chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a 63 year old male patient. The patient's medical history was not provided. The patient did not have any known drug reactions or allergies. The patient's concurrent condition included chronic obstructive pulmonary disease (COPD). His concomitant therapies included BREO, PROAIR and NEXIUM. On 29-AUG-2017, the patient was intramuscularly vaccinated with a dose of PNEUMOVAX 23 lot # N003993, expiration date 20-OCT-2018 (dose was not reported) for prophylaxis. On approximately 29-AUG-2017, the patient experienced hives on arms, back and chest which did not itch and was seen by the reporter on 30-AUG-2017. He took one dose of BENADRYL)on 30-AUG-2017 that provided relief. No lab diagnostic studies were performed. The outcome of urticaria was reported as not recovered/not resolved. The relatedness between the event and the suspect drug was not reported.
Within 5-10 minutes of patient receiving TdaP and gardasil, pt had a 30 second episode of stiffening and blank staring.  Since that time she has had a headache and blurry vision.  Had some flushing as well.
feels like she is getting sick; tired; lot of anxiety; This is a spontaneous report from a contactable consumer. This female consumer reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 10Feb2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took flu shot for flu vaccination and feels sore. On 10Feb2021, the patient experienced feels like she is getting sick, tired, lot of anxiety. She and her husband just got vaccinated this morning. She feels stuff and she is worried, and it is 5 o'clock, and asked if it is normal or not. She usually gets the flu shot and she feels sore but that does not bother her that much and she felt a little bit not well after the flu shot for the next 24 hours and then the next day, she feels a little bit better. With the covid vaccine she felt a little more not normal and felt like she is getting sick. She felt tired and a lot of anxiety when she went to get the shot. She declined to provide further details to complete report and wants to ask if these are normal side effects. The clinical outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Caller stated she had a CT scan and was told the lymph nodes are reactive.; Caller stated she did not pay attention; Caller stated they are hard, round nodules; Noticed swelling in her neck; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Lot number and Expiration date were not reported), via an unknown route of administration on 03Mar2021 as, single dose for covid-19 immunisation. Medical history included, on 24Jan2021 she woke up and had swollen lymph glands on the same side, had wrist surgery on an unknown date. The patient's concomitant medications were not reported. The patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Lot number and Expiration date were not reported), dose 1 via an unknown route of administration on an unknown date in Feb2021 as single dose for covid-19 immunisation. The patient previously took doxycycline. The patient reported that, she did not paid attention and one morning she was brushing her teeth and noticed swelling in her neck. It was reported that since 03Mar2021 she had the hard, round nodules and swelling in her neck. She had a CT scan and was told the lymph nodes are reactive. The patient reported that the HCP was not sure why they are there and had made a case via a conference to see if this was from the vaccine or not. HCP told that it could be correlated to the immune system. The patient wanted to ask how many other people reported the same thing. The outcome of events was unknown.  Follow up information has been requested.
extreme pain in arm, radiating into biceps tendon area. Cannot lift arm more than 10 degrees
Recieved COVID 19 vaccine 2/24/21  and 3/24/21. On 4/10/21 started noticing left lower leg discomfort. 4/13/21-Duplex showed DVT
Abdominal pain that proceeded to get worse into the next day. Connected with PCP, had labs drawn and ultrasound ordered. Ended up going to ER. Determined to have Appendicitis, needed and had appendectomy on 12/29/2020.
1st Moderna shot received 4/22/21.  Swollen lymph appeared on left side of neck 2 days later on 4/24/21. I had neck pain and the size of the lymph node did not go down in size. It was golf ball sized. I had a body massage on 5/8/21 where the massage therapist tried to do a lymphatic massage to promote circulation and drainage. This helped the lymph node reduce in size within 24 hours. It went from a golf ball size to kidney bean size.  The lymph node has stayed the same kidney bean size since 5/9/21 and has not gone down in size. I had another massage on 6/5/21 in hopes that that it would help, but it has not.   I had a doctor's visit on 5/14/21 because I had concerns about getting my 2nd Moderna shot. Ultimately, I did get my second vaccine but was advised by my doctor to revisit in July or August if my lymph node doesn't go away. Since it is still here, I will have to schedule that visit.  The lymph node is kidney bean size, and does feel like it causes tension pain in my neck at times.
Chills Extreme pain/aches throughout body for at least 10 hours even after taking Tylenol Sharp chest pains on both left and right side of chest near breasts Sharp pains went from chest to upper back
The newly FDA (Food and Drug Administration) authorized Moderna bivalent formulation has a slightly higher dosage than what their child recently received.  According to the guidelines from the CDC (Centers for Disease Control and Prevention), it is recommended that we repeat their child?s most recent dose of COVID-19 vaccine to ensure proper protection. No adverse effects
p/vax pt exp pain in lt upper arm;bandaid applied @ inj was removed & skin came w/it;a cellulitis rxn;tx w/Augmentin;
Pt received 2nd dose on Pfizer Vaccine on 1/26.  He had COVID symptoms on 3/26. He tested negative then. Symptoms continued over the weekend. Patient returned to clinic for another COVID test and results were positive for the virus.
Mentrual bleeding completely out of cycle. I track my cycle and was not due to start menstruating for at least two weeks. Bleeding and symptoms began about five hours of receiving second dose. The bleeding is not temporary, it seems as though the shot has initiated an early cycle.
The second day I only had a sore arm where I received the injection. Thereafter, and up until 4/2/21 PM when going to bed I had fluctuations of hot and cold sweats, difficulty sleeping, daily low grade fever, neck and shoulder pain, mild to medium headaches, and a much lower than usual energy levels.
APPROX 2 HRS AFTER VACCINE GIVEN, STARTED TO GET HIVES, SELF MEDICATED WITH BENEDRYL, BY THE NEXT MORNING I HAD SEVERE HIVES ALL OVER MY BODY, CONTINUED WITH BENEDRYL. ON THURSDAY MORNING WENT TO URGERT CARE AND WAS GIVEN STEROID AND ANTI ITCH PILLS. ON SATURDAY SYMPTIOMS WERE NO BETTER SO WENT TO ER CLINIC AND WAS PRESCRIBED PREDNISONE AND ADDITIONAL ANTI HISTIMINES. HIVES WERE COVERING MY ENTIRE BODY AND WERE CAUSEING MY SKIN TO BE A PURPLE, DARK RED COLOR.  I  AM ON DAY 7, STILL HAVE SPOTS WHERE HIVES HAVE BEEN, STILL ITCH, SKIN IS SORE AND WARM TO THE TOUCH. I HAVE 2 FULL DAYS OF MEDS TO KEEP TAKING.
Diagnosed with MYASTHENIA GRAVIS. Symptoms appeared 2 1/2 weeks after Covid booster. Symptoms are Diplopia and ptosis. Currently being treated (ineffectively) with pyridostigmine and prednisone.
she developed a shingles rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2022, the patient received the 1st dose of Shingrix (intramuscular). In July 2022, 7 days after receiving Shingrix, the patient experienced shingles. The patient was treated with famciclovir. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK receipt date: 07 July 2022 Reporters comment: The patient self-reported this case. The patient received Shingrix dose in left arm and experienced shingles rash on her left arm. Her doctor prescribed famciclovir to treat the shingles. The reporter did not consent for follow-up.
flu; Initial information received on 12-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media.  This case involves  patient of unknown demographics who had flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency, route, administration site, lot number and expiry date was unknown) for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"The worst case of flu I ever got was the year a got the flu shot."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
She did not receive the full dose; The needle was not screwed in all the way and some of the dose leaked out.; The needle was not screwed in all the way and some of the dose leaked out.; This case was received via an unknown source no reference has been entered for a health authority on 29-Apr-2021 and was forwarded to Moderna on 29-Apr-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of not receiving the full dose, the needle was not screwed in all the way and some of the dose leaked out, and the needle was not screwed in all the way and some of the dose leaked out in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced not receive the full dose, the needle was not screwed in all the way and some of the dose leaked out, and the needle was not screwed in all the way and some of the dose leaked out. On 28-Apr-2021, She did not receive the full dose, the needle was not screwed in all the way and some of the dose leaked out, and the needle was not screwed in all the way and some of the dose leaked out had resolved.        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.   No concomitant medications were provided. Treatment for the events were not provided.
fatigue; Nauseous; extreme headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous), HEADACHE (extreme headache) and FATIGUE (fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Brain tumor (Experience regular headache).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced NAUSEA (Nauseous) and HEADACHE (extreme headache). On 09-Mar-2021, the patient experienced FATIGUE (fatigue). At the time of the report, NAUSEA (Nauseous) outcome was unknown and HEADACHE (extreme headache) and FATIGUE (fatigue) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient states that her headache was extreme to an extent it dwarfed her tumor headache and it was different. On 10-Mar-2021, her headache and fatigue seemed to be improving. Concomitant medications were not reported. Treatment information in response to events was not provided.
pain at injection site, fatigue, fever, severe muscle pain growing most severe between 4 hours until 12 hours after injection
Maternal exposure during pregnancy; Administered with vaccine that has been outside the refrigeration for more than 24 hours; temperature excursion; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that has been outside the refrigeration for more than 24 hours), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    The patient's past medical history included COVID-19.   On 12-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 14-Feb-2022 at 12:30 PM, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion). On 15-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that has been outside the refrigeration for more than 24 hours). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 15-Feb-2022 at 4:30 AM, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) outcome was unknown. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that has been outside the refrigeration for more than 24 hours) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that  about 5.5ml vial that was left outside the refrigerator for more than 24hours (14Feb2022 at 12:30 to 15Feb2022 at 4:30pm) and administered to patient on 15Feb2022. Patient was fine and there is no show of any sign and symptoms.  Storage condition at the time of the excursion - Ambient temperature.  It was reported maximum or minimum temperatures reached (specified temp is in C or F)- 65 degrees Fahrenheit  Excursion duration was 24 hours  Vial(s) moved from freezer to refrigerator on 13Feb2022 at 4:00pm  Vial was Discarded  On Visual inspection noting any vaccine state change Vial was Thawed / in Liquid form  Proposed desired Use by Date - Vial used on 15Feb2022  Number of vials/doses impacted-1 (5.5ml)  It was reported vials were not punctured before the excursion  No concomitant and treatment medications were reported.
Sore arrm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arrm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arrm). At the time of the report, PAIN IN EXTREMITY (Sore arrm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-079221 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up information received on  29-JUN-2021.Event outcome  updated(from unknown to recovered/resolved).
Pfizer booster dose given from a vial that was used 3 days beyond its use-by date of 12/31/21 (in error) Vial thaw date of 11/30/21. Manufacturer contacted who recommended re-vaccination as no viability data available beyond 32 days from the thaw date Multiple attempts done to contact patient via phone to inform them of the error and the need to get re-boosted.  Letter mailed to patient's home address to contact PCP and come in for re-vaccination (booster dose)  New policies adopted at Medical Center to improve tracking of vaccine use-by dates.
pt recv vax & next day woke up w/marked weakness lt side of face unable to completely close lt eye & side of mouth;Bells palsy but pt actually in because of URI & pharynx inflammed;
it was rpt fr person in MD ofc concerning pt who was vax & subsequently pt exp measles w/small bumps all over lasting 2-3.
low grade fever x 48hr;nausea x 48hr;achiness in upper body x 48hr;
DIFFICULTY SLEEPING; FORGET THINGS; NECK NOT FEELING GOOD; HEADACHE; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight was 220 pounds, and height was 71 inches. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient was not a drug abuse or illicit drug user.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 06-SEP-2021) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced difficulty sleeping, forget things, neck not feeling good, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of difficulty sleeping, forget things and neck not feeling good was not reported. This report was non-serious.
High fever, chills, body aches on all joints, severe headache. missed the next two days of work.
Appearance of allergic reaction around the point of application of the vaccine. It was treated with medicine due to itching and redness at the site. The allergic reaction lasted a day and then disappeared.
Muscle joint aches; Arm pain; Joint pain; Fever; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Muscle joint aches), VACCINATION SITE PAIN (Arm pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MYALGIA (Muscle joint aches), VACCINATION SITE PAIN (Arm pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever). At the time of the report, MYALGIA (Muscle joint aches), VACCINATION SITE PAIN (Arm pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: in the past in the Past.     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.   No concomitant product use was provided by the reporter.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Starting 07/18/2022, when I woke up, I had severe body aches like a very bad fibromyalgia flare up. Also, I felt very sleepy. This has been affecting my daily life and things I need to do. I have had to cancel appointments, dog sitting visits and more. Most of the time I feel bad, with a few days where I was able to do things. My fibromyalgia had been mostly under control for about 2 years before this happened. I have been seeing my regular internist and am trying to find a rheumatologist. Also, I have had a hernia for the last 2 months.
Menstrual cycle rapid reoccurrence: My period ended March 31 as normal, then returned April 9-14, then returned again April 20. Blood loss is more than usual and is resulting in difficulty with daily activities. Phizer COVID vaccine administered March 18 & April 13
No PQC or additional AEs reported; expired dose of ROTATEQ was administered; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.  On 14-MAY-2021, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliters (ml) administered orally for prophylaxis  (dose number and vaccination scheme frequency were not reported; lot number 1676324 has been verified to be valid, expiration date reported and validated as 21-ABR-2021) (expired product administered).  The reporter requested information regarding the potency of vaccine. No additional adverse events (AEs) reported.
Information has been received from a consumer concerning her 19 year old daughter with allergic reaction to Tdap (the patient was starting into space and constantly crying) and a history of shingles (onset when she was five years old) who "about three weeks ago", on approximately 24-JUL-2008, was vaccinated with a first dose of GARDASIL. "About 6 weeks ago", on approximately 03-JUL-2008, the patient had a neurological episode where she losing her vision, muscle spasms and had severe headaches. It was reported that the patient was seen by a neurologist who did blood work, spinal tap and at first they thought she was having a brain amorism, and then they ruled that out with everything else and diagnosed her with having a full blown migraine episode. The reporter stated that the patient was hospitalized for a short time for blood patches because her spinal fluid was leaking for three days, and she was having severe spinal headaches. It was reported that at hospital the patient was given VICODIN and other medications, which were unspecified. The reporter stated that it took her sometime for the headaches to go away. But "about three weeks later", on approximately 24-JUL-2008, the patient went to her pediatrician and was given a dose of GARDASIL. After the vaccination, the patient was "still having mild headaches", but the patient had been given medication, which the name and manufacturer was unspecified, to treat her migraines. It was reported that the patient needed hospitalization or prolonged hospitalized. At the time of the report, the patient was recovering from the event. No further information is available.
PATIENT COMPLAINED AND WAS TOLD SHOT WAS GIVEN TO HIGH AND CAUSED BURSITIS IN  SHOULDER BY URGENT CARE MD