chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose 2 of havrix / given to a 21 year old patient / instead of the adult dose.; Dose 2 of havrix / given to a 21 year old patient / instead of the adult dose.; Dose 1 / administered on 06/23/2016 / Dose 2 was given on 6/17/2021; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 21-year-old female patient who received HAV (Havrix pediatric) (batch number 532H4, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (received 1st dose on 23rd June 2016).   On 14th June 2021, the patient received the 2nd dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. On 14th June 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose, adult use of a child product and drug dose administration interval too long. On an unknown date, the outcome of the underdose, adult use of a child product and drug dose administration interval too long were 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 follows: The adult patient received pediatric dose of Havrix on 14th June 2021 which led to adult use of child product and underdose. The patient received 2nd dose of Havrix, more than the recommended interval, which led to lengthtening of vaccination schedule. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021133172:same reporter (FU1)
When entering the vaccine for today's first dose clinic, I noted that he had already received the first dose on Feb. 13,2021 and he had returned and received a second dose of the same vaccine.
The patient experienced an outbreak of rash typical of erythema multiforme. She has experienced pruritis and mild pain treated initially with diphenhydramine at home. After 2 days of symptoms, she presented to the office. Her lesions are present bilaterally on upper and lower extremities, including inner thigh, palms, and soles. The lesions are erythematous papules with central and surrounding clearing. Some show features of vesicles. No systemic symptoms.  Patient was prescribed an 11-day course of prednisone, QID dosing of diphenhydramine, and a referral to allergy for consideration of further vaccination.
This spontaneous case reported by an other healthcare professional, describes the occurrence of diarrhea in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 3, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 3, 2021, patient experienced diarrhea. The patient treated with Imodium (loperamide hydrochloride); 1 dosage form. At the time of the report, diarrhea outcome: unknown. The reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event: not applicable. Reporter stated the patient is on many medications but did not give additional information. Reporter did not allow further contact.
This spontaneous report as received from a 68-year-old female patient regarding herself with no drug reactions or allergies and no pertinent medical history. The patient was vaccinated with dose 2, 0.5 milliliter PNEUMOVAX 23 (lot# not reported) either subcutaneously or intramuscularly on 03-OCT-2012. Concomitant medications included unspecified thyroid and blood pressure medications (meds). On 04-OCT-2012 the patient noticed that the injection site was sore, very tender and contained a bump. She claimed to have gotten a PNEUMOVAX 23 shot 6-7 years ago, and worried maybe it was some kind of overdose. There were no laboratory diagnostic tests performed. Treatment was not given for the adverse events. Patient did not seek medical attention but called FDA. The reported events did not resolve at the time of this report. Additional information has been requested.
fever on arm of inj rt excruciating pain in arm;chills every joint hurt;slept most of the time for 3 days;p/vax pt couldn't walk for several hr took advil for 3 days, did not call MD stated that could have been hosp;
started to get muscle weakness in less and got worse to where she couldn't walk, eyes swollen shut and itching her head...went to the Dr. and she had contracted Shingles in her eyes after taken the vaccine
Headache, Diarrhea, arm soreness Narrative: Headache, diarrhea, arm soreness; taking advil.
13 hours after vaccine I woke with a fever around 103 with chills, body aches, joint pain, headache, ear pain and upset stomach.  All of Saturday these symptoms went on and I had a tightness in my throat, not pain.  I was very delirious and speaking jibberish when awake.  Sunday the fever lessened and I felt more alert, but a large swelling started in my armpit in the left arm.  Monday the fever was gone but I still had major joint pain, off and on headache and overall sick feeling.  Today I woke and have a very upset stomach and achy feeling all over.  The lump in my arm pit has gotten smaller but is still painful and visible.
2/7/2021 12:00pm - diahreah 8:00 pm - headache, chills 9:00 pm - + slight fever, nausea Continued 02/08/2021
Patient stated after the injection she felt light headed and a little dizzy. She felt numbness down her neck to her left arm.
Numbness in right hand fingers, short of breath, chest pain, weakness in legs, headache
Dizzy; Nauseous; Neck hurts; Hot flashes; Site is still bleeding; This is a spontaneous report from a contactable consumer. This 27-year-old female consumer (patient) reported for herself. A 27-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in Arm Left on 14Aug2021 12:00 (at the age of 27-years-old) as a single dose for COVID-19 immunization. Medical history included rubber sensitivity, COVID-19 prior vaccination. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient had allergies with Latex. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Aug2021 12:00, the patient experienced dizzy, nauseous, neck hurts, hot flashes, site is still bleeding. The patient underwent lab tests and procedures which included sars-cov-1 test: positive; covid prior vaccination. The patient did not receive any treatment. All the events were reported as non-serious. Outcome of the event was not recovered, at the time of this report. Device Date was 14Aug2021. Follow-up attempts are completed. No further information is expected.
Palpitation; Woozy; jaw pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 70-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09May2021 11:07 (Lot number: EW0173) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart palpitations", start date: 05Jan2013 (ongoing), notes: It started out of nowhere and was on and off from Jan-Apr-May, I saw doctor was put beta blocker; "woozy", start date: 05Jan2013 (ongoing), notes: It started out of nowhere and was on and off from Jan-Apr-May, I saw doctor was put beta blocker. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Date/Time: Date: 18Apr2021, Time (24hr): 11:50 am, Site and Route of Injection: Anatomical Site of injection: (L) Arm, Route of administration: Intramuscular, Batch/Lot number: EW0169), administration date: 18Apr2021, when the patient was 70 years old, for Covid-19 immunisation, reaction(s): "Palpitations".  The following information was reported: DIZZINESS (non-serious) with onset 09May2021 11:07, outcome "recovered" (2021), described as "Woozy"; PAIN IN JAW (non-serious) with onset 09May2021 11:07, outcome "recovered" (2021), described as "jaw pain"; PALPITATIONS (non-serious) with onset 13May2021, outcome "recovered" (2021), described as "Palpitation". Therapeutic measures were not taken as a result of dizziness, pain in jaw, palpitations.  Additional Information: No prior vaccinations (within 4 weeks).  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administration date 12Jan2021 (Lot number: EL3246) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot Number: EL1284), administration date: 23Dec2020, when the patient was 40 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Jan2021, outcome "recovered" (Jan2021), described as "Fever".  No follow-up attempts are possible. No further information is expected.
Severe muscle cramps after second shot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Severe muscle cramps after second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Severe muscle cramps after second shot). At the time of the report, MUSCLE SPASMS (Severe muscle cramps after second shot) outcome was unknown.            No concomitant and treatment medications were reported.
Chills, body aches, sharp pain in left arm pit left breast, fatigue Narrative:
My hand got numb and tingled immediately. Within 15 minutes, I could not move my arm and was in severe pain. Three days later, I am still in pain. I will be going to my PCP on Wednesday.
Clinician drew up 1.3 ml of diluent, added it to the vaccine vial, then drew up 0.2 ml, which she administered to the patient. However, after giving the vaccine, she drew up the remaining doses and found that only a total of 6 doses could be drawn up (not the anticipated 10 doses she should have gotten). Parents were notified on 2/4/2022. Patient had no side effects from the vaccine and parents declined the offer to repeat the dose in case she was under-dosed or given saline only.
Pt developed localized reaction. Redness at injection site approx. 3 inches circular diameter. Minor itching to the area. Warmth upon touch sore. Pt also noted body aches in addition to arm soreness. Pain and itching improving but redness not resolved.
one week after the shot I developed a rash about 3" long and 1-2 inches wide on my left upper arm, It was quite itchy at first and bright red.  I began treating it with calendula cream and then Arnica which took away the itching,  Yesterday the redness started to fade but the rash got larger in area. It is still there, fainter in color and not itchy or painful but still getting larger in area.  I reported these symptoms to the pharmacist where I received the shot last Friday.
Patient called Pharmacy on 10/11/14 and said that when she woke up she had a rash on left arm, chest, and back.  Patient went to urgent care type facility as a precaution where Nurse Practionier said it looked like hives also.  Patient took Diphenhydramine and rash/hives went away.
4-5 hours after the vaccination (9-10pm), I had a bad headache. 6 hours after receiving the vaccination (11pm), I started to feel flu-like symptoms. Throughout the night, I had chills, was hot, sweating, body aches, etc. By 7 am, i felt like had the flu blown flu. I could barely walk, my body hurt so bad. I had a fever of 100.1. I had slight nausea. It lasted 24 hours. The next day, I felt 85% better. The following day, the symptoms were gone.
Large (approx. 2 inches in diameter) red inflammation, warm to touch. Slightly hardened. Suggested cold compress which patient had already done. Also suggested OTC Benadryl.
Started with hot flashes , light headed, partial   facial numbness on the ride side. Light heart problems
Hives on arms, neck, chest 1/2 hr post vaccination. Hematuria, low back pain, abdominal pain (10-18-16) rash on buttocks (shingles) 10-18-16, sore throat, hoarse voice, diarrhea 10-18-16, myalgia LBP, leg muscles, weakness, tachycardia.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The patient was inoculated with ZOSTAVAX in or about 2012 at the county health department for routine health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In 2012 (reported as shortly after receiving ZOSTAVAX), the patient began to experience a feeling of itchiness and discomfort throughout her body. Thereafter, she was diagnosed as suffering from an outbreak of shingles, which led to significant and severe scarring throughout her body. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events were unknown at the time of this report. Causality assessment was considered related to ZOSTAVAX. Additional information has been requested.
Couple hours after vaccine - itching at site; Later arm (around site) was red, swollen diameter, itching. (Upper arm swelling) and hot. 10/24 - Patient doing ok, taking BENADRYL PRN for itching.
Moderna] use for COVID-19 under Emergency Use Authorization (EAU):Moderna second dose resulted in adhesive capsulitis of shoulder
Slight itching, slight swelling at injection site, red and blotchy. Mild soreness. A week after vaccine was given
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 13-year-old patient of unknown gender. On 18-MAY-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) and VARIVAX lot number N027002 (expiration date 28-SEP-2019). This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
Approximately 1 hr after vaccine administered, child became fussy and whiny, had no appetite. T of 100 degrees F noted 7 hrs after vaccine.  Nine hours after vaccine child began to shake "like spasms" or writhed 3 times. He was taken to the ER, evaluated and sent home.  He remained listless until the ??
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 12:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 47 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's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergies.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid treatment from 21Apr2023 to 26Apr2023.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
pt. recvd M-M-R II & EXP. "mumps-like synd" w/ "testicular involvement".
Fever x 2 days, Chills x 2 days, Sweats x 2 days, Pain and heat at injection side,  nausea with lack of appetite - current day 3,  right finger numbness- current day 3, herpes in optical nerve out break on third day, headache- current day 3, muscle spasms x3 days, heart flutter x 2 days  Ibuprofen- current day 3 Tylenol x 2 days Valacyclovir- started day 3
Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe, Additional Details: patient states she has hives only on the left side of her body and swelling on the left side of her body. She stated that she had previously gotten vaccinated and had swelling on her armpit area and controlled it with ice pack, second vaccine much more swelling
Vaccine administered after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 9:35 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 9:35 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  On 30-Mar-2021, Excursion temperature at 9 am was 33, total doses given for the day was 173, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021 and 3 vials were moved to clinic. Vaccine BUD date was 22-Apr-2021 for batch number 019B21A.  Temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
No additional AE; Nurse inadvertenly administered PROQUAD instead of MMRII; Nurse inadvertently administered PROQUAD on 07/27/2021 to a Patient who was, at same time, administered VARIVAX; This spontaneous report was received from a nurse referring to a 52-week-old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 27-JUL-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneous  lot number T035268, expiration date 15-OCT-2022 (dosage regimen was not reported) for prophylaxis and inadvertently the nurse administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live(rHA)(PROQUAD) lot number T030480, expiration date 07-MAR-2022 (dosage regimen and route of administration) (extra dose administered and wrong product administered) instead measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). No adverse events were reported.
I tested positive for Covid 19 on July 2022, I experienced sore throat; hoarse voice; stuffy and runny nose; congestion; body aches. I was taking antiviral for my symptoms.