chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional AE; HCP called to state that the patient was given an expired dose of GARDASIL 9.; This spontaneous report was received from medical assistant, referring to patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 14-JUN-2023, the patient was vaccinated with expired the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (formulation pre-filled syringe, 0.5 mL, lot #U007667, expiration date 23-MAY-2023, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). No known temperature excursions. No additional adverse event (AE) (No adverse event) and product quality complaint (PQC). ; Sender's Comments:  US-009507513-2306USA008127:
Fatigue, muscle aches, coughing, sore throat, fever of 102.6, chills and tremors, and nausea all lasting approximately 4 hours. Fatigue and nausea remained for 24 hours total.
devel inconsolable cry following DTP/HIB/OPV vax; became difficult to arouse w/variable periods of alertness vomited x 2;
About 12 hours after injection, I started feeling achey 13 hours later, I had a spell where I could not hear anything and felt as if I wasn?t in control of my body- in talking to medical personnel they say what I?m describing is what happens right before one passes out. I came out of it within 10 minutes. 16 hours later I had a 102 fever. Took Tylenol Felt fine 24 hours later 32 hours later I started to get a headache and light sensitivity. Fever back to over 99- low grade for me.  35 hours later I had such a bad headache and light sensitivity. I couldn?t watch tv, be on my phone, or look at a computer screen. I also started to get bouts of nausea. 38 hours later, I vomited for the first time. Same symptoms as what I described last. 42 hours later, I vomited again. 48 hours later - 5 days later, light sensitivity and  migraine symptoms continued , but improved slowly each day.               6 days later, all previous symptoms were gone. I woke up with a bump in my inner eye. Slowly went away throughout the day, then developed a itchy, red bump in between my lips and nose, that progressively got bigger throughout the day and made my lip swell. Bump was about 2 inches in diameter at its biggest. Took Claritin, cleaned face with alcohol, and by 24 hours later it was not noticeable.  8 days later, the bump appeared again in between lip and nose on the opposite side of my face.  Took Benadryl, bump slowly went down throughout the day. By 24 hours later it was gone
a dose of PROQUAD which experienced a supported temperature excursion was administered; This spontaneous report as received from a physician refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 16-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (lot number: T037955, expiration date: 09-MAY-2022; dose and route of administration were not provided) (product storage error temperature too high). The vaccine was stored in temperature 15.1 degrees Fahrenheit for 3 hours and 40 minutes. There was previous temperature excursion. Digital data lodger was involved.
Hives/whelps over 50% of body - sudden onset 4-6 hours post vaccines.
Information has been received from a consumer concerning her 17 year old daughter with no pertinent medical history who on 06-JUL-2007 was vaccinated IM with a first dose of Gardasil.  There was no concomitant medication.  On 23-AUG-2007 the patient was vaccinated with a second dose of Gardasil.  On 24-AUG-2007 the patient experienced headache and migraine the day after the second dose.  Unspecified medical attention was sought.  Subsequently, the patient recovered from the headache and migraine on 24-AUG-2007.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Information has been received from a consumer concerning her 17 year old daughter with no pertinent medical history who on 06-Jul-2007 was vaccinated IM with a first dose of GARDASIL. There was no concomitant medication. On 23-Aug-2007 the patient was vaccinated with a second dose of GARDASIL. oN 24-Aug-2007 the patient experienced headache and migrane the day after the second dose. Unspecified medical attention was sought. Subsequently, the patient recovered from the headache and migrane on 24-Aug-2007. The follow up information from the physician indicated that the physician never heard from the patient about any adverse reaction.
Pfizer primary series; Moderna Booster  Itchiness and Redness. PT reports no shortness of breath or throat swelling. No difficulty breathing noticed. Respirations equal and full. Redness noted on PTs back and itchiness throughout torso. PT did not mention to clinical and non clinical staff that she had a reaction in the past. PT reports the same reaction after the second covid vaccine. PT failed to mention any health issues/allergies to clinical reviewer or vaccinating nurse. Clinical Manager notified immediately and facility physician notified by facility staff. MD present in the room at 1005 11/30/21.  Pt given Benadryl 50mg PO @09:55. Pt stable and released from the vaccination site.  Recommended f/u w/ PCP and avoid mRNA vaccines in the future.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with VAQTA (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.
Patient received Fluzone High Dose Quadrivalent instead of Fluzone Quadrivalent
Vertigo began at 0530, continued through next day with vomiting and back pain.
Reports had a reaction to the shingles vaccine 1st was on 5/9, no reaction, was told to repeat it. 2nd was 5/29 and had severe reaction, severe pain in the arm, numbness to fingers, nausea, vomiting, severe diarrhea lasting through the following day.
8 minutes after injection I began to get dizzy. The nurse right away put ice packs on my neck. She checked my blood pressure and it had spiked. She had me drink a full bottle of cold water. She monitored me. Then after 25 minutes I was transported in a wheelchair to a observation area. About 1 hour later the dizziness went away. I also broke out in a rash on my neck for 3 days
Blood pressure was 157/90 when normally is 120/80; blood pressure still remains a little high (in the 135 to 145 over 85 range); This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE ABNORMAL (Blood pressure was 157/90 when normally is 120/80) and BLOOD PRESSURE INCREASED (blood pressure still remains a little high (in the 135 to 145 over 85 range)) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), COLECALCIFEROL (VITAMIN D SUPPORT) and TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE ABNORMAL (Blood pressure was 157/90 when normally is 120/80) and BLOOD PRESSURE INCREASED (blood pressure still remains a little high (in the 135 to 145 over 85 range)). At the time of the report, BLOOD PRESSURE ABNORMAL (Blood pressure was 157/90 when normally is 120/80) was resolving and BLOOD PRESSURE INCREASED (blood pressure still remains a little high (in the 135 to 145 over 85 range)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include statin group of drug.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received, an adverse event was added.
This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 09-OCT-2015, the patients received an improperly stored doses of VARIVAX (lot#L009205, expiration date 17-MAR-2017, lot reported as L624124 expiration date 06-MAR-2016, lot#J013734 expiration date 30-OCT-2015) (doses, routes of administration and anatomical locations were not reported). No adverse effects reported. It was stated that all vaccines underwent a temperature excursion at 7.7 Fahrenheit for 15 min, date of temperature excursion as of 09-OCT-2015. The digital data logger was involved. The product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004383: US-009507513-1705USA004379: US-009507513-1705USA004380: US-009507513-1705USA004381: US-009507513-1705USA004382: US-009507513-1705USA004377: US-009507513-1705USA004376: US-009507513-1704USA008135:
Customer Safety Compromised: Pregnant. Vaccine was administered to a pregnant participant. Participant was informed to advise OB/GYN of vaccination.
Warmth at injection site; Aching pain in upper left arm; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 24Feb2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 24Feb2021 at 15:00, the patient experienced warmth at injection site and aching pain in upper left arm lasting about 2 days after the vaccination. On 24Feb2021, the same evening as the vaccination the patient experienced headache. On 25Feb2021, one day after the vaccination headache continued with fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache and fatigue were recovered on 25Feb2021 after a duration of 1 day and that of the events warmth at injection site and aching pain in upper left arm were recovered on 26Feb2021, after the duration of 2 days.  No follow-up attempts are needed. No further information is expected.
had both shots came close to going blind from it/suspected vaccination failure; close to going blind from it; ill; sick; itching; tingling on forehead; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had both shots came close to going blind from it/suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: close to going blind from it) (serious criteria GSK medically significant), unwell (Verbatim: ill), sickness (Verbatim: sick), pruritus (Verbatim: itching) and tingling (Verbatim: tingling on forehead). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, unwell and sickness were not reported and the outcome of the pruritus and tingling were not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, unwell, sickness, pruritus and tingling to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, unwell, sickness, pruritus and tingling to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 23-MAR-2023 The case  was received from the patient via interactive digital media. The patient stated that he/she came close to going blind from it. The patient was so sick that before he/she could heal enough to fly his/her mother died and he/she could not be there to hold her hand.  The patient stated that three and half years later he/she still get the itching and tingling on forehead. The patient had both shots and the shots made him/her quite ill also. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from registered nurse refers to 8 year old patient of unknown gender. On 14-JAN-2014, the patient was vaccinated with M-M-R II injection (strength, dose number, dose unit, lot# and route unknown) that has expired on 10-JAN-2014. No untoward effect was reported. The outcome of expired dose of M-M-R II was administered and no untoward effect was unknown. No further information provided. Additional information has been requested.
Swelling and pain at injection site also a small lump - lasted for 4 wks - seen today - resolved.
The pt experienced a fever of 103 within 12 hours and then became afebrile in the next AM.
Site was warm to touch; Patient experienced a rash; Fatigue; Mild pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Site was warm to touch), RASH (Patient experienced a rash), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Mild pain) 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, the patient experienced VACCINATION SITE WARMTH (Site was warm to touch), RASH (Patient experienced a rash), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Mild pain). At the time of the report, VACCINATION SITE WARMTH (Site was warm to touch), RASH (Patient experienced a rash), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Mild pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
The resident was noted with left-hand grasp weakness, left eye drooping, lethargy, and slow response. Able to let needs known, then could not verbalizing became difficult. 911 was called and patient was transferred to ER to rule out CVA. Resident admitted with diagnosis of Stroke.
This spontaneous report was received from a male patient of unknown age who is also a pharmacist. The concurrent condition and medical history was not reported. On 13-AUG-2010, the patient was vaccinated with RECOMBIVAX HB dose 1, 1 ml, intramuscular. The concomitant medications were not reported. On 10-SEP-2010, the patient was vaccinated with dose 2 of RECOMBIVAX HB and on an unknown date in August 2011 with dose 3 of RECOMBIVAX HB (inappropriate schedule of drug administration). No adverse experience reported. Additional information has been requested.
Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Severe, Additional Details: Pt received prevnar 13 and flulaval quad at our store but received covid at another location. Pt states she felt feverish and ended up fainting later that day. At the hospital, they stated that her getting 3 shots that day may have resulted in her body being overloaded.
After breakfast on Friday, 10/02/2015, our child began showing signs of ataxia and loss of coordination.  Normally, he was able to walk on his own without support.  As the morning progressed he could not walk, stand, or sit up on his own without falling over.  After arrival at the doctor's office that morning, he began vomiting.  He did not have a high temperature.  His condition slowly improved over the next 24-48 hours and was completely resolved by the end of the week.  However, on Monday, 10/05/2015, he developed a red rash on his upper left thigh, where his chicken pox vaccine was administered.  The rash eventually went away after about one week.
URTICARIA ON THE ANTERIOR AND POSTERIOR AREA OF HER ABD WHICH LATER SPREAD TO THE ANTERIOR PORTION OF HER RIGHT ARM, INNER THIGHS, AND BEHIND HER RIGHT AND LEFT KNEE. SHE RECEIVED RX FOR PREDNISONE PO X 6 DAYS WHICH HELPED RESOLVE THE URTICARIA.
I took the first dose of the vaccine( lot numberEW0196 ) on 06/16/2021, and the second dose (lot number FA6780) on 07/07/2021, The injection site started to swell and be very painful and the lymph nodes under the armpit were very swollen and painful, I also had tiredness and a headache, and I don't really get headaches. The whole left arm was also very painful. This lasted for two and a half days.
Received Vx, then shingles/Suspected vaccination Failure; blind in right eye; shingles; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Received Vx, then shingles/Suspected vaccination Failure) (serious criteria GSK medically significant), blind right eye (Verbatim: blind in right eye) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and blind right eye were not reported and the outcome of the shingles was unknown.   It was not reported if the reporter considered the vaccination failure, blind right eye and shingles to be related to Shingrix.     It was not reported if the company considered the vaccination failure, blind right eye and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-MAR-2023 The case was reported by patient's friend. The reporter's other phone was ringing and she had to go before details could be collected. She did not have the details (date, lot, expiry date, etc) regarding the vaccination. The reporter consented to follow up via postal mail. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule ,time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case had been linked to US2023035548, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023035548:Same reporter
Tested NAAT positive for COVID 10/24/21 after being fully vaccinated.
Moderna COVID-19 Vaccine EUA - 12/31/20 Patient was fatigued and slight headache, arm had bump, hard and very sore.  1/1/21: Patient was hot, sweaty and fever, very tired, arm had bump, hard and sore. 1/2/21: Patient was hot, sweaty and fever off/on, very tired, arm had bump, hard and tender. 1/3/21: Patient had no symptons except arm still had bump, hard and tender. 1/6/21: Patient  where shot was given still bump, hard, turned red (like small rash just in that area) and very itchy.  1/7/21: Patient  where shot was given still bump, hard, red (like small rash just in that area) and itchy (not as itchy as 1/6/21).
PER PT SHE IS EXPERIENCING A FEW SIDE EFFECTS OF THIS VACCINE.  1. SOREARM - USE ICE PAK AND ARNICA PAIN OINTMENT  2. VACCINATION SITE IS HOT, RED AND BACK/BLUE MARK ABOUT 3 INCHES
Cough, fever three days after immunizations - persisted and turned into pneumonia, treated for pneumonia. On 7/19/15 had a VT which cardioverted. Placed on TOPROL XL 50mg. Had RVOT VT in Aug 2015 - received ablation, March 2016, another VT had repeat ablation, July 2016 - wide complex tach. converted. Still with cardiac problems most recent ablation 9/13/16.
I had fever of 106. I had body ache, SOB, and nausea.  These lasted about about 2 days.  I am still dealing with SOB.  I went to the ER. They gave me medicine, blood work, and chest x-ray.  They said it was a reaction to the Covid-19 test.  They also gave me an inhaler.
Case previously recorded as MA2009-3777. Initial case report received from a physician via MedCom on 04 NOV 2009. A patient 3-year-old male was inadvertently vaccinated with 0.5 mL S-OIV FLUVIRIN (batch no. 1008136P) once i.m. on 04 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-007589.
102' fever, shaking, stiff neck & shoulder, locked Jaw, vomiting, weak, nausea pain that gradually subsided. -Advised patient on 8/21/20 evening when reported the reaction to go to ER. -Contacted patient again on 8/23/20. Patient indicated she did not go to ER or contact Doctors about it but feeling better. -Advised patient on Sunday 8/23/20 to at least call her doctor tomorrow to describe the event & get advise on what to do.
High Blood pressure; cluster headaches; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 25Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient previously took vaccine for shingles in the left arm on 02Feb2021 within four weeks prior to the COVID-19 vaccination. Medical history included thyroid, high cholesterol. The patient was allergic to sulfa drugs. Concomitant medications included levothyroxine sodium (SYNTHROID), rosuvastatin calcium (CRESTOR) and montelukast sodium (SINGULAIR) from an unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced high blood pressure and cluster headaches for a week. Blood pressure normally on the low end, and it was running 150/100 (unspecified units). It was unknown if the patient received treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event high blood pressure and cluster headaches were unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
c/o body aches and headache X 1 day after inoculation. Current complaint as of 6/22/2021 - contracted COVID-19 virus post vaccination.