chrisvoncsefalvay/vaers-outcomes huggingface dataset:
could feel heat in her arm and chest; tongue started tingling; couldn't sleep; could feel the heat from her elbow to her wrist; nervous; felt anxious; Blood Pressure spiked up; a burning feeling; arm was sore; very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (could feel heat in her arm and chest), PARAESTHESIA ORAL (tongue started tingling), INSOMNIA (couldn't sleep), FEELING HOT (could feel the heat from her elbow to her wrist) and NERVOUSNESS (nervous) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0C17AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PROPAFENONE, MONTELUKAST SODIUM (SINGULAIR), ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (could feel heat in her arm and chest), PARAESTHESIA ORAL (tongue started tingling), INSOMNIA (couldn't sleep), FEELING HOT (could feel the heat from her elbow to her wrist), NERVOUSNESS (nervous), ANXIETY (felt anxious), BLOOD PRESSURE INCREASED (Blood Pressure spiked up), BURNING SENSATION (a burning feeling), VACCINATION SITE PAIN (arm was sore) and FATIGUE (very tired). At the time of the report, VACCINATION SITE WARMTH (could feel heat in her arm and chest), PARAESTHESIA ORAL (tongue started tingling), INSOMNIA (couldn't sleep), FEELING HOT (could feel the heat from her elbow to her wrist), NERVOUSNESS (nervous), ANXIETY (felt anxious), BLOOD PRESSURE INCREASED (Blood Pressure spiked up), BURNING SENSATION (a burning feeling), VACCINATION SITE PAIN (arm was sore) and FATIGUE (very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported to have taken Benadryl for heat sensation after vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up Included No new Information
Chest pain; Low oxygen saturation; Sore throat; Fatigue which initialy started on 28Apr2021 and continued after COVID test was positive; Cough; woke up at 4:30 am with deltoid muscle pain; unable to move arm; fever of 101.17 degree; chills; body ache; Injection site pain; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (Injection site pain), MYALGIA (woke up at 4:30 am with deltoid muscle pain), VACCINATION SITE MOVEMENT IMPAIRMENT (unable to move arm), PYREXIA (fever of 101.17 degree F) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, MULTIVITAMIN & MINERAL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). On 30-Mar-2021, the patient experienced MYALGIA (woke up at 4:30 am with deltoid muscle pain), VACCINATION SITE MOVEMENT IMPAIRMENT (unable to move arm), PYREXIA (fever of 101.17 degree), CHILLS (chills) and MYALGIA (body ache). At the time of the report, INJECTION SITE PAIN (Injection site pain), MYALGIA (woke up at 4:30 am with deltoid muscle pain), VACCINATION SITE MOVEMENT IMPAIRMENT (unable to move arm), PYREXIA (fever of 101.17 degree), CHILLS (chills) and MYALGIA (body ache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included LEVOTHYROXINE, MULTIVITAMIN & MINERAL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) are included.  Patient was treated with two tablets of Tylenol 500 mg at 4:30 am.  For events with onset date 28Apr2021, i.e., sore throat and cough, patient took Zinc lozenges as treatment.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: events updated
Patch of Itchy red rash and slight bump at vaccination site, 6 days after vaccination, still not cleared, 3 days after start of symptoms.
Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.
Subsequently post vax, the vaccinee experienced a bullous type of rash from head to toe. He was treated with Benadryl.
pt recv vax & 2hr later broke out in gen hives;saw MD following day; p/that to MD that evening was treated w/ATB for 10 days followed by another 10 days on 19JUN97;shadow of hives remain;also had gen itching;
Pregnant pt was given AIV H1N1 vaccine. Obstetrician notified 10/21/09. Pt was started on TAMIFLU within 24 hrs.  10/25//09 Medical records received.  Pregnant patient received live nasal mist flu vaccine in error. Tamiflu given. EDD 2/23/10, LMP 5/19/09.  To recheck in 2 mos.
Second dose of SHINGRIX produced extreme fatigue and flu-like symptoms (chills, diarrhea, muscle aches thought body).
Sinuses are messed up; Severe headache; 102+F fever; 101 fever; This is a spontaneous case reported by consumer to agency (reference number: SEQ19-03173) and initially received on 24-Sep-2019, concerning an 81-year-old, male patient.   The patient's medical history and concomitant medications were not provided.   On 20-Sep-2019, on Friday, the patient was administered INN Flu Vaccine [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiration date: not reported] for influenza prophylaxis.  On 22-Sep-2019, two days after vaccination, the patient had fever, at 101 Fahrenheit.  On 23-Sep-2019, the third day after vaccination, the patient had fever with 102+ Fahrenheit.  On 24-Sep-2019, four days after vaccination, the patient had a severe headache and reported that his sinuses were messed up. Additionally, the patient reported that his life was horrible.  At the time of initial reporting, the outcome for the events was not reported.  The reporter did not provide seriousness and causality criteria.  Non-significant follow up received by other non-health professional (consumer) on 08-Oct-2019: Reference number (SEQ19-03930) added. No changes were made in the narrative.  Company Comment: The patient experienced sinus disorder, headache and pyrexia after vaccination with the suspect product INN Flu Vaccine. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: The patient experienced sinus disorder, headache and pyrexia after vaccination with the suspect product INN Flu Vaccine. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.
Patient had severe swelling at injection site at a few hours after vaccine for 48 hours. Swelling was 1inch by about 4-5 inches. Patient compared to size of a goose egg or rubber ball. Treated with soaking, ice, topical diclofenac.
Pt started to run fever the night of immunization. Temperature subsided with Tylenol. Pt was given Tylenol at 6:30 AM, and when she was seen in office at 2 PM, her temperature was 102.8 tympanic. Pt had runny nose for 2-3 days prior and was treated with Actifed and Motrin and told to return if fever persisted.
vaccines are ineffective, but you are not allowing those of us that got all three and got COVID to participate; vaccines are ineffective, but you are not allowing those of us that got all three and got COVID to participate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "vaccines are ineffective, but you are not allowing those of us that got all three and got COVID to participate".  Clinical Information: Th patient got COVID vaccine at the end of Jan and stated the vaccines are not working.  The lot number for bnt162b2 was not provided and will be requested during follow up.
12;20 to 13:15 Hives and itchiness on face, throat and scalp. Bp spike to 170/90  (normal is 90/60).  Pulse Ix 83. When I reported my symptoms to a Staff member I was sent care and examined by the Physician on Call.  No treatment was given at that time.  It was suggested that I take Benadryl when I returned home.    Symptoms subsided over course of the day.
2 days after receiving my second vaccine shot I developed covid arm. My arm is sore at the injection site.
Received Janssen vaccine on 3/12/21 COVID-19 positive by PCR on  1/10/22 admit to hospital on 1/10/22 d/t frostbite, pt incidentally COVID positive
Upper right abdominal pain, vomiting, diarrhea. Ultrasound, MRI, and Cat Scan confirm gallbladder is inflammed. No stones but bile duct enlarged.
Patient received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and indicated vaccine maintained activity necessary to protect against covid 19 at time of administration. Patient also did not call in with adverse event.  This is an administration error without adverse event.
As soon as vaccine was administered, patient's arm swelled up at injection site. Injection site got red and bumpy. Ice was applied and injection site swelling decreased slightly after 15 minutes but still present when patient departed the pharmacy.
Pt. was vaccinated on 10/3/11 at approx 3pm. Pt. returned next day with 2 1/2 inch redness. Warm to the touch. No fever, no raise.
I had an excruciating migraine the following day of 1/29/21 that lasted for just under 2 days.  I rested and took excedrin and stayed out of light and noises until it subsided.  However, since the second injection I have not had a single menstrual cycle since and I have always had regular menses and I am an RN so I am fully aware of what regular and irregular is. I have since November and December of this year in hoping my cycle would restart started seeing an obgyn, which led to seeing other specialists to figure out the cause of an otherwise healthy 31 yr old woman.
his body was aching; a low grade fever of 100.3F; the chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (his body was aching), PYREXIA (a low grade fever of 100.3F) and CHILLS (the chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for an unknown indication.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN (his body was aching), PYREXIA (a low grade fever of 100.3F) and CHILLS (the chills). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN (his body was aching), PYREXIA (a low grade fever of 100.3F) and CHILLS (the chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 100.3f (Inconclusive) low grade fever of 100.3F.         No Concomitant medications were provided
digestive issues; loss of appetite; Loose stools; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 11:30 (Lot number: EW0151) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, lot number: EN6208), administration date: 15Mar2021, for COVID-19 immunization, reaction(s): "she was pretty much fine". The following information was reported: DECREASED APPETITE (non-serious) with onset Apr2021, outcome "not recovered", described as "loss of appetite"; DIARRHOEA (non-serious) with onset Apr2021, outcome "not recovered", described as "Loose stools"; GASTROINTESTINAL DISORDER (non-serious) with onset 06Apr2021, outcome "unknown", described as "digestive issues". Therapeutic measures were taken as a result of decreased appetite, diarrhoea, gastrointestinal disorder.  Additional information: AE treatment: Caller says she was taking a probiotic and eating pretty light. She says the probiotic was pharmacy generic version of probiotic, LOT: 61278 EXP: July 2022. Caller says she has not had any other recent vaccinations within the last four weeks or day of COVID-19 vaccination. Patient underwent intestinal surgery in Mar2019.  No follow-up attempts are possible. No further information is expected.
Positive for Covid; Positive for Covid; first /second/first booster/second booster : Moderna/last booster: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 84 years for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), on 10Mar2021 as dose 2, single (Batch/Lot number: unknown), on 13Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 27Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Sep2022, outcome "unknown", described as "first /second/first booster/second booster : Moderna/last booster: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Mar2023) Negative; (21Mar2023) Positive; (27Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
My lymph nodes in my neck and around my collarbone are swollen and painful; My lymph nodes in my neck and around my collarbone are swollen and painful; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to melons, and berries. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive concomitant medications. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 01Apr2021 at 13:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient previously received  cefaclor (CECLOR) and experienced drug allergy. On 23Apr2021 at 06:00, the patients lymph nodes in neck and around collarbone were swollen and painful. The day of report was day 4 since the second shot and she had noticed only a one big swollen lymph node on left collarbone but as the days went by, patient was finding more. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lymph nodes in neck and around collarbone were swollen and painful were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient reported tingling lips at about 20 minutes post injection. Her lips were also noted to be swollen. She was given Decadron 10 mg IM @ 0905. She was then given Benadryl 50mg IM @ 0915. She was monitored another 20 min. Her lip swelling and tingling resolved. She left the facility and was driven home by a friend.
Took my second Pfizer shot on Jan 25. About 5 days later Left arm muscle really hurt. After 2 months, it STILL hurts-- . Feels like a pulled muscle and sometimes extends to my breast bone. Cannot sleep on that side. Very tender to the touch but not red or inflamed. But it has not gone away.  Has that reaction been experienced by others? Is there something I can do about it? Will it eventually go away?
Pt received Moderna as 1st dose on 2/11/21, returned 3/4/21 and was given Pfizer vaccine
Intitially excessive pain at injection site, chills/tremors, fever, nausea and vomiting and joint pain.
Loss of hearing in right ear.  Treated with oral prednizone protocol.  No notieable improvement.
I had a scratchy throat and generalized body aches. I took my temperature, and I didn't have a fever. The next day I still felt body aches, and developed a cough, and congestion. I took an at home COVID-19 test and it came back positive. On 2/21/23 I had a telehelath visit and my doctor prescribed me Paxlovid. I took the medicine for 5 days.  I started to develop headaches at night after I stared taking Paxlovid. By day 5 of taking the medicine I felt completely better.
immunocompromised; expired ACT-HIB administered; Initial information regarding an unsolicited valid serious case was received from a other health professional via regulatory authority (Reference number- 00525503) and transmitted to Sanofi on 18-Mar-2021.  This case involves a 65 year old female patient who had immunocompromised (immunodeficiency), while she received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ158AAA and expiry date 26-Nov-2020) via unknown route in right deltoid for prophylactic vaccination.  On an unknown date, the patient developed a serious immunocompromised (immunodeficiency) unknown latency following the administration of HIB (PRP/T) VACCINE. This event was assessed as medically significant.  It was also medication error case due to expired ACT-HIB administered (expired product administered) (latency same day).  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown for immunocompromised .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: This case concerns 65 year old female patient who had immunodeficiency after vaccination with ACT-HIB. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Patient has pain, rash, and injection site is warm. Took BENADRYL and got a little better.
Patient states that the morning after she was vaccinated she woke up with numbness and tingling on the left side of her face. This numbness and tingling was above the baseline of the regular level of numbness and tingling she has on the left side of her face due to Bell's Palsy from 20 years ago. She indicates that the original occurrence of Bell's Palsy was not the result of a previous vaccination but of a traumatic stressful event. She has been under the care of a neurologist since that time. The new numbness and tingling on the left side of her face lasted for a day and by the next day she had returned to her previous level of sensation on the left side of her face. Patient notified her physician of her reaction to the vaccination and they suggested she call the Health Department to see if she should have the second Pfizer vaccination. RN encouraged patient to call physician to discuss whether a second dose of the Pfizer vaccine should be given due to the physician's greater knowledge of the patients complex medical history. Patient verbalized understanding and said that she would follow up with her physician to discuss.
Weakness in legs for a couple of months, lower back pain, followed by weakness in arms.  After consulting several doctors  went to hospital on June 27.  Took 5 days of nonstop testing to finally identify it as a motor neuron disease, ALS.  In a rehab center now.  Cannot walk or stand.
10 x 8.5cm area of swelling and induration to right leg at vaccine site. Was given Benadryl 1/4 tsp q 6hrs as necessary and to use cool compresses.