chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Very fatigued; Loss of appetite; White blood cells were elevated; white blood count was high; Sick; Bad aches; This is a spontaneous report from a contactable consumer. A 92-year-old male patient (husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 08Feb2021 (at the age of 92-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included diabetes, high blood pressure, high cholesterol. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization and stated that, they neither had any problems with the first one. It was reported that, this was the first case out of the 2 cases. This was the case where caller (patient's wife) was reported for husband (patient). Stated that, the caller just had a question. Stated that, she could not seem to be getting answer about their COVID-19 vaccine. Stated that, the caller and her husband had their second vaccine on Monday, last Monday, a week ago, on 08Feb2021 (later confirmed). Stated that, they neither had any problems with the first one and with the second one, the caller had few body aches but the patient did not, except the sore arm. Stated that, now her question was, the patient started to get sick on 13Feb2021, Saturday and he has been sick for 3 days. He was at work, he was not that bad but he was very fatigued and has loss of appetite and stated that, what the caller was wondering was and one of the things, the caller wanted to ask-on Wednesday, he got bad aches on 10Feb2021 and he had lab work that he does every 6 months and they called him on Friday and told him that his white blood cells were elevated and he told them that he has had the vaccine and they said that it can happen, you know when you have the vaccine. Stated that, what the caller wanted to know was that, it took too long for him to get side effects from the second vaccine. Stated that, he had on Monday and he stated, getting sick on Saturday. Stated that, the caller did not have LOT# and expiration date. Stated that, the patient took the vaccine on Wednesday and his white blood count was high and they told him that it could be from the vaccine. The caller was provided with the contact# for Pfizer Medical Information. Treatment was not received for the events. On 10Feb2021, the patient underwent lab tests and procedures which included white blood cells (white blood cell count), resulted as elevated/high. The outcome of the events for sick was recovered on an unspecified date in 2021 while for the other events was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Injection site is pink half way down my arm and warm to the touch. No pain but discomfort.
received vaccine at 9:30 am  noted frontal headache @ 9:40am VS 124/76 HR 75 O2 Sat 95%  Denied SOB, difficulty swallowing, numbness tingling given acetaminophen 650 mg 9:50 am given ibuprofen 600mg @ 10:22am  VS BP 137/90 HR 71, O2 Sat 97%, feeling dizziness nausea, transported to ED
Information has been received from a medical assistant(also reported as office manager) referring to a15 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 24-APR-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # reported as  L025738, expiration date: 14-AUG-2017; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
Shoulder pain (L) and reduced range of motion. Muscle twitching in (L) forearm. Saw primary care doctor on 11/12/14, who advised naproxen and gentle exercise. Took two courses of naproxen but symptoms continue to date. (Muscle twitching subsided, though).
Moderna 4/14/21, 5/16/21. Positive on 3/14/22
blood clot; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that this patient who is a physician, experienced blood clot on an unspecified date. The outcome of the event was unknown.  Information on batch number has been requested
On 3/21/01 at 14:00, mother woke infant from a nap. She was pink in coloration; no response X 2 minutes; disoriented X 1 hour; limp X 2 hours; hypotonic and hyporesponsive until 16:30. At 17:00, doctor dx'd possible pertussis reaction. No treatment.
Swollen and painful to the touch at injection site for several days still some swelling and pain at this time. Severe fatigue for about 36 hours with some dizziness chills and nausea feelings.
new onset of Tinnitus on 4/12/21 --  PCP &  ENT consultation -- no other cause found.  Still ongoing Tinnitus symptoms.
Vaccine administered after more than 1 temperature 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 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 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:39 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:39 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). 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 67.44.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 08 AM, temperature was 32, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 31-Mar-2021. 4 vials were sent to clinic. 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 Fisherbrand 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.
One day post vax, the pt experienced a low grade fever, headache, maculo-papular rash and generalized aches. No treatment was given. The information received on 5/17/00 reported the symptoms resolved.
This spontaneous report was received from a physician referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concmitant medications were not provided. On an unknown date, the patient was vaccinated with RECOMBIVAX HB for prophylaxis (strength, dose, frequency, anatomical location, route of administration, lot # and expiration date were not reported). On an unknown date, an unspecified laboratory study was performed to measure the Hepatitis B titer and the patient had negative Hepatitis B titers (hepatitis b antibody negative). Additionally, the physician reported the patient had elevated liver enzymes (hepatic enzyme increased) and elevated creatinine level (blood creatinine increased). The patient sought the physician for medical attention, but no treatment was given to him for the adverse experiences. At the reporting time, the patient was not recovered from hepatitis b antibody negative, hepatic enzyme increased and blood creatinine increased. The causality assessment between the aforementioned adverse events and RECOMBIVAX HB was not provided.
Shortness of breath after first dose.  Shortness of breath, chest pain, bradycardia after second dose.
It was reported that a pt (4 of 5) received an Imovax Rabies ID vaccination on 3/14/01. Reportedly, the pt developed a headache, sore muscles and a local reaction, lasting 2-7 days. Further information is requested. From telephone conversation on 4/6/01, it was reported that the pt recovered from this experience. From additional correspondence received on 4/18/01, it was reported that the pt did not experience nightmares and insomnia as previously reported. The pt did become weak for 24 hours and developed tightness in chest for 2 days. Additional pt, vaccine, responsible physician and vaccine administrator information was also provided. This case is closed.
Patient reported not being able to lift arm after vaccine administration and also shoulder pain. Saw primary care provider who diagnosed possible rotator cuff tear, patient is going to physical therapy to try and help injury
Pt developed itching and hives within minutes of receiving TDAP/BOOSTRIX vaccine in (L) deltoid. Hives around eyes and at injection site. Pt was given 2 tsp of BENADRYL in office and within 20 minutes hives improved with minimal itching. Pt was sent home.
Clear Liquid (Not Blood) ran down his arm after the Second Shot; Clear Liquid (Not Blood) ran down his arm after the Second Shot; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Clear Liquid (Not Blood) ran down his arm after the Second Shot) and DEVICE CONNECTION ISSUE (Clear Liquid (Not Blood) ran down his arm after the Second Shot) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced UNDERDOSE (Clear Liquid (Not Blood) ran down his arm after the Second Shot) and DEVICE CONNECTION ISSUE (Clear Liquid (Not Blood) ran down his arm after the Second Shot). On 12-Mar-2021, UNDERDOSE (Clear Liquid (Not Blood) ran down his arm after the Second Shot) and DEVICE CONNECTION ISSUE (Clear Liquid (Not Blood) ran down his arm after the Second Shot) had resolved.            Patient stated that right after getting the second dose, a Clear Liquid (Not Blood) ran down his arm with a little bit of blood. The person who vaccinated him didn't say anything. But now he is wondering if he should get another shot with the Delta variant being around.  No relevant concomitant medication information provided.  No relevant treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Updated verbatim of the event.
Nausea, headache, severe low back pain, fever, sore arm, muscle pain, joint pain, flu like symptoms . All resolved by 10:00 pm  on 2/25/21
Patient called pharmacy on Sunday 8/18/19 stating her arm was still sore,red and warm to the touch. She had been taking daily Zyrtec and no relief. I suggested adding a cold compress on to the site as well. These are all listed as side effects to both vaccines, and were given in her non dominant arm as she got another vaccine in her dominant arm. Told her to follow up with her primary MD if no relief Monday Am on 8/19/19. Patient stated not getting worse or better but staying the same since the day after the vaccinations.
This spontaneous report was received from a female patient of unknown age. On 23-JUN-2014 the patient was vaccinated with ZOSTAVAX (details unspecified), frequency, one time vaccine. No concomitant therapy was reported. On 23-JUN-2014 (same day vaccination) the patient's eye started watering after lunch. No product quality complaint (PQC) was filed. The action taken was assessed as not applicable. The outcome of event and causality were not reported. Additional information has been requested.
Pt recvd 3 doses of Engrix-B & 1 1/2 hr p/3rd dose had sl rash @ site; then had numb & tingling lt arm but can move arm, & cool moist skin; seen by MD 26MAY92;
covid vaccine breakthrough case  dose 1 on 3/21/21  EN 6202 dose 2 on 4/13/21 ER 8733
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Patient got Moderna with vaccine Ndc code. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. No treatment medication were provided.
Patient stated she noticed itching and red patches over her body - none were directly at the injection site though.
This spontaneous report as received from a pharmacist refers to an adult patient of unknown age and gender. The reporter stated that on 25-SEP-2014 the patient was vaccinated with VARIVAX (Merck) (dose, lot number, route of administration and anatomical location were unknown) instead of ZOSTAVAX. Pertinent medical history and concomitant medications were unspecified by reporter. No symptoms reported. The outcome of the events was unknown. No other details were provided. Additional information has been requested.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 30-MAY-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot#  N024562 and expiration date 06-MAR-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
Approx 1 hours and 20 min after receiving vaccine patient c/o nausea, dizziness and tingling to right side of her tongue.
A week after my 2nd vaccine, I broke out with a rash on my legs and arms. I waited a week to see if it went away, it did not, it got worse all over body.  Made appt to see my primary, and subsequent 2 other appts followed.  On the 3rd appt, the PA I saw, set up an urgent Dermatologist appt for 5/6/2021 medical office.  I saw Dr. there.  She examined me, took pictures and did 2 punch biopsies.  One in the left thigh and the other in the right thigh sent it off to pathology.   I am still awaiting the results from those.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 injection, lot # L016429, expiration date 09-AUG-2017 (strength, dose, route and site of administration were not reported), which were exposed to the temperature of 49.1 Fahrenheit degrees for 13.5 hours (cumulative time to the date of reporting). No adverse effect was reported. There were no previous temperature excursions. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
diarrhea; sugar levels elevated; dehydration; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), BLOOD GLUCOSE INCREASED (sugar levels elevated) and DEHYDRATION (dehydration) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced DIARRHOEA (diarrhea), BLOOD GLUCOSE INCREASED (sugar levels elevated) and DEHYDRATION (dehydration). At the time of the report, DIARRHOEA (diarrhea), BLOOD GLUCOSE INCREASED (sugar levels elevated) and DEHYDRATION (dehydration) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Blood glucose (120-150 mg/dl): 185 mg/dl High, 196 mg/dl High, 221 mg/dl High and 211 mg/dl High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medications were provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
an adverse reaction as expected; This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had adverse reaction as expected per the VIS or PI. The reporter asked should we proceed differently with the 2nddose. The reporter did not consent to follow up. No communication with health care professional from call center.
1 day after vaccination: Moderate to severe headache - off and on for 2 days  1 day after vaccination: sore left arm 4-5 days after vaccination: left elbow joint pain 6 days after vaccination: hot, itchy rash on left arm, right arm, right and left legs from hip to ankle; skin is hot to touch and red in color
Knot or bump formed at injection site that is red and warm to the touch two weeks after the injection.
Large red  rash area at site of injection with some hardness and more headaches than usual.    Eight days out now from receiving this dose #1 of Moderna.
Headache - dizziness - blurry vision/no treatment. I was checked out by the nurse at work - symptoms didn't change - went to outpatient clinic next, which stated it was a reaction to the flu shot.
We are reporting this event as the child received an adult dose of Hep A as well as a pediatric dose of Hep A in the same visit. As far as we know there have been no adverse events from this med. administration error but we will keep in touch with the mother.
Fever; chills; headache; joint pain; This is a spontaneous report from a contactable nurse(patient). A 18-year-old female patient received first dose BNT162B2, intramuscular at Arm Left on 11Jan2021 14:00 at the 18 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported.   On 11Jan2021 17:00 the patient experienced Fever, chills, headache and joint pain.There was no treatment received for the adverse events. The patient had no covid prior vaccination. There was no covid tested post vaccination. The outcome of the events was Not recovered.   Information about Lot/Batch has been requested.
received VARIVAX during Temp Excursion; No additional AE; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (single dose, lot#: W012166, expiration date: 12-APR-2024; strength, and route of administration were not reported) for prophylaxis. The vaccine administered experienced temperature excursion before (product storage error). No additional adverse events (AE) (no adverse event).  This case was received from the same reporter with the case 2307USA007631 and 2307USA009506.