chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fell Down; Dizzy; Unusually Thirsty; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Apr2021 17:00 at single dose for COVID-19 immunization. Medical history and concomitant medications none. The patient had no Prior Vaccinations within 4 weeks. The patient previously received first dose of BNT162B2, Lot Number: ER8734 on 07Apr2021. The patient got his second dose of the Covid injection yesterday 27Apr2021 at 1700. Today 28Apr2021 at noon he got out of his car, got very dizzy, and then fell down. The patient stated he felt he was about 90 percent recovered from being dizzy. Later in call mentions that he had been unusually thirsty all day today. The outcome of Dizzy was resolving. The outcome of other events was unknown.  information about lot/batch number requested.
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter. The patient had took booster dose.
day 2 after injection, severe fatigue and body ache; resolved early day 3; day 5 after injection severe headache came on suddenly, then dizziness and nausea; six hours after onset of dizziness/nausea, tachycardia of 150 bpm; called paramedics; resolved by time they'd arrived; day 6 after injection feeling good again
I have severe dizziness; vertigo; dose received: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), solution for injection, administered in arm left, administration date 09Dec2021 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown.), administration date: May2021, when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown.), administration date: Mar2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "dose received: 3"; DIZZINESS (non-serious) with onset 15Dec2021, outcome "recovering", described as "I have severe dizziness"; VERTIGO (non-serious) with onset 15Dec2021, outcome "recovering", described as "vertigo". Therapeutic measures were not taken as a result of dizziness, vertigo. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient reported that four days after the injections she had severe dizziness/ vertigo, lasting 2 days. (The patient never experienced this before in her life). It was reported that lot number details was misplaced/discarded .  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day one: Exhaustion, lightheadedness, fever/chills, severe headache/pressure. Day two: same as day one plus itchy pink skin rash on torso and back.
Headache, Myalgia, Arthralgia, Fever, chills Narrative:   Other Relevant History:
inadvertently administered Moderna's COVID-19 vaccine to patients outside the product's labeled storage conditions.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered Moderna's COVID-19 vaccine to patients outside the product's labeled storage conditions.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered Moderna's COVID-19 vaccine to patients outside the product's labeled storage conditions.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered Moderna's COVID-19 vaccine to patients outside the product's labeled storage conditions.) had resolved. Not Provided          No concomitant medications were provided.  No treatment information was provided.
Lump and swelling in right armpit; pain at injection site and in upper arm, headache, body ache, back ache, exhaustion, fever (usual temp is 97.5 by ear. Fever started 98.6 the night of injection 03/31/21, at 0430 04/01/21 temp raised to 100.9-highest thus far) controlled by Tylenol.
Patient got the COVID vaccine (first dose) last Thursday the 11th, and had some reaction to it. I felt itchy all over, my right heel has been red and swollen, a couple of nights I had chills but was sweating when I woke up and felt hot, the tops of my hands and fingers were red, irritated  and extremely itchy until this morning, the injection site has been itchy but the red rash went away last night. I?ve been waking up puffy/swollen in my hands, face (eyelids, lips(not severe), today my feet are a bit swollen and my hands don?t seem red or itchy now.
Eighteen hours after vaccines patient started to experience swelling in leg.  Patient went to ED on Saturday 9/16/23 and was diagnosed with a DVT. Per ED patient had no other risk factors for DVT aside from age. Patient has received flu vaccine annually without problems
took the medication Miralax and had reaction to it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), .  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; macrogol 3350 (MIRALAX), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INTERACTION (non-serious), outcome "unknown", described as "took the medication Miralax and had reaction to it". The action taken for macrogol 3350 was unknown.  Additional information: The caller is calling on behalf of his wife. Both of them took the covid 19 vaccine and his wife took the medication Miralax and had reaction to it. He is asking if there the Covid 19 vaccine has any reaction with the medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Night of vaccine had right leg pain from hip to ankle. On 12/22/2020 knee began to stiffen and swell while leg pain subsided. Knee swelling and pain continued for next week.
Starting a few hours after pneumonia shot pt started having significant pain and swelling of entire (R) arm. Pt was unable to move arm and entire underside of arm filled with fluid such that skin was distended approx. 1 inch beyond normal. Pt also had fever, loss of appetite x 1 wk. As swelling subsided, pt's entire arm began itching. Pain unrelieved by pain reliever (unknown med name/dose).
Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) in a 60-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Patient received vaccine in question as a first dose. It was not known which arm the patient received the vaccine. The Nurse reported no adverse reactions or side effects to the Moderna Covid-19 vaccine.  On 3MAR2022 vials were  moved from freezer to refrigerator.Vials were refrigerated at the time of the excursion. There were multiple temperature excursions as reflected above. Maximum Temperature was 49 degrees Farenheight, Minimum Temperature was 37.7 degrees Farenheight. The temperature excursions occurred on 4MAR2022, 5MAR2022, 7MAR2022, 8MAR2022, 8MAR2022, 9MAR2022, and 10MAR2022.    Treatment information was not provided.
Information has been received from a 38 year old female physician, for the Pregnancy Registry for VARIVAX (Merck), who on 04-DEC-2009 was vaccinated with a dose of VARIVAX (Merck) (Lot number not reported). Other suspect therapy included a dose of MERUVAX II (manufacturer unknown) (lot number not reported). Concomitant therapy included poliovirus vaccine (lot and manufacturer not reported). On 25-DEC-2009 the patient learned that she was pregnant. The patient stated that on 25-DEC-2009 she had a urine pregnancy and on 30-DEC-2009 she had a blood test done to see how many weeks pregnant she was. Her LMP was 14-NOV-2009. Expected date of delivery was 21-AUG-2010. No adverse reactions were reported or no other information was available. The patient sought medical attention via clinic. Follow-up information has been received from the physician. She reported that she delivered a full-term healthy baby girl via C-section on 13-AUG-2010. The reason for the C-section was not reported. The baby's birth weight was 5lbs. 9oz, length 17 inches. She also reported that the baby was normal for growth and development (currently 12 months). Upon internal review the C-section was considered to be an other important medical event. Additional information is not expected.
Swabbed positive for covid after coming into hospital for SOB and chest heaviness and upper GI bleed blood loss. Stated previously positive 4.16.21 but record not in system.
Patient reported, feeling "like I have to cough," dizziness, lightheadedness, headache. Patient evaluated by EMS staff. BP 167/95, P 116, O2 100%. Upon further questioning, patient reports h/o POTS syndrome, autonomic dysfunction, dual chamber pacemaker and low BPs on occasion. Re-evaluated by EMS done 15 minutes later, BP 170/95, P 100, O2 100% patient refused to go to ER. Patient monitored in clinic for an additional 30 minutes. Stated symptoms had resolved.
This spontaneous report as received from a physician refers to a 17 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 26-MAY-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # M046140 with expiration date on 27-SEP-2019 (dose and route of administration were not reported). Since 25-APR-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
renal infarction; This is a spontaneous report from a contactable consumer (patient). An 84-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in arm right on 02Mar2021 at 12:00 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 (lot number: EN5318) on 05Feb2021 at 12:00 PM (at the age of 84-years-old), administered in right arm for COVID-19 immunisation. The patient received other medications in two weeks (unspecified). Fourteen (14) days after the 2nd dose on 16Mar2021, the patient experienced renal infarction. The patient was hospitalized for renal infarction for 1 day on an unspecified date. Therapeutic measures were taken as a result of renal infarction. The outcome of the event was recovered with sequelae on an unspecified date. The event resulted in Emergency room/department or urgent care, hospitalization.
given FluLaval after being frozen at -0.45C; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 9-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) (batch number AD49D, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was 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 nurse given FluLaval after being frozen at minus 0.45 Celsius for 15 minutes to the patient, which led to incorrect storage of drug. The reporter consented to follow up. This case was 1 of 10 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230180:same reporter US-GLAXOSMITHKLINE-US2021230191:same reporter US-GLAXOSMITHKLINE-US2021230178:same reporter US-GLAXOSMITHKLINE-US2021230173:same reporter US-GLAXOSMITHKLINE-US2021230188:same reporter US-GLAXOSMITHKLINE-US2021230181:same reporter US-GLAXOSMITHKLINE-US2021230186:same reporter US-GLAXOSMITHKLINE-US2021230192:same reporter US-GLAXOSMITHKLINE-US2021230177:same reporter US-GLAXOSMITHKLINE-US2021AMR231962:same reporter
had headache for 2 hrs; This is a spontaneous report from a contactable Consumer. This 59-Year-old male Consumer reported in response to Non-HCP letter sent in a cross-reference case which included that: A 59-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 59-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 3Dec2020 as single dose for covid-19 immunisation and experienced the events Feeling tired, Headache, Nauseous and had the chill. Patient reported that I was feeling tired & had the chill for three after first shot. Second shot had headache for 2 hrs. The outcome of the event was reported as recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
RASH PAIN LETHARGY REDNESS HIVES SEEN IN OFFICE BENADRYL SENT ALLERGY LAB SENT WILL F/U AFTER RESULTS ARE IN
facegot swollen; itchy; This is a spontaneous report from a Pfizer sponsored program support from a contactable female consumer(patient). A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 30Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced face got swollen and itchy after the 1st dose. The outcome of the events was unknown.  No Follow-up attempts are needed. No further information is expected.
Fever, headache during night. Then, it subsided until 12/25 night and it hit me like a semi truck: horrible headache, fever, cough. It lasted for 3 days. The worst part was that family visited for Christmas, so my husband and 7 others came down with it within 72 hours.
patient said on 2.7.21 around 12 pm she got light headed and black out/fainted for a few minutes and blood pressure dropped to 93/56, she felt like it could be vaccine related, no treatment, patient feeling better
Agony in left arm - 16:15 on 5/25/2021 Exhaustion - 20:00 on 5/25/2021 Migraine - 16:00 on 5/26/2021
On Wed. (9-29-10) after shot, parent noticed child only complained of arm being sore. There was no redness or irritation. On Thur (9-30-10) parent noticed child's arm felt warm. When long sleeve shirt pulled up area was hard, red, swollen and hot.  Child was afebrile. Parent applied ice to arm and gave child one dose of Tylenol (1 tsp).  Parent reports area is improving. Today area is red and hard to touch, no swelling.  Redness measures 95mm x 70 mm.
Red, swollen Lt. arm. Measured 1 1/2 inch diam. Patient was given ibuprofen (400 mg) for the pain and swelling. Also - ice pack applied to the area.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 18-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection, lot # L039093, expiration date 06-OCT-2017 (dose, route and site of administration were not reported). No adverse effect was reported. The administered dose of VARIVAX underwent temperature excursion at -7.5 degrees Celsius for 12 hours and 30 minutes. There were no previous temperature excursions. Data logger was involved. Additional information has been requested.
pt recvd vax & had persistent crying on & off for 2 hrs; inject site was very swollen & red;
they lay to rest most of the time/Suspected Vaccination Failure; they lay to rest most of the time; painful; itchy; nerve's a basket case; 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.   The patient's past medical history included shingles (had been getting shingles since 1979).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: they lay to rest most of the time/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: they lay to rest most of the time), pain (Verbatim: painful), pruritus (Verbatim: itchy) and neurological symptom (Verbatim: nerve's a basket case). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain, pruritus and neurological symptom were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus and neurological symptom to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure, shingles, pain, pruritus and neurological symptom to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient had been getting shingles since 1979 and they were absolutely terrible and not much back then could be done but due to the shingles vaccine, they laid to rest most of the time. The patient experienced painful, itchy, nerve's a basket case, etc. 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 follow up would not possible as no contact details were available.
On day 8 following vaccine and large area of redness appeared on left deltoid spreading from injection site down and inward. Area is very firm, red, swollen, painful, and itches.
Vial was not diluted. After the visit medical assistant did a follow call to the parent. POP stated that child is doing well, no adverse reactions.
This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to 4 elderly patients of unknown age and gender. There was no information about the patients' concomitant therapies or medical history provided. Concurrent conditions included hospitalization. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 followed by pneumococcal 13v conj vaccine (CRM197) (dose, route of administration, lot # and expiration date were not provided for both) for prevention of pneumococcal diseases. The patients received a second, duplicate dose of PNEUMOVAX 23 after the age of 65. A copy of the published article is attached as further documentation of the patients' experience. This is one of three reports received from the same authors. Sender's Comments: US-009507513-1903USA004220; US-009507513-1902USA011509.
This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. Pertinent medical history was unknown. The reporter stated that the patient was administered a dose of ZOSTAVAX (dose/frequency was reported as single dose, subcutaneous, anatomical location and lot number was unknown) on 21-APR-2014 and, inadvertently was administered another dose of ZOSTAVAX (dose, route of administration, anatomical local and lot number was unknown) on 01-OCT-2014. Concomitant medications were unspecified by reporter. The outcome of the events was unknown. No further information was provided. Additional information has been requested.