chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 22 year old female patient. The patient was administered the first dose in GARDASIL (dose, route, lot # not specified) series on an unspecified date in 2007. On 17-JUL-2013 patient was in the physician's office to receive her second dose in the GARDASIL series (dose, route, lot # not specified). No adverse effects were reported. Additional information has been requested.
On Wednesday April 20, 2022. a vaccination vendor set up a vaccination clinic at Center. An administrative error occurred at the close of the clinic when the Moderna vial, Lot number noted above was punctured a 21st time, one time more than recommended, to obtain a 21st dose for a walk in client. No adverse effects have been reported by the vaccine recipient 48 hours after administration.
VACCINE ADMINISTERED WAS STORED AT FREEZER TEMPERATURE FOR TOO LONG. PATIENT HAS BEEN ADVISED AND MAY GET REVACCINATED.
Fatigue; Achy; Pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Achy) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Jun-2021. On 31-Dec-2020, the patient experienced FATIGUE (Fatigue), MYALGIA (Achy) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at a dose of 1 dosage form. On 31-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, FATIGUE (Fatigue) and MYALGIA (Achy) outcome was unknown.            The patient had established prenatal care. Number of fetuses was reported as 1.
At 2 mo shots pt was sleepier for days.  At 4mo shots pt was sleepier that eve. At 2AM mom noted fussiness, check child and found her limp/ grey and lethargic. Mom tried to breast feed child and she refused breast until 15 min later when she became more normal. Pt not seen by provider until 6 month visit.
Information has been received from a nurse referring to an unspecified number of patients.  Information about concurrent condition, concomitant medication and medical history was not provided. The nurse reported that an unknown number of doses of PEDVAXHIB, (Lot # M014925 Expiration date 16-FEB-2019) experienced a temperature excursion of -4F for 4 hours 31 minutes, and an unknown number of might have been administered to an unspecified number of patients. It was unknown if any patients experienced any side effects following administration of any of the vaccines. No other information was available. This report is one of the reports from same reporter. Additional information is not expected. because no consent to contact. Sender's Comments: US-009507513-1612USA003524: US-009507513-1612USA004348.
A physician described the inability of an adult female of an unspecified age to respond to 2 series of Hep B vaccine (brand unknown). The subject's medical history, concurrent conditions, and concurrent medications was unknown. On unspecified dates, the subject received 2 series of Hep B vaccine injections. At an unspecified time following her 6th immunization, she was found to be a nonresponder.
Severe, debilitating, crushing, headache; debilitating; migraine-type; vision issues; sensivity to light; noise; arm swelling; hot; red; nausea; dizziness; muscle aches; This is a spontaneous report from a contactable consumer or other non-HCP. A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267; Expiration Date: 31May2021), intramuscular, administered in Left Arm on 18Feb2021 as DOSE 2, SINGLE (at the age of: 65-year-old) for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection, Lot number: EL3247) intramuscular, administered in Left Arm on 20Jan2021 (at the age of: 65-year-old) for covid-19 immunization. Medical history included psoriatic arthropathy from 1980 and ongoing, fibromyalgia, covid-19 from Feb2020 and she believes she had covid-19 in Feb2020. There were no concomitant medications. The patient previously took statins and experienced drug hypersensitivity, bnt162b2 for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered is mentioned as Hospital. Vaccine was not administered at Military facility. Other vaccine in fourweeks as Pfizer COVID 19 on 04Feb2021. Prior to vaccination, Unknown about the patient was diagnosed with COVID-19 and since the vaccination, the patient has been not tested for COVID-19. On 20Feb2 021 the patient experienced severe, debilitating, crushing, headache, debilitating, migraine-type, vision issues, sensivity to light, noise, arm swelling, hot, red, nausea, dizziness, muscle aches. The patient underwent lab tests and procedures which included sars-cov-2 test: had covid-19 on Feb2020 I believe I had covid-19 in Feb2020.  Therapeutic measures were taken as Pain med, office visits, MRIs as a result of severe, debilitating, crushing, headache. The outcome of event severe, debilitating, crushing, headache was not recovered while outcome of rest all events unknown. Follow-up attempts are completed. No further information is expected.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE TRANSIENT CEREBRAL ISCHEMIA RIGHT FACIAL MUSCLE WEAKNESS 12/26/2022 --  RECURRENCE OF SAME SYMPTOMS
Two minuets post vaccination client experienced severe arm pain, severe headache, upset stomach. Client was placed on mat on floor with feet raised and cool cloth applied to forehead. Provided client juice. At 1012 client began to shiver and teeth shattered uncontrollably and continued to complain of right sided head pain. Client denied shortness of breath or difficulty breathing. At 1023 clients symptoms continued with no improvement and EMS was called to evaluate. At 1026 EMS arrived and performed a 12 lead EKG and assessment with no abnormal findings. Client refused transport to hospital. At 1100 client provided snack and symptoms shivering resolved but head pain still 8 out 10. Client called mother who transported client home.
Moderna booster vaccine administered accidentally, instead of J&J initial vaccine Narrative:  Employee arrived for J&J Dose #1 (Initial Dose) Moderna "booster" 0.25mL dose administered accidentally Nurse decided to administer a second "booster" 0.25mL dose so that the patient had "full" 0.5mL dose Employee should have received J&J initial dose Employee advised of error and was in agreement with the above. Employee scheduled for Moderna #2 on 1/12/2022.
01/25/2022 Woke up running a fever 105.4. Took 3 Advil and it knocked it down to 104.8. I emptied my entire colon in several bowel movements. I had general aches and pains I had no appetite and bad nausea. I drove myself to the pharmacy 2 days later to get a COVID test and results came back positive. Basically, the next 2 weeks were blank. I don't remember anything, and you were unable to eat much. I could only eat rice, apple sauce and toast. I lost over 20 pounds. I still do not feel good. I am out of breath and very tired, sleep a lot.
Pt had onset of headache within 1 hour. I call pt. approximately 4 hours later pt complaining of itching all over and "aches all over".
Administered 1.0 mL in place of 0.5 mL of vaccine
site of DTP has gotten very red & swollen-swollen to about the size of pt's fist; couldn't-wouldn't move arm; cold compress provided some comfort, no change in swelling;
Pain in my left arm where I had received vaccination; Headache 3-4 hours after receiving the shot; Tiredness - I feel like I need to rest and sleep; Reluctant to do any physical activities; I feel-like that my heart rate increases; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 29Mar2021 11:00 (Lot number: EP6955) at the age of 36 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1, administration time: 11:15, location: right arm, lot number: EL3247), administration date: 08Mar2021, for COVID-19 immunisation, reaction(s): "Pain in my left arm where I had received vaccination". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Mar2021 15:00, outcome "recovering", described as "Pain in my left arm where I had received vaccination"; HEADACHE (non-serious) with onset 29Mar2021 15:00, outcome "recovered" (Mar2021), described as "Headache 3-4 hours after receiving the shot"; FATIGUE (non-serious) with onset 29Mar2021 15:00, outcome "recovering", described as "Tiredness - I feel like I need to rest and sleep"; MALAISE (non-serious) with onset 29Mar2021 15:00, outcome "recovering", described as "Reluctant to do any physical activities"; HEART RATE INCREASED (non-serious) with onset 29Mar2021 15:00, outcome "recovering", described as "I feel-like that my heart rate increases". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, fatigue, malaise, heart rate increased. Therapeutic measures were taken as a result of headache.  Additional information: The patient had no known allergies. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient did not receive other vaccines in 4 weeks.  The patient received Tylenol 500 mg 2x as treatment for headache.  No follow-up attempts are possible. No further information is expected.
All symptoms come in waves, shaky, light headed, heat moving across body irregular heartbeat, fatigue, extremely dry mouth and sinuses, squirrelly stomache odd sensations
has hives on her back, arm and stomach; Eyes and face swollen; Eyes and face swollen; This is a spontaneous report from a contactable consumer.   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 of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced hives on her back, arm and stomach. Eyes and face swollen. Therapeutic measures were taken as a result of events and treatment included steroids. The outcome of events was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
pt vax 4Jan91, On 5Jan91 RLT had red hard swollen area approx 1/2 $ size, Saw MD on 7Jan91, Meds-Keflex, pt seeing MD weekly, 18Jan91 lump size of nickel
No localized reactions at injection site. Adacel given at about 1600 8/22/07. On 8/23/07 0400 became febrile 102-104. Had 1 episode of nausea and vomiting. Was given Tylenol 650mg by mom. Cool shower. By 0800 T was 101. Afebrile at noon. 8/24 tired and afebrile.
her throat closed up and she could not breath; her throat closed up and she could not breath; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced her throat closed up and she could not breath. The patient was hospitalized due to the events on an unspecified date. It was reported that ten minutes after her first covid vaccine, her throat closed up and she could not breath. Thankfully, paramedics were standing by to tend to her and rush her to the hospital. She was okay after a few hours and stated that their hospital bills were outrageous. Reporter stated that this was all due to that vaccine and believed that the company should pay the rest of what they owe. Outcome of events was recovering.  No follow up attempts are needed. No further information is expected.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Itchy and mild redness on face and neck. I gave 1 Benadryl 25mg and observed for 30 min after itching. She left with advice to keep taking Benadryl-Mild, Additional Details: Itching on face and neck. She felt better and she left.
APPROXIMATELY 30 MINUTES AFTER THE ADMINISTRATION OF VACCINES, MOTHER SAW A RASH ON THE FOREHEAD AREA EXTENDING TO THE BUTTOCKS AREA. INFANT GIVEN 1/4 TEASPOON BENADRYL PER RN.
Patient called in December to report the flu shot she received in September had caused an adverse reaction. She was sore for a few days and unable to raise her arm. Upon consulting with an orthopedic specialist she was informed the vaccine she received was most likely administered incorrectly. It was most likely administered too high causing shoulder damage/pain.
close friend having adverse side affects over the past three days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (close friend having adverse side affects over the past three days) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced VACCINATION COMPLICATION (close friend having adverse side affects over the past three days). At the time of the report, VACCINATION COMPLICATION (close friend having adverse side affects over the past three days) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.
4 days after receiving the first dose of the Moderna vaccine, I developed acute epididymitis.  Ultrasound confirmed.  Resolved over 14 days, including 10 days of Septra DS. BID.
Information has been received via the Merck pregnancy registry, from a physician concerning a 15 year old female patient, who on 13-JUN-2007 was vaccinated with the first dose of Gardasil (Lot #655620/0171U).  There was no concomitant medication.  After receiving the vaccination (date not reported), the patient learned that she was pregnant (date of LMP and estimated date of delivery not reported).  Follow up information received from the physician, via a company representative, indicated that the pregnancy resulted in a premature birth (date and gestational week not provided).  The infant (gender not specified), also was "a low birth weight baby" (weight not specified).  At the time of this report, the outcome and details of premature birth and low birth weight baby were unknown.  No further details were provided.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007.  Initial and follow-up information has been received via the Merck pregnancy registry, from a physician concerning a 15 year old female patient with an allergy to Penicillin, who on 13-JUN-2007 (also reported as March 2007) was vaccinated with the 0.5mL first dose of GARDASIL (Lot #655620/0171U).  There was no concomitant medication.  After receiving the vaccination (date not reported), the patient learned that she was pregnant (date of LMP and estimated date of delivery not reported) (also reported that the patient became pregnant in January 2007). Follow up information received from the physician, via a company representative, indicated that the pregnancy resulted in a premautre birth (date and gestational week not provided).  The infant (gender not specified), also was "a low birth weight baby" (weight not specified).  At the time of this report, the outcome and details of premature birth and low birth weight baby were unknown.  It was reported that "everything is ok."  The patient was hospitalized when she had the baby for a little over one day.  No further details were provided.  Follow-up information was received on 24-MAR-2008 and on 07-APR-2008 from a physician and a woman from the physician's office.  It was reported that in July or August 2007, the patient was vaccinated intramuscularly with one 0.5 ml dose of GARDASIL (previously reported as 13-JUN-2007).  In October 2007, the patient became pregnant (previously reported as January 2007).  During her pregnancy, the patient had a bladder infection and was restricted to bedrest because of preterm labor.  The outcome of the patient was not reported.  This is a consolidation of two reports.  Additional information has been requsted.
Patient stood up after receiving vaccination and fainted into mother's arms. Patient regained consciousness after a few minutes. 911 was called. EMT arrived and took patient to hospital for evaluation.
Started with nausea, racing heart, and dizziness.  Within a few minutes scratchy throat and Epi was administered along with O2 at that time.  Sent to ER.
flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient was the caller's daughter.  The age at vaccination was not reported. The patient received Shingrix and flu-like symptoms that lasted for 3 days and better at the time of reporting. The reporter consented to follow up. This case linked with US2020126266 and US2020126273, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020126266:same reporter US-GLAXOSMITHKLINE-US2020126273:same reporter
The diluent used for the Yellow Fever Vaccine had expired on 6/21.  The patient had no adverse reaction.  She was contacted to return 28 days after the first dose to receive a second valid dose of Yellow Fever Vaccine.
Right ear clogged and slight pitched sound. Checking with doctor. She had left the office foe the day
Migraine numbness of lips tingling in right foot and right leg  Chills sweating memory issues hard to think of words granddaughter sad she thought I slurred some words
Woke up in the middle of the night 6 hrs after the vaccine with sever stabbing pain through entire shoulder joint into back. Not a muscle ache. 6 hrs later the pain was shooting across my back and down my arm into my hand and was intolerable. Within 24hrs of getting the vaccine I was unable to raise my arm at all. There was tingling numbness and shooting pain in shoulder, back, ribcage, down arm and into hand. By the 2nd day. My hand had started to swell and my shoulder swelled.  I iced and took tylenol but nothing helped. I couldnt dress myself. I didn't sleep from severe pain for the subsequent 3 nights.  My shot was tuesday night and my symptoms didn't subside to a tolerable level until the following Saturday. I am still having difficulty raising the arm and its been a week. I noticed that the person who gave me the injection did it so high in my shoulder that it was about 2 mm below the bone at the top of my shoulder. It seemed a very strange location for a shot.
sore; redness; headache; tired; felt out of sorts; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient 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 pain in arm, erythema, headache, tiredness and feeling abnormal. On an unknown date, the outcome of the pain in arm, erythema, headache, tiredness and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema, headache, tiredness and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on an unknown arm. The patient experienced headache, a sore arm, redness that lasted for weeks, and felt out of sorts and tired. For tolerance of 2nd dose of Shingrix, refer case US2019AMR114601.
Information has been received from a physician assistant concerning a 22 year old female who in April 2007 and June 2007, was vaccinated with a first and second dose of Gardasil vaccine. Since June 2007, the patient has experienced abnormal menstrual cycles. The patient received the 3rd dose of Gardasil in Oct 2007. The patient received unspecified medical attention and at the time of this report it is unknown if she has recovered. Additional information has been requested.
1st day - headache - 2nd day - fever - bright red rash under breast about 4" deep under both. Lft. injection site swelled size of an orange - very red & painful - took BENADRYL at night x 2.
I had some of the side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse drug reaction in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine at an unknown dose. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that the patient got the Tdap vaccine so she could be around her new grandson who is expected in February.  The patient had some of the side effects after receiving Tdap Vaccine but it was still worth it. The case has been linked with the case US2019AMR174475, reported by same reporter.
Person receiving the vaccine developed a tingling in her mouth. Not short of breath or itchy, no hives. Vital signs 156/90, Pulse 72, SPO2 97. Gave her water and candy, sat her in recliner with feet up. She remained with us for over 30 minutes. Felt better after water. Vital signs before leaving were 147/90, pulse 73, SPO2 97
1. Swollen lymph node in arm pit in same arm as injection. On going. No active treatment. 2. Mouth sores on tips and sides of tongue as well as sores on top pallet of mouth.  On going. No active treatment.
Difficulty breathing, heavy chest, pain in lower back. Dissipated after 10-15 minutes. All seems fine now.