chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 11:06 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 11:06 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Vaccination date was reported as 02 Apr 2022 11:06:16.The patient received second booster dose. Its 30 days Expiry date vaccine went into 2 to 8 °C thaw state on or about to 20-Dec-2021, this vaccine administered until its Mfg date of 04-Apr-2022.  No treatment information was reported.   This case was linked to MOD-2022-542869 (Patient Link).
Patient fainted approximately 1 minute after receiving vaccination.  Patient reported a history of fainting in response to "needles" prior to vaccination.  Patient reported feeling warm just after vaccination and moved to lie on the floor under her own power until she was assisted by reporter and partner who accompanied her. She lost consciousness for <30 seconds. Patient continued to breath and pulse was present. Patient was observed after regaining consciousness for 30 minutes. Patient reported resolution of symptoms and felt "normal" at departure from pharmacy.
Patient received a refrozen dose of the vaccine; vaccine had been refrozen and rethawed; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received a refrozen dose of the vaccine) and PRODUCT STORAGE ERROR (vaccine had been refrozen and rethawed) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received a refrozen dose of the vaccine) and PRODUCT STORAGE ERROR (vaccine had been refrozen and rethawed). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received a refrozen dose of the vaccine) and PRODUCT STORAGE ERROR (vaccine had been refrozen and rethawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported. No treatment medications reported.   This case was linked to MOD-2021-381132 (Patient Link).
Information has been received from a registered nurse concerning a 19 year old female with pertinent medical history and drug reactions/allergies reported as none who on 25-APR-2007 was vaccinated with the first dose of Gardasil (lot #657621/03857U), 0.5 ml, IM. Concomitant therapy included amoxicillin and hormonal contraceptives (unspecified). On approximately 28-APR-2007 or 29-APR-2007 (nurse was not sure which date), the following weekend, the patient developed an itchy rash. The rash developed first on the patient's arms and then on her legs. The patient sought unspecified medical attention. The patient took BENADRYL for the symptoms. There has been no improvement so the patient will be seeing a dermatologist. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 05-JAN-2013, the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot number 670177/0419AA, expiration date: 16-APR-2013) (dose and route not reported). No adverse effect was reported. Additional information has been requested.
This is a 61-year-old female with history of chronic back pain, hypertension, GERD who was recently discharged after being admitted to hospital for acute kidney injury, monomorphic V-tach, paroxysmal atrial fibrillation, hematuria and pancytopenia with UTI. She was at the subacute rehabilitation center Bartley. She was doing okay until last few days when she started having some diarrhea, and urinary frequency, urine analysis and cultures were sent and she was started empirically on ciprofloxacin. Yesterday in the morning patient became acutely short of breath and had severe sore throat with acute hypoxia down to 70s and hypotension with systolic blood pressure in 70s as well hence she was referred to the ER. Her covid test came out positive. In the ER patient was started on empiric antibiotics as per sepsis protocol after cultures were sent, she did not respond to fluid resuscitation hence she was started on Levophed and admitted to ICU.
Shingles; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. No information has been received regarding the pt's past medical history, concurrent conditions, or concomitant medications. On or about 01-JUN-2012 (at 64 years old), the pt was inoculated with zoster vaccine live (ZOSTAVAX) at a clinic, by a healthcare provider, for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, anatomical location, lot number and expiration date were not provided). Subsequently, the pt was treated by healthcare providers at a clinic for shingles (herpes zoster) and other zoster-related conditions (ill-defined disorder). The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
bursting blood vessels on hand x 2 now. One is R hand finger and now in L hand palm. No reason of injury.
FACILITY ADMINISTERED BIVALENT VACCINE FOR A 2ND DOSE INSTEAD OF THE MONOVALENT VACCINE.
This 99 year old female received the Covid shot on  4/9/21    and died on 5/8/21.
Case previously recorded as MA2009-4541.  Initial case report received from a nurse via agency on 18 NOV 2009.  An 8 month-old male patient was vaccinated with 0.5 ml of FLUVIRIN 2009/2010 (batch no. 1021261P1A) i.m. on 17 NOV 2009, an off-label indication.  No adverse event was reported.  Off-label use is unexpected for S-OIV FLUVIRIN (2009/2010).  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008426.
Nerve pain; internal tremors; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EL9264) via an unspecified route of administration in the left arm on 01Apr2021 at 15:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient had known allergies to gluten, dairy and shellfish. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 12Mar2021 at 11:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 02Apr2021, at 12:00 hours, the patient experienced nerve pain. On an unknown date in Apr2021, the patient experienced internal tremors. Therapeutic measures were not taken as a result of the reported adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event internal tremors was unknown at the time of report. The clinical outcome of the event nerve pain was recovered on 03Apr2021, after the duration of 12 hours.   No follow-up attempts are possible. No further information is expected.
Stumbled and broke her right arm in 3 places; Stumbled and broke her right arm in 3 places; Got a big chip in her hip; Chipped the acetabulum on her pelvis, there is a big chip on that, but it did stay in place, so no surgery is needed; Precipitous drop in energy level; Fuzzy mentally; Acute lethargy; A little arm soreness; Low blood pressure; She wasn't feeling well; In a lot of pain with the chip in her hip; Fell on her right side and it was in her house, of course, on her tile floor; Low cholesterol; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6206; Expiration date was not reported) on the right deltoid on 11Mar2021 (09:45) as a 2nd dose, single, with route of administration unspecified, for COVID-19 immunization at the clinic (not in a military facility). Medical history included ongoing hypothyroidism diagnosed probably 10 years ago. Concomitant medication included levothyroxine for hypothyroidism. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on 17Feb2021 on the left deltoid for COVID-19 immunization. On 12Mar2021, the patient had a little arm soreness. On 13Mar2021, the patient had precipitous drop in energy level (50% drop in energy her level; then 30% down at the time of reporting); was fuzzy mentally enough that her friends event noticed it; and had acute lethargy. On 20Mar2021, the patient had stumbled, and right arm x-ray AC and lateral showed she broke her right arm in three places; got a big chip in her hip; and right hip x-ray showed she had chipped the acetabulum on her pelvis (there was a big chip on that), but it did stay in place, so no surgery was needed. The patient had a surgery on the right arm, and had to have a 4-hour surgery to replace the Olecranon where it should have been, and a plate and a couple of screws. The events, 'stumbled and broke her right arm in three places', 'got a big chip in her hip' and 'chipped the acetabulum on her pelvis', were assessed as serious (medically significant). On an unspecified date in 2021, the patient had low blood pressure (110/60); was not feeling well due to the second dose of vaccination; was in a lot of pain with the chip in her hip; fell on her right side and it was in her house, of course, on her tile floor; and had low cholesterol. The reported events had resulted into an emergency room visit and physician's office visit (orthopedics). The outcome of the events was recovering for 'stumbled and broke her right arm in three places', 'precipitous drop in energy level', 'fuzzy mentally' and 'acute lethargy'; was not recovered for 'got a big chip in her hip'; was recovered on 14Mar2021 for 'arm soreness'; and was unknown for all the other events.  No follow-up attempts are possible. No further information is expected.
2/15/07 received Tetanus vaccine on left arm at clinic. (vax also given to husband) came back to clinic next day with large reddened swollen area around site of immunization, that was tender to touch, feverish; refers to provider. Case seen by ER on 2/16/07, Keflex x 10 days, warm compress to site x3-4 days, returning problems. Public health nurse spoke with pt on 2/23/07-feeling better, arm less red, swelling decreased.
The patient had an anaphylactic reaction to the MMR vaccine. He felt that his tongue felt funny. He started to hypersalivate and began to wheeze and cough, he lost all his color, his freckles, and his eyes started to roll back.; The reaction that he had on 31 Oct 2014 was due to the gelatin in the MMR vaccine; This spontaneous report was received from a nurse practitioner who was also the patient's mother, concerning a 4-year-old male patient. No information was provided regarding the patient's relevant medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies.  On 31-OCT-2014, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported), as prophylaxis. Afterwards, he felt that his tongue felt funny, and the doctor noticed he started to hypersalivate and began to wheeze and cough, he lost all his color, his freckles, and his eyes started to roll back (anaphylactic reaction). He was not admitted to the hospital, he was driven to the emergency room (ER) and was covered in hives and treated with steroids and antihistamines. When he woke up, he asked his mom if he could be superman and she let him go trick or treating. He would have the same kind of reaction when he chewed gummy vitamins to where his tongue felt funny. He did a food challenge and it turned out he was not allergic to any of it. The reaction that he had was due to the gelatin in the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (allergic reaction to excipient).  At the time of the report, the patient had not recovered from allergic reaction to excipient. The outcome of anaphylactic reaction was unknown.  The causal relationship between the events and the suspect vaccine was related.  Upon internal review, the event of anaphylactic reaction was determined to be medically significant.
The next day, patient experience soreness below the injection site and on her lower arm, and difficulty with mobility. These symptoms are improving but continue 30 days later.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).   A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 10:00 (Lot number: FH8027) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included VITAMIN D3; VITAMIN C; ATORVASTATIN. Vaccination history included Bnt162b2 (Dose Number: 2, Batch/Lot No: Pfizer EL3247, Location of injection: Arm Right, Vaccine Administration Time: 10:30 AM), administration date: 23Feb2021, when the patient was 58 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Pfizer EL3247, Location of injection: Arm Right, Vaccine Administration Time: 10:30 AM), administration date: 02Feb2021, when the patient was 58 years old, for COVID-19 immunisation.  The following information was reported IMMUNISATION (non-serious) with onset 03Dec2021 10:00, outcome unknown; PAIN IN EXTREMITY (non-serious) with onset 03Dec2021 20:00, outcome recovering; MYALGIA (non-serious) with onset 03Dec2021 20:00, outcome recovering; HEADACHE (non-serious) with onset 03Dec2021 20:00, outcome recovering; MALAISE (non-serious) with onset 03Dec2021 20:00, outcome recovering. Therapeutic measures were not taken as a result of pain in extremity, myalgia, headache, and malaise.  No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.  Follow-up attempts are completed. No follow-up attempts are possible. No further information is expected.
6pm arm started to hurt, next day large red oval shaped red spot which felt hot, had fatigue through the next day.  Began to easing Friday night.  Saturday less red about same size (avocado cross-section sized)soreness was much less.  No fever was noted at any time.
Fever of 100.5 and higher. Body aches, sinus passages filled, difficulty breathing. Fever lasted for over 4 days. Stuffy nose, fatigue, and difficulty breathing along with cough continues. Going on 8 days. Making an appointment with family doctor.
Breast soreness, lump, pain, swelling, warmth on right side. Began shortly after vaccine. No pain or problems prior to injection in the right arm. Symptoms have increased and remain constant. Screening Mammogram: no breast cancer detected, very dense breast tissue. During mammogram, told nurse about right breast concerns. Dr. appointment 12/15/2021: treated for mastitis with two Rx's: steroid and antibiotic. Symptoms remained. Diagnostic mammogram and ultra sound ordered and appointment scheduled for 01/26/2022.
Information has been received from a medical assistant(also reported as office manager) referring to a 2 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 26-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; 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 2. 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:
Tinnitus in left ear.  Started very strongly the day after the second vaccination.  Has continued for 1 week without relief.
This spontaneous report as received from a pharmacist refers to a 70 year old female patient with DEMEROL reaction (sick stomach) and IgA deficiency. On 29-APR-2013 the patient was vaccinated with ZOSTAVAX (lot # J000494 and expiration date 14-APR-2014), 0.65 ml, subcutaneous in the left arm for immunization. There was no concomitant medication. The pharmacist stated that later in the day on 29-APR-2013, the patient experienced flu like symptoms, a temperature of 101 degrees F, and joint pain in her shoulders and fingers after receiving ZOSTAVAX earlier that day. The patient took an unspecified dose of TYLENOL at 7:00 pm and again at 9:00 pm on 29-APR-2013. By 10:00 pm on 29-APR-2013, the patient was beginning to feel better. Patient sought medical attention by went back in to pharmacy on 03-MAY-2013. Laboratory tests were not performed. At the time of the report the outcome of flu like symptoms, joint pain in her shoulder and fingers and temperature of 101 degrees F was reported as recovering. This is one of two reports from the same source. Additional information has been requested.
The pt was screaming in fear during the injection and then he passed out. He did not get a fall injury or hit his head but I wanted to report that he passed out in case of a later reaction.
This spontaneous report has been received from a medical assistant referring to a 9 year old patient (gender was not provided) No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 13-DEC-2018, the patient was vaccinated with an adult dose of VAQTA (strength, frequency and route of administration were not provided)lot # R022983, expiration date 09-AUG-2019, for prophylaxis. No adverse event was reported. This is one of two reports from the same reporter (MARRS#1812USA007388) Sender's Comments: US-009507513-1812USA007388.
This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th December 2021, the patient received the 1st dose of Shingrix. On 14th December 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional details were provided as follows: The medical assiatant at the office went to administer a first dose of Shingrix to a patient and when the patient received it, she moved causing some of the vaccine to leak out onto the patient's arm and also reported that, some of the vaccine was left in the syringe as well but the medical assistant threw the syringe away immediately so they are unable to know how much of it was administered and how much was leftover, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. The reporter did not consent to follow up.
Received DTaP and IPV to right arm on 8/25/04. Complained of itches. DTaP site with bruising. Redness/ heat to site IPV x 24 hour increase in redness. No prior reaction. Redness appeared 26AUG.
Patient experienced itching and localized erythema after Tdap vaccination, no fever or systemic symptoms.
pt presented with increased confusion and covid. neuro work up done, pt discharged back to ALF with wife.
Afternoon of the 29th I began to feel rundown, as if coming down with the flu.  By early morning of the 30th, my right arm and hand were swollen and a painful, warm lump developed near the injection site.
Patient didn't respond at all to the Pfizer COVID Vaccine; Patient didn't respond at all to the Pfizer COVID Vaccine; This is a spontaneous report based on the information received by Pfizer (Reference ID: NUS2021US049495). A contactable consumer reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection; lot number and Expiry Date was not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient did not respond at all to the Pfizer COVID Vaccine. He read somewhere that there is an interaction between Myfortic and COVID Vaccine. The patient stopped the medication so he can get the COVID Vaccine.  The outcome of the evets was unknown.  Information about batch/lot number has been requested.
Tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the 1st shot on 21Jan2021, tested positive for Covid on 01Feb2021, 2nd round should be on Thursday. Asking if he needs to get the 2nd shot. The patient underwent lab tests and procedures which included Covid test: positive on 01Feb2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.