chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a consumer (patient's parent) on 03-Apr-2017. This case involves a two-year-old male patient who was vaccinated with first, second and third doses of DIPHTHERIA-6.7/TETANUS-5 ADSORBED TOXOIDS (DT) (Batch number: U2105BA, expiry date: 29-Jan-2010 for all three vaccines) (dose, dose in series, route of administration were not reported) in thigh, first dose of ACT-HIB (Batch number: UF225AA, expiry date: 17-May-2009) in thigh and second and third doses of ACT-HIB within four weeks of other vaccinations (Batch number: UF461AA, expiry date: 21-Oct-2009 for all two vaccines) (dose, dose in series, route of administration were not reported) in thigh at 6 months, 8 months and 1 year respectively on an unspecified date of 2008. Illness at the time of vaccination was reported as reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions none developing normally until two years old. Concomitant medications were not reported. On an unspecified date of 2008, the patient had a sudden reversal of development and had a diagnosis of pervasive developmental disorder not otherwise specified which was a form of Autism marked by developmental delays and speech delays and communication avoidance. The patient required ER/ doctor visit. The patient had no laboratory data. Corrective treatment reported that patient was undergoing a detoxification program to improve his delays at age of nine years. Patient was not recovered from the events. Upon internal review, the company decided to consider the event serious because of important medical events pervasive developmental disorder not otherwise specified, sudden reversal of development, developmental delays, speech delays, communication avoidance. List of documents held by sender: none. Sender's Comments: This case concerns a 2 years old male patient who received DIPHTHERIA-6.7/TETANUS-5 ADSORBED TOXOIDS and HIB (PRP/T) VACCINE and experienced Pervasive developmental disorder not otherwise specified. Time to onset is compatible with the role of vaccine. Further information on medical history including birth history, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Moreover, as two vaccines were administered concomitantly, the role of each component cannot be assessed separately.
Numbness left side of their face, neck, ear, and back of head; Tingling of face, neck, ear, and back of the head; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness left side of their face, neck, ear, and back of head) and PARAESTHESIA (Tingling of face, neck, ear, and back of the head) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness left side of their face, neck, ear, and back of head) and PARAESTHESIA (Tingling of face, neck, ear, and back of the head). At the time of the report, HYPOAESTHESIA (Numbness left side of their face, neck, ear, and back of head) and PARAESTHESIA (Tingling of face, neck, ear, and back of the head) outcome was unknown. Not Provided          Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Very fussy after DTaP, Pneumococcal, and Influenza vaccines administered at 3:45 PM and refused all food/drink.  Vomited one time at 7pm.
Significant soreness in the arm where I received the injection, as well as a swollen lymph node in the underarm of the same arm. In addition, muscle aches, fatigue and chills. No fever recorded so far.
Abnormal period/menstrual cycle; came 7-10 days early and was heavier than normal
The needle fell off and some of the vaccine spilled on nurse and on the patient's pants; The needle fell off and some of the vaccine spilled on nurse and on the patient's pants; A spontaneous report was received from a pharmacist, concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine and while receiving vaccine the needle fell off and some of the vaccine spilled on nurse and the patient's pants.   No relevant medical history and concomitant medications were reported.   On 11-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 11-Jan-2021, while nurse was giving a patient his 1st dose of the Moderna vaccine, she had to change the needle as he was a larger man. When nurse was administering the vaccine, the needle fell off and some of the vaccine spilled on her and on patient's pants. The patient became irate that he couldn't get a replacement dose.   Action taken with the first dose of mRNA-1273 in response to the event was not reported.   The outcome for the event the needle fell off and some of the vaccine spilled on nurse and the patient's pants was considered to be resolved on 11-Jan-2021.; Reporter's Comments: This report refers to a case of a male patient who experienced non-serious event of the needle fell off and some vaccine spilled on nurse and the patient's pants (Incomplete dose of vaccine administered, needle issue)  for mRNA-1273 (lot # 025L20A, Exp date-unknown). There were no reported AEs associated with the event of  the needle fell off and some vaccine spilled.
Within a couple of minutes of the shot, I felt dizzy, weak and as if I were going to pass out.  Waiting a 5-10 minutes before asking for medical assistance.  Nurse  on site said she heard an irregular heartbeat, with blood pressure at 80/40.  After drinking water and eating a couple of peanut butter crackers begin to feel a little better.  Another  check of heart rate it was normal and blood pressure was within normal range of 120/72.  Resting a few more minutes and felt better.  Came home and slept most of the day.  Symptons had disappeared in an hour or so.  I plan to follow up with my family doctor to see if anything else is going on medically with me.
c/o temp high not documented 1st day;temp next day 103 c/o irritability 4hr p/shot;no local rxn
83-year-old male with extensive past medical history including aortic regurgitation, aortic stenosis, atrial fibrillation on anticoagulation, CAD, diabetes, hyperlipidemia, hypertension, Parkinson's, end-stage renal disease, pulmonary hypertension presents to the emergency department from hospice services for fever and positive COVID-19 diagnosis.  Patient was receiving hospice services multifactorial including worsening protein calorie malnutrition and dysphagia, along with worsening kidney function and need for dialysis. He has been on hospice services for several months. Hospice service was contacted by emergency department and it was stated that they were unable to adequately isolate and take care of the patient while he is COVID-19 positive and not risk infecting other residents.  I spoke with the son on the phone regarding goals of care. He plans on having goals of care remain the same including comfort care only measures. Patient is a do not resuscitate. He does not want to aggressively treat the patient's failing kidneys or protein calorie malnutrition. Does not wants to aggressively treat cardiac pathology. Tested positive on 01/06/2022.
On 7-5-2022, I had head congestion, slight cough and slight headache. I took TYLENOL OTC as needed. The next day, I started having a runny nose, sneezing, continued cough and overall not feeling well. I went in to see the doctor the morning of 7-6 and he did not prescribe anything. He told me to take OTC meds to treat symptoms. They did perform a Covid19 test in the office and he told me it was positive. I took VICKS cold and flu syrup. I felt better after 2 days. I am reporting my breakthrough case of Covid19.
hair loss; eyebrows are almost gone; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (hair loss) and MADAROSIS (eyebrows are almost gone) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B22A, 039K20A, 028L20A and 012F21A) for COVID-19 prophylaxis.     The patient did not have previous COVID-19 diagnosis.  The patient's past medical history included Thyroid activity decreased. Concurrent medical conditions included Blood pressure high.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (hair loss) and MADAROSIS (eyebrows are almost gone). At the time of the report, ALOPECIA (hair loss) and MADAROSIS (eyebrows are almost gone) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Thyroid function test: not related..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ALOPECIA (hair loss) and MADAROSIS (eyebrows are almost gone) to be related.    Concomitant medication not reported.   In the past, patient had high cholesterol.  The patient went to see her Dermatologist and they confirm it might be related to the covid vaccine. Her medical doctor did a thyroid test and it was not related. They even change her medication, and it was not the thyroid causing it. She took thyroid medication.
Headache; some nausea; body soreness; This is a spontaneous report from a contactable consumer or other non hcp (Patient herself). A 51-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 23Feb2021 07:30 (Batch/Lot Number: EL9265) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Other medication in two weeks was provitalize. No treatment received by AE. No COVID prior vaccination and not tested post vaccination. No Known Allergies.The patient experienced headache, some nausea, body soreness on 23Feb2021 21:30. The with outcome of the events was recovering.
Shot injected into Left tricep, area red, raised, hot to touch, measuring 8.5 x 7 cm. No treatment.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included pravastatin sodium (Pravastatin). On 29th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than an hour after receiving SHINGRIX, the patient experienced injection site pain. On 11th June 2018, the patient experienced raised rash, itching, rash and redness. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the raised rash, itching, rash and redness were unchanged. The reporter considered the injection site pain to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the raised rash, itching, rash and redness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient experienced pain at the injection site approximately within 15 minutes of receiving the vaccine. The pain at the injection site lasted for about two to three days, and was resolved at the date of reporting. 13 days after receiving SHINGRIX, the patient experienced rash associated with redness, itching and bumps on her thigh. The patient stated that the rash appears in 9 to 10 different patches on her thigh, and it was spreading. The patient had denied permission to contact their physician. No further details were provided, all questions were asked.
Information has been received from a registered nurse referring to a patient of unknown age (reported as minor) and gender. No relevant medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL (lot # L040459, expiration date 06-APR-2017; dose and route were not reported). No adverse symptom was reported. The dose of GARDASIL had been exposed to 0.3 Celsius degree for 11 hours with no previous excursions, and data logger was involved. Additional information has been requested.
Rash on neck, 26 1/2 hours, post vax. Took Benadryl (self prescribed).
This spontaneous report as received from a 78 years old female consumer with hypothyroidism and cortisone allergic and can't take any cholesterol medications refers to herself. The patient was vaccinated with the first dose of ZOSTAVAX (Lot# and exp date unspecified) intramuscular in May 2011. No other co-suspects were reported. Concomitant medications included estrogens, PREMARIN, SYNTHROID and aspirin. The patient stated that, in June 2011, about a month or so after she received ZOSTAVAX she noticed her wrist started hurting and swelling. She stated it was worst in her right wrist. She describes the pain as gradual and is now intense at times and increases with movement. The swelling and pain almost daily and keep her awake at night often. She also side that ice packs do help some and aspirin takes some of the pain away. The patient had sought unspecified medical attention. The patient had performed with X-rays laboratory diagnostics (result not provided). The outcome of "wrist started swelling, pain as gradual and is now intense at times and increases with movement and wrist started hurting" was reported as not recovered/not resolved at the time of reporting. Additional information has been requested.
11:00 Onset of nausia, 11:05 coughing, 11:15 throat feeling scratchy.  11:30, nausia gone, throat still sore and cough remaining.  Released
I had little soreness at the injection site the first 24 hours after the shot.  Thereafter, I felt no side effects until the 8th day after my shot, I noticed a 3 inch circle of red rash just below the injection site.  It has gradually faded these past four days. There was no discomfort.
Suspected vaccination failure; I had the shingles shot and still ended up with them twice.; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient had the shingles shot and still ended up with shingles twice. This case was considered as suspected vaccination failure since the details regarding dose number, time to onset and laboratory confirmation was were not reported.
Covid test result: Positive; Covid test result: Positive; Vomiting; Nausea; Diarrhea; Black Stool; This is a spontaneous report from a contactable consumer. An 18-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a positive COVID test result on an unknown date. It was unknown if the patient was pregnant at the time of vaccination, or had COVID prior vaccination, or if the patient had other vaccine in four weeks. The patient also had vomiting, nausea, diarrhea and black stool. The patient underwent lab tests and procedures which included Covid test: positive on an unknown date. The outcome of the events was unknown.   Information on the batch/lot number has been requested.
Pt wanted to test BP prior to shot. Rph said pt BP was a little high so they waited and took BP again a minute or 2 later. BP had gone down some, so they agreed to proceed. After dose, pt was dizzy, sweaty, unresponsive for a short time. Once he was more responsive, we helped him sit on the floor against the wall as he was quite dizzy. We called 911 and pt refused transport to hospital, but was evaluated.
This medically confirmed report (initial receipt 25-Sep-2012) concerns a 37-year-old female patient who had a medical history of drug allergies to morphine sulfate controlled-release (CR) 100 mg tablet and hydrocodone-acetaminophen 7.5-500. Concomitant medications included acetaminophen, diphenhydramine, heparin, lidocaine, sodium chloride, EPIPEN, CYMBALTA, diclofenac, KLONOPIN, AXERT, NORVASC, albuterol, DILAUDID, AUGMENTIN, vitamin E and ZIAC. On an unspecified date the patient received a flu shot (manufacturer and batch no. not specified) and PRIVIGEN (batch no: 4350900263) 60 gm every 3 weeks intravenously for common variable immunodeficiency. On an unspecified date the patient experienced a reaction to the flu shot and a sinus infection. The patient missed 2 days of work. The outcome for the events was unknown. Reporter's comment: The reporter considered the events as non-serious and unlikely related to PRIVIGEN. The patient experienced a reaction to the flu shot. A relationship between the sinus infection and flu shot was not specified.
47 year old female received below vaccines, reports 3 1/2 later worsening pain in right arm, felt dizzy and hot. Witnessed syncopal episode by husband (physician) approximately 10 second duration. No rash or other symptoms. Recovered without problems. Has history of syncopal episode after PCN shot & PPD test many years ago. Near syncopal episode one year ago from severe pain after tooth injury (cracked).
The patient vomited a few minutes after receiving the vaccine. He sat for a while with a cold compress on his forehead/neck, then appeared to be fine and left with his parent.
Swelling of upper right arm with reddness around vaccine site; vaccine given was Pneumovax.
woke up to a fast heart rate; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (woke up to a fast heart rate) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PALPITATIONS (woke up to a fast heart rate). At the time of the report, PALPITATIONS (woke up to a fast heart rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Heart rate: 105 (abnormal) fast heart rate around 105.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.
had shingles after the shot/suspected vaccination failure; had shingles; 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 shingles before shot).   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: had shingles after the shot/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Mar-2023 The case was received from the patient via interactive digital media. The patient got his/her too, had shingles before and after the shot. The patient stated that hopefully that was it for him/her. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
36 hours or so after the shot: Noted dizziness with gait and standing, lightheadedness. The symptoms were not vertigo. Rather feeling of being off and easily symptomatic with movement. Thereafter symptoms stayed the same the next 4 weeks or so. Stimuli and stress and lights and any activity worsened symptoms. Affected job. Could not focus at work or partake in any physical activity past a low level stationary bike. Baseline I swim 1 mile a day and workout daily.
Chills, achy, no appetite , headache , unable to lift right arm, very sore from 3am til 3pm
pharmacist denied giving her the second dose; developed swollen lips for approximately 3 days.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/Lot number was not reported) via an intramuscular route of administration in left arm on 30Mar2021 as single dose for COVID-19 immunization. The patient was 60-years-old at the time of vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that, the day after receiving the vaccine on 31Mar2021, she developed swollen lips for approximately 3 days. She had no difficulty breathing and didn't go to urgent care. She wanted to receive her second dose but the pharmacist denied giving her the second dose stating she needed more medical supervision than what was available at the pharmacy. When she called the hospital they told her she had to receive her second dose where she received her first dose. Her primary care doctor said he could not advise her to get the second dose of the vaccine or not because he did not see the lip swelling. The outcome of the event lip swelling was recovered and for pharmacist denied giving her the second dose was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Resident stated, "I vomited real bad this morning. She said it was a lot and she has never thrown up like that before". Resident felt better by that evening.