chrisvoncsefalvay/vaers-outcomes huggingface dataset:
burning sensation on the injection site; Initial information was received on 22-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced burning sensation on the injection site after receiving meningococcal a-c-y-w135 (d conj) vaccine [Menactra] and meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi].  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 dose of suspect meningococcal a-c-y-w135 (t conj) (Solution for injection) for immunization and meningococcal a-c-y-w135 (d conj) vaccine (Solution for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on batch number was unknown at this time.  On an unknown date the patient developed a non-serious event of burning sensation on the injection site (vaccination site pain) (unknown latency) following the administration of meningococcal a-c-y-w135 (t conj) vaccine and (unknown latency) following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  Action taken with meningococcal vaccine (Menquadfi) and meningococcal vaccine (Menactra) was not applicable.  It was not reported if the patient received a corrective treatment for the event (burning sensation on the injection site).  At time of reporting, the outcome was Unknown for the event burning sensation on the injection site.
Upper arm (a few inches below injection site) swollen, very sore, & had rash accompanied by headache. Took tylenol & symptoms improved & in about 3 days. Disappeared in a couple more days.
PATIENT WAS GIVEN H1N1, TETANUS AND B12 INJECTIONS AT CLINIC.  30 MINUTES AFTER, EXPERIENCED BLURRED VISION AND TACHYCARDIA WHILE DRIVING HOME.  STOPPED AT A LOCAL MED CTR AND WAS SENT TO A NEIGHBORING LARGER TOWN TO BE EXAMINED IN ER BY DOCTORS.  PATIENT WAS OBSERVED 2 HOURS AND RELEASED.
Redness, slight swelling, and warmth in area around injection site (upper left arm)(approximately 4 to 5 inch red patch) that has lasted 3 days.   Muscle sore around injection site.  Second in series of vaccinations for shingles.  General feeling of tiredness the day after the vaccination.  Took OTC pain medication (aspirin, Tylenol).  Feeling better after 3 days; however, injection site still red, warm, and sore.
Site: Pain at Injection Site-Mild, Systemic: loss of hearing in one ear-Medium
I developed Tinnitus shortly after receiving the 1 shot. I went to an ENT who prescribed prednisone and did not eliminate the ringing in my ear.  Due to the risk/benefits I did receive my second shot 28 days after the 1st shot.
patient was administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient administered expired vaccine which was initially stored on 04-NOV-2021 patients were administered with dose in which some vaccinated on 05-NOV-2021 and 12-NOV-2021. The vial did not undergo any temperature excursions. No Treatment medications were reported.
lt testicle & lt lower thigh hurting; pt afraid to eat; rash on both arms on tuesday 3MAY93; 27MAY93 follow up call MD said URI;
joint pain in left index finger; muscle stiffness in left shoulder; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 09Feb2021 (at the age of 46-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported.  The patient previously took amoxycillin and had known allergies. The patient experienced joint pain in left index finger and muscle stiffness in left shoulder on 22Feb2021. There was no treatment received for the events. The outcome of the events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A short time after the vaccine. A matter of days, I started having migraines. They would last up to 7 days at a time which would often cause me to go to bed with ice packs and use over the counter medication. Due to this, I was unable to consistently fulfill my working responsibilities. They would occur in clusters during each month. 3-4 clusters a month lasting up to 7 days at a time.
After patient left vaccination site (25 min later) she had tightness on her chest,and difficulty breathing for over 10 min.  Pt drove home, and she felt better like 1 hour later.  Three days later, on 03/07/2021 she was seen by her provider who ordered her:  1.Stress test, 2.Eco-cardio Doppler, 3. PFT (Pulmonary Functional Test).  Provider didn't tell patient not to take the second dose of Pfizer vaccine, but to wait until patient completes these tests.  Patient understood she  must wait for her provider to indicate if she is allow to get Pfizer Anti-covid vaccine second dose, or not.
A few hours after I developed hives all over my body resulting in me taking Zyrtec and Benadryl this persisted and got worse so after about 6 weeks I reached out to my PCP who gave me a Kenalog shot and advised to take a Pepcid/ Allegra mixture to help with the symptoms. And currently I have to take Benadryl nightly just to sleep because the hives are just so bad and taking the Pepcid/Allegra mixture twice daily as well.
Modern a COVID-19 Vaccine EUA After 12- 36 hours- slight nausea, 101.5 degree F. fever, sore arm and muscles, fatigue, bone pain, blood clots in nose, sweating, headache
Pfizer booster to Jansen covid vaccine given in spring 2021.   2 days after vaccination patient had jaw pain and left arm pain that was intense for about 15 minutes.  He reported more mild jaw pain and left arm pain continuing up to 11/9/2021.   Patient reported to Pharmacy on 11/9/21,  referred patient to see a physician for evaulation
Duration of approximately 1 week. Localized swelling of vaccination site.  Fever, and warm to touch at site.  Swelling measured approximately five inches by three inches, encompassing most of patient's thigh.  Interfered with walking and comfort for approximately six days.
Pain at the injection site, poor range of motion with left shoulder, some night tingling or numbness of left arm.
Vaccinated left deltoid.  Approximately 20 minutes after patient received vaccine she notified that she was having swelling in her left forearm.  She did have minor swelling noted mid-posterior forearm,   No SOB, no cough, no rash, no itching,  She was referred to see the clinic physician who evaluated her and had her return for follow up the next day.  On follow up visit she advised she also had some swelling of her left leg which was evaluated by the MD,  Continued with no other complaints.
Information has been received from a healthcare worker concerning 2 patients who on an unknown date, were vaccinated with a dose of ZOSTAVAX (Merck) (doses, routes and lot numbers not reported). Two patients developed shingles "about 3-4 months" after receiving ZOSTAVAX (Merck). Acyclovir was given as a treatment for shingles. At the time of the report two patients recovered from shingles, date unspecified. The patients sought medical attention, were evaluated by their physicians (physicians unspecified). Follow-up information has been received via telephone call from a pharmacy clerk stated that she had spoken with the pharmacist and neither she nor the pharmacist could remember the patients. The pharmacy clerk stated that the patients developed shingles several months after receiving ZOSTAVAX (Merck). The pharmacy clerk was not able to provide any additional information at that time. Additional information is not expected.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2021-395985.
Patient received MENACTRA 2/2013 and returned today 5/2/13 with what appears to be lipodystrophy at the site.
Reported first on 1/3/07. Then seen in EHS 1/4/07. Left upper arm around deltoid with indentation/depression. States day after she received injection her left arm was sore within one week had redness, swelling, warm, raised area, no drainage.
Patient came in for her second dose of Moderna vaccine. About 5 minutes after administration, patient was having trouble breathing and she said her throat was "closing up". She was feeling lightheaded as well and mentioned she might "pass out". Her husband provided her a beverage to drink (not water). Patient carries around an Epi-Pen and she injected herself with the pen. It was not helping her breathing; called 911. Paramedics took her to the hospital.
diarrhea lasted 4-5 days was bloody towards the end; funny feeling in her brain, felt like a pulling sensation; metallic taste in mouth; oral inflammation; bottom lip white spot that looked like blister; both kidneys hurting bad; Raw red and very irritated; Raw red and very irritated; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number was not reported) via an unspecified route of administration on unspecified date in 2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's Concomitant medication(s) included acetylsalicylic acid (BABY ASPIRIN). Patient stated that receiving her first dose of the Pfizer BioNTech Covid-19 vaccine experienced some normal side effects and others she would like to know if they are normal and if others have reported these- metallic taste in mouth, oral inflammation, raw red and very irritated, bottom lip white spot that looked like blister, both kidneys hurting bad, diarrhoea lasted 4-5 days was bloody towards the end funny feeling in her brain, felt like a pulling sensation. Patient stated that she saw her HCP for treatment, and he told her to stop taking baby aspirin, take Pepto Bismol and delay her second dose by a week. The Pepto Bismol stopped the diarrhea. The outcome of the events diarrhoea lasted 4-5 days was bloody towards the end was resolved on unspecified date in 2021, remaining events it was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient got visual disturbance.  She said was seeing black dots.
24OCT pt c/o aching all over, joints hurt; no elevated temp; on 24NOV to ER dx pneumonia, rt lung, spit up blood several times;
Narrative: COVID infection following COVID vaccine series 01/22, Pfizer, dose #1 04/19, Pfizer, dose #2 10/26 CXR impression: 1. No evidence for acute pulmonary disease. 12/21 COVID swab, result: detected 12/19 pt cc: cough, fatigue, rhinorrhea exposure: unknown
Patient received second Shingrix vaccine on 11/19/19 and by 11/28/19 he and his wife needed to go to an urgent care for treatment for an active shingles outbreak. Patient previously had shingles on his head (many years prior to this incident) and after receiving the second Shingrix dose had shingles reactivate in the same location on his head.
On 7 June 2021, member received the first dose of Pfizer. On 7 August 2021, member presented to Air Base COVID-19 Vaccination Line to receive a dose of Janssen. Member documented that no prior doses of COVID-19 vaccine was received during patient screening. Upon record reviews conducted on 20 August 2021, it was revealed that member received a dose of Pfizer prior to 13 August.
This spontaneous report as received from a medical assistant referring to an patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9) (dose, frequency and route of administration were not reported) (lot # N003703, expiry date: 29-OCT-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Mother reported on 8/22/2014 that the patient had redness and swelling to the arm.  Mother reported that the patient was having trouble breathing on 8/21/2014. Mother was instructed to take the patient to the ER.  Mother did take the patient on 8/22/2014.
This is a spontaneous report from a contactable consumer. A 75-year-old female consumer received the first dose of PREVNAR13, in her right arm, on 17FEB2015. Medical history includes cataracts in both eyes, diagnosed about 3-4 months ago and for which she is due to have surgery next week (06MAR15), 3 transient ischemic attacks (TIA) in 2013, and high blood pressure. Concomitant medication include hydrochlorothiazide, valsartan 80-12.5 mg daily for high blood pressure, ASPIRIN, (unspecified manufacturer) 81 mg daily, and methotrexate 2.5 mg 4 tablets weekly. She also informed that she received a prescription for the shingles vaccine, but has not yet gotten it since she "does not feel well". The consumer reported she was prescribed PREVNAR13 by her physician during a physical yesterday (17FEB2015). She then received the vaccine on the same day at a pharmacy. Today (18FEB2015) her right arm is sore, after the shot and her arm has become increasingly sore today. Caller states her doctor is not aware of her experiences since receiving the shot. The consumer did not specify her clinical outcome.
Breakthrough case admission after three vaccines  Moderna 6/5/21 Lot# 022B21A;  Moderna 7/3/21 Lot# 033C21A;  Moderna 3/31/22 Lot# 083J21A
Shingles on the left side of my face; Enlarged Cervical Lymph Nodes; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Apr2021 at 16:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 08:00, the patient experienced shingles on the left side of her face and enlarged cervical lymph. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with valacyclov and ibuprofen 800 mg from unknown date for an unknown indication. The clinical outcome of the events shingles on the left side of my face and enlarged cervical lymph were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
malaise; only received Adjuvant portion; only received Adjuvant portion; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2022, the patient received the 2nd dose of Shingrix. On 3rd January 2021, less than a day after receiving Shingrix, the patient experienced malaise, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the malaise was not recovered/not resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided as follows: This reporter was the concerned patient. The patient received a dose of Shingrix and since the date of injection patient was feeling malaise which had not gone away at the time of reporting. Upon health care professional preparing the injection, the patient noted that they only withdrew liquid from one vital and did not reconstituted into the powder vital. After receiving the shot, the patient received a call from the office stating there was a mistake and he only received the liquid (adjuvant) portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient's health care professional recommended to come in for an additional full dose.  The patient wanted to know what to look out for in this case.  The reporter provided health care professional's information but did not remember the name of his physician.  The patient provided permission to contact health care professional. The reporter consented to follow-up.
About 35 minutes after the shot, I started having numbness on the right side of my face.  The shot was in my left arm.  The numbness could best be described as similar to when I would get novacaine or a similar anesthetic at a dentist before drilling cavities.  My face does not feel puffy, but when I touch the skin on my right side from my right eye socket down my cheek to my jaw line, I feel numbness compared to my left side.  I did not have this side effect after my first dose of the Moderna shot.
Have some past expiration administrations that have surfaced; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Have some past expiration administrations that have surfaced) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Have some past expiration administrations that have surfaced). On 29-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Have some past expiration administrations that have surfaced) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was happened 6 months ago and reported that  not sure of the exact date it was pulled from the freezer.  No concomitant products were reported. No treatment drugs were reported.  Company comment- This is a case of Expired Product Administered concerning a patient of an unknown age and gender with no relevant medical history, who experienced no other associated adverse events. The event occurred the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow up received included non significant information.; Sender's Comments: This is a case of Expired Product Administered concerning a patient of an unknown age and gender with no relevant medical history, who experienced no other associated adverse events. The event occurred the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
2-3 days after the vaccine I felt tired and felt a strange malaise feeling and I had a low grade fever. I had the fever for about a 1-1.5 weeks. I feel flushed now but no fever. I feel irritable and fatigued. I have headaches with sharp pain in the side of my head that is mild to moderate. I take Tylenol and aspirin to get rid of it. Body/muscle aches. It has been 2 weeks of this now. Very dizzy and unsteady.
Hypotonic, Hyporesponsive response.  IPV MMR DTAP, was given on 04/19/2005.  Mother took child to hospital on 04/19/2005 at 14:16, Baby dazed, feet swelling.
PATIENT HAD PFIZER VACCINE,  Dose 1 date: 12/23/2020,  Dose 2 date: 01/13/2021, AND TESTED POSITIVE TO COVID.
104.9. 2:30 Pm child started to run a temp of 104.9. Was taken to hospital and released at 10:00PM. Was instructed to continue with Tylenol.
No additional adverse event; a dose of PROQUAD was administered intramuscularly to the patient.; This spontaneous report was received from a medical assistant and refers to a 14-year-old female patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 27-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (also reported as Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R) conflicting information) at a dose of 0.5 mililiter, lot number U016976 who had been verified to be a valid number, expiration date: 24-NOV-2022, for prophylaxis (strength, frequency and anatomical location were not provided). On the same date, it was reported that the vaccine was administered intramuscularly instead of subcutaneous (incorrect route of product administration).   It was reported that the event was noted and informed to the provider and the patient. It was reported that the immunogenicity was achieved, also that there was no ill consequence and that no more future interventions were necessary for the patient (no adverse event).
Seen on 15MAY92 by MD for eval of pain sole rt foot; poss stress fracture; (x-ray neg); unable to bear wt on foot for approx 1 month; foot returned to nl end of JUN91;