chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temperature excursion with our Moderna Covid-19 vaccine; No adverse event; Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion. This spontaneous case was reported by another health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.) and NO ADVERSE EVENT (No adverse event) in a 69-year-old 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. 045H22A) for COVID-19 prophylaxis. No Medical History information was reported. On 07-Mar-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 07-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and POOR-QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.) The concomitant medication was not reported by reporter. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The treatment medication was not reported by reporter. This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report). Sender's Comments: US-MODERNATX, INC.-MOD-2023-715674:Master Case.
15May90 pt vax 2nd vax;  25May90 was seen in ER w/ induration at inject site.  Pt devel temp 102F.  By 29May90 whole upper arm was involved w/ erythema & induration.
Woke up in the middle of the night feeling feverish and nauseas. Developed a ringing in my ears before vomiting for several minutes, followed by chills. Felt better going back to bed. This morning my arm is sore.
Rec'd 1st 3 shots in anthrax series Jul-Aug 2000. I have shot record.  Noticed tingling and numbness (09/2000). Diagnosed with Multiple Sclerosis (01/2001) Injecting self w/Copaxone daily since.
Hives within 2 hours and then onset of Tachycardia lasting 36 hours on and off.
This is a 68-year-old male with a PMHx of ESRD on HD (TueThursFri), hypertension, hyperlipidemia, CHF, BPH, and chronic O2 supplementation presents to hospital via EMS from rehabilitation center secondary to testing positive for COVID-19.  Per ED note, patient unable to return to facility due to not having isolation rooms.  Patient currently complaining of fatigue however denies any chest pain, shortness of breath, fever, chills, abdominal pain, N/V/D, cold symptoms, or any other symptoms.ill admit patient under observation status for further evaluation and treatment.
Fever, chills, muscle aches, headache, nausea, lots of inflammation, swelling hotness and redness at injection site.
Treatment of COVID-19; Treatment of 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 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 24Feb2021 as dose 2, single (Lot number: EN6204), in left arm, on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: FH4991), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild stroke", start date: 11Mar2021 (unspecified if ongoing), notes: Mild stroke 11Mar2021; "high blood pressure" (unspecified if ongoing), notes: high blood pressure and cholesterol- take Praluent injections 75 mg; "cholesterol" (unspecified if ongoing), notes: high blood pressure and cholesterol- take Praluent injections 75 mg; "known allergies Penicillin" (unspecified if ongoing); "known allergies aloe vera" (unspecified if ongoing); "known allergies Azulfidine, Demerol, Erythromycin" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 05Apr2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. From 21Dec2022 to 26Dec2022, patient received Paxlovid for COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous non valid report was received from a nurse and refers to a unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in October 2017 (reported that from 10-OCT-2017 to 12-OCT-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018, lot # M046133, expiration date: 26-SEP-2019), PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) and GARDASIL 9 (lot # L036301 expiration date: 20-DEC-2017, lot # M028323, expiration date: 26-SEP-2018 and lot # N017686, expiration date: 2-FEB-2020) (for all vaccines doses and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius (C) to 25C (11.4C) for 1 hours. Data logger was involved. Follow-up information has been received from the nurse on 11-JUN-2018. She provided that the temperature excursion took place on 10-OCT-2017. The patient identification information was not readily available. Follow-up information has been received from the nurse on 11-JUN-2018 concerning a patient of unknown age and gender. The patient was vaccinated with PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018) of temperature excursion which took place on 10-OCT-2017 from 16:32 until 19:02 (maximum temperature 11.4C). No adverse effects were reported. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is now valid because the patient's identifier was received. Sender's Comments: US-009507513-1710USA007686.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications on use were not provided.  Patients were given doses from vials that were stored in an ultracold freezer which is colder than they should have been. The vial undergone temperature excursions for one month. The vial was in frozen state at the time of the excursion. The vials moved from freezer to refrigerator on 23 Nov 2021. The maximum and minimum reached temperatures was negative 82 degrees Fahrenheit. The vials were returned to the freezer or refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  No treatment information was provided.   This case was linked to MOD-2021-402935.
7 minutes after vaccine I felt a heat wave moving from the left side side of my body to the right. First, my heart starting palpitating, my chest got tight, the right side of my throat felt like it was swelling. I felt like I had to go to the bathroom and my left big toe was pulsating and cramping at the same time. My left sided throat swelling persisted until 1100 am Wednesday sept. 1 2021.
Received three doses; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 23E5G, expiry date 11th February 2024) for prophylaxis.   On 25th November 2022, the patient received the 3rd dose of Shingrix. On 25th November 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 05-DEC-2022. Reporter's Comment: The pharmacist had reported that the patient had received three doses of Shingrix. The reporter had consented to follow-up. Additional supportive information: The patient had received the 3rd dose of Shingrix vaccine, which had led to extra dose administered.
Vomiting, severe abdominal pain, body aches, severe body chills. Began approx. 10 hours following vaccination and continued until for 48 hours.
Patient already received 1 dose of Jannsen in 2021. Received the Moderna Primary series vaccine when she likely wanted to have the bivalent booster.
This spontaneous report as received from a physician refers to a 51 year old female patient. On an unknown date the patient was vaccinated with MMR II (lot # and expiration date unspecified) one shot, subcutaneous (dose and anatomical location unspecified). On an unknown date the patient developed a high fever of 104 or 105 degrees Fahrenheit five days after she received the MMR II. The patient was fully recovered. The patient did not seek medical attention. Additional information is not expected.
Pt seen Urgent Care on 10/6/22 by PA-C with redness and pain in left arm, cellulitis documented, Keflex 500mg BI for 7 days ordered along with Benadryl 25mg at bedtime, zyrtec every morning, tylenol and ibuprofen as need for discomfort. No respiratory s/s or fever. Pt to follow up with primary provider Dr docoumented following week.
blood glucose levels are increasing (231); This spontaneous case was reported by a physician and describes the occurrence of BLOOD GLUCOSE INCREASED (blood glucose levels are increasing (231)) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00182TA) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood glucose levels are increasing (231)). At the time of the report, BLOOD GLUCOSE INCREASED (blood glucose levels are increasing (231)) 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.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No new information.
Pt. states that after receiving the 1st dose of Phizer 11/05/2021, started experiencing symptoms immediately of left side of vision "blinded" and leg swelling (12hrs later). Primary communications recommendation for Water Pill for swelling. Mouth swelling, throat swelling, facial swelling, and Edema of the tongue. Admitted to the ICU for life threatening conditions.
Patient had slight swelling at site of injection within 30 seconds of administration. Pressure and ice pack was applied to area and mostly subsided. Patient had normal respiration and did not experience any dizziness. Patient was given 50mg of diphenhydramine as a precaution
No additional AEs; Medical assistant reported that an expired PNEUMOVAX 23 was given to a patient on 8/15/2023.   No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 15-AUG-2023, the patient was administered with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) pre-filled syringe, lot number: U027357, expiration date: 25-MAR-2023 (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse events (AEs) were reported (no adverse event). No further information was provided. There was no product quality complaint (PQC).
Immediately following vaccination client developed itching at the site and it spread to a generalized itching from the waist up.  She had tinglinig in her lips as well.  She developed a baseball sized area at the injection site that was red and hot and lasted about four days.  The reaction required OTC Benadryl be taken at the time and again later that evening, as well as once the following day.
Left deltoid region red and hot - getting larger.  No induration, no fluctuance, no MIS.  Treatment: Ibuprofen, Benadryl, cold compresses.  Prescribed Omnicef if not improved in 24 hours.
Patient experienced burning upon administration but thought was normal.  By end of day pain was fairly extreme and had trouble lifting arm.  Next day pain was extreme and arm was red. Went to hospital, was told vaccine administered too high and patient had cellulitis at administration site.  Went home with pain meds and antibiotics but when issue worsened, patient went back to hospital and was admitted.
@ site of DT lt deltoid has 3" diameter red area warm to touch & tender; no fever;
Symptoms within 10 minutes of vaccination included: "tingly" hands, metallic taste in mouth, headache described as "achy", and "fogginess",
Noted with red rash to both hands, arms after eating lunch. Itching, mo applied cream to rash. No BENADRYL given 1/15/15. Rash noted to drying up. Small amt of rash noted to hands, arms clear. Instructed mom to give BENADRYL if itching continues and continue hydrocortisone cream as needed. Report to PMD or ER if symptoms re-occur.
two patients (a 52-year-old man and a man in his 60s) were administered nonavalent HPV vaccine to potentially reduce the number of new skin cancers; This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 52-year-old male patient.  The patient's concurrent conditions included Crohn's disease, multiple cutaneous warts, basal cell carcinoma, squamous cell carcinoma and immunosuppression. The patient's medical history was not reported. Concomitant therapies included mercaptopurine and nicotinamide.  The patient had Crohn's disease and had been taking mercaptopurine 100 mg daily since his diagnosis over 22 years ago. He had a history of multiple cutaneous warts and keratinocyte carcinomas (KCs). Over a 4-year period (2015-2019), prior to the first dose of the vaccine, he had 15 KCs (8 squamous cell carcinoma (SCCs) and 7 basal cell carcinoma (BCCs)).  In October 2019, the patient was administered nonavalent human papillomavirus (HPV) vaccine (manufacturer unknown) to potentially reduce the number of new skin cancers (off label use). Since starting the HPV vaccine series (manufacturer unknown) and niacinamide 500 mg twice a day, he had two SCCs.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports derived from the literature article (cross referenced with MARRS # US-009507513-2206USA005068).  Literature Report: Sender's Comments:  US-009507513-2206USA005068:
Hives head to toe hours after vaccine given. Vaccine was also given against parents will. Child's hives got increasingly worse over 24 hours after injection. Child started with severe eczema within weeks that was felt to be related to vaccine by all doctors.
This spontaneous report was received from a physician regarding a 5 year old female patient. Pertinent medical history and drug allergies or reaction was reported as none. On 10-MAR-2016, the patient was vaccinated with PROQUAD (Merck) lot # L034930, expiration date- 03-MAR-2017, intramuscular instead of the intended subcutaneous route. Concomitant medication was reported as none. On 10-MAR-2016, a few hours later after vaccination patient experienced soreness at the injection site. Patient was treated with MOTRIN and a warm compress to the injection site. No laboratory diagnostic studies were performed. Patient seek medical attention from office clinic. The outcome of soreness at the injection site was reported as not resolved. The outcome of intramuscular instead of the intended subcutaneous route was unknown. Causality between PROQUAD (Merck) and soreness at the injection site was unknown. Additional information has been requested.
Starting feeling burning right after injection, about 20mins later starting feeling itchy, and body aches and bruising. No fever symptoms worsen overnight. Patient was advised by PCP to use BENADRYL for itchiness also recommended using cold pack to relieve pain and bruising.
About 15 minutes after receiving COVID 19 vaccine, patient/employee began to c/o of dizziness. Shortly after patient also stated that she felt shaky, experiencing SOB, legs tingly and numb. Patient was transferred from the chair to a stretcher, and was further evaluated by the EMT staff. Patient was later transferred to the hospitalized due to elevated BP.
Patient reported swelling at injection site the same day as vaccine was given. On Sunday, she stated her thigh and calf were swollen. She normally takes an ADVIL and ZYRTEC nightly. She reports normal conditions on Monday with no more swelling.
Patient had written that their birthday was 01/14/2003 and that they were 18 years old on their form. When entering into WebIZ, patient was found (same address/phone number) with a different birthdate; 10/14/2003. Their WebIZ profile stated that they were 17 not 18. Vaccination was given based on their form, stating that they were 18.
itchiness; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) and RASH (rash) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchiness) and RASH (rash). At the time of the report, PRURITUS (itchiness) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Information has been received from a health professional concerning a patient who on an unknown date was vaccinated with a dose of PNEUMOVAX 23. On an unspecified date, the patient experienced injection site pain in the arm. It was reported that the pain lasted four days or so and resolved on its own. The reporter stated that no additional intervention was needed. Additional information is not expected.
Vomiting; chills; sweating; fever; extreme joint pain (especially in my knees); extreme skin inflammation pain; pain; restlessness; nausea; gassiness; piercing headache; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 15Apr2021 11:00 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation. Medical history included bipolar 2, allergies to red dyes, and detergents. The patient is not pregnant at time of vaccination. Concomitant medication included lamotrigine (LAMICTAL); trazodone; fluoxetine and multiv. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, administered in arm left on 25Mar2021 11:00 (Batch/Lot Number: ER2613) for covid-19 immunisation. The patient experienced vomiting, chills, sweating, fever, extreme joint pain (especially in her knees), extreme skin inflammation pain, restlessness, nausea, gassiness, piercing headache, muscle aches all on 15Apr2021 19:00. Symptoms onset 8 hours post second dose, went away by hour 20 post second dose, except for splitting headache which lingered for several days. Tylenol taken on regular schedule didn't kill pain. Alternated rosin salt bath/hot shower through the night. No treatment was received for other events. All events were serious. Prior to vaccination, no patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No other vaccine in four weeks. The outcome of event headache was unknown, while other outcomes of events were recovered.   No follow-up attempts are needed. No further information is expected.
Life threating allergic reaction of Anaphylaxis, full body jerking seizure lasting over an hour, loss of consciousness. Taken to ER, coma lasting one week.