chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient reporting for herself). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, on 29Mar2021, as a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in 2021, it was reported that the patient was due for her second dose, she but developed shingles and her doctor put her on valaciclovir (VALTREX). It was also queried if the valaciclovir will interfere with receiving the vaccine and if it's contraindicated in people who are immunocompromised. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recvd 2nd dose of vax for 2-3 days had h/a, fever; parents do not want OPV again MD recommends completing series w/IPV;
About 13 hours after vaccination,  I had a 101.5 fever, vomiting and extreme lethargy.  I am now 48 hours post vaccine and still have a 99 degree fever and very tired. I am not vomiting anymore. Vomiting only lasted about 5 hours.
Fever 101.6, headache, chills, aches pains, lethargic
Information has been received from a registered nurse referring to an unspecified amount of patients of unknown age and gender. The nurse reported that an unspecified amount of doses of GARDASIL (lot#, dose and route not reported) that underwent a temperature excursion was administered to the unspecified amount of patients on an unknown dates. No adverse effect was reported. Additional information has been requested.
Severe arm and shoulder pain past seasonal influenza vaccination - Right arm. Pain persisted - seen in employee health 10/1/09 - Referred to occupational medicine. Seen in urgent care 10/4/09. Continues to treat with doctor in occupational medicine 10/7/09.
sx rash, inc temp, h/a, tired feeling (arms);CP, itchy x 4 days;T98.1;dx adverse rxn to immun;tx med;
I received the TDAP shot Monday 09-21-09 at the time I had no problems three days later my right under arm (lymphnoid) swelled up and was very painful I took a 800 mg ibuprofen and it did help a little but the site stayed swollen for several days.
developed a lump over the left clavicle 24 hours after vaccination into ipsilateral deltoid
Joint pain in hips, groin, left shoulder, and both wrists.60 day follow-up dated 09/29/00 states the pt has pain in back of neck. Pain hampers walking and driving an automobile. The annual follow-up states neck pain, loss of flexibility in both wrists and weakness. Also, the right shoulder pain and much groin pain.
Widespread red rashes and itching started on the morning of 11/23/21. Heartburn started at 12pm on 11/23/21. Pounding headache started at night on 11/23/21. Symptoms have been present since but have been mild since 12/01/21 as I was prescribed prednisone (20mg), cetirizine (10mg), and famotidine (20mg). I went through all the foods that I ingested in the 48h prior to the onset of symptoms and nothing stood out besides two new supplement (folic acid + vitamin B6) and parsnips. The reaction may not be related to the vaccine but I wanted to do my due diligence in case it's the trigger for these symptoms.
High blood pressure (190/70) Painful headache due to high blood pressure Heart palpitations Hives on left arm above elbow
pt recv vax & devel an intense, burning pain @ the inj site which lasted 10min;pt screamed for a good ten minutes;
Parent states 1 week after recieving MMR and Varicella vaccine, child is limping. Parent denies any trauma/fall. Parent concerned about joint pain, which was mentioned in MMR VIS form. Recommended to parent to have child examined by pediatrician.
Dizzy, nauseous, vomiting, headache, body aches, sore arm, sleepiness.
Extreme fatigue, muscle aches and weakness.  Began to feel very tired the evening after the H1N1 vaccine (Monday).  By Wednesday was feeling extreme fatigue, unable to work.  No other symptoms (no nasal congestion, sore throat, etc.) Fatigue continued through Friday, went to see doctor (got blood test, no results yet).  On Saturday felt much better.
Nausea, low heart rate (40) high blood pressure, dizzy, chest pain.
Patient was felt normal after leaving the pharmacy. In the evening after the vaccination, patient started to experience muscle aches, chills,and tremors throughout the evening.  Experienced slightly elevated fever approximately around 100 degrees Fahrenheit. Struggled to mobilize her arm that was vaccinated. Reported poor appetite and flu-like symptoms. Patient tried alternating taking ibuprofen and acetaminophen. On the next morning, patient went to the gym and noticed bruises on arm.
My thyroid levels dropped to an abnormal range of .33. I am under doctors care to get it back to normal. I will return  to doctor in March to have THS levels evaluated.
COVID-19 Infection; COVID-19 Infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 9-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 8 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Mar2022, outcome "unknown", COVID-19 (medically significant) with onset Mar2022, outcome "recovered" and all described as "COVID-19 Infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2022) Positive. Therapeutic measures were not taken as a result of covid-19.  Clinical course: No vaccine in 4 weeks and no other medication in 2 weeks. No covid prior vaccination. patient was tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The Moderna Bivalent Booster given on 12/16/22 was administered 9:42AM after being punctured at 2pm on 12/15/22 and stored at ambient temperature. This exceeds the 12 hour recommended range to store this vaccine at ambient temperature. The CDC and manufacturer was contacted and information gathered from both. This vaccine is considered safe to administer for up to 24 hours after puncture though there is a minute increase in risk for microbial infection, repeat dosage is not recommended.
12/28/2020 After the first vaccine my arm hurt for over a month, and it was throbbing and in constant pain. This pain was also in my shoulder as well. After a month it slowly went away and Then after receiving my second vaccine, the arm pain was not as much and it slowly went away. I was simply tired and took some Tylenol to ease any discomfort.  After my booster shot, I began to experience some dizziness and took some Tylenol. The day after I started to feel cold, tired, and a headache came on very strong. This lasted for a few days and then I began to feel much better. The only symptoms I have are a little fatigue, and dizziness.
Day 1 - Felt a warm tingling sensation in my arm and shoulder within minutes of receiving the injection.  After 2-3 hours became very tired and developed a moderate level of general soreness around the injection point and surrounding shoulder area.   Day 2 - Upon waking up in the morning, my shoulder area felt itchy and I noticed a rash was begining to grow.   Day 3 - The rash grew worse and ai started noticing a slight burning sensation.  I called Teledoc and reported my symptoms. The doctor prescribed me Prednisone (20mg) as well as Triamcinolone Acetonide Ointment (0.1%).  He also instructed me to take 2 Benadryls before bed, which I have been doing since day 3.  I took the Prednisone twice per day for 5 days and applied the ointment 3-4 times per day along with using surgical pads when I had to wear a shirt.   Day 4 - Blisters developed and began to secrete a puss like liquid.  Burning sensation intensified.   Day 5 - Similar to day 4.   Days 6-9 - Same.   Day 10 - Finally started to stop blistering and begin to scab.   Day 12 - Redness began reducing and burning sensation has stopped.  Slight itchiness still persists.
Client sitting in his wheelchair after 1st COVID 19 vaccination, arrived in observation room 1:57pm. Client with complaint of headache. He reported rating as 5 and said headache usually followed by syncope. He then lost consciousness and aroused by a nurse present in the room. He was maintained in his wheelchair. He was breathing on his own and has a pulse. He noted headache still present, again lost consciousness and was aroused by a nurse in the room. EMS arrived and assisted client to the floor. He aroused. EMS assessed the client, and brought paramedic assessed EKG. Client was transferred to stretcher, awake responsive. Client
Swelling ankle; Neck pain; Hair shedding; Pain in the back leg; Wrist pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling ankle), NECK PAIN (Neck pain), HAIR DISORDER (Hair shedding), PAIN IN EXTREMITY (Pain in the back leg) and ARTHRALGIA (Wrist pain) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Swelling ankle), NECK PAIN (Neck pain), HAIR DISORDER (Hair shedding), PAIN IN EXTREMITY (Pain in the back leg) and ARTHRALGIA (Wrist pain). At the time of the report, JOINT SWELLING (Swelling ankle), NECK PAIN (Neck pain), HAIR DISORDER (Hair shedding), PAIN IN EXTREMITY (Pain in the back leg) and ARTHRALGIA (Wrist pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was reported.
His rashes continued and spread to both arms the back of his legs and calves, and on his side; This spontaneous case was reported by a consumer and describes the occurrence of RASH (His rashes continued and spread to both arms the back of his legs and calves, and on his side) in a 72-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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-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 RASH (His rashes continued and spread to both arms the back of his legs and calves, and on his side). At the time of the report, RASH (His rashes continued and spread to both arms the back of his legs and calves, and on his side) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-068333 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068333:1st dose
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 06-MAR-2018, the patient was vaccinated with an expired dose of VARIVAX subcutaneous, lot# M009766, expiration date 23-FEB-2018, for prophylaxis (strength, dose, frequency were not reported). The vaccine was reconstituted with an Merck sterile diluent, lot # M004656, expiration date 13-AUG-2018. No temperature excursions were involved. No symptoms reported.
Information has been received from a physician concerning a 4 year old male patient with a history of bone marrow transplant from brother for Hemochromatosis (histiocytosis) in 2008 and no history of chickenpox who on an unspecified date was vaccinated with VARIVAX (Merck) (site of vaccination unknown). On 06-MAR-2011 the patient experienced herpes zoster (dermatome L2, 3, 4) from right thigh to generalized. There were about 50 vesicles lesions that distributed at right thigh, face and chest. The physician also added that she was unsure if the patient was vaccinated for chicken pox and the patient titer was .04; the brother was vaccinated and had a titer of 2.7 and 2.26 prior to treatment. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. A skin lesion sample was collected on 08-MAR-2011. The final result was vaccine strain. On 09-MAR-2011, the patient had a fever of 102.0 F degrees. The patient was hospitalized briefly for antiviral therapy. The patient was treated with acyclovir. At the time of reporting, the patient was recovering. Additional information has been requested.
13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. List of concomitant medication were not given. In source document stated that vaccine was pulled from the freezer on 10/13/2021 with a "use by date" of 11/12/2021   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up  contains no new information.
I got a big red hot rash on the left side of my arm, a week later I had a couldn't move or fold my leg /hip on my left side. I made an appointment two weeks later and Dr. asked me if I had started a new exercise which I haven't, so I was Prescribed Steroids and it took me about a week to get 100 % better.
A short time after receiving the anthrax vaccine, this individual came back to the clinic complaining of shortness of breath/difficulty breathing. His heart rate was high and he was sent to the family practice clinic, where he was given epinephrine and sent to ER. Reporter was later told that this subject had a previously unknown "unusual health condition". Reporter couldn't recall what the condition was. Reporter states that a VAERS report was submitted. Subject recovered.
Patient says he has been experiencing severe muscle pain for approximately the past 10 days. He received the first dose over 3 weeks ago. The pain is almost unbearable per the patient. I instructed patient to get immediately with his md.
COVID VACCINE CAUSED SORE ARM; HEADACHE; PAIN EVERY DAY; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (PAIN EVERY DAY), VACCINATION SITE PAIN (COVID VACCINE CAUSED SORE ARM) and HEADACHE (HEADACHE) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2019, the patient experienced PAIN (PAIN EVERY DAY). On an unknown date, the patient experienced VACCINATION SITE PAIN (COVID VACCINE CAUSED SORE ARM) and HEADACHE (HEADACHE). At the time of the report, PAIN (PAIN EVERY DAY) had not resolved and VACCINATION SITE PAIN (COVID VACCINE CAUSED SORE ARM) and HEADACHE (HEADACHE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment details were unknown.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
From initial information received on Jul 01 2005 from a registered nurse regarding an adverse event, it was reported that an 18 year old female patient received a dose of Menactra vaccine, lot number U1640AA, administered in the left deltoid on June 27 2005. reportedly the next day the patient developed diarrhea, nausea and vomiting for two days. On Jul 01 2005 the patient developed lightheadedness, dizziness and lower back pain. The patient was seen by a physician, her recovery status was reported as not recovered.
This spontaneous report as received from a registered pharmacist refers to a female patient in her 50's. In July 2013 the patient ws vaccinated with single standard dose of ZOSTAVAX for prevention of shingles (route and lot # not reported). In July 2013 the patient developed a rash, swelling and hives after receiving  ZOSTAVAX. The patient talked to their doctor for medical attention. The outcome of hives, rash and swelling was unknown. Additional information has been requested.
Patient received a re frozen dose of the vaccine; Patient received a re frozen dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a re frozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patient received a re frozen dose of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 23C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a re frozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patient received a re frozen dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a re frozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patient received a re frozen dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious events of expired product administered and product storage error. The events occurred  unknown date after the third dose of Moderna vaccine.  The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious events of expired product administered and product storage error. The events occurred  unknown date after the third dose of Moderna vaccine.  The benefit-risk relationship of Moderna vaccine is not affected by this report.
Pain, tenderness, redness, and swelling at the injection site 9 days after 1/15/21 shot after the initial pain had resolved. Several hours after the arm pain, fatigue, mild fever, and chills started.
rash began on shoulder evening of 17DEC97;w/in 12-18hr spread to back, down arm & front chest area around collar bones;itching, raised, bumpy feeling, red in color;saw MD given DPH po & cream;rash lasted 3d;MD felt should not complete serie
Caller reports no further AE; Caller states the vaccine was administered yesterday (29-MAR-2021), today the office realized the vaccine expired on 14-MAR-2021; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 29-MAR-2021, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dosage regimen was not reported), lot # S007813 (rHA) and expiration date 14-MAR-2021 administered as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT).  No additional adverse event was reported.
Starting at 1:00am  3/22/21 I woke to have chills where I could not get warm.  The original soreness in my right arm had radiated to the side of my neck and down to my shoulder blade.  By 3:00am I had a fever of 101 and was feeling nauseous.  By morning  6:00am I was just sore all over my body with a light headache.  This  continued through out the day with feeling tired and groggy.  Went to bed at 930pm and awoke 630am 3/23/21 feeling sore on the arm and body aches but, much better.
Initial spontaneous report received from a healthcare professional on 13 NOVEMBER 2014. A 49-year-old female patients, whose medical history was not reported and concomitant medication was reported as vitamins, had received intramuscular a dose of FLUZONE (batch number: UI207AA), expiry date of vaccine and number of dose was not reported) in right deltoid on 26-OCT-2014. On 03-NOV-2014, patient experienced trouble picking arm up and soreness. Illness at the time of vaccination was reported as none. Pre-existing condition and illness at the time of vaccination was reported as none. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none.  Follow up report received from a healthcare professional on 24 FEBRUARY 2015: The vaccine was confirmed to be Influenza Quadrival A-B vaccine and hence had been changed from FLUZONE to Influenza Quadrival A-B vaccine. Follow up report received from a healthcare professional on 10  MARCH 2015: No new information was reported.
Patient called to say she believe vaccin was administered too high on her arm. It was administered in inverted triangle in the appropriate area but she said she still has pain after 11 days and her doctor agreed it was administered too higher on the arm.
no adverse event; Expired ROTATEQ was administered to 2 month old baby; This spontaneous report was received from medical assistant, concerning a 2 months old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  On 26-OCT-2020, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered orally (lot number S001101 which was verified to be a valid lot number, expiration date reported and upon internal validation established as 21-OCT-2020) (expired product administered) for prophylaxis (strength, dose and vaccination scheme were not reported). No additional adverse events were reported.