chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; Tired/ exhaustion; This case was reported by a consumer and described the occurrence of general body pain in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date, refer case US2019AMR157415).   On 27th August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced general body pain and tiredness. On an unknown date, the outcome of the general body pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient experienced body aches and so tired. The patient asked how long it would last.
Information has been received from a physician concerning an 11 years old patient who was vaccinated with two doses of VARIVAX on an unspecified date. On 15-JUN-2009 the patient experienced a mild case of chickenpox breakthrough. The patient reported that the patient had no fever. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Information has been received from a physician concerning a 14 year old (previous reported as 11 year old) male with environmental allergy and food allergy who on 22-MAY-2008 was vaccinated with the second dose of VARIVAX in the left deltoid at 3:30 pm. At the time of vaccination, the patient had a well child check up. On 15-JUN-2009 the patient not itchy red spots on trunk with lesions and vesicles on torso and legs. It was diagnosed to be varicella-mild case. At the time of the report, the patient recovered. No further information is available.
Patient turned pale, blue lips and circles around eyes. He started to shake heavily and felt cold. After about 5 minutes he vomited and shook heavily for about 30 minutes. We were able to warm him up with a blanket. He felt better after about 45 minutes.
Narrative:  COVID following COVID vaccine series 01/08 COVID vaccine dose #1 01/29 COVID vaccine dose #2 06/21-07/26 Tested for COVID every 3-4 days d/t CLC resident-NEGATIVE 07/29 COVID positive, admitted to inpatient for isolation 08/07 clinically resolved, asymptomatic entire course
Moderna COVID-19 Vaccine EUA Immediately after injection: 2-3 days of fever, chills, flu type feeling, exhaustion, heavy and sore arm.  1 week after shot: injection site and surrounding area became inflamed, itchy, stinging pain and hot/sore to touch. Reduced after 3 days.  2 weeks after shot: injection site and surrounding area (3 1/2? x 3 1/2?) has become inflamed, itchy, stinging pain and hot/sore to touch.  Both upper arm and lower forearm of injected arm (left) feel heavy and weak.
Pt called call center on 4/22/21with c/o rapid heartbeat and feeling of something stuck in pt's throat. Pt said, she received pfizer vaccine from location on Monday, 4/19/21. Pt said on her drive home, she got itchy which went away after 2 days. Informed pt she needed to go to an ED ASAP. Pt verbalized understand and said she has someone to take her to the ED.
Five minutes after second dose of moderna, patient complaints of scratchy throat and numbness to the left side of his tongue.  Benadryl 50 mg given IM and monitored additional 30 minutes and patient called X 2 in the next two hours with resolution of symptoms.   Follow up with PCP, UC or ER if any worsening of symptoms. CNP
no adverse event or side effects...pt was given vaccine that was beyond use date by 3 weeks
Dose given beyond 12 hours vial open; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given beyond 12 hours vial open) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given beyond 12 hours vial open). On 08-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose given beyond 12 hours vial open) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was given a booster dose on 08-Dec-2021 before 9am from a Moderna vial that had been open on 07-Dec-2021 at 8:15. The vial was taken out of fridge at 7:45am on 07-Dec-2021 and then used throughout the day and left at room temperature.  No Concomitant product use was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2021: Non significant information was received.
Vaccine - Fluzone HD  Couldn't walk, legs would not move at all. Called PCP, told this could be an AE. Recovered by 11/1/19.
pt recvd vax & was screaming for 3-4 hrs; leg swollen & red; pt had pain & local rxn;
painful swelling of scrotum & problem walking x 2 days; seen by MD 8AUG94; mild orchitis secondary to mumps component of MMR; APAP given; 16AUG94 fully recovered no pain;
fever & rash 30 hr p/vax;irritable had blood count, blood cult, hosp for 2 days for IV ceftriaxone & observation;15MAR had classic enteroviral exanthem;
Since the last dose I feel a lot of muscle pain and joint pain but it is very strong and I am a health professional and they demand the 3rd dose, can I still use it feeling like this?
Initial tingling in fingers and numbness in his arm. Fever in the left arm and soreness in his left arm and chest.
he passed away within 48 hours; This is a spontaneous report from a contactable consumer. A 64-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 15:30 (Batch/Lot Number: em9809) as dose 1, single for covid-19 immunisation. The patient has no medical history. Concomitant medication included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Feb2021, 12:00, the patient passed away within 48 hours. The patient received defibrillation as treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient died on 11Feb2021 due to cardiac disorder. An autopsy was not performed.; Reported Cause(s) of Death: Cardiac
This spontaneous report was received from a physician assistant via a company representative and refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 14-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX23 injection (dose, route of vaccination, lot# and expiration date were not reported) for prophylaxis. Since an unknown date in October 2016, after the vaccination, the patient was unable to move the arm where he received the injection. As of 18-OCT-2016, the outcome of the event was not resolved. The relatedness between the event and PNEUMOVAX23 was not provided. Additional information is not expected. Sender's Comments: MERCK 1610USA010455: Mfr number.
In  January  &  February  2021  I  took  the  first  2  doses  of  Moderna.   September 2021  I  took  the  Moderna  booster. April  2022  I  took  the  second  Moderna  booster,  and  in  September 2022  I  took  the  Moderna  Bivalent  booster.  In  September  2022  I  experienced  Shortness of Breath  that  felt  similar  to  the  previous  episode  in  2021   (see my  report # 919644 ).   I  Contacted  my  primary  physician  for  help.  He  ordered  another  CT  of  my  chest  with  contrast,  and  D-Dimer  blood  test.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Vomiting-Severe, Additional Details: caregiver (husband) came in to pharmacy to report severe reaction to his wife after covid 19 1st dose and hospitalization, he didnt want her to get second dose
Headache, Myalgia, Fever, fatigue, cough, dyspnea Narrative: Employee reported following vaccination 1/8/2021 low-grade fever 100°F for 24 hours. Moderate fever returned 01/17/21 and 01/18/21. Mild myalgia 1/9/21 and moderate myalgia 01/17/21 until 01/19/21. Mild cough with dyspnea 01/17/21 until 01/18/21. COVID 19 screening 01/19/21 was negative. Resulted in unable to work 01/19/21 and 01/20/21.
DAYS 1-4 headache, chills, body aches, injection site pain Narrative:
This spontaneous report as received from a registered refers to an unspecified patient. On 09-SEP-2014 the patient was vaccinated with expired MMR II (dose, frequency, lot no. unknown). The lot had expired on 24-AUG-2014. No concomitant medication was reported. No adverse effects were reported. Product quality complaint was not involved. The outcome of events was unknown. Additional information has been requested.
Information has been received from a company representative concerning a female who on unspecified date was vaccinated with Gardasil (lot# unspecified) and experienced muscle soreness all over her body.  Unspecified medical attention was sought.  At the time of this report the outcome was unknown.  No other information was provided.  Additional information has been requested.
Suspected vaccination failure; shingles; Rash on left chest area that is just above left breast and moves over to sternum area, itchy; red Red; Pimples that was extremely itchy; Pimples sore to touch / Whole body aches; Low grade fever; Some weeping; headache; stomach pain; heat rash; Itchy rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high.   In January 2019, the patient received the 1st dose of Shingrix. In March 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a year after receiving Shingrix and between 6 and 7 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, itchy rash, red rash, pimples, pain, low grade fever, secretion discharge, headache, stomach pain, heat rash and itchy rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, shingles, itchy rash, red rash, pimples, pain, low grade fever, secretion discharge, headache, stomach pain, heat rash and itchy rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, itchy rash, red rash, pimples, pain, low grade fever, secretion discharge, headache, stomach pain, heat rash and itchy rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 68 or 69 years old. She noted she takes a blood pressure medication but otherwise was healthy. Within the last week, 5 days before the date of reporting, the patient started with a rash on her left chest area that was just above her left breast and moves over to her sternum area. It was red, has pimples that was extremely itchy and sore to touch.  The patient stated there was some weeping, but she put alcohol on the rash because she thought it was a heat rash. This case was considered as suspected vaccination failure since the details regarding completion of time to onset and laboratory confirmation were unknown at the time of reporting. The patient had not started the Valtrex yet, because she wants to be sure, so she has an appointment with her primary physician office in the afternoon of reporting day. The patient had low grade fever of 100 to 102 degree C, with whole body aches, headache and stomach pain.  She was concerned because she had both doses of Shingrix and now got the shingles. The reporter consented to follow up.
pt recv vax 28MAY96 & onset of chickenpox 13MAY98 seen in office 15MAY98 dx varicella vax failure;
COVID infection; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID infection) in a 121-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for an unknown indication.     No Medical History information was reported.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID infection). At the time of the report, COVID-19 (COVID infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided. Concomitant medications were not provided.
Information has been received from a physician concerning a female pt who on 7/14/99 was vaccinated with MMR and in July 1999, post vax, the pt developed measles. The reporting physician noted that the "pt was dx'd as having developed measles but she has not seen pt and does not know the source of the dx". No further information is available.
Information has been received from a 75 year old female patient via a company representative concerning herself. The patient concurrent condition included bone strength disorder and cholesterol abnormal. The patient did not have drug reactions/allergies. On an unknown date in 2012 the patient was vaccinated with a dose of ZOSTAVAX (one time vaccination, dose and route not reported). Concomitant therapies included BONIVA and LIPITOR. On an unknown date (reported as a few months ago) the patient experienced shingles rash on her waste. The rash went away within three weeks but the pain was still there. The patient went to doctor to seek medical attention. The physician prescribed pain medication as treatment for patient. There was no diagnostics studies performed. The outcome of event was not resolved. Additional information has been requested.
My pregnancy ended in stillbirth on June 30, 2021. I was 34 weeks pregnant. My doctor confirmed no heartbeat on June 28, 2021. The estimated date of delivery was August 11, 2021. This was considered a low-risk pregnancy. There is no cause found for the still birth after multiple blood tests and during delivery.
9 days after injection woke up with redness directly below injection site (two inches long, one inch wide, slightly raised). No discomfort or itching. Resembled an allergic reaction (hive). Began to dissipate after 24 hours, took loratadine (antihistamine) before bed and redness mostly resolved upon waking.
7 hrs p/inject felt feverish & chills occurred; didn;t take temp but fell feverish & "out of it"; took temp !@ 10AM (12 hrs later) & nausea lingered another few hrs;
Severe stomach pain, vomiting, severe headache at top of head, lightheadedness, dystonic movement of legs and shoulders.
I went back to the hospital and couple days later they told me that actually I have Deep vein thrombosis now in my legs; my Crohn's had caused really bad flare up/I have been in the hospital for 5 days now with the clot and Crohn's Flare; I also have superficial clot in that left leg that was the pain began on the edges/blood clot; the arm is much better now. You know that's not really sore; I just was too tired/extreme fatigue; really bad like pain; Shortness of breath; This is a spontaneous report received from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 29Mar2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation.  Medical history included multiple sclerosis from an unknown date and unknown if ongoing, ileostomy from an unknown date and unknown if ongoing, back surgery from an unknown date and unknown if ongoing, Crohn's disease from an unknown date and unknown if ongoing , blood clot in arm back from 2014 to an unknown date. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on 08Mar2021 and experienced terrible diarrhea and neuralgia. Concomitant medication(s) included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; valaciclovir hydrochloride (VALTREX) taken for an unspecified indication, start and stop date were not reported; diazepam (DIAZEPAM) taken for an unspecified indication, start and stop date were not reported;  (ZOFRAN) taken for an unspecified indication, start and stop date were not reported; oxycodone (OXYCODONE) taken for an unspecified indication, start and stop date were not reported; lansoprazole (PREVACID) taken for an unspecified indication, start and stop date were not reported.  After second dose on 29th  (29Mar2021) immediately he was really bad like pain and had shortness of breath. The patient stated that she had a back surgery and so she always felt bad, so she didn't think anything of it. But then she ended up into ER after the second dose and discovered that her Crohn's had caused really bad flare up. She mentioned her foot was looking strange but she was just too tired and left the ER. She then went back to the hospital and couple days later they told her that she actually had deep vein thrombosis now in her legs. She also had superficial clot in that left leg where the pain began on the edges. The patient reported that the vaccine was basically started the Crohn's flare up. The patient also stated that  "the arm was much better now and not really sore".  The patient was hospitalized for DVT from unknown date and for Crohn's flare up for 5 days.  The patient underwent lab tests and procedures which included endoscopy, sigmoidoscopy, ultrasound scan: all on  unknown date with unknown result. The patient was treated with Entyvio and on blood thinners now for a blood clot. The outcome of pain in extremity was recovering while others was unknown.
The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse events had been reported. Patient has not yet returned for the full dose.
This spontaneous report was received from an administrator referring to a 5 years old patient of unknown gender. The patient had no known drug allergies. The patient's concurrent condition, pertinent medical history and concomitant medication were not reported. On 20-MAY-2019, 04-JAN-2022 and 03-MAY-2023, the patient received vaccination with PROQUAD (strength, exact dose, route, lot # and expiry date were not provided) for prophylaxis (Extra dose administered). Confirmed no other adverse event (AE) occurred. Inquired about adverse events that would occur if a third dose of PROQUAD was given to a patient.
3/08/07 nausea and malaise 2 hours after vaccination.  3/9/07 - 3/13/07 Nausea, hot flashes, dizziness, joint pain and jaundice.    3/14/07 To physician, lab studies performed.  3/15/07 Elevated bilirubin and liver enzymes.  Symptom improvement noted.
Cold urticaria: getting hives, redness and swelling to skin exposed to cold; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 31Mar2021 at 10:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had known allergies to pethidine hydrochloride (DEMEROL). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 18:15, the patient experienced cold urticaria: patient got hives, redness and swelling to skin exposed to cold. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event cold urticaria was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
cold; fever; headache; This is a spontaneous report from a contactable Consumer. This consumer reported for her son (patient).  A male patient of an unspecified age received first dose of BNT162B2(solution for injection; Lot number and expiration date was not reported), via an unspecified route of administration on 03May2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced cold, fever and headache. Reporter stated that her son got the first dose of the COVID vaccine on 03May and is scheduled for the second dose of the covid vaccine on 24May but at this time the patient had cold, fever and headache. Reporter wanted to know can already do the covid test before the second dose or it may be after. Reporter wanted to know if those side effects are normal since she had seen those in the papers they were given after vaccination. Referred CDC to check about recommendations on covid tests. Information about lot/batch number has been requested.  Information about lot/batch number has been requested.
Child felt fine during appointment.  Received vaccine of Menactra in left arm with little pain and Trumenba in the right arm with a lot of pain that has continued to worsen thru the day & into the night. His right arm has swollen slightly near injection sight. And right shoulder is sore.  Has pain moving his arm at all.  In addition, he has become increasingly ill feeling.  Developing a headache, nausea, & chills from 7:00 pm & it is continuing now at 1:30 am.  I have given him 3 tsp. of Childrens liquid Advil every 6 hours without much relief.  The pain has not let up, nor his other symptoms.  He has been drinking water & ice chips throughout the evening.  He feels so terrible right now after feeling fine going into his appointment to get these vaccines.  They were the only 2 he received today.  My son has not been sick in over a year! Until today. :(
On the 1/23  I started to have a rash at the area of the injection site. It was very uncomfortable. Very itchy and felt very hot.  I had to ice pack it and put calamine lotion to help with the symptoms. I did not take anything orally as I was not sure if it was safe to take anti histamines being that I am pregnant. The next day I went to work however I was still having a lot of itchiness in the area of injection.  I took a benadryl table at around 9 am.  At around 10 o'clock I started feeling dizzy and not myself.  I felt that I could not think clearly and I was worried about passing out.  Specially due to my pregnancy ( 13 weeks at that time)  I decided to seek medical attention and went to urgent care.
Facial swelling and pain at site of previous facial filler.  Woke me up around 3am 1/30/21.  Treatment:  watch and wait, no meds.  Outcome: Swelling and tenderness is almost gone as of 2/1/21 12pm.