chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mom stated pt began having a rash with blistery type lesions to left lower extremity and buttocks. Pt did not have fever - blisters became red and then popped. Pt complained they hurt but did not itch. Mom stated pt did not act sick & played with other children and ate as usual. Lesions have improved at time of visit - per Mom. Mom denies problem at injection site. Pt had been exposed to caregiver with history of MRSA.
Area around injection site red and tender. Pt started flushing and feeling unwell. Eye watering and face swelling. BP 200/100 and pt sought medical help at emergency room around 3 pm.
Fever to 103F on 28NOV90; c/o pain "all over", irritable, h/a; mid-wk c/o chest & stomach pain, to ER- viral infect dx next day; c/o weakness, difficulty walking to ER dx gastroenteritis;
Breakthrough case admission after 2 vaccines Pfizer 5/25/21 lot# Ew0172;  Pfizer 6/17/21 lot# Ew0179
24 hours after vaccine: fatigue, low grade fever 48 hours after vaccine: nausea, severe congestion, sore throat, fatigue, sleeplessness 72 hours after vaccine: all of the above plus swollen lymph nodes Treatment tried was OTC cold medicine but symptoms were unresponsive to this
Information has been received from a physician concerning an 11 year old female who was vaccinated with a dose of the Gardasil. Concomitant therapy included hepatitis B vaccine, recomb (MSD), meningococcal vaccine (unspecified) and DTAP-IPV. Subsequently, the patient 'kept walking right into the wall". "got dizzy" and "thought she was going to pass out". The patient sought unspecified medical attention. The patient recovered on an unspecified date. Additional information has been requested. Initial and follow-up information has been received from a physician concerning an 11 year old female who on 19-JUN-2007 was vaccinated with first dose of GARDASIL (lot # 657868/0523U).
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Mar-2021 at 10:36 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021, 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). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. The age of patient was provided as 62.59. Concomitant products were not provided. On 20-Mar-2021, Excursion time was 09 AM and 10 AM, temperature was 34 and 37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 9-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 8-Apr-2021. On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
my brother also took Pfizer. He has A-fib now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "my brother also took Pfizer. He has A-fib now".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nodule in right deltoid at vaccine injection site with ecchymosis x 1 week, improving in size, with no more overlying skin changes
I was asked to sit for 15 minutes in a chair.  Didn't have any reactions till i was being driven home and that's when the fever and headaches and abdominal pain started. I haven't had a chance to visit a hospital because I'm too weak to stand let alone move.
Diagnosis: SIRVA - Shoulder injury related to Vaccine administration.   Signs and Symptoms: Extreme should pain, limited range of motion, when motion is attempted - shoulder is extremely painful and does not go away from stopping the activity (prolonger pain), stiffness.  Unable to sleep on the left side or complete daily activities.   Manifestation:  Started within a few weeks of the 2nd vaccination in my left shoulder.   Did not feel anything during administration which was odd.  Limited pain for the few days following.  Then pain started.  I thought it was the typical pain everyone was experiencing from the COVID-19 Vaccine - but mine never got better.  Finally - after a few weeks I decided to make an appointment with an orthopedic dr.  I had a 10-week waiting period to see him.  Finally went in in August (08/18/21), he suggested MRI (SEP 22, 2021)to confirm the findings. Confirmed as SIRVA he gave me  corstisone shot that day in my left arm and referred me for PT - I've gone to 4 PT appts so far.
02/24/22 presents to Cardiovascular Surgery for "elective TAVR procedure". PMHx of "cardiomyopathy, HLD, HTN, VT s/p dual AICD, melanoma, CLL, AAA and severe AS".
lost power on arms and legs and ended up in hospital; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, In Mar2021, got the Pfizer CN6206.), administration date: Mar2021, for COVID-19 immunization; Bnt162b2 (A couple of weeks later, got the second vaccine and had no problems what so ever, no reactions, DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: Sep2021, for COVID-19 immunization, reaction(s): "lost power on arms and legs and ended up in hospital". The following information was reported: MONOPLEGIA (hospitalization, medically significant), outcome "unknown", described as "lost power on arms and legs and ended up in hospital".  Clinical course: The reporter wanted to know if there were any preventive medicines for interactions caused by the Pfizer COVID-19 Vaccine. After caller was transferred, he mentioned he received the first two COVID-19 Vaccine doses on Mar2021and was everything was fine, he had no problem. Then, on Sep2021 he received the booster and 24 hours later he lost power on arms and legs and ended up in hospital after 911 call and then he had to take some therapy. On Apr2022 he got another booster and again got the same reaction 24 hours later. On Sep2022 he took another booster and the same thing happened. Caller wanted to know if this had been reported since he didn't find any information on the internet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201325029 similar report from same reporter;
no additional AEs; CMA called to report TE from 2/22/23 and states that 4 doses of PROQUAD were administered prior to stability evaluation on 3/2/23; This non-valid spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown ages and genders. Information about the patients' pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On 22-FEB-2023, the patients were vaccinated with improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (once, 0.5 mL, lot number: W034977 has been verified to be a non-valid lot number, expiration date: 05-MAY-2024, routes of administration and anatomical locations were not provided) for prophylaxis (product storage error).   On 22-FEB-2023, the vaccines experienced a temperature excursion from -14 to -10 (-13.6) degrees Celsius for 21 minutes. It was stated that 4 doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were administered prior to stabilty evaluation. There were no reported previous temperature excursions. No additional adverse events (AEs) or product quality complaints (PQC) were reported (no adverse event). No further information was provided. The outcome of product storage error and no adverse event was unknown.   This case is non-valid due to an unknown number of patients and lack of patients' identifiers.  Follow-up information has been received from a medical assistant on 16-MAR-2023  The patient was a 5 years-old male, who had a birth weight 6lbs 11.9 oz.  On 01-MAR-2023, the patient was vaccinated with improper storage vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD)( lot # W028568 has been verified to be valid lot, expiration date 06-MAR-2024), subcutaneously in right deltoid (product storage error). The outcome was informed as recovered.  The reporter considered the event to be attributable to the suspect vaccine, and important medical event (medically significant); Sender's Comments:  US-009507513-2303USA006895: US-009507513-2303USA006896: US-009507513-2303USA006894: US-009507513-2303USA000873:Master Case US-009507513-2303USA000873:Master Case
presenting today for Chills (chills, nausea, can't smell anything, weakness. has been exposed to covid)   .    History provided by patient- presents with nausea and vomiting that started this am. He is having chills. He states he works in health care which would be his exposure to covid. No direct contact. He took zofran this am but did not help much. No fever.  Physical Exam  Constitutional: He appears well-developed and well-nourished. He is cooperative.  Non-toxic appearance. He does not have a sickly appearance. He does not appear ill. No distress.  Cardiovascular: Normal rate, regular rhythm and normal heart sounds.  Pulmonary/Chest: Effort normal and breath sounds normal. No respiratory distress. He has no decreased breath sounds. He has no wheezes. He has no rhonchi. He has no rales.  Abdominal: Soft. Normal appearance and bowel sounds are normal. He exhibits no distension. There is generalized abdominal tenderness. There is no rebound and no guarding.  Neurological: He is alert.  Skin: Skin is warm. He is not diaphoretic.  Psychiatric: He has a normal mood and affect.  Please self quarantine.  This means going no where; and staying in your house.  Please follow CDC guidelines for self quarantine. You can go to website and click on Covid-19 to learn more.    Wear a mask after your quarantine.  Monitor for signs and symptoms. If you develop shortness of breath go to the ER.    You can try the following medication for your symptoms. Take Flonase for a minimum of 10 days. Take an oral antihistamine such as Claritin, Zyrtec etc. May take Regular Musinex twice a day for 10 days. Cepacol lozenges for sore throat Robitussin 12 hour extended release for cough May take Sudafed or Sudafed PE for per instructions on the packaging.
dose administered to patient after more than 1 temperature excursion; dose administered to patient 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 (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 2:54 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 3:03 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 65.03 and 65.11.  Concomitant products were not provided.  On 02-Mar-2021, excursion time was 09 AM, 10AM, 11AM, 12PM, 02PM and 03 PM  and temperature was 27, 29,32, 33, 35 and 36 respectively, total doses given for the day was 177, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vial was moved to clinic on 02-Mar-2021. Vaccine BUD date was 26-Mar-2021.    On 30-Mar-2021, excursion time was 09 AM, and temperature was 33, respectively, 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. 03 vial was moved to clinic on 30-Mar-2021. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. 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.  Treatment medications were not reported.
24 hrs after receiving vaccine (this is my first vaccine), I became nauseous, had diarrhea and headache, and 48hrs after receiving vaccine, I had moderate lower back pain which lasted for 2days.  10days after receiving my vaccine, my injection site (lt arm), became very itchy, red and swollen.  And I experienced another bout of diarrhea and headache which last approx. 24hrs.
Information has been received from a pharmacist concerning an over 60 year old female who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient developed a "tender but not painful" lesion on her forehead two weeks after receiving vaccination.  Unspecified medical attention was sought.  No other information was provided.  There was no product quality complaint involved.  Additional information has been requested.
The injection site has swollen up, turned red and itches. I also am running a fever of 99.6° and I have the biggest cold sore I have ever had in my life.
Tongue felt heavy after shot was administered at approximately 12:52pm. Headache followed along with nausea. When I got home I felt hives on my forehead and had chills as well. Later on that night my asthma started to act up with wheezing. The next day I experienced my throat swelling/ closing at which point my husband drove me to the Emergency Center. The doctor gave me Benadryl and a steroid (orally). I was monitored and subsequently released. The doctor prescribed Banophen(Benadryl) and prednisone for the next five days.
Menstrual spotting . I have the nexplanon implant and have not had a period in 4 years,  and have heard of similar complaints from other providers who have received the vaccine. Mine started yesterday (1/15/2021) and the spotting continues to this moment.
I broke out in hives around my trunk and arms; This is a spontaneous report from a contactable nurse (patient).   A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on Dec2020 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and the patient's concomitant medications were not reported. The patient experienced "I broke out in hives around my trunk and arms" on an unspecified date with outcome of unknown. The patient went to the ER.  They had given her packs of Benadryl and steroids.   The lot number for the vaccine, bnt162b2 was not provided and will be requested during follow up.
Information has been received from a medical assistant concerning a 55 year old male patient with elevated liver enzymes, renal insufficiency, 3 liver biopsies and dyslipidaemia who on 15-DEC-2004, was vaccinated with the first dose of RECOMBIVAX HB 0.5 ml, intramuscularly (Lot number ENG5563A4 is an invalid lot number for RECOMBIVAX HB), (Exp: August, 2005). On 10-JAN-2005, the patient was vaccinated with the second dose of RECOMBIVAX HB 1ml, intramuscularly (Lot number ENG5589A4 is an invalid lot number for RECOMBIVAX HB) (Exp: September, 2005). On 09-JUN-2005, the patient was vaccinated with the third dose of RECOMBIVAX HB 1 ml, intramuscularly (Lot number AHBVB125AA is an invalid lot number for RECOMBIVAX HB) (Exp: October, 2006). Concomitant therapy included testosterone, INDOCIN, DIOVAN HCT, prednisone and ANDROGEL. The medical assistant mentioned the patient had not been immune. The patient sought medical attention by office visit. Titers for hepatitis B were performed. There was no treatment for the event. At the time of the report titer showed not immune. Follow-up information has been received a medical assistant concerning a 55 year old male (199 pounds, 75 inches) on 15-DEC-2004, was vaccinated with the first dose of RECOMBIVAX HB in his left arm. On 10-JAN-2005, the patient was vaccinated with the second dose of RECOMBIVAX HB in his right arm. On 09-JUN-2005, the patient was vaccinated with the third dose of RECOMBIVAX HB in his right arm. The medical assistant who reported that the manufacturer of the "Hep B" vaccine was unknown. The patient did not have any illnesses at the time of the vaccinations. On 15-APR-2011, a serum hepatitis B surface antibody screen result was <5 MIU/ml- patient did not have immunity to hepatitis B virus. All available medical records will be provided upon request. Additional information has been requested.
This spontaneous report as received from a pharmacy technician concerning a currently 2 year old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 08-APR-2014, the patient was vaccinated with VARVAX lot#J009165; expiration date: 24-JUL-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 14-NOV-2012 at 13:46, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Throat itching.  Vital Signs normal.  Was sent home after 30 minutes of observation.
This spontaneous report was received from a pharmacist regarding a 66 year old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 06-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose 0.65 ml, route subcutaneous, lot # L013546, expiration date 17-JUL-2016). On 09-OCT-2015 (reported as next day), the patient experienced a "rash" at the injection site. The rash was "a red circle about 2 inches in diameter" and was also painful and itchy. On 13-OCT-2015, the patient was seen by the pharmacist. The patient did not receive any treatment for the adverse events. There was no lab diagnostics and studies performed. The patient's outcome was not recovered/not resolved. The relatedness between the events and the therapy with ZOSTAVAX was not provided. Additional information has been requested.
a lot of pain in my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), administration date: 2022, for COVID-19 immunization, reaction(s): "Severe arm pain that lasted at least 10 days". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "unknown", described as "a lot of pain in my arm".  Additional information: The patient just got his/her COVID booster and patient was having a lot of pain in his/her arm where the shot was given. This is his/her 5th COVID shot. He/She had no trouble with the first 3 but his/her booster last year caused severe arm pain that lasted at least 10 days. Patient was querying if this was normal.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.