chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She got her flu vaccine, the injection was uneventful, in and out pretty standard.  Later that day she felt soreness at the injection site.  The next day she was pretty run down, really didn't think mush of that.  When taking a shower she noticed what she thought was tenderness on top of her arm at the injection site she noticed her armpit was very puffy, very tender to touch in the nodes, and it's now starting going down the nodes closer to her chest and up into the throat and back of the neck on the right side only.   Her arm between the elbow and shoulder is puffy and edematous, but the armpit actually sticks out on that side.  She went to her PCP on 10/13/21 and saw the PA as her PCP was out of town and she agreed that it was weird, not running a temp and she was put on Ibuprofen 600 mg b.i.d., as well as Cephalexin 500 mg t.i.d. for 7 days in the case is was a cellulitis and to use warm compresses on that and she is doing all of the above as instructed.   This does not seem to be working and she is going to call her doctor on Monday to see if she can be seen by the PCP herself.  It is very tender and cannot settle down to sleep and it wakes her up at night and keeps her from sleeping.    She was told to watch things over the weekend and if not better to call back and be seen next week.  Was advised that if she got worse as she is traveling to go to an UC or ER.    She did have her COVID vaccines on 1/4/21 and 2/1/21 and had chills, fever and was down for 3 days with the first one.  The 2nd one she was not as sick with that one.
This spontaneous report as received from a health professional refers to a 11 years old female patient with no preexisting allergies, birth defects or medical conditions. The patient was vaccinated with lot # (669796/0840AA) dose 1 GARDASIL, right deltoid on 27-DEC-2011 at 16:48. No other co-suspects were reported. Concomitant medications included MENACTRA (lot # U4055AA), BOOSTRIX (lot # AC52B073CA) and FLUMIST (lot # YL2068). It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at a temperature of 32 degrees F or less. No adverse reaction occurred. This is one of several reports from the same source. Additional information is not expected.
Thaw on 18-Mar-2022 and took vaccine on 21-Apr-2022; Received a booster dose from an expired Moderna vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a booster dose from an expired Moderna vial) and PRODUCT STORAGE ERROR (Thaw on 18-Mar-2022 and took vaccine on 21-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2022 at 10:20 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2022 at 10:20 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a booster dose from an expired Moderna vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Thaw on 18-Mar-2022 and took vaccine on 21-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a booster dose from an expired Moderna vial) and PRODUCT STORAGE ERROR (Thaw on 18-Mar-2022 and took vaccine on 21-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant product was not reported.  patient received a booster dose from an expired Moderna vial.  Thaw date reported on 18-Mar-2022.  Treatment product was not reported.
This case was reported by a pharmacist and described the occurrence of hypertension in an adult female subject who was vaccinated with FLUARIX (GlaxoSmithKline). There were no concurrent medications. On 31 October 2008 the subject received a dose of FLUARIX at 0.5 ml. On 31 October 2008, less than one day after vaccination with FLUARIX, the subject experienced hypertension, trouble breathing and tachycardia. She was seen in the emergency room and was treated and released. The pharmacist considered the events were clinically significant (or requiring intervention). On 1 November 2008, the events were resolved. The pharmacist considered the events were possibly related to vaccination with FLUARIX.
Pt describes needing to work hard to focus on conversations, sometimes struggling to understand words.  They do administrative work and teach some classes over Zoom, but their attempt to teach on 3/10 was very difficult - several children were talking at once and they literally could not understand a word of it.  They left work early, went back today but this was "a mistake."  Wife did note they were slurring their speech at one point today, although they are not right now.    Pt reports that this is exactly the reaction they had to the 2nd dose of Gardasil when they were 11, and they missed a week or more of school for it.  It gradually resolved on its own.  At that time they also felt they had lost the instinct to breathe and had to constantly remind themselves to inhale; that has not happened this time.
Patient developed left shoulder pain at the deltoid corresponding to the site of injection.  This began about 1 week after injection and has lasted for 3 weeks.  It is 7/10 in severity and requires anti-inflammatories.
Employee states he noted rash the evening after receiving the influenza vaccine. He continues to have it to present day. He had been worked up for various other conditions which he indicates have come back as negative. He is currently being referred to a Dermatologist.
No additional AE reported, and no further information provided. No PQC identified; the patient had been inadvertently administered PROQUAD and V ARlV AX at the same appointment.; the patient had been inadvertently administered PROQUAD and V ARlV AX at the same appointment.; This spontaneous report has been received from a health care professional, referring about a 1-year-old male patient. Information about the patient's pertinent medical history, concurrent conditions and previous drug reactions and allergies was not provided. The patient's pertinent concomitant medications included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine inactivated (unspecified) (+) tetanus toxoid (DTap), hepatitis A virus vaccine inactivated (HAVRIX), Hib conj vaccine (tet toxoid) (ACTHIB), and pneumococcal 13v conj vaccine (CRM197)( PREVNAR 13/PCV13). The patient had 3 siblings (2 brothers and 1 sister).   On 15-APR-2021, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type: rHA), at a dose of 0.5 milliliter (mL), administered subcutaneously, in the right thigh; lot number T013542, with and expiration date on 17-OCT-2021 for prophylaxis. On the same date, the patient was also vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX), at a dose of 0.5 mL, administered subcutaneous in the left thigh, lot number T006345 and expiration date 20-FEB-2022 (conflicting information since it was also reported as "15-AUG-2019") for prophylaxis. The nurse practitioner reported that the patient was administered both vaccines inadvertently by the health professional since it was in training probation period. (inappropriate schedule of product administration) (incorrect dose administered). She inquired what to tell the parents to watch in regard to safety. No additional adverse event reported.  The vaccines were not available for returned for evaluation since they were used as a single used syringe. No temperature excursion occurred as a result of a reading from a Digital Data logger.
her arm bothered her for a week after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (her arm bothered her for a week after the 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (her arm bothered her for a week after the 1st dose). At the time of the report, LIMB DISCOMFORT (her arm bothered her for a week after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Headache, Myalgia & Fever Narrative:  muscle aches and chills for 36 hours. severe headache on 2nd day
Pfizer-BioNTech COVID-19 Vaccine EUA Extreme sudden lethargy, similar to blood sugar drop, slurred words, couldn?t keep eyes open.
After 2nd COVID VACCINE on 6/15/2021, 6/28 Notices Lump on my neck and went to Doctor Dr sent me for X-RAY After 6/28, i had feeling tires/fatigued and notices the lump on neck started smelling and pain. 7/6 I went to see a Dr and she was referred me to 1) take blood draw 2) ultrasound on my neck. After both results were completed, she was referred me to ENT doctor. 7/15 I went to see (ENT doctor) and I was referred to do biopsy my thyroid nodule. 7/23 i had biopsy my thyroid nodule.
Moderna 2/24/21, 3/31/21. Positive on 9/6/22
Cough maybe not be from vaccine; fever of 101F; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough maybe not be from vaccine) and PYREXIA (fever of 101F) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced COUGH (Cough maybe not be from vaccine) and PYREXIA (fever of 101F). At the time of the report, COUGH (Cough maybe not be from vaccine) and PYREXIA (fever of 101F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 101f High.         Patient reported that after first dose the patient had no symptoms No concomitant medication reported  No treatment medication reported
suspected vaccination faliure; shingles; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination faliure) (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 Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAY-2023 The patient received Shingrix vaccine and developed Shingles. No further information was provided. The reporter did not consented to follow-up. 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.
Client told nurse they were itchy, and had hives on neck. Client took 25mg of Benadryl that she had with her. About 5min later client stated that she felt better. Denied any shortness of breath, or swelling of tongue. 15 minutes later client said she does still feel better. Redness gone and client's lungs sounded clear. Client released to personal vehicle.
pt recv vax & pt devel a rash;pt devel a progressive rash, stiff neck & h/a 2 to 3 wk post vax;pt recovered;
chills; joint pain; a strong headache; I started spotting, which is unusual; headache that worsened with movement; This is a spontaneous report from a non-contactable consumer or other non hcp. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 12Apr2021 10:00 (Batch/Lot Number: Ep753304) as dose 2, single (age at vaccination 35-year-old) for covid-19 immunisation. Medical history included known allergies: Pollen from an unknown date. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on 19Mar2021 (age at vaccination 34-year-old), lot number Ep7534 for Covid-19 immunisation. Prior to 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. The patient was not pregnant at the time of vaccination. On13Apr2021 12:00, the patient experienced chills, joint pain, a strong headache, i started spotting, which is unusual, headache that worsened with movement. The day after the second dose patient had chills, joint pain, and a strong headache that worsened with movement. The second day after the shot patient started spotting, which was unusual. Her period had ended 5 days before the shot. The outcome for all events was recovering.   No follow-up attempts are possible. No further information is expected.
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced COVID-19 (Covid-19) (seriousness criterion hospitalization). The patient was hospitalized from 25-May-2021 to sometime in June 2021 due to COVID-19. At the time of the report, COVID-19 (Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  On both hospital admissions, the patient was given plasma treatment along with other unspecified medications. She was discharged after one week but was re admitted in another hospital because she was not doing well. She stayed for another week and was transported to an in-house rehabilitation for OT, PT and nursing care. She was eventually discharged on 28Jun2021. It was reported that their son died due to Covid on 18-May-2021 and patient was exposed to him..  Company comment: This spontaneous case concerns a female patient with no relevant medical history who experienced serious unexpected event of COVID-19. The event occurred approximately 2 days after the first dose of the Moderna COVID-19 vaccine, respectively. The patient was hospitalized due to COVID-19 and discharged however, the patient was hospitalized again due to not doing well. The patient was on rehabilitation. Rechallenge was not applicable since due to nature of the event of COVID-19, unknown outcome and lack of information on the second dose, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient with no relevant medical history who experienced serious unexpected event of COVID-19. The event occurred approximately 2 days after the first dose of the Moderna COVID-19 vaccine, respectively. The patient was hospitalized due to COVID-19 and discharged however, the patient was hospitalized again due to not doing well. The patient was on rehabilitation. Rechallenge was not applicable since due to nature of the event of COVID-19, unknown outcome and lack of information on the second dose, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
LOSS VISION IN RIGHT EYE  (Optic  Neuritis) 6 WEEKS AFTER  INFLUENZA INJECTION
fever of 101; developed swelling left side neck and below ear; swollen jaw and ear on left side (possible lymph nodes); golf ball sized lump on clavicle same side (L) as injection; swollen jaw and ear on left side (possible lymph nodes); swollen jaw and ear on left side (possible lymph nodes); pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date, refer case US2021104543).   On 14th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). In May 2021, 24 hrs after receiving Shingrix, the patient experienced pain, fever, neck swelling, ear swelling, bone swelling, jaw swelling and enlargement of lymph nodes. Rechallenge with Shingrix was positive. In May 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain, neck swelling, ear swelling, bone swelling, jaw swelling and enlargement of lymph nodes were not recovered/not resolved.   It was unknown if the reporter considered the pain, fever, neck swelling, ear swelling, bone swelling, jaw swelling and enlargement of lymph nodes to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The patient received second dose of Shingrix in Left arm.  On 15th May 2021, the patient developed swelling on left side of neck and below ear, golf ball sized lump on clavicle on left side, swollen jaw and ear on left side (possible lymph nodes), pain and fever of 101 degree farenheit.  No lot number or expiry date was available.  The patient was recommended follow up with her healthcare professional and was offered Shingrix package insert. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021104543:same patient (1st dose)
pt recv vax 7JUL97 & 13JUL97 pt devel a fever 103.8;
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State  for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Varivax given 8/15/03. On 08/17/03 pt had fever of 103; vomiting and diarrhea. Went to ER on 8/17/03, elevated WBC's, given IV fluids. Followed up in office on 8/21/03.
1 day after TDAP had site tenderness, fatigue, restless sleep & headache.
I started with a shortness of breath and a burning feeling when I would cough. I went to see a doctor and was put on a Z-Pak first. That didn't clear it up so I went to the ER. They gave me a stronger antibiotic and a steroid to take, but that didn't clear my symptoms up either. I still had a shortness of breath. My lungs weren't clear so it was hard to breath, and I ended up going to the hospital twice by ambulance. My oxygen levels were too low. I was given intravenous antibiotics to clear up the infection. They put me on forced oxygen because I could not oxygenate my blood. I was in ketoacidosis. I spent a week in the hospital. I could not breath because the mucus in my lungs would not come up, and I could not get air in. The doctors know I have a bacterial infection in my lungs, but they don't know what it is.
Vaccination site Pain; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site Pain) and PAIN IN EXTREMITY (Sore Arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site Pain) and PAIN IN EXTREMITY (Sore Arm). At the time of the report, VACCINATION SITE PAIN (Vaccination site Pain) and PAIN IN EXTREMITY (Sore Arm) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details are not provided.
I received my shot at 9:15AM at 11.5 hours later I began feeling foggy, fatigue and flu like symptoms. I had a slight fever and just stayed in bed the day after. Ibuprofen seemed to help the headaches but not the body aches. No nausea. Within 72 hours I was almost back to my normal self, but still extremely tired, and my neck and back hurt quite a bit. Today marks 13 days. As of 5 days ago I began to get cold like symptoms. Neck and back still extremely uncomfortable, neck barely able to move side to side. I have a bit of a cough with phlegm. Headaches are still happening quite a bit, and still super tired all the time. I feel like I?ve been sick ever since I took the shot, and have to take several days off work.
Tinnitus 8/10 two weeks after 2nd Moderna dose.  Progressively worse.  Nonstop, blasting.  Today 12/10.  Very intense.  Worse after eating, upon waking, and in afternoons.
PT WAS 18 YEARS OLD AND NOT IMMUNOCOMPROMISED. WE ADMINISTERED A 2ND BOOSTER (4TH SHOT). PT DID NOT QUALIFY FOR THE 2ND BOOSTER.
I got the shot, got shingles a couple years later/then got shingles again/Suspect vaccination failure; I got the shot, got shingles a couple years later/then got shingles again; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and got shingles a couple years later, got treated (unspecified) and then got shingles again after a couple more years. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation for shingles were unknown at the time of reporting. The follow up would not be possible as no contact details were available.