chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Achylia gastrica; soreness in her arm; tired; achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Feb2021 (Lot number: EN6198) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "afib" (unspecified if ongoing), notes: The caller had a surgical procedure that made it stop.; "no thyroid gland" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for atrial fibrillation; LIPITOR; SYNTHROID. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "soreness in her arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tired"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "achy"; ACHLORHYDRIA (non-serious), outcome "unknown", described as "Achylia gastrica".  Additional information: Patient stated she received the second dose of the Pfizer-BioNTech COVID-19 vaccine a month ago, and experienced "mild reactions to both injections" such as : being "tired and achy". She specified she had soreness in her arm after the first dose and it went away after a couple of days. She said after the second vaccine, however, her arm was "way more sore than the first time". She explained after a day or two it got better, but her arm never "got ok". She specified it is "70% better". She explained her arm still has a "little soreness, but it's "not debilitating", she feels discomfort when rolling/laying on it in bed, when she uses, or when she lifts it. She said she noticed the second dose seemed to have been administered in the middle of her arm, and therefore she doubts she has received it in the muscle. Again stated with the first vaccine the patient had a mild reaction- little achy lasting about a day or two, and soreness in the arm. Patient received vaccine right upper arm in the deltoid and expiration date was unknown. The patient did not take anything outside of her normal medication.  No follow-up attempts are possible. No further information is expected.
Follow up information was received from the reporter on 11/24/03 providing the patient's name, date of birth and county of vaccine administration. Information regarding Flumist nasal solution was received from a healthcare professional regarding a 6 year old female who received the vaccine on 10/28/03. Within 15 hours post immunization, the patient developed a fever of 102.5 degrees F and a croup-like cough. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on 10/28/03. Dose regimen was 1 dose 1 time per day (nasal). Concomitant medications were not reported. Within 15 hours post immunization, the girl developed a fever of 102.5 degrees F and a croup like cough.
Significant gerd immediately following administrationsing; left arm and shoulder pain; left arm and shoulder pain; This is a spontaneous report from a contactable consumer, the patient. A 51-Year-old (non-pregnant) female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6203, Expiration date: unknown), via an unspecified route of administration in left arm on 27Feb2021 14:30 (at the age of 51-year-old) as single dose for COVID-19 immunization.   The patient medical history included colitis ulcerative, fibromyalgia, premenstrual dysphoric disorder all from an unknown date and unknown if ongoing. Known allergies includes food allergy (lobster), contrast media allergy (contrast dye). Allergies to medications includes, drug hypersensitivity with ZIPACK, BACTRIM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient concomitant medications were not reported. No COVID prior vaccination. Prior to vaccination, the patient has not been tested for COVID-19.  On 27Feb2021 14:45 (at 02:45 PM) the patient experienced Significant GERD immediately following administration and left arm and shoulder pain within a couple of hours. The GERD was surprising not the arm and shoulder pain. The patient did not receive treatment for the adverse event. Since the vaccination, the patient has not been tested for COVID. Seriousness of the event was reported as non-serious. The outcome of events was not recovered.  No follow up attempts are possible. No further information is expected.
Initial report received from a health care professional on 04 October 2013. A 15-month-old male patient, with no history of allergy and concomitant medications details were not reported, had received an intramuscular dose of FLUZONE QIV vaccine (lot number: U4779AA) on right thigh on 02 October 2013. It was reported that, after vaccination on the same day i.e. 02 October 2013, her son experienced fever of 102.2F and fatigue, no interest in playing, poor appetite. Patient received TYLENOL. Stated symptoms lasted 36 hours and then resolved. No other symptoms noted. Documents held by sender: none.
Presented to MD office with rash on right buttocks and posterior thigh lesions are consistent with Herpes Zoster, site cultured,pt prescribed Valcyclovir.
Information has been received from a licensed practical nurse through the Merck Pregnancy Registry concerning a 17-year-old Hispanic female with no history of previous pregnancies who on 23-JUN-2006 was vaccinated with Varivax (Lot # 652454/1017R). Two-and-a-half-weeks after vaccination (last menstrual period on 05-JUL-2006) the patient was found to be pregnant. A screening ultrasound was performed on 27-OCT-2006, results were normal. On 25-OCT-2006, MSAP testing was performed and results were reported as abnormal. No maternal adverse events such as local reaction at vaccine site, varicella or shingles after vaccination occurred. No additional information provided. Additional information has been requested.
numbness in arm; felt like someone hit arm with a bat; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like someone hit arm with a bat) and HYPOAESTHESIA (numbness in arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING ABNORMAL (felt like someone hit arm with a bat). On 30-Mar-2021, the patient experienced HYPOAESTHESIA (numbness in arm). On 06-Mar-2021, FEELING ABNORMAL (felt like someone hit arm with a bat) had resolved. At the time of the report, HYPOAESTHESIA (numbness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Starting on the day of the vaccine, nothing significant. The next day when I woke up, I noticed my arm was extremely sore and felt very dizzy.  I sat down when I realized I was about to faint.  My husband found me passed out and was able to wake me up. He took me to the ER.  They did a CAT scan, MRI, ECHO cardiogram, EEG, EKG,  ultrasound of carotid artery, blood work.  Everything normal except EEG showed spikes and maybe potential seizures.  I was in the ER for 2 nights (3/27/2021-3/29/2021).  They put me on Keppra (seizures) for 6 months.  Now I am being followed up with the neurologist.  Since then, I have had no issues, but I am being followed up with neuro.
Did not have any symptoms to the booster.   After the test - 2 days later - fatigue and muscle cramping, mild tension headaches. Hot and cold flashes like I was fighting off something.
So I have excruciating pain in my left shoulder blade, shoulder, arm, fingers and hand. It keep me up at night because of the pain. It is a constant and sever pain. I am seeing a chiropractor and acupuncture on my own, it's not covered.
Struggle with breathing; One week soreness in ligaments; Aches; High fever -102; Chills; Administration date 12Nov2021 at 13:30, dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 13:30 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYMBICORT. Past drug history included: Amoxicillin, reaction(s): "Allergy", notes: Known allergies: Amoxicillin. Vaccination history included: Bnt162b2 (Dose 2, single, Lot number: unknown, Anatomical site: Left arm, Administration time: 14:45), administration date: 31Mar2021, when the patient was 52 years old, for COVID-19 immunisation, reaction(s): "Administration date=17Mar2021, Dose 1/Administration date=31Mar2021, Dose 2"; Bnt162b2 (Dose 1, Lot number: unknown, Anatomical site: Left arm, Administration time: 13:30), administration date: 17Mar2021, when the patient was 52 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021 13:30, outcome "unknown", described as "Administration date 12Nov2021 at 13:30, dose number: 3"; DYSPNOEA (non-serious) with onset 13Nov2021 19:30, outcome "unknown", described as "Struggle with breathing"; LIGAMENT PAIN (non-serious) with onset 13Nov2021 19:30, outcome "recovered" (20Nov2021), described as "One week soreness in ligaments"; PAIN (non-serious) with onset 13Nov2021 19:30, outcome "unknown", described as "Aches"; PYREXIA (non-serious) with onset 13Nov2021 19:30, outcome "unknown", described as "High fever -102"; CHILLS (non-serious) with onset 13Nov2021 19:30, outcome "unknown", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, ligament pain, pain, pyrexia, chills.   Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. At 30 hour, after 3rd dose patient experienced high fever -102, chills, aches, struggle with breathing and 1 week soreness in ligaments. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.
8 days after the injection I have developed a larger than golf ball size, hard, lump under the skin at the site of the injection. It is warm to the touch. Not painful. Slight bruising
First trimester miscarriage; Received the Moderna COVID-19 Vaccine while pregnant; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (First trimester miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received 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 an unknown date, the patient experienced ABORTION SPONTANEOUS (First trimester miscarriage) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (Received the Moderna COVID-19 Vaccine while pregnant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion.  At the time of the report, ABORTION SPONTANEOUS (First trimester miscarriage) outcome was unknown and EXPOSURE DURING PREGNANCY (Received the Moderna COVID-19 Vaccine while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported.  No treatment details were provided.  Company Comment : This is a case of product exposure during pregnancy with associated AEs for this female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs for this female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pain, swelling, lumps in my arm, fever  around the injection site, redness at the site and down the arm, tiredness, achiness  all over, sore neck.
Extreme fatigue, and all over body aches.  No fever, just the aches and headaches for two days.  Took Nyquil and slept most of he day both days.
Got the Tdap because I am pregnant, due date is October 27th 2020. Pregnancy has been smooth sailing so far, no abnormalities in myself or the baby.   As soon as I got the shot (11:30am) in my upper arm the injection site stung. After about half an hour it became sore and as the day progressed it became very tender to the touch and I could not lift my arm past shoulder height. Once I got home from work around 1am and tried to go to sleep I was nauseous which I haven?t been durning the pregnancy for several months now. I felt achy all over not just at the injection site and very hot. I do not have a thermometer on hand to take my temperature but I felt like I was burning up. It made it extremely difficult to sleep and I am still achy all over (7am) though I don?t feel as hot anymore.
vaccines were exposed to a low temperature of 29F in April 2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, HAV (Havrix) for prophylaxis and DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Infanrix, Menveo, Boostrix, Pediarix, Havrix and Kinrix. On an unknown date, an unknown time after receiving Infanrix, Menveo, Boostrix, Pediarix, Havrix and Kinrix, the patient experienced incorrect storage of drug (Verbatim: vaccines were exposed to a low temperature of 29F in April 2023). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-JUN-2023 The reporter was a medical assistant. The reporter reported that Kinrix, Havrix, Pediarix, Boostrix, Menveo (2 vial formulation) and Infanrix vaccines were exposed to a low temperature of 29 degree F in April 2023.  It was not noticed at the time and the vaccines were subsequently administered to patients.  At the time of reporting, she did not have any patient details, lot number/expiration date information, and she did not know how many vaccines were administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter reported that Kinrix, Havrix, Pediarix, Boostrix, Menveo (2 vial formulation) and Infanrix vaccines were exposed to a low temperature of 29 degree F and administered, which led to incorrect storage of drug.
I got after the first dose what some people are to experience after their second dose.  This could be because I had Covid in November and probably have circulating antibodies already.  My right arm had 10/10 pain starting around midnight waking me up and was persistent with any movement which extended up into my neck and down to my elbow area.  Ibuprofen and tylenol did not help with the pain. Currently on post-vaccine day 3 I still am unable to get full ROM to my right arm due to pain but it is better than yesterday.  Other symptoms I had was the fevers, chills, headache, extreme hypersensitivity to my skin, and bone pain with movement especially to my hips and back with walking which seems to be subsiding.  whole body aches/pain which seems to be subsiding as well.  What I don't see mentioned in a lot of the expected side effects is TINNITUS.  I am experiencing moderate tinnitus.  I have experienced this previously in my 20's when taking a full dose of aspirin and I avoid aspirin products because of that.  I did not see anywhere that there is aspirin products in these injections.  It has not subsided yet at this time and I am wanting to report this.  Not sure if others are experiencing this as well.
She started feeling dizzy while waiting after taking the shot. Then she said her stomach began to hurt and she wants to vomit. She reported extreme dry mouth. She describes a feeling of being sick to her stomach. She describes slurring.
1/13/05 Developed swelling, redness, itching of entire left upper arm along with heat (hot to touch) 1/15/05 Developed what patient describes as a dime-sized lump in left axilla. By 1/16/05 it was about the size of a nickel along with nausea and vomiting.  As of 1/18 still persists. As per annual follow up report 04/25/2005 lump in left axilla persists, non painful. Family physician recommends removal and believes this is a result of the immunization. If patient decides to have it removed, will contact the local public health agency with pathology report.  NOTE: the patient states that she had a tetnus shot three years ago, but did not have record of it and needed this for school program.
Developed Covid 4 days later from first dose of the vaccine, tested positive on 1/10/21
NAUSEA, CHILLS, HEADACHE, BODY ACHES, SHAKING, LOSS OF TASTE 4 DAYS OF PREDNIZONE WITH A FEW DAYS OF RELIEF, THEN ALL THE SYMPTOMS RESUMED IN A VENYANCE
This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 17-year-old female patient who received BEXSERO (batch number 16A201, expiry date 31st January 2019). On 19th September 2017, the patient received BEXSERO .5 ml. On 19th September 2017, 2 hrs after receiving BEXSERO, the patient experienced vomiting, injection site pain and lip swelling. The patient was treated with (NOS) BENADRYL and ZOFRAN. On an unknown date, the outcome of the vomiting, injection site pain and lip swelling were unchanged. It was unknown if the reporter considered the vomiting, injection site pain and lip swelling to be related to BEXSERO. Additional details were reported as follows: The patient was seen in the office for further treatment with BENADRYL and ZOFRAN. No further information was reported regarding the event.
Within a few months of the vaccination on 12/05/06, I became less stable on my feet, and experienced symptoms of neuropathy including foot drop, loss of muscle strength, loss of reflexes, muscle loss, problems with gait, pain and numbness in feet, and now numbness in hands.  I did not seek medical attention immediately, and, at first, attributed symptoms to old age or low back condition.  I eventually saw my family physician in 8/07 to discuss my symptoms which were continuing to get worse.  In 10/08, I was diagnosed with very severe and very chronic neuropathic disease.  Medical records received 10/4/08 to 10/17/08. Assessment: Progessive weakness of lower extremities and foot drop on the right. Patient presents with numbness, muscle spasm, weakness in legs. Paresthesias and muscle wasting from knees to feet. Dorsiflexor weakness right greated that left. Unable to elevate great toe. Weight loss. Follow-up: Loss of feeling, muscle strength in my hands and feet - nearly disabled, and getting worse as the months go on. Walking now with leg braces.
Pt recvd 3 doses of Engerix-B vax & did not respond; 4th dose of Engerix-B given 18DEC91; titer retested 29JAN92; pt had converted;
Missed my period after the first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 16Sep2021 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MENSTRUAL DISORDER (disability) with onset Sep2021, outcome "not recovered", described as "Missed my period after the first dose". The event "missed my period after the first dose" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2021) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of menstrual disorder. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
within 48 hours developed sinus congestion and pain, fever 100.5 and severe flare on neuralgia in her LUE
Runny nose, sore throat, cough with yellow phlegm, loss of taste and smell. Currently 32 weeks pregnant. Still no sense of taste or smell to date. No medications prescribed. No OTC medications taken. Diagnosed as viral infection.
Swollen gland behind ear, right side; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen gland behind ear, right side) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016A21A) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis in 2010, Allergy to antibiotic (Allergy to Avelox), Drug allergy (Allergy to Demerol), Drug allergy (Allergy to Lipitor), Drug allergy (Allergy to Nitrofurantoin) and Drug allergy (Allergy to Meperidine). Concomitant products included TELMISARTAN and HYDROCHLOROTHIAZIDE for Blood pressure management, PYRIDOSTIGMINE BROMIDE (PYRIDOSTIGMINE BROMIDE EXTENDED RELEASE) and PYRIDOSTIGMINE BROMIDE (MESTINON TS) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen gland behind ear, right side). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Swollen gland behind ear, right side) had not 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.   Patient has a medical history of Myasthenia gravis from  08-??-2021  Patient has taken Telmisartan (40mg/ tab)as concomitant medication for high blood pressure from  01-??-2007. Ongoing: yes Patient has taken Hydrocholrthiazide (25mg/ tab)as concomitant medication for Water pill for HBP from 01-??-2007. Ongoing: yes Patient has taken Pyridostigmine bromide (60mg/ tab)as concomitant medication for 240mg 3 times a day indication unknown from 08-??-2010 Ongoing: yes Patient has taken Mestinone ER (180mg/ tab)as concomitant medication 1 tab at bedtime indication unknown from 08-??-2010 Ongoing: yes Patient has taken Advair diskus (100/50, cap)as concomitant medication inhale 1 puff indication unknown from 01-??-2010 Ongoing: yes   This case was linked to MOD-2021-218665 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up document contains Reporter details, Patient demographics, medical history,concomitant medication details and event start date were updated.