chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Erythema, tenderness, itching at the site of the injection. 6 cm of slightly raised erythema. Treatment to include Claritin during the day and Benadryl at night until resolved.
Left arm felt heavy a couple hours after second COVID vaccine. By evening she had tenderness to left axilla. In am on 2/10/21 she could not move left arm due to swelling and pain in lymph nodes. Woke up 2/11/21 and still couldn't move arm due to discomfort. Also developed a runny nose, slight upper abdominal pain, and slight headache.
Initial information received on 30-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA209352, 2018SA209359 and 2018SA209360 (same reporter). This case involves a five years old male patient who received a 0.5 mL fourth dose of vaccine IPOL (lot N1G41, expiry date: 28-Jul-2019) via intramuscular route in left deltoid on 30-Jul-2018, which was supposed to be discarded related to an excursion and incorrectly stored. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage with an excursion of Opened Polio 48.6 degrees F. x 2 hours and 40 minutes and deteriorated drug administered. It was reported that patient had a Polio vaccine from the same vial that was supposed to be discarded related to an excursion. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. Documents held by sender: none.
This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 20-SEP-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # N023828 with expiration date reported as 25-JUN-2020 (dose, frequency and route were not provided) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 47 Fahrenheit degree to 77 Fahrenheit degrees with a time frame of 1 hour and 10 minutes and previous temperature excursion of 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 27 minutes and 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 5 minutes. Digital Data logger was involved. This is one of eight reports received from the same reporter. Sender's Comments: US-009507513-1809USA013685: US-009507513-1809USA013686: US-009507513-1809USA013687: US-009507513-1809USA013684: US-009507513-1809USA013688: US-009507513-1809USA013682: US-009507513-1809USA012930.
Sore neck, extreme pain in back of skull.  Swollen lymph nodes Sore throat Open sore on side of tongue
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 11-year-old female patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 17-FEB-2023, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Nausea; Severe pain and muscle cramping upper arm-rated 10 of 10-visibly in sever pain left arm; Afebrile; Diaphoresis "cold sweat"; Inability to move arm with ease; Entire area was rock hard-no redness/warmth or bruising.
Medical Information Potential AE; rash on her lower stomach area; This is a spontaneous report from a contactable consumer (patient). A 60 year old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on 19Mar2021 as a single dose for COVID-19 Immunization. The patient's medical history and concomitant medication were not reported. It was reported that Yesterday morning patient developed a rash on her lower stomach area. Patient wanted to know she could treat this at home with cortaid or anti itch cream or should she see her family physician and get an antibiotic. The outcome for the events was unknown.  Information on the lot number and batch number has been requested.
ipsilateral lymphadenopathy, supraclavicular. started 5 days after vaccination. associated with malaise and URI symptoms that were present 2 days after vaccine. arm painful, red, hot and tender to touch. this extended up into shoulder, back and neck.
COVID+ 1/21/23.  Vaccination Status - Moderna x4 + moderna BIVALENT x1 Discharge Summary DO (Physician) ? ? General Medicine  BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider: MD Admission Date: 1/21/2023 Discharge Date: Jan 23, 2023    Active Hospital Problems   Diagnosis Date Noted POA ? COVID-19 01/21/2023 Yes ? Hypoxia   ?  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 83 y.o. female with a past medical history of chronic obstructive pulmonary disease, paroxysmal atrial fibrillation on Eliquis, rheumatoid arthritis, essential hypertension, among other comorbid conditions presented to the Hospital Emergency Department on 01/21/2023 with complaints of worsening shortness of breath and rhinorrhea onset approximately 2 days prior to presentation.  In addition the patient reported significant fatigue.  On evaluation in the emergency department the patient was found to be hypoxic and COVID-19 positive.  She was admitted to the hospital service under observational status for ongoing management and coordination.  She was started on supplemental oxygen, improving her oxygen saturation from 85% on room air to approximately 94% on 2 L of supplemental oxygen via nasal cannula.  In addition she was started on Decadron 6 mg daily as well as remdesivir. Over the course of approximately 48 hours of admission the patient is a hypoxia resolved and was able to maintain oxygen saturation above 92% on room air.  The remainder of her hospital course was uncomplicated.  On 01/23/2023 with labs and vitals stable condition, able to oxygenate well without supplemental oxygen, the patient was discharged home with instructions follow-up with her primary care physician within 7 days of discharge.
Narrative:  Pt received a zoster vaccine on 3/17/2016 at Primary Care Clinic. On 3/18/2016 pt presented to ER with swollen upper lip. Pt was given oral prednisone & oral diphenhydramine to continue at home for 5 days and discharge home. Condition resolved. Primary Care provider flagged pt chart on 7/28/22 with history of this ADR.
fever; nausea; pressure on her head; chest pain on the side where she received the shot; swelling and a little lump down her armpit on the side where she received the shot; swelling on her face on the side where she received the shot; thirsty; dry throat; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, lot number and expiry date were unknown), via an unspecified route of administration on 17Apr2021 at single dose for COVID-19 immunization. The patient's medical history ongoing high levels of thyroid hormones. Concomitant medications were not reported. She received the first dose on Saturday (17Apr2021) and developed the following side effects: fever, nausea, pressure on her head, chest pain on the side where she received the shot, the presence of swelling and a little lump down her armpit on the side where she received the shot, 3 days ago in the morning she presented swelling on her face on the side where she received the shot in Apr2021. The first day after receiving the first dose she was really thirsty, yesterday and the day before yesterday she had a dry throat, her physician prescribed her with Benadryl for this, and indicated that this could be a reaction to the vaccination. Her physician wanted to know if high levels of thyroid hormones could affect the response to the vaccination. She also wanted to know if the patients who develop an allergic reaction to the vaccine might have a lower response to the vaccination. She also wants to know how long could these side effects last. Patient was referred to her physician to speak about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Patient wanted to know if she should receive the second dose of the Pfizer COVID-19 vaccine considering the side effects that she presented with the first dose of the vaccine. The events assessed as non-serious. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
A report has been received from a Health Professional concerning a female patient, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient was administered expired FLUMIST QUADRIVALENT. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Moderna Lot# 061B22A expired 11/27/22 and was given to this patient on 11/30/22. Moderna was contacted to determine stability and determined that the vaccine maintained the activity necessary to protect against CoV-2 (COVID-19) virus at the time of administration.
Cold symptoms for 2-3 weeks; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Jun2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient was not allergic to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and fluoxetine hydrochloride (PROZAC). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously 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 01Jun2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 23Jun2021, the patient experienced cold symptoms for 2-3 weeks. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event cold symptoms was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number unknown) and in August 2010 "within the last two weeks", she developed a "high fever" for several days. Patient's family was very concerned and took her to the local emergency room. The patient was not hospitalized. At the time of report, the patient's outcome was unknown. Follow-up information has been received from a physician concerning a 13 year old female who on 09-AUG-2010 AM was vaccinated IM in the left deltoid with the third dose of GARDASIL (lot number 666163/0664Z). On the same day, in the afternoon the patient experienced 102.0 degree fever and headache. The fever and headache were required emergency room/doctor visit. At the time of the report the outcome was not reported. Additional information has been requested.
developed mild head ache and body ache around 7 pm on 1/11/2021, worsened after 7:30 pm with chills and fever and severe body ache through the night with mild congestion and more pronounced head ache by 1/12/2021. Took Tylenol to reduce fever. Fever and chills returned as medication effect reduces over 6 hours, it has continued today on 1/13/21
Spots on elbows; Plaque psoriasis flare on hands; Primary series completed on 16-Apr-2021 and 3rd dose on 31-Aug-2021; Flu like symptoms following COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms following COVID vaccine), SKIN DISORDER (Spots on elbows), PSORIASIS (Plaque psoriasis flare on hands) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary series completed on 16-Apr-2021 and 3rd dose on 31-Aug-2021) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 31-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary series completed on 16-Apr-2021 and 3rd dose on 31-Aug-2021). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms following COVID vaccine), SKIN DISORDER (Spots on elbows) and PSORIASIS (Plaque psoriasis flare on hands). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms following COVID vaccine) had resolved, SKIN DISORDER (Spots on elbows) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary series completed on 16-Apr-2021 and 3rd dose on 31-Aug-2021) outcome was unknown and PSORIASIS (Plaque psoriasis flare on hands) was resolving.            No concomitant product was reported. Patient had plaque psoriasis flare on hands and it was clearing as of now. She was still peeling and cracking. She had spots on elbows. She had 24 hours of flu like symptoms following the COVID vaccine. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report as received from registered nurse refers to a female patient of unknown age. On an unknown date in July 2013, the patient was vaccinated with first dose of GARDASIL (dose, frequency and route were not reported). On an unknown date in November 2013 the patient was vaccinated with second and not received her third dose yet (09-JUN-2015). No adverse effects were reported. Additional information has been requested.
PATIENT RECIEVED DTAP AND HEP A ON 07-13-2007. PARENT INFORMED OUR OFFICE ON 07-16-2007 THAT PATIENT WAS TAKEN TO HOSPITAL ON SATURDAY 07-14-2007 AND DIAGNOSED WITH A FEBRILE SEIZURE.
sever rash, swelling, and pain at the injection site 2-3 days after vaccination.
Patient bled immediately after needle was retracted. Bleeding was stooped with cotton ball and applied pressure. Knot formed immediately after. Knot at injection site (left deltoid) about the size of a quarter. Patient reported feeling fine. Patient had high-dose vaccine in 2015 with no reactions.
Pt recvd APAP 2PM & 6PM & felt warm & was fussy evening 3JUN92; woke 4AM 4JUN92 very warm gave APAP; lethargic in AM; t104.6; repeated APAP; vomited @ 945AM;
Break though COVID-19 Case: I was exposed by my husband. I had nasal congestion, sore throat and ear pain which is the same symptoms my husband was experiencing. On 6/05/2022 I decided to test for COVID-19 using a home rapid test which was negative.  My symptoms stayed the same until 06/08/2022.  On 06/08/2022 I started to have neck pain, congestion, body aches, fatigue and my headaches were intense. I decided to go to a clinic to do a PCR test. The next day I received my tests results on the following day.   I felt worse on 06/09/2022 and had a tele visit with another clinic. They discussed my symptoms. I did another home test with the provider online and it came back positive. i was prescribed Paxlovid. I felt progressively better by 06/11/2022. I do have a little it of symptoms, but not what they were. I did test again today 06/15/2022 and it came back positive.
numerous Herpes Type 1 sores on my vulva; severe myalgia; chills; 103 degree fever; headache; nausea; gastrointestinal pain; extreme fatigue; pain at injection site; large red rash around the injection site; This is a spontaneous report from a contactable 44-year-old female Other HCP reported for himself that she received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 (Batch/Lot Number: Lot EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included hyperthyroidism from an unknown date and unknown if ongoing Hyperthyroidism, controlled with medication. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took hydrocodone and experienced drug hypersensitivity, hydrocodone and experienced pruritus, bnt162b2 for covid-19 immunisation. The patient experienced Within 8 hours of receiving the second dose, I developed chills, 103degree fever, headache, severe myalgia, nausea, gastrointestinal pain, extreme fatigue, pain at injection site. These symptoms mostly subsided as of Sunday February 21 by 7 PM. At 10 PM on Sunday February 21 I developed a large red rash around the injection site. I also developed numerous Herpes Type 1 sores on my vulva. I know they are Type 1 as I was tested for all STDs and this is the only one I have. The sores appeared once before following an illness I had in December 2019 that was accompanied by a high fever. I was tested for Covid19 antibodies in April of 2020 and was negative. When the sores were cultured in December of 2019, they were Herpes 1 type appearing in the genital region. The patient underwent lab tests and procedures which included body temperature: 103 on 21Feb2021 degree, sars-cov-2 antibody test: negative on Apr2020. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the event was reported as not recovered.
Information has been received from a nurse midwife which reported that "a mother of one of her patients said she read somewhere" concerning a 17 year old female who on an unspecified date was vaccinated with a dose of GARDASIL.  Subsequently the patient developed autism.  It was unknown if the patient sought any medical attention.  The outcome of the patient was unknown.  Upon internal review, autism was determined to be an other important medical events.  Attempts are being made to verify the existence of an identifiable patient and reporter.  Additional information has been requested.
Found dead.  Evidence of diffuse alveolar pulmonary damage (ARDS, DAD).
Sore throat, loss of appetite, achy, typical arm soreness, bumps on tongue
At 1:30 am I woke up and decided to go to the restroom.  On my way back to bed, I passed out and landed on the floor next to the bed.  My husband heard the fall, tried to rouse me and, after a few minutes, was able to get me to sit upright.  I had no memory of feeling dizzy or lightheaded.  He went to get something in case I was nauseas and when he returned I was doubled over, passed out, with my right hand in a fish and my arm drawn up rigidly to my chest and completely unresponsive.  When I finally came to and tried to talk, it was unintelligible.  After a few minutes he was able to help me to bed.  I am a thin, athletic woman who, in general, is in excellent health.  When I took the 2nd of the initial 2 COVID vaccines several years ago, I also passed out twice.
This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 22-OCT-2012 15:59, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Right deltoid is red, raised and warm to touch below injection site. Affected area measures 8x9.5cm
Headache, fatigue, chills, intermittent shooting nerve pain  at the left angle of my mandible.  I went to work on Tuesday because my work was short staffed but was allowed to go home 3 1/2 hours early.  I took Advil every 4-6 hours on Tuesday and half of Wednesday.  I came straight home and slept until dinner, ate and then went back to bed and slept until midnight, took more Advil and drank a full glass of water, and slept the rest of the night.  Wednesday I felt a bit better, headache not as bad and jaw pain not as frequent, still pretty tired.  I went to bed straight after dinner and then felt great on Thursday.
patient received his first dose of the Moderna Covid-19 vaccine. After receiving in our immunization room, he left the room and then shortly walked over to the pharmacy in-window and told the pharmacy tech that he did not feel well and felt dizzy. Tech had him go sit down in the waiting room and went and got the nurse, who went out to check on patient. Patient was slumped in the waiting room chair with eyes closed and very sweaty. Patient said he wanted water, so staff quickly got him water. After a few sips, patient's head rolled back and he lost consciousness for roughly 10 seconds before waking up startled and confused. Ambulance was already called and when the arrived they triaged the patient for around 15 minutes. After about 15 minutes the patient seemed much better and the paramedics decided it was OK for him to leave and drive himself home.