chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case's symptoms began about 5 hours after receiving the Pfizer booster vaccination. (She stated she had a pretty severe reaction after receiving the 2nd vaccination.) She went to the ER to get the antibody treatment but said the doctors gave her plasma. She has been in the ICU since she was admitted on 09/02/2021. . She has been on Optiflow oxygen and will remain until her oxygen level increases and remains at a safe level. She has remained house-bound for the past 18 months because she has difficulty doing a lot of moving around."
After 2-3 hrs. I had a headache, low grade fever and fatigue. That night I began to have sore muscles, sore throat and higher fever (101F) On Wednesday March 7, in the morning my fever began to be higher (102F) and I started to have kidney and lower back pain and coughing.  On Wednesday night, my fever was 103F. I had severe pain in my back, neck and legs. Tylenol helped lower the fever but it has not gone away entirely. Thursday morning I had the fatigue and back pain and wasn't sure I could stand at first. I feel so weak today that I called my physician and I will see her tomorrow.
Ache; Fever; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), PAIN IN EXTREMITY (Pain in arm) and PYREXIA (Fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Attention deficit hyperactivity disorder.    Concurrent medical conditions included Ankylosing spondylitis and Attention deficit hyperactivity disorder.   On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 18-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Ache) and PYREXIA (Fever). On 19-Nov-2021, PAIN (Ache), PAIN IN EXTREMITY (Pain in arm) and PYREXIA (Fever) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medications were reported.  It was reported that on an unknown date patient experienced drug use for unapproved indication (Humira for attention deficit hyperactivity).  The reporter's causality for the event(s) of PATIENT WAS TAKING HUMIRA FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER was not provided. The reporter's causality for the event(s) of ARM FELT ACHEY, FEVERISH ACHEY FEELING onset 18 Nov 2021 and FEVERISH ACHEY FEELING onset 18 Nov 2021 with HUMIRA(ADALIMUMAB) was no reasonable possibility.  No treatment medications were reported.  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.
Unexplainable itchy hands without bumps or rashes. It feels extremely itchy but when scratched it is unsatisfying and still feels itchy. Kind of hard to explain so I hope you?ll understand.
Denies pneumonia. That night chills - (R) arm very sore back, shoulder and neck. Ibuprofen - Hot to touch at injection site. By day 3 felt better.
This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 23-FEB-2015, the patient was vaccinated with an improperly stored GARDASIL dose 1, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
neuralgia on the right side of the head down the ear 5 days after the vaccine; has not seen the doctor (2/26/2021)
Patient received the dose at the age of 16 under the recommended age of use. Patient father has been notified and no adverse events have been noted, patient is doing well. Called CDC for additional guidance and received information that was in turn provided to the parent of the patient. Father states he wished to continue with the series and will sign a waiver.
Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA312656 (same reporter). This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number and expiry date was not reported) that was stored in a low temperature for 12 hours on an unknown date. 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. It was not reported if any adverse event occurred or not. 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 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.
The facility had positive cases for COVID 19 when the vaccine was received and administered to patient.  With her advanced age and chronic conditions, she did not have time to build immunity between the time of vaccination and her testing positive.
Directly after the injection, my arm was bleeding.  The staff at the pharmacy had to help the bleeding to stop.  A couple of hours later, I had extreme fatique, headache, dizziness.  The next day I continued to have extreme fatigue, headache, nausia,  dizziness and fainting spells.  I fainted twice and had to be assisted to bed because I fell suddenly on the floor.  These symptoms lasts about 2 days.  I also experiences arm soreness.
Presenting sensitivity to sun/heat and cold by experiencing topical prickly skin sensations and itching .  Symptoms began on 10/10/2021.  Partial relief with Benedryl, however this medication isn't metabolized well and causes him to be "spun up".  Seeking guidance for another anti-histamine or treatment option. *Doctor listed is PCP but did not give the vaccination.  Clinic listed is where the shots were administered -not a patient.  Doctor said to call Clinic to report adverse reaction.  Clinic stated they are only responsible for the first 15-minutes after injection, since non-patient.
Pt. received pediatric dose instead of adult dose - no adverse event. Adult dose was provided 8/9/23.
2 days p/vax hives & rash appeared over entire body;on third day p/vax DPH given;Zyrtec was given on day 2;all sx gone by 13JAN97;
Pfizer vaccine vial was incorrectly diluted with 1.6ml of sterile 0.9%sodium chloride instead of 1.8ml. Pt was injected with 0.3ml of diluted vaccine. Vaccine administrator was informed of vaccine dilution error as soon as error was realized (before vaccine was administered). Patient was stable after administration and left clinic after observation. Clinic manager and supervising MD were notified on same day. I was advised to report event to VAERS and ERS per manager. Patient was not contacted for status check per manager recommendation on 4/30.
Rev'd flu shot in lt. arm about 2:30Pm-At 8pm that evening arm got warm and very sore. Following morning could not move arm pain was so bad-radiating down arm. Now 3 weeks later-radiating into lt. neck area-limited ROM of (L) arm.
Lung cancer; A spontaneous report  was received from a consumer concerning a 79-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced lung cancer.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 09 Feb 2021, approximately 0 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient tested positive for lung cancer. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event lung cancer was unknown.; Reporter's Comments: Based on the current available information and the very short duration of onset between the use of the product and the start date of lung cancer, a causal relationship is unlikely. Further information has been requested.
Redness, tenderness and warmth at injection site; induration 14 x 16 cm.
"motion sickness" for 48 hours; Nausea; This spontaneous case was reported by a pharmacist and describes the occurrence of MOTION SICKNESS ("motion sickness" for 48 hours) and NAUSEA (Nausea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to drug and Osteoporosis since 2006. Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis, MULTIVITAMIN [VITAMINS NOS] and CALCIUM for an unknown indication.   On 04-Jan-2021 at 7:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced MOTION SICKNESS ("motion sickness" for 48 hours) and NAUSEA (Nausea). At the time of the report, MOTION SICKNESS ("motion sickness" for 48 hours) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, SARS-CoV-2 antibody test negative: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No information regarding treatment was reported by the patient.   This case was linked to MOD-2021-141731 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Added Patient BMI, race information, relevant history, Concomitant medications, Onset date and outcome.
the patient administered moderna vaccine after the pfizer covid 19 vaccine on 19Aug2021; two doses on one day in 22MAR2021 and a third dose 13APR2021.; patient received three doses of the Pfizer Covid 19 vaccine; This is a spontaneous report from a contactable pharmacist. A 47-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 22Mar2021 (age at the vaccination 47-years-old) as dose 2, single, and dose 1 (Batch/Lot number: ER2613) on 22Mar2021 as dose 1 single, and dose 3 as extra dose on 13Apr2021 as dose 3, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A patient received three doses of the Pfizer COVID 19 vaccine: two doses on one day in 22Mar2021 and a third dose 13Apr2021. The patient came to the pharmacy and the patient stated he had not had a COVID vaccination, so the patient administered moderna vaccine after the pfizer covid 19 vaccine on 19Aug2021 after the pfizer covid 19 vaccine. The events assessed as medically significant. The outcome of events was unknown.  Caller states causality as no, unrelated.   Product: Moderna COVID 19 vaccine; treatment 19AUG2021 at 1615PM in left deltoid; lot 017C21A; NDC 80777-273-10; expiration date 19OCT2021; dose 0.5ml.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events: Extra dose administered and Inappropriate schedule of product administration ;and the administration of the vaccine cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101086686 same AE/drug, different patient.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2021 at 10:00 as dose 1, single (Lot number: EN6205), in right arm, on 23Mar2021 at 08:30 as dose 2, single (Lot number: ER8733), in right arm, on 18Oct2021 at 20:00 as dose 3 (booster), single (Lot number: FH8020), in right arm and on 28Apr2022 at 17:30 as dose 4 (booster), single (Lot number: 001M21A) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer survivor" (unspecified if ongoing), notes: Verbatim: Breast cancer survivor. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive, notes: positive rapid test on 22May after testing negative on 20May. Initial positive test was 12May; (20May2022) Negative, notes: positive rapid test on 22May after testing negative on 20May. Initial positive test was 12May; (22May2022) Positive, notes: positive rapid test on 22May after testing negative on 20May. Initial positive test was 12May. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with Paxlovid for covid 19 from 12May2022 to 17May2022. Patient received no other medications in two weeks.   No follow-up attempts are possible. No further information is expected.
still feeling dizzy; lack of appetite; swollen arm,my arm swollen up pretty much; sore arm; Muscle ache; nausea; heart raising,my heart raising really up; blood pressure up; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart raising,my heart raising really up), HYPERTENSION (blood pressure up), DIZZINESS (still feeling dizzy), DECREASED APPETITE (lack of appetite) and PERIPHERAL SWELLING (swollen arm,my arm swollen up pretty much) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Allergic to everything) and Anxiety. Concomitant products included AZELAIC ACID for Acne.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced PALPITATIONS (heart raising,my heart raising really up) and HYPERTENSION (blood pressure up). On an unknown date, the patient experienced DIZZINESS (still feeling dizzy), DECREASED APPETITE (lack of appetite), PERIPHERAL SWELLING (swollen arm,my arm swollen up pretty much), PAIN IN EXTREMITY (sore arm), MYALGIA (Muscle ache) and NAUSEA (nausea). The patient was treated with DIAZEPAM ongoing since an unknown date for Anxiety, at a dose of half pill twice. At the time of the report, PALPITATIONS (heart raising,my heart raising really up) and HYPERTENSION (blood pressure up) had not resolved and DIZZINESS (still feeling dizzy), DECREASED APPETITE (lack of appetite), PERIPHERAL SWELLING (swollen arm,my arm swollen up pretty much), PAIN IN EXTREMITY (sore arm), MYALGIA (Muscle ache) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, Blood pressure measurement: high (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medicine included Tersac  and patient is on blood pressure pills.  The patient had an appointment in November to get some cardiac test. Included cardiac lab values (ECG, cardiac test, cardiac enzymes)   This case was linked to MOD-2021-370575 (Patient Link).
Severe headache radiating to back, nausea, meningismus. Treated with Toradol initially; no relief; Subsequently treated with Flexil and Tylenol #3. Symptoms lasting 21 week.
On Wednesday, an hour after recieving  flu vaccine right sided headache occured.  Head ache felt like a jolt of pain at the top right of head that would come and go.  Pain would be precipitated by  sometimes touching top of head and hair, sound and would also be painful with no stimulus at all.  Occured for 4 days. On the weekend it became more intense and frequent.  Went to  the emergency room and was given Reglan, Torodol,  and IV fluids.  Headache still present but less frequent. Purchased an ingested CBD oil before bed on Saturday and frequency of pain became significantly less.  By Monday the pain did not come back.
The evening of 4/15/2003 my daughters were administered the Varivax vaccine. The vaccine was given IM (it is supposed to be given Subcutaneously)  I also noticed she did not aspirate before injection into the muscle tissue.  My daughter complained that her leg her since that date and this morning I noticed approximately 3" diameter cirle surrounding the injection site which was raised, red, streaked, and very hot to the touch.  She also ran a low grade fever yesterday. She was also limping and complaining of severe leg pain.  I took her to the Dr.  and she diagnosed cellulitis/phlebitis around and surrounding the injection site and we are now treating with Keflex.  She also let me know it is not supposed to be given IM.
No adverse event; HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL); This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) and NO ADVERSE EVENT (No adverse event) in a 9-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Relevant medical history or conditions, allergy, concomitant diseases, and risk factor were unknown.     On 27-Jul-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information about 4th patient out of 12.
shoulder was sore and painful; This is a spontaneous report from a contactable consumer (patient's husband).  A female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2), Batch/lot number was not provided, via an unspecified route of administration from an unspecified date as a SINGLE DOSE for COVID-19 vaccination.  Medical history was none.  There were no concomitant medications.   The consumer reported his wife had the same vaccine and her shoulder was sore and painful on an unspecified date. They still have pain when they move their shoulder. The consumer later clarified that her shoulder is not sore anymore. They put an ice on their shoulder. Outcome of the shoulder was sore and painful was recovered on unknown date. Information on lot number/batch number was requested.
Attended vaccine clinic with friend. After receiving vaccine and moving to observation area, pt reports noticing? her mouth feels numb and tingly?. Pt has history to surgery for non-cancerous tumor on skull that involved the nerves in the early 2000s resulting in facial asymmetry and some swelling and redness around her left nares. Face inspected and her friend reports that it looks normal for her. Facial asymmetry continues but when assessing face, her friend reports the asymmetry is her norm. VSS BP 166/108, HR-68, Resp 14. She reports that BP goes up. She has no side effects with the first dose but reports feeling ?extremely anxious about coming to get this vaccine?. Arm and leg strength are equal bilaterally. Pt drank water and says she is feeling better by 2:42. She reports no longer feeling tingly but her lips are still numb> 2:52 symptoms resolved with no additional symptoms reported. 3:01 no further s/s reported. Reviewed s/s of reactions vs side effects. Agrees to notify PCP of response after vaccine and also agrees to call 911 with any s/s reaction upon leaving Facility.
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patient were vaccinated with an improperly stored dose of M-M-R II (Lot # J008153, expiration date 08-JUL-2015; lot #J010208, expiration date 23-AUG-2015; or lot # K000738, expiration date 16-JAN-2016) (Strength, dose and route were not provided). Concomitant medication was not reported. The healthcare worker confirmed that improperly stored M-M-R II (Lot # J008153, expiration date 08-JUL-2015) was not administered after the expiration date, but administered on unspecified dates prior to 08-JUL-2015. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.