chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was given the liquid portion only of Pentacel in the left thigh the powder portion was not given with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and consumer/non-health care professional via the Regulatory Authority (Reference number- 00754655) and transmitted to Sanofi on 03-Sep-2021.  This case involves 18-month-old male patient who was given the liquid portion only of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] in the left thigh the powder portion was not given (product preparation issue).  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  On 03-Sep-2021, the patient received the liquid portion only of a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ413AA and expiry date: 09-Oct-2021) via unknown route in the left thigh for prophylactic vaccination the powder portion was not given (product preparation issue).  It was reported,"MA (Marketing authorization) states that only the liquid from the PENTACEL was given, MA did not know of the powder. Physician requests on behalf of the MA, to know if there are any AE's (adverse event) that they should be aware about. Does the DTaP and IPV count? What should we do about getting the Hib dose? The caller was referred to the reconstitution guide."  This case was an actual medication error due to inappropriate reconstitution technique (latency: same day).  At the time of reporting, no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fatigue, no energy, tiredness, sores in the inside of the mouth and around the outside, PCP provided steroid ointment. Dermatologist confirmed yeast infection in mouth. Hot flashes, fever, nauseated, severe headache, and body aches.
- Nausea/Vomiting starting 10 hours after shot, lasting until 30 hours after shot.  Did not respond to Nauzene or Pepto-bismol. Continue to have food aversion.  - Extreme lower back and hip body aches (similar to severe period cramps) while not menstruating starting hour 18 and lasting until hour 32, mildly helped with Tylenol and heating pad.  - Severe headache (though not a migraine) on entire left side of head, traveling down left side of neck starting at hour 18 and lasting until hour 30, mitigated with Tylenol.
Patient / administrated with an expired dose of Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Men B NVS (Bexsero) (batch number ABXA14BA, expiry date 31st March 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th April 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 8th April 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follow: The case reported by other health professional via call center rep. The patient received an expired dose of Bexsero. No other adverse events were reported related to vaccine. The reporter consented to follow up. No patient's identifiers were provided.
After patient received the vaccination and was sitting in pharmacy area for 15 minutes post vaccine, her friend said she didn't seem "right", so I went over to the patient and her head started to loll and she was passing out and the color was draining from her face.  I had one of her friends help me place her on the floor with her feet up in the chair and I noticed she felt hot.  I called for a technician to bring me a cold pack and placed it on her forehead.  I asked her friends if she had eaten today and they said she skipped breakfast and only had a bagel for lunch.  After a minute or 2 on her back, she began to revive  and when she felt up to it, I had her sit up on the floor and gave her some water to sip.  After a few more minutes, she said she felt good enough to sit up in the chair, so we helped her get up and put her in the chair.  She stayed around for about 30 minutes after that and was feeling better and left
Started to develop a rash all over my body the day after my second dose. I have been using Benadryl at night and Claritin during the day and also spray Itch relief. Starts to get better during the day but worsens at night especially right first thing in the morning.
10 patients administered vaccine past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported. On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.
This spontaneous report as received from a nurse refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improperly stored PEDVAXHIB (lot # N000238, expiry date: 25-OCT-2019) for prophylaxis. Nurse reported that the vaccine underwent temperature excursion at 50 degree Fahrenheit for 30 minutes. No data logger was involved. No adverse effects were reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1708USA009647.
pt recv vax 20FEB97 10AM;6PM pt cried & cold but seating, some temp elevation @ 8PM APAP given;21FEB crying, would not take formula;0500 awake w/scream cry & regurgitations & hands & feet cold;27FEB seen in ER t98.2 dx poss colic;
Mom states child got Flu shot in clinic around 930 1000 on 1/23/18. States child was fine at home all night. States he woke up next morning and arm was red; swollen. Went to school. Had no fever, not other symptoms. School nurse outlined swelling and redness put warm compress on arm. Area still red on 1/26/18 at 1700, swelling down.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 00:15 as dose 4 (booster), single (Lot number: AS7163B) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (Treatment start date- 16Apr2023; Treatment stop date- 20Apr2023).; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300168413 Same patient, different product, different event;
Sudden tinnitus which has been constant, doctors have ruled out most causes, have attempted ear flush, antibiotics, antihistamines, diuretics, and decongestants. No previous history of any sort of ear issues or any tinnitus, is currently ongoing.
Pt recv vax on 11/3/98; 20 min post vax pt exp staggering, elevated blood pressure, lethargic, crying, anxious, headache, shaky
Pain on arm of injection ("not as intense as before"); Rash on arm of injection; Lump on injection site; Intense pain on arm of injection ("could not move or lift it"); Tiredness; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Intense pain on arm of injection ("could not move or lift it")), FATIGUE (Tiredness), PAIN IN EXTREMITY (Pain on arm of injection ("not as intense as before")), VACCINATION SITE RASH (Rash on arm of injection) and VACCINATION SITE MASS (Lump on injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0401421A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ROSUVASTATIN, SPIRONOLACTONE, ISOTRETINOIN (ZENATANE), FLUOXETINE and VILAZODONE HYDROCHLORIDE (VIIBRYD) for an unknown indication.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (Intense pain on arm of injection ("could not move or lift it")) and FATIGUE (Tiredness). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain on arm of injection ("not as intense as before")), VACCINATION SITE RASH (Rash on arm of injection) and VACCINATION SITE MASS (Lump on injection site). On 31-Mar-2021, PAIN IN EXTREMITY (Intense pain on arm of injection ("could not move or lift it")) and FATIGUE (Tiredness) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain on arm of injection ("not as intense as before")), VACCINATION SITE RASH (Rash on arm of injection) and VACCINATION SITE MASS (Lump on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information were not provided.
received second vaccine 3 weeks and 2 days after the 1st vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second vaccine 3 weeks and 2 days after the 1st vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 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. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second vaccine 3 weeks and 2 days after the 1st vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second vaccine 3 weeks and 2 days after the 1st vaccine) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot #: Unknown) with no associated AEs.
no adverse effect; patient received GARDASIL 9 by subcutaneous injection; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. This report concerns 1 patient and 1 combination product.   On 03-JUN-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter, subcutaneous, lot # S004578, expiry date 29-SEP-2021, formulation was not reported, but upon internal validation established as syringe (anatomical location, dose number and frequency were not reported) for prophylaxis. Subcutaneous route of administration was considered inappropriate. No adverse effects were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S004578; expirationdate: 29-SEP-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
(L) thigh - 1 cm redness and indurated, nontender, not warm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient started Paxlovid one day after he started showing symptoms and testing positive. Symptoms went away and tested negative. Then 4 days later he started showing symptoms again and tested positive. His symptoms were worse than the first time.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Heart racing, lightheaded and passed out causing a traffic accident on the way home. Just as quick as it came on it went. Under regular care for years with no problems that would of caused this. The only thing that was different on the day of the reaction was the 2nd Covid shot. No problems at all with the first one.
Mother noticed reaction on R arm, 1 day later that vaccine was given. It was red and warm around area, 19 x 4 1/2.
Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-APR-2022 Reporter's comment: This case was reported by patient via  interactive digital media. The patient reported that he/she received first shot of Shingles vaccine and experienced shingles second time. The patient was supposed to get other shot in July but patient still thinking about not getting it.  Additional Supportive Information:  The follow-up would not possible as no contact details were available.
Rash developed in the LT arm followed by a warmth sensation from the bottom of spine all the way to the throat which started to get swollen and constricted about 38 min after the vaccination. Self treated with 1 dose of claritin which relived partially the throat constriction and rash 10 min later. Throat constriction lasted for 6 hours, developed subsequent muscle pain and tingling sensation in all muscles that is not going away till today
Pharmacy left Pfizer vaccine vials in the freezer for longer than 2 weeks at temperature (-25 and -15 degrees C). We gave doses out of these vials, rendering them possibly less effective.
Patient started with an outbreak of zoster on 1/12/06 in the dermatonal distribution where the vaccine was originally given (S2 on the right).
Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023; No adverse event; Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 19 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:master case
Arm was sore and went away in a few days. Pain, stiffness and immobility started at the hips 9 days after vaccine, could not walk. Also, had pain at base of skull and neck started at same time (as the hip pain), pain still exists and is minimal depending on treatment. Arthritis on all fingers starting Dec. 31st, which lasted about a week. Left index palm knuckle formed a knot after the end of January in which pain still exists with touch. Patient did not see a physician with symptoms however she did see a chiropractor due to the fact that the symptoms were arthritic, patient tried TYLENOL, ibuprofen, which did not ease the pain, naproxen did help with pain and stiffness. Patient used hot tub morning and night, heated massage unit, emu oil rub, TIGER BALM. Chiropractor did adjustments and electrical stimulation.
Resident received the 2nd dose of Covid-19 Vaccine on 01/29/2020, reported feeling Nausea on 01/30/2021 and had 2 falls, second fall resident became lost consciousness while ambulating and abruptly feel to the ground .  Paramedics were called and transported her to ER evaluation.
Patient received first dose on 09/07/2022 and erroneously received a second dose on 09/13/2022.
05/11/2021 "PMH including prostate ca s/p radiation, hx of CVA, TIA,  s/p left supraclinoid ICA aneurysm pipeline stenting, refractory hematuria requiring multiple clot evacuations and BL PCN placement, hx of C diff, DVT s/p IVC filter, HTN, VRE and staph bacteremia, who presented to ED for evaluation of AMS"; D/C'd home on  5/18/2021.
Initial case received from a consumer, who is also the patient, on 07 September 2011. A female patient received FLUZONE HIGH-DOES (lot not reported) on 04 September 2011. One day post-vaccination, she experienced aches, leg shakes, weakness, and chills. She did not take her temperature, but self-treated with acetaminophen. She was not seen by a physician, and reported that it was her first year receiving FLUZONE HIGH DOSE.
Dizziness, unstable when walking, great fatigue. Bedrest and Tylenol. In bed for 7 days. Still not steady on feet. Still fatigued.
Bruising, aches, fever, chills, severe headache, arm sore and tender (top and bottom - tender to put on deodorant), pain shooting from shoulder to left ear