chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He can't get the bowel movement out of him as easily as he could before. It really takes a lot of effort.; This spontaneous case was reported by a patient and describes the occurrence of BOWEL MOVEMENT IRREGULARITY (He can't get the bowel movement out of him as easily as he could before. It really takes a lot of effort.) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A, 031A21A, 013F21A and 056A22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BOWEL MOVEMENT IRREGULARITY (He can't get the bowel movement out of him as easily as he could before. It really takes a lot of effort.). At the time of the report, BOWEL MOVEMENT IRREGULARITY (He can't get the bowel movement out of him as easily as he could before. It really takes a lot of effort.) had not resolved.            No concomitant medication was reported. It was reported that patient received bivalent dose on 28-Oct-2022. It was reported that patient was inoculated, he found out his push muscle to remove bowel movements has not worked as well as it had for the last 81 years of his life. He was wondering if there was something that could be done about it. He explained that when he goes to the toilet to have a bowel movement, he has to wiggle and squirm. He can't get the bowel movement out of him as easily as he could before. It really takes a lot of effort. When he had a bowel movement, it doesn't seem to be complete. He still had some in him. He noticed this shortly after his first shot on 13-Feb-2021. No treatment information was provided.
12:45 Received Hep B, Hep. A and Flu vaccine. Returned to immunization area approx. 1 1/2 - 2 hours later c/o SOB, coughing, chest tightness. States feeling ill x 2 days, was not able to sleep last night due to coughing. B/P 126/78, P 100, R 22, T 97.8.
Sore Throat; Bad Sinus Problems; Itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), SINUSITIS (Bad Sinus Problems) and PRURITUS (Itching) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), SINUSITIS (Bad Sinus Problems) and PRURITUS (Itching). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat), SINUSITIS (Bad Sinus Problems) and PRURITUS (Itching) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications include Z-Pack and Zyrtec.
Vaccines administered @ 12:00, after checking out and going home pt returned and reported hives on both upper and lower extremities @ 12:45 (no swelling of lips, tongue, throat) administered benadryl 25mg IM, PO benadryl 25mg Q6 x 2 days. No further problem.
Rash developed on 1/10/06 worse on 1/11/06.  Diffuse morbilliform rash-some areas coalesced into one large papule.
Noted 2 hives next to MMR injection site (within one inch) left arm. Complained of localized pruritis. Hives gone by 2.5 hours  with continued complaints of localized pruritis mild. Ice pack was applied to site. (mobile unit).
Low grade fever; severe chills and shaking; severe chills and shaking; severe joint pain for 5 hours; sweats; Post fever fatigue; other vaccine same date vaccine date=21Jan2021; other vaccine same date vaccine date=21Jan2021; This is a spontaneous report from a contactable other HCP (patient). A 65-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 13:00 at single dose in right arm for COVID-19 immunisation. The patient medical history was not reported. There were no known allergies. Concomitant medication included irbesartan. 3 days post-vaccine on 24Jan2021 19:00, the patient experienced low grade fever, severe chills and shaking, severe joint pain for 5 hours and then sweats, post fever fatigue. No treatment received for these events, and these events were recovered on Jan2021. The patient received other vaccine on the same date 21Jan2021. The patient received COVID test post vaccination via Nasal Swab on 25Jan2021, COVID test result was Negative.   Information on the Lot/Batch number has been requested.
Brain vibrating. Has not stopped for the majority of each day for the past 2 weeks.
Information has been received from a 56 year old female medical assistant with hypertension, asthma, hypercholesterolaemia, penicillin allergy and a history of heart attack in 2006 and stroke in 2007 who in approximately 2007 or 2008 was vaccinated with a first dose of PNEUMOVAX 23 (lot # not reported). On 01-SEP-2009 she received second dose of PNEUMOVAX 23 (lot # 662905/1162X.) 0.5ml, intramuscularly into left arm. Concomitant therapy included PROCARDIA XL, trazadone HCl, spironolactone, PLAVIX, CELEXA and IMDUR. On 02-SEP-2009 the following day after vaccination she was having chills and her temperature was 100.6 degrees. The arm which was vaccinated was achy, red, had red streaks and looked it had cellulitis. It hurt to move that arm. The arm was warm to the touch and felt like a softball. The physician put her on BACTRIM and she had been icing her arm but her symptoms have not improved. She also took TYLENOL PM last night. The patient sought medical attention office visit. At the time of the report on 03-SEP-2009 the patient had not recovered. There were no laboratories diagnostic studies performed. This is one of two reports from the same source. Additional information has been requested.
Took third dose of VIVOTIF. Wrenching vomiting, pain all around abdomen and back, extreme headache. Have had 2 kidney stones in my past. I felt worse from this than the kidney stones. Called doctor who said to discontinue use. Feel much better today after sweating heavily most of the night.
She first complained to me of dryness in her left eye. it progressively got worse by the end of the night.  I gave her lubricant eye drops but she said it didn't help much.  The following morning, she began feeling a tingly sensation on the left side of her face. Ever day or every other day, she complained of worsening symptoms. The tingling feeling has grown to numbness and lack of feeling, which has begun to spread to her ear, tongue, neck.  She unknowingly bites the inside of her cheek when eating. Her muscles and facial movements on the left side are less apparent than on the right side.
24Sept2021: I received my first dose of Pfizer COVID 19 vaccine at 1:00 pm in my left arm intramuscular. Later that night, I experienced chills and slight headache. On 25Sept2021: I was very fatigued, chills, injection site soreness, headache and nausea that resulted to one episode of vomiting.  I took ibuprofen and aleve to help with injection site soreness and headache.   On26Sept2021: Headache, nausea (with no vomiting), and lymph node swelling and pain under left armpit.  The swelling is tennis size and very sore to touch. 27Sept2021:  I reported my AEs but still have nausea and lymph node swelling and pain under left armpit.
15 min after injection, site became swollen to size of golf ball and hot to touch. Swelling went down over the next hour. Site was painful and arm had limited mobility for two days. Exactly one week post injection, site became itchy swollen and covered in hives.
Bell's Palsy. Examined on 3/29/2021, he had moderate weakness, House-Brackmann Grade III
12 hours after injection had fever chills and severe back pain. 48 hours after injection large red rash at injection site and tenderness in armpit area. Rash is warm to the touch.
Swollen Lymph Nodes in neck tacacardia motteling of the skin nausea vomiting rigors fever
Site: Redness at Injection Site-Severe, Additional Details: pt just complained that she got the red patch 8 days after receiving the vaccine. no itching/no burning just redness
headache, fever, body aches and local reaction as tenderness, induration lasted 2 days and started a day after the vaccine.
Pt filled out intake form and denied that he had been vaccinated. When vaccination entered in medical record pt had already received Moderna 2 doses. Pt would not answer phone or return calls to discuss further.
The client tested positive for COVID-19 on 3/8/21. Symptoms began on 3/6/21. Client was fully vaccinated.
Fever, chills, headache, nausea beginning at 9pm.  Additional nausea and lightheadedness, hard to stand up upon waking in am at 7. Took DayQuil to alleviate symptoms.  All resolved by 2pm day after shot.   Felt muscle soreness for three days after shot at injection site.  felt weak and headache two days after injection.
Teeth hurt; dull headache; felt like she was going to die, she felt like a vegetable; Unable to get off the couch and couldn't open her windows; she couldn't think about moving; left arm started to feel sore; didn't feel well all through the night,she thinks it will kill her and is harming her body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm started to feel sore), VACCINATION COMPLICATION (didn't feel well all through the night,she thinks it will kill her and is harming her body), FEELING ABNORMAL (felt like she was going to die, she felt like a vegetable), MALAISE (Unable to get off the couch and couldn't open her windows) and ASTHENIA (she couldn't think about moving) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 20-Nov-2020 to February 2021. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm started to feel sore) and VACCINATION COMPLICATION (didn't feel well all through the night,she thinks it will kill her and is harming her body). On 03-Mar-2021, the patient experienced FEELING ABNORMAL (felt like she was going to die, she felt like a vegetable), MALAISE (Unable to get off the couch and couldn't open her windows) and ASTHENIA (she couldn't think about moving). On 05-Mar-2021, the patient experienced TOOTHACHE (Teeth hurt) and HEADACHE (dull headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, every 4-6 hours. On 05-Mar-2021, PAIN IN EXTREMITY (left arm started to feel sore), VACCINATION COMPLICATION (didn't feel well all through the night,she thinks it will kill her and is harming her body), FEELING ABNORMAL (felt like she was going to die, she felt like a vegetable), MALAISE (Unable to get off the couch and couldn't open her windows) and ASTHENIA (she couldn't think about moving) had resolved. At the time of the report, TOOTHACHE (Teeth hurt) and HEADACHE (dull headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Large swollen spot in my right armpit; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received first dose of BNT162B2 (brand= Pfizer Biontech), lot no. EL3248, via an unspecified route of administration (right arm) on 05Feb2021 15:00 at a single dose for COVID-19 immunization at a pharmacy or drug store. The patient had no relevant medical history. No known allergies. No COVID prior to vaccination. Concomitant medications included levothyroxine sodium and escitalopram. No other vaccine in four weeks. The patient experienced large swollen spot in her right armpit on 06Feb2021 16:00. No treatment received for the event. No COVID test post vaccination. The outcome of the event was not recovered.
Nausea and vomiting, fever, body chills and shaking, headache, malaise. All for about 24 hours.
URTICARIAL MACULOPAPULAR ERUPTION COVERING ENTIRE TRUNK & ARMS
fever of 103.1; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 103.1) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PYREXIA (fever of 103.1). At the time of the report, PYREXIA (fever of 103.1) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not reported.  The reporter not sure whether the patient and Patient's partner had food poisoning and that was caused the fever.
After ~30 minutes of receiving vaccine I developed tingling in my lips which progressed to numbness in my right cheek/jaw and cold, numbness and tingling in my right hand/forearm.  Symptoms improved within 24 hours and were gone in 48 hours.
MOTHER THAT APPROXIMATELY 30 MIN. AFTER RECIEVING THE FLU VACCINE THAT SHE HAD SWELLING OF THE LIPS WITH SOME ITCHING.  PT. CAME FOR THE FLU VACCINE AT APPROXIMATELY 4:30 P.M. AND DURING DINNER TIME SWELLING WAS NOTICED.  THE HELATH DEPT. WAS CLOSED BY THEN . PT. DID NOT GO TO THE ED BUT RETURNED TO THE HEALTH DEPT. ON 12/20/06 @ APPROXIMATELY 9:30.  THE SWELLING WAS REPORTED AS DECREASED WHEN SHE ARRIVED- LOWER LIP NO LONGER SWOLLEN BUT UPPER LIP SLIGHTLY SWOLLEN. PT. REPORTED NO ALLERGIES TO EGGS OF MEDICINE ON THE REGISTRATION FORM AND AT THIS RETURN VISIT. BP 98/64 AND WT. 74 LBS. GIVEN BENADRYL 25 MG.
Sore shoulder with very limited range of motion. Very hard to perform daily activities (bathing, dressing, toileting). Pain very bad in bed and keeps me up throughout nights. Went to PCP on 10-11-12. Dr. said needle had hit nerve. Prescribed 20 tablets of Naproxen 500 mg. Still seeing no improvement 25 days after vaccine administered.
On day 8, I developed a small round area above the injection site that was a little raised with a small rash. On day 9, the area doubled and then on day 10 the area doubled again. On day 11, I went to the Dr and was prescribed Clindamycin 300mg tid as well as 3 days of Prednisone and Traimcinolone cream for the area.
Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Janssen (Batch number-1855835 and Dose 1.) on 18-Jan-2022. Past adverse reactions to the above products included No adverse event with Janssen.    On 01-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  The Nurse had discovered 2 temperature excursions of the Moderna Covid-19 vaccine for two different lot numbers of the Moderna Covid-19 vaccine. The temperature in the refrigerator that the Moderna Covid-19 vaccine reached 13.1 degrees Celsius on 28-Jun-2022 and on 19-Jul-2022, the vaccine reached a temperature of 9 degrees Celsius. None of the vaccine in the refrigerator underwent two different temperature excursions.  The temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna Covid-19 vaccine was stored in. The Nurse had used the online Temperature excursion tool and was comfortable that her patients doses were valid and that the affected vaccine was viable for future doses.  Side effects after any dose was reported as unknown.  No treatment medications were provided.
01/09/21 - 1st dose - Exhaustion.  01/30/21 - 2nd dose - Exhaustion, slight headache, soreness at injection site. possible TIA or complex migraine, was given Plavix (blood thinner) 12/29/21 - Booster - Wave of exhaustion, tingling sensation in face area, tightness in temple and back of the head area.
rash / rash presented on her abdomen, breasts and upper thighs; flu like symptoms; chills; low grade fever; headache; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number X7Z52, expiry date 5th November 2022) for prophylaxis.   On 30th March 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 31st March 2021 06:30, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, chills, fever and headache. On 1st April 2021, the patient experienced rash. On an unknown date, the outcome of the influenza-like symptoms, chills, fever and headache were recovered/resolved and the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, chills, fever, headache and rash to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix in right arm and the next morning she experienced flu like symptoms reported as headache, chills and low-grade fever and those symptoms had resolved. The patient presented a rash on her abdomen, breasts and upper thighs.  The rash was improving but not resolved. The reporter consented to follow up.
diabetic ketoacidosis; HCP advised that Inkovana is known to interact with vaccines; Sore arm; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of DIABETIC KETOACIDOSIS (diabetic ketoacidosis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]) from January 2021 to an unknown date for Diabetes.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Jan-2021, the patient experienced DIABETIC KETOACIDOSIS (diabetic ketoacidosis) (seriousness criterion life threatening) and DRUG INTERACTION (HCP advised that Inkovana is known to interact with vaccines). At the time of the report, DIABETIC KETOACIDOSIS (diabetic ketoacidosis), PAIN IN EXTREMITY (Sore arm) and DRUG INTERACTION (HCP advised that Inkovana is known to interact with vaccines) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.       Treatment included blood sugar monitoring.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Within 2 hours mucas started pouring out of both nostrils, soreness in joints, coughing, sneezing, temp of 100.1 to 101 continuing for 6 days.
Fever, muscle aches and some congestion lasting 18 days.  Was seen in clinic and had other causes ruled out. i.e. Urinealysis, chest X-ray, threat culture.  All were negative.
PARENT REPORTED AT 5:30 PM HE NOTICED SWELLING AROUND HIS DAUGHTER'S EYES.  HE RETURNED TO CLINIC AT 5:45PM CLIENT PRESENTED WITH SWELLING AND REDNESS AROUND EYES AND EYE LIDS ALSO WITH SWELLING.  CLIENT GIVEN 25 MG OF BENADRYL PO FATHER ALSO REPORTS CLIENT HAVING SLIGHT PROBLEM BREATHING.  DR NOTIFIED PER PHONE. 911 CALLED.  CLIENT TRANSPORTED TO HOSPITAL.  CLIENT REMAINED ALERT.  CLIENT SEEN IN ER AND ASSESSMENT DONE.  CLIENT SENT HOME WITH PREDNISONE RD.  MOTHER REPORTS PATIENT IS ACTIVE AND NOW HERSELF. SHE IS GIVING PREDNISONE 15 MG/ML 1 TSP 2X DAILY FOR 3 DAYS.  CLIENT TO BE FOLLOWED BY PRIVATE PHYSICIAN.
Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to case ID 2018SA322129 (another female office staff, same reporter). This case involves a female patient (office staff) who was exposed to vaccine MENACTRA (Batch number: U6016AA, expiration date: 09 Oct 2019, dose) on an unspecified date. It was a case of occupational exposure as it was reported that female office staff drew the MENACTRA from a multi-dose vial (with their syringe and needle) and the needle cracked and sprayed the vaccine on her. It was also reported that vaccine was splashed in the eyes and face. (Occupational exposure to product via eye and exposure via skin contact). It was also a case of product issue. The MENACTRA was not given. It was unknown if patients had adverse event due to this. 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 and Module VI of the 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. List of documents held by sender: none.
PATIENT'S GRANDMOTHER REFERS THE NEXT DAY OF VACCINATION HE BEGAN EXPERIECING DIARRHEA AND WHITE SPOTS IN THE MOUTH. THE NEXT DAY DARK RED STOOL, WAS HOSPITALIZED. LOW HEMOGLOBIN - 9.