified if ongoing); "Known Allergy: Kiwi" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL, start date: 02Jan2006, stop date: 13Sep2023. Past drug history included: Ciprofloxacin, reaction(s): "Known Allergy: Ciprofloxacin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  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 pharmacist via Pharmacy Risk Management General Liability and described the occurrence of nausea in an adult male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 28 October 2013 the subject received a dose of FLULAVAL (unknown, left arm). In October 2013, within days of vaccination with FLULAVAL, the subject experienced nausea and pain. Medications prescribed from visit to the primary care physician included Promethazine 25mg for symptoms of nausea after the flu shot administered on 28 October 2013; was told to take TYLENOL for pain. On 01 November 2013, four days after vaccination with FLULAVAL, the subject experienced injection site arm pain radiating to anterior neck, pain radiating up arm, skin infection and swelling at injection site area. On 01 November 2013, four days after vaccination, the subject presented to the emergency room (ER) for severe pain that traveled from the upper left arm where the shot was administered to the left shoulder and left side of the neck. Also developed a skin infection and swelling in the left arm surrounding the area where the flu shot was administered. The subject received KEFLEX 500mg four times daily, BACTRIM DS 800/120 mg twice daily, MOTRIN 800 mg three times daily and PERCOCET 5/325 one to two pills every six hours. The intravenous medications the subject received in the ER included Morphine, ZOFRAN, TORADOL (two) antibiotic ROCEPHIN and Doxy. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified.
Skin look burnt and inch of size; Hives started on left side of chest/hives spread to stomach, bend of elbow inside of arms, palms of hands and in between fingers; Skin feels like leather to touch; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN BURNING SENSATION (Skin look burnt and inch of size), URTICARIA (Hives started on left side of chest/hives spread to stomach, bend of elbow inside of arms, palms of hands and in between fingers) and INDURATION (Skin feels like leather to touch) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01M20A and 025J202A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Heart disease, unspecified (Was taking heart medication) and Seizure. Concomitant products included TOPIRAMATE (TOPAMAX) for Seizure, RANOLAZINE, VITAMIN B6, ACETYLSALICYLIC ACID (ASPIRIN LOW) and THYROID for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced SKIN BURNING SENSATION (Skin look burnt and inch of size), URTICARIA (Hives started on left side of chest/hives spread to stomach, bend of elbow inside of arms, palms of hands and in between fingers) and INDURATION (Skin feels like leather to touch). At the time of the report, SKIN BURNING SENSATION (Skin look burnt and inch of size), URTICARIA (Hives started on left side of chest/hives spread to stomach, bend of elbow inside of arms, palms of hands and in between fingers) and INDURATION (Skin feels like leather to touch) outcome was unknown.            Treatment medication were not provided. concomitant medication includes blood pressure medications.   This case was linked to MOD-2021-046304, MOD-2021-110283.
Within 2 hours of injection, got a dry mouth, felt kind of woozy and was "kinda numb" and tingly down her legs.  Eyes "kind of blurry".  Had trouble feeling her feet.  Symptoms persisted for approximately 2 hours and were gone by 1900.
1 of 2 pts who devel a local rxn following vax; seen in ER & tx w/ATB:
Diarrhea and abdominal pain cramping for 2 weeks after 2 mo vaccines.
How the Vaccine affected my Sleep Apnea  Diagnosed: Severe Sleep Apnea Obstructive & Central 2 ½ years ago with 55 events/hour Machine: BiPap ResMed AirCurve 10 ASV with Memory Foam Full Mask  Vaccine: Moderna  My first shot had little effect with minimal soreness in my arm and a slight headache. The second shot had much more effect on me. I was very active the day of the second shot and the next day. Then it hit me hard. One of the greatest benefits of my Bi-Pap is how it works on my depression and anxiety. I was really sick with headaches, fever, no energy, body aches and really being in bed all day. Unfortunately the depression hit me also. It is like a lead blanket (like the dentist uses for x-rays) over you as you ball up in bed as your mind thinks why do I exist and how to end it with more feeling of anxiety. It really felt like I would die but knew from my experience that it may pass. Luckily it did but it took 10 days before feeling alive again. I also wondered why my events/hour increased at this time and concluded that the vaccine affected my Sleep Apnea.  My Data:  30 day average: 6.34 events/hour  90 day average: 4.64 events/hour 365 day average 3.89events/hour  As you see I have a good events/hour average but it has really increased this month since I got the Vaccine. Here are my numbers.  First Vaccine February 2021 18th  3.0 events/hour (day of shot) 19th  8.6 events/hour 20th  5.2 events/hour 21st  3.1 events/hour 22nd 2.2 events/hour  Second Vaccine March 2021 18th 4 events/hour (day of shot) 19th 6.8 events/hour 20th 15.5 events/hour 21st  5 events/hour 22nd 7.1 events/hour 23rd  5.3 events/hour 24th  5.2 events/hour 25th  6.9 events/hour 26th  3.6 events/hour 27th  2.9 events/hour
This non serious case was received on 24 February 2009 from VAERS (reference number 336906) via a search of QScan database. A four month old female patient received FLUZONE SV 2008-2009, second dose of ROTATEQ, PREVNAR, PEDIARIX, and HAEMOPHILUS influenzae  type b (HIB) (manufacturer unknown) 02 October2008. On 18 July 2008 the patient was seen at the doctor's office for matting the left eye with redness for the two days and was treated with VIGAMOX on drop twice daily for five days both eyes. The patient had a small bony prominence redness noted. No irritability, nose congestion, and a red throat. The patient had a positive had a positive strep test. Lab showed the infant's white count elevated at 14.4 10^3/uL. She was treated with OMNICEF 125 mg per 3 cc, 3 cc, a day for 10 days. On 10 September 2008 the infant came to the doctor's office and noted to have nasal drainage and fussiness which she had for the past 2 days. She had a mild right ear effusion, sinusitis, and mild external swelling of the ear canal. She was treated with AMOXICILLIN 125 mg, 5 cc three times a day for ten days. The mother reported that on 10 October 2008 the infant was vaccinated with FLUZONE SV 2008-2009 administered in the right thigh. On 22 October 2008 she experienced non productive cough rhinorrhea but no sign of infection. Recovery status was not reported.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies  were not provided. On 08-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot# L026553, expiration date: 16-JUL-2017, (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 Celsius degree for 1 hour and 36 minutes and also at a temperature of -12.3 Celsius degree for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Information regarding PREVNAR was received from a pediatrician regarding a 9-month-old female patient who experienced injection site swelling and redness.  The patient received a dose on an unknown date in Dec-2007.  Relevant medical history was not provided.  Product was administered on an unknown date in Dec-2007.  Dose regimen was 0.5 mL 1 time per day (intramuscular).  Concomitant medications were not reported.  The patient experienced injection site swelling and redness on an unknown date in Dec-2007.  An ice pack was applied to the site, which eliminated the redness and swelling within one hour.  No additional information was available at the time of this report.
Swelling in neck; This is a spontaneous report from a contactable consumer (reporter's friend). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling in neck. On an unspecified date, the patient recovered from the event.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Acute exacerbation of Chronic Urticaria intractable to steroid taper and antihistamines. Sent to Immunologist. No Improvement.
Onset of severe nausea, emesis, and bloody diarrhea, requiring hospitalization for 8 days, infusion care for 4 days after discharge due to  hypokalemia, and resulting in diagnosis L ischemic colitis and hypokalemia.
Fever, Tachypnea, SHORTNESS OF BREATH, FATIGUE Narrative:  SEEN AT UC AND TREATED WITH BENADRYL AND OXYGEN AND RELEASED.