chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered 0.25 ml of the bivalent dose instead of 0.50 ml; No Adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (administered 0.25 ml of the bivalent dose instead of 0.50 ml) and NO ADVERSE EVENT (No Adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (administered 0.25 ml of the bivalent dose instead of 0.50 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (administered 0.25 ml of the bivalent dose instead of 0.50 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (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 ACCIDENTAL UNDERDOSE (administered 0.25 ml of the bivalent dose instead of 0.50 ml).    No Concomitant medications were provided. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-643040 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-643040:1st patient case
On Monday 29th pt stopped and stated her arm was sore. Suggested ice pack and BENADRYL if inflamed. Pt stopped by again on Nov 8 and was still having pain in arm.
Pt came to office on 8/14/00, complaining of 1 week history of itchy bumps and blisters that look like chicken pox. Had about 20 lesions on body; 2 lesions look secondary infected. Treated with Keflex.
Administered expired doses to patients past the published expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired doses to patients past the published expiration date) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired doses to patients past the published expiration date). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired doses to patients past the published expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vial was initially stored in the refrigerator on 20-Oct-2021.   Concomitant medications were not provided. Treatment medication was not provided.
After receiving TDAP, MCV4, and HPV pt was sitting in lobby and fainted.
Deep Vein Thrombosis discovered at the end of August.; Pulmonary Embolism; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 22Apr2021 (Batch/Lot Number: EW1070) as DOSE 2, SINGLE for covid-19 immunisation at the age of 43-year-old. The patient medical history was not reported. No other vaccine in four weeks. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]); clarithromycin (CLARITIN), Birth control, allergy to Ibuprofen. The patient previously took bnt162b2 dose 1 (Batch/Lot Number: ER8734) in Left arm on 01Apr2021 for covid-19 immunisation at the age of 43-year-old. The patient experienced Pulmonary Embolism and Deep Vein Thrombosis on 27Aug2021 with outcome of recovering. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and hospitalization for 4 days. No COVID prior vaccination and COVID tested post vaccination with unknown results. Therapeutic measures taken for deep vein thrombosis and pulmonary embolism included Blood thinners.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated intramuscularly with the first and second 0.5 ml dose of GARDASIL (Lot # not reported) in 2007 and December of 2011. It was not known if the patient sought for medical attention. No adverse effect reported. Additional information is not expected.
Headache, fatigue, vomiting, fainting, muscle soreness, digestive issues.
pt recvd vax; devel rash at inject site; spread to legs & arms;
Series of mini strokes over the course of a few months followed by a major stroke on March 15, 2021. The mini strokes were mistaken as blood sugar issues but brought to light that she had experienced a series of smalls strokes prior to the major stroke.
Information has been received from a registered nurse concerning a 21 year old female with osteopenia who on 11-JAN-2007 was vaccinated with Gardasil vaccine (yeast) (lot#655165/1425F), intramuscularly in the left arm. Concomitant therapy included FOSAMAX and calcium (unspecified). Subsequently, on 11-JAN-2007, the patient "passed out", "fainted", was dizzy and nauseated. The patient recovered. There were relevant diagnostic or laboratory tests. It was noted that the patient had eaten before vaccination. Unspecified medical attention was sought. The reporter considered the patient's experience to be disabling because the patient was incapacitated for a short time. Additional information has been requested.
pt. received Varicella injection on 7-18-07.      On 7-19-07 noted redness, warm to touch, pain and nodule 2 X 4 cm on left arm.  Pt. seen via PCP on 7-20-07 with treatment order. On 7-22-07 s/s had improved.
rash in area of shot on left arm after one week, dr said it was Shingles, he precscribed valACYclovir 1 gram tablet
Elevated temperature (104.8), emesis x 2 on 01/21/04.  Right middle lobe pneumonia by chest x-ray on 01/22/04.  Treated outpatient with Roweshim IM and Omnicex by mouth.
When I lay down myself, I feel uncomfortable in lung, and feel a little bit of difficulty to breath.
significant fatigue; temperature was taken when waking up - 101F orally; she slept more; localized injection site pain and redness; localized injection site pain and redness; This is a spontaneous report from a contactable nurse (patient). This 63-year-old female Nurse reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular at right arm on 17Dec2020 08:30 PM at single dose for COVID-19 immunization. Facility type of vaccine was hospital. Medical history included shingles in Jun2020 after illness that mimicked COVID-19 but all tests came back negative - was sick for 3 weeks; no other chronic health conditions; severe beef/pork allergy - anaphylaxis. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medications were not reported. No other vaccine in four weeks. On 18Dec2020 02:00 PM, patient experienced significant fatigue; she slept for 1 hour and temperature was taken when waking up - 101F orally; she slept more; she had localized injection site pain and redness for 3-5 days. No treatment was received for events. It was reported as non-serious. Outcome of events was recovered in Dec2020.
bells palsy; This is a spontaneous report from a contactable consumer (patient herself).. A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN9581), via an unspecified route of administration on 10Feb2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (solution for injection, lot number: EL3246) on 20Jan2021 via an unspecified route of administration as dose 1, single for covid-19 immunization.The patient was diagnosed with bells palsy after her second dose of the vaccine, and asks if there are any reports of Bell's Palsy with the booster dose. Patient had her first dose was 20Jan2021 and her second dose was supposed to be on the 31st but she didn't get it until 10Feb2021 and got Bell's Palsy days afterwards. Days after her second covid shot she had an ER visit and was diagnosed with bells palsy. She was scared to death to get the booster. Patient stated none of her doctors will advise her, they remain neutral and she was scared to get the booster because she did not want Bell's Palsy again. Patient also asked if she can get the booster or not. This event was considered as medically significant. Clinical outcome of the event was reported as unknown.
Patient had red welts after her 2nd SHINGRIX dose. She tried a warm compress, and it didn't help. She also reported that it was very painful. We advised her to call her doctor, unsure if she went in to be seen or not.
I woke up three days after the shot with a headache. I was running and I got a sharp pain in my hamstring muscle in my right leg. I had to stop running and the leg pain persisted for two days. I went and saw my doctor and my tests were normal. The headache lasted for several days and was dull at first and then concentrated at the back of my head. The leg pain was present for a couple of days. All of the symptoms are gone after two weeks. I still haven't returned to running daily as I normally do.
On 4/12/01, I received the 3rd in a series of 3 Lymerix vaccinations. 2 1/2 days, post vax, I had flu-like symptoms. One week later, I had extensive pain in my left foot, ankle and bottom of foot. The joints stiffened up in my feet, wrists, fingers and knees. Since 4/12/01, I have been to 7 doctors with no direct answer to my condition. I am still in pain and I can barely walk some days. I am presently taking 3200mg of ibuprofen and using doxycycline.
Stroke; This is a spontaneous report received from a contactable consumer. This consumer reported for a female patient (reporters friend's mom) that an unspecified age elder female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date was not reported), via unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date was not reported), via unspecified route on an unspecified date as single dose for COVID-19 immunization. On an unspecified date patient died she had a stroke, and they were trying to say that because she was older, she just passed her organ test, and she was perfectly fine and 2 days later after her second shot she had a stroke (Not clarified hence split not made) and it was like they keep on and understood that there were multiple reasons that someone could have a stroke specially if patient was older. The outcome of evet was fatal  Information on the lot/batch number has been requested. Additional information is requested.; Reported Cause(s) of Death: stroke
This spontaneous report was received from a pharmacist via company representative concerning a 62 year old female patient. On 30-JAN-2013, the patient was vaccinated with ZOSTAVAX (lot # H013017, exp: not reported), 0.65 ml/ one shot, subcutaneous. Pharmacist informed that a patient after receiving the ZOSTAVAX developed increased swelling in the back of their left arm, pain and very large swelling, on 30-JAN-2013. The outcome of increased swelling in the back of her left arm, very large swelling and pain was unknown. The relationship between medication and events was unknown. The patient did not seek medical attention. Additional information has been requested.
KINRIX given 7/14/10. 13 x 15 cm pink, warm area around injection tender, induration 2 cm on (R) thigh- reaction noted 7/16/2010.
Patient unconsolably after receiving vaccines on 4/8/13. The crying started exactly 4 hours after the time of administration.
Adverse event did not occur. We are reporting a vaccine administration error for a wrong dose given. The 12yr old patient was inadvertently given the Pfizer 5-11yr dose for his booster on 06/04/2022 at the vaccination clinic.  The patient previously received the Pfizer 5-11yr dose for his 1st and 2nd dose. He turned from 11 to 12yrs of age one month before his booster appointment.  We contacted the vaccine manufacturer (Pfizer) and CDC for guidance. We also spoke with patient's mother on 06/07/2022 and was informed that patient is doing  ok with no adverse events. Informed patient's mother of the advice from the CDC provider that her child does not need to not repeat the booster dose, and that there's no safety concerns other than the typical side effects expected after COVID-19 vaccinations. Patient's mother expressed understanding and had no further questions.
Arm stll hurts; This case was reported by a pharmacist via patient support programs and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient's arm was still hurting after receveing vaccine. The reporter consented to follow up. This case had been linked to US2020AMR090636, reported by same reporter.
Information has been received from a registered nurse concerning a 6 year old male with no known allergies who on 16 AUG 1996 was vaccinated with varicella virus vaccine live subcutaneously in his right arm (616867/0243D). There was no concomitant medication. On 13 APR 2001, the patient was seen again with erythematous vesicles/papules; 50 to 100 vesicular lesions all over and a mild fever. Subsequently the patient recovered from the erythematous vesicles/papules. No further information is available.
Flu-like feeling; Had major headaches; I had severe lower backpain.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like feeling), BACK PAIN (I had severe lower backpain.) and HEADACHE (Had major headaches) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like feeling) and HEADACHE (Had major headaches). In December 2021, the patient experienced BACK PAIN (I had severe lower backpain.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 13-Dec-2021, INFLUENZA LIKE ILLNESS (Flu-like feeling) and HEADACHE (Had major headaches) had resolved. In December 2021, BACK PAIN (I had severe lower backpain.) had resolved.            No concomitant medications were reported Patient had reported that she did not had rising temperature.
Nosebleed within minutes of administering Flumist intranasally. Nurse reported that patient was scared but parent helped and head was kept still. Administration was nontraumatic. After Flumist, other vaccines were given by injection, and nose began to bleed.
3 months after 2nd dose, a first episode occurred of autoimmune disease Myasthenia gravis, that required hospitalization; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 2, single (Lot number: EL8982) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Myasthenia gravis (ocular)" (unspecified if ongoing), notes: Myasthenia gravis (ocular), Slight hypertension, Slight cholesterol issue - all under control.; "Slight hypertension" (unspecified if ongoing), notes: Myasthenia gravis (ocular), Slight hypertension, Slight cholesterol issue - all under control.; "Slight cholesterol issue" (unspecified if ongoing), notes: Myasthenia gravis (ocular), Slight hypertension, Slight cholesterol issue - all under control.; "Penicillin (maybe - childhood response) allergy" (unspecified if ongoing), notes: Penicillin (maybe - childhood response) allergy. Concomitant medication(s) included: LISINOPRIL, start date: Jan2019; PRAVASTATIN, start date: Jan2019. Vaccination history included: pfizer / BioNTech (Dose Number: 1, Batch/Lot No: EL3246, Location of injection: Arm Left), administration date: 08Jan2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: MYASTHENIA GRAVIS (hospitalization) with onset Apr2021, outcome "recovered" (May2021), described as "3 months after 2nd dose, a first episode occurred of autoimmune disease Myasthenia gravis, that required hospitalization". The patient was hospitalized for myasthenia gravis (hospitalization duration: 5 day(s)). Therapeutic measures were taken as a result of myasthenia gravis. Clinical Course: It was reported that 3 weeks after 3rd dose, another bout of M.G. [myasthenia gravis] occurred, and was treated with infusion therapy at home. Is there a link between vaccine stimulating immune system and onset of autoimmune disease? No idea but treating neurologist has recommended that patient not get any additional vaccines at this time. The patient took other medications/products within 2 weeks of starting COVID-19 treatment? Yes. The patient had previously received a COVID-19 Vaccine.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.
No additional Ae's reported; Temperature excursion involving administered PROQUAD vaccines; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's medical history and concomitant medications were not provided.  On 14-DEC-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (reported Lot # U022726 and expiry date : 16-JAN-2023) for prophylaxis after involving in temperature excursion (Product storage error). No additional Ae's and no PQC's were reported.
redness at the needle location; sore at the needle location; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The patient got vaccine and it was sore for about two days with redness at the needle location.  The patient was fine now. The reporter reported better than having shingles. Had it over his/her back.  It was worse experience behind Covid.
Approx. 60 seconds after my vaccine injection: - Highly accelerated heartrate - Difficulty breathing (due to accelerated heart rate) - Dizziness - Feeling faint - Headache - Fever These symptoms lasted 10 min; however the dizziness, headache and fever lasted 45 minutes.  No pain in the arm at all.
pt recv vax 11JAN96 & 6FEB96 pt exp varicella like rash in 3 distinct areas; no further details were provided;
This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-JUN-2018, the patient was vaccinated with an improperly stored doses of VARIVAX lot # N029632, expiry date 23-OCT-2019 and lot # N022980, expiry date 23-AUG-2019, subcutaneously for prophylaxis. The doses of vaccine were stored between 15 degrees Fahrenheit (°F) to 46°F (-9 degrees Celsius (°C) to 8°C)) (-7.5°C) for 2 hours 30 minutes. Previous temperature excursions were detected: 15°F to 46°F (-9°C to 8°C) (-5.8°C) for 4 hours 19 minutes. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1808USA000259.
administered an extra dose of Daptacel with no reported adverse event; Initial information received on 27-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old male patient who was administered an extra dose of daptacel with no reported adverse event while receiving vaccine diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (prevnar) for immunisation; hepatitis b vaccine (hepatitis b [hepatitis b vaccine]); diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (pentacel); and rotavirus vaccine (rotavirus vaccine) for immunization (for all concomitants).  On 27-Feb-2023, the patient received 0.5 ml QD (daily) dose 2 of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (batch number- C5980AB and expiration date-06-Apr-2024) via intramuscular route in the left vastus lateralis (strength: not provided) for Immunisation.  On 27-Feb-2023 the patient was administered an extra dose of daptacel with no reported adverse event (extra dose administered) (latency- same day) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the 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 guidelines. 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.
Light-headed, tiredness, impaired work ability, mobility decreased, injected limb mobility decreased, pain upon movement, sleep disturbed, Injection site pain, redness, swelling, induration and warmth.