chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The client's daughter reported that the day following vaccination the client experience tremors all extremities bilaterally for approximately 24 hours. She reports the client stated the tremors were not "chills" but were uncontrollable tremors. No residual effects noted once they subsided.
This spontaneous report as received from a physician assistant (PA) refers to a patient of unknown age and gender. The patient received 1st dose of GARDASIL, 0.5 ml, subcutaneously in February 2012 and her second dose of GARDASIL, 0.5 ml, subcutaneously in March 2012 and on 18-JUN-2013 was in the office to receive her third dose of GARDASIL. PA reported that the third dose of GARDASIL had not been administered yet. No adverse effect was reported. Additional information has been requested.
Heart rate went wild **immediately** upon inoculation.  Was wearing a running watch -- rate was 158 and higher.  Felt lightheaded, scared as this had **never** happened with a shot before.  Pharmacist had me drink water & orange juice, stay there for 45 mins.  Heart rate continued to be high for about two hours, but was able to calm it by lying down.  Feel uneasy about taxing my heart again with second dose.
soreness in right armpit, sore in the armpit; fatigue, tired; body aches; high anxiety; Swollen lymph node/ lymphodenitis; This case was reported by a consumer via call center representative and described the occurrence of axillary pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2022, the patient received the 1st dose of Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced fatigue, general body pain, anxiety and enlargement of lymph nodes. On 19th May 2022, the patient experienced axillary pain. On an unknown date, the outcome of the axillary pain, fatigue, general body pain, anxiety and enlargement of lymph nodes were not recovered/not resolved.   It was unknown if the reporter considered the axillary pain, fatigue, general body pain, anxiety and enlargement of lymph nodes to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient received Shingrix 1st dose on the day before reporting and on 19th May 2022 in morning experienced sore armpit, patient asked it was normal. The patient was experienced fatigue, tired, and body aches and had very high anxiety. The patient asked about lymphadenitis and patient said it did not sound like horrible probably just due to the injection area but was the lymphadenitis something bad or was it something that just had settle down.  The patient did talk with nurse who gave the injection and she said because we have lymph nodes everywhere and when we inject something into body lymph nodes were kind of attacking it and sent it causes pain that could what feeling
SEVERE HEADACHE; BODY ACHES; NAUSEA; LOW GRADE FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-JUL-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-JUL-2022, the patient experienced body aches, nausea, and low grade fever. Laboratory data included: Body temperature 101.5. On 06-JUL-2022, the patient experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, nausea, body aches, and low grade fever. This report was non-serious.
Patient states she had pain immediately while receiving the injection in her left deltoid. Denies numbness or tingling. No redness, edema, or bruising at injection site. Patient contacted me 3 weeks after the vaccine, stating her deltoid still hurts.
Cold sores appeared all over her mouth and lips; slight pain in the arm after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sores appeared all over her mouth and lips) and VACCINATION SITE PAIN (slight pain in the arm after vaccination) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Cold sores (stated she is susceptible to cold sores in the winter with cold dry air) and No adverse event (Medical history not provided). Concomitant products included ACYCLOVIR [ACICLOVIR].    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (slight pain in the arm after vaccination). On 11-Jan-2021, the patient experienced ORAL HERPES (Cold sores appeared all over her mouth and lips). In January 2021, VACCINATION SITE PAIN (slight pain in the arm after vaccination) had resolved. At the time of the report, ORAL HERPES (Cold sores appeared all over her mouth and lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Patient is susceptible to cold sores in the winter with the cold, dry air.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 18-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Extreme full body rash  hives and itching.  Have had rashes now for 4 days.
Pt developed a large (5 1/2 inch) swollen red area at the injection site.
No adverse reaction to patient noted.  Vaccine administered over 12 hours after vial punctured
4-5 watery stools/day from (7/5/10) to present - (7-8-10). Decreased appetite. Afebrile.
Pt was instructed to remain in the waiting area for 15 min after receiving his 2nd Pfizer shot.  He chose to leave without waiting , he left the waiting area but shortly turned around and told the front desk he felt dizzy and then fainted on the floor, face first, causing a forehead laceration. Pt was sweating and was nauseated, when he woke up.  He was oriented, BP was 100/60, FSBS 88, given a bottle of water.  911 was called due to facial laceration, hitting his head from a standing position and blacking out.  Pt left on his own with the squad to go to the ER for evaluation .
vials were compromised at high temperatures; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (vials were compromised at high temperatures) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PRODUCT STORAGE ERROR (vials were compromised at high temperatures). At the time of the report, PRODUCT STORAGE ERROR (vials were compromised at high temperatures) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. No treatment information was provided.
I woke up with a severe headache around 6am. Around 8:30am I walked to the bathroom and sat down. My vision started to go black and my hearing went out. I sat on the floor and crawled back to the bed a few minutes later. My fiance took my blood pressure and it was 87/53. My pulse ox was 91%. I drank some water. Took BP again and it was 89/59. Pulse ox was still 91-92%. I layed down and tried to drink a lot of water. I fell asleep for an hour, took my BP again which was 90/60. Pulse ox was 92%. It wasn't until the next morning  (11/7) that was BP went above 100/60 and my pulse was above 92%. My blood pressure norm is 105-115/70s and pulse ox norm is 100%
Patient received Moderna Booster on 11/24, He thought the injection was a bit more painful that the previous two and noticed the bandage was much higher up on his shoulder. He woke up the morning of 11/25 with severe shoulder joint pain and limited ROM. Pain and ROM has continued to worsen over the past 24 hours. Recommended rest and ice application as initial management and recheck in 5-7 days for further evaluation.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021 at 11:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 11:51 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     No concomitant medications were reported.  Batch number 016M20A underwent temperature excursion on 08-Feb-2021 with temperature 29 degrees Fahrenheit at 10:00 AM and 35 degrees Fahrenheit at 11:00 AM. This vial was moved to fridge on 02-Feb-2021 and beyond use date for the vial was reported as 04-Mar-2021. Product moved to clinic on 08-Feb-2021. Total doses given for the day was 30. 3 vials sent to clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a  traceable temperature monitor at every hour.  No treatment medications were reported.
On April 19 woke up with severe sore throat on left side, on 4/26 still sore so went to primary care doctor  and was diagnosed as acid reflux. 6 weeks later was still experiencing voice hoarseness, pain in my joints and severe swelling in my lower legs and feet, after many blood test and exam by an ENT Dr. I was diagnosed with a viral infection.
Vaccinated with 0.5 ml subq.  PNEUMOVAX on 11/03/08, reported chills, flushed  face 4.5 X 5 cm red warm circular area to injection site on 11/5/08.
Nosebleed; Mysterious bruising on legs; fatigue; Vertigo; Ringing in ears; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0177) via an unspecified route of administration in the right arm on 25May2021 at 15:15 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ethinylestradiol, norgestimate (TRI LINYAH) from an unknown date taken for birth control. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28May2021 at12:00 since receiving the vaccine, the patient experienced fatigue, vertigo and ringing in the ears. On an unknown date in Jun2021, at the time of this report, the patient had a nosebleed for the first time in life seemed for no reason and also noticed mysterious bruising on legs.  The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events fatigue, vertigo, ringing in ears, nosebleed and mysterious bruising on legs were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient received the vaccine in the morning. Later in the evening, I was holding her, and she flung herself backwards into a seizure. Her body stiffened, head nodding, and she was non-responsive. I took her to the emergency room after she came back to herself. The doctors checked her, and said it's possible she had a seizure, but said the only way to verify it was for sure a seizure was to do a brain scan, which they do not recommend in babies after only one seizure following a vaccine.
I came home, started throwing out, I called my doctor. I took COVID-19 test and it was Positive. I had a cold and a cough, had fever the first day (101).
May 17, 2018, at night, she had headache, ache and fever 102 not helped by Tylenol/ibuprofen. Severe pain and had to take Norco. She was advised by pharmacist to call emergency if not better. She went to emergency room 5/19/18 and was treated with antibiotic and pain meds (toradol, morphine, prednisone, Benadryl).
Case number PHEH2013US009706, is an initial spontaneous report received from a nurse on 25 Apr 2013: This case refers to a 11-years-old male patient. He received only MENVEO vaccine (batch number: M11047) reconstituted with sterile diluent on 24 Apr 2013. He did not received MENVEO vaccine. No adverse reaction reported following this adminsitration error.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022; patient received 0.3 ml of booster; Vaccine administered to patient past its 30 day expiry date, Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date, Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022), PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022) and OVERDOSE (patient received 0.3 ml of booster) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions. It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. It was unknown if other vaccines were given on the same day as Moderna COVID-19 Vaccine to the patient. It was unknown if patient received other vaccines within one month prior to any dose of Moderna COVID-19 Vaccine.     On 01-Apr-2022 at 1:37 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .3 milliliter. On 01-Apr-2022 at 1:37 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date, Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022) and OVERDOSE (patient received 0.3 ml of booster). 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 01-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date, Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022), PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022) and OVERDOSE (patient received 0.3 ml of booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received second booster dose of Moderna COVID-19 vaccine.  No concomitant drug information was provided.  The 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 exp date of 04-Apr-2022No treatment drug information was received.  Covid-19 vaccine that were given beyond the 30 day use by date   This case was linked to MOD-2022-542869 (Patient Link).
Employee states that 2-hours after receiving the COVID vaccine he developed upper back "tightness" that he described as muscular.  States that pain has increased and made it difficult to walk up stairs and carry light loads.  States that he had been snowboarding extensively several days prior to the vaccination but had not noticed any back pain.
Sore arm after first vaccination; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm after first vaccination) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 019B21A) for COVID-19 vaccination.     The patient's past medical history included Cardioversion (has had no issues with arrhythmias since procedure in 2019) in 2019. Concurrent medical conditions included AFib. Concomitant products included LOSARTAN, ATORVASTATIN, FLECAINIDE, FUROSEMIDE (LASIX [FUROSEMIDE]) and POTASSIUM for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm after first vaccination). On 08-Mar-2021, VACCINATION SITE PAIN (Sore arm after first vaccination) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
still not feeling well/doesn't feel well; feels miserable from it; little lightheaded; got a little clammy; throwing up/throwing up for 8-10 hours; low-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (still not feeling well/doesn't feel well), FEELING ABNORMAL (feels miserable from it), DIZZINESS (little lightheaded), COLD SWEAT (got a little clammy) and VOMITING (throwing up/throwing up for 8-10 hours) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E22A and 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (still not feeling well/doesn't feel well), FEELING ABNORMAL (feels miserable from it), DIZZINESS (little lightheaded), COLD SWEAT (got a little clammy), VOMITING (throwing up/throwing up for 8-10 hours) and PYREXIA (low-grade fever). At the time of the report, MALAISE (still not feeling well/doesn't feel well), FEELING ABNORMAL (feels miserable from it), DIZZINESS (little lightheaded), COLD SWEAT (got a little clammy), VOMITING (throwing up/throwing up for 8-10 hours) and PYREXIA (low-grade fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported.   This case was linked to MOD-2021-346807 (Patient Link).
4/2/2021 3PM, Exhaustion and Chills 4/3/2021 8AM, Swollen left foot, painful to walk on 10/10 level of pain. Low back pain left side.  4/4/2021 - 4/15/2021: Exhaustion continues on and off
Vaccine given 10/30/02. Now some itching, rash (urticaria) on 11/2/02.
Altered menstrual cycle including breakthrough bleeding and early onset pms; Altered menstrual cycle including breakthrough bleeding and early onset pms; Altered menstrual cycle including breakthrough bleeding and early onset pms; This is a spontaneous report from a contactable healthcare professional (patient).  A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 17Feb2021 at a single dose for COVID-19 immunisation.  Medical history included COVID (if COVID prior vaccination: Yes).  The patient's concomitant medications were not reported. The patient has no known allergies. The patient experienced altered menstrual cycle including breakthrough bleeding and early onset PMS on 04Mar2021. The patient did not receive treatment for the events. The patient was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. Outcome of the events was unknown.   Information on the lot/batch number has been requested.