chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Trouble with diarrhea/bad episode; A spontaneous report was received from a consumer concerning a male patient of unknown age  who received their first of two planned doses of mRNA-1273 vaccine and experienced trouble with diarrhea/bad episode.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 24 Dec 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection.   The patient reported that on 04 Jan 2021 he was having trouble with diarrhea. He stated he had a bad episode as of the morning of this report.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
ADMITTED TO ACUTE CARE 6/8/2021 W/SOB, WET PRODUCTIVE COUGH, HYPOXIA, DM STILL AN INPATIENT
After first injection diahrrea occurred for 3 weeks.  After second injection vomiting/diahhrea occurred.  After third injection what appears to be erythema nodosum has occurred.  Been to primary doctor twice.  No explanations.  Been to dermatologist, back to original obgyn and have been referred to a rheumatologist.
Patient had received Pneumovax lot# 1314y to the right arm. She developed swelling over right upper arm, shoulder to mid right upper arm, hot to touch, painful, numbness and red. She had applied cold compress to right arm. She was seen and examined by FNP. Patient was instructed to keep applying cold compress and elevate arm. If problem persists to be evaluated by MD/NP at Urgent Care.
The evening of my vaccine, my vision became blurry. My hands began to tingle with pins and needles sensation. Concerned, I looked up side effects online but all I could find was possible fainting. I did not feel faint, so I continued to monitor myself. I finally fell asleep around midnight. I woke up around 8 still with pins and needles sensation; however, in my left big toe it had subsided. My blurred vision seemed better. Still concerned I called the doctor's office.
Blood Clot which led to Pulmonary Embolism, Pneumonia, and death.
Patient got Hepatits A vaccine on 01/20/2005 and on 01/22/2005 broke out with hives all over body and had some hoarseness.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium
No issues with the first two shots of Moderna.  It was the booster shot received at Pharmacy that I started to have issues with my left arm. I had my 1st Booster Shot in March 2022.  In the first two weeks, the vaccination site on my left arm started to experience severe pain (scale of 7 - 8 )  when I moved my arm, either sideways or raised. A sudden pain will arise and persist for a few seconds to a minute.   It has been five months since my booster shot and I also suffer pain in my left arm when I sleep on my left side, so I have to stop sleeping on my left side altogether.  Please explain this dilemma I am experiencing and what nerve is affected.  How long will it takes for this condition to go away?  Thank you for your attention to this serious matter.
Couldn't keep blood sugar up, even though was being fed every half hour. Terrible jaundice we had to get extra testing for. Couldn't have a bowel movement. Still struggles with eczema.
Vaccination given on 12/27/99.  Dental work performed on 12/28 and 12/29 with local anesthetic.  Broke out in hives on 12/29 - still some hives on the 30th.
HYPOXIA 1/20/2022 CKD STAGE 4 (GFR 15-29)
In September 2022 after vaccination, I had a very itchy scalp and getting dandruff that I've never had before. I went to the dermatologist, and he said I had a fungal infection on my scalp. He gave me a medicated shampoo and steriod to ease the itching. I went back three months later, and it still has not resolved. I now have to go back to be treated again. There has been an improvement on the dandruff end but not the itching of my scalp.
OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; COVID-19 VIRUS TEST POSITIVE; This spontaneous report received from a physician concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number was not reported, expiry unknown) dose was not reported, 1 total, administered on 01-APR-2021 (first dose 1), and on an unspecified date in 2021 (second dose: off label use and inappropriate schedule of vaccine administered) for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non company suspect drug include adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose and frequency were not reported on an unspecified date for moderate to severe ulcerative colitis. No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 20-Dec-2021, therapy with adalimumab was discontinued. The patient received Non-company suspect vaccine included: bnt 162 (dose number in series 2) (form of admin unknown, intramuscular, batch number was not reported) dose was not reported, administered on 01-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-JAN-2022, the patient experienced feeling bad, fever, tiredness (captured as confirmed covid-19 infection) and laboratory data included: COVID-19 virus test (NR: not provided) Positive. (dose number in series 1 and 2). The action taken with covid-19 vaccine ad26.cov2.s, and adalimumab was not applicable. The patient recovered from covid-19 virus test positive, and the outcome of off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This report was associated with a product quality complaint:90000211928.
ON THURSDAY (DAY OF VACCINE): COLD CHILLS; FRIDAY: FATIGUE, NO APPETITE.
Patient experienced cold feeling that traveled from feet and rose up to knees 3-4 minutes after receiving vaccination.  When she walked, it traveled up to her thighs.  When she sat down, it went back to her lower extremities (from knees to feet).   She drank water and gatorade, but this didn't help the situation.  Patient was also anxious and feeling lightheadedness, but she's feeling better.  She's not having difficulty breathing or any other symptoms.   Oxygen saturation is at 99.
Rec'd Td IM three hours before R16 and Rabavert Tx begun. Pt was mildly sedated and went home and slept. Report noing increased joint pain, stiffness, joint throbbing and muscle soreness when woke in am along with anxiety and tension post initial Tx on 7/4/02. With each subsequent dose of PCEC pt reports throbbing pain at all bite sites but most concentrated on R hand and occas. up into neck. The joint pain, stiffness and throbbing with muscle soreness persisted x 2 wks post initial dose.
The site of the pneumonia shot was red swollen, & very painful.  Had fever, chills and extreme fatigue.
0757  - c/o itchy eyes, Benadryl given 25 mg oral. 0820 - 133.76, 80, states itching gone. Discharged home in stable condition.
RN Vaccinator did not note patients birthdate which indicated she was 17 years and not eligible to receive the Jansen vaccine. There were no adverse after effects noted.
Information has been received from a physician concerning a female who was vaccinated in the left arm with Gardasil. Subsequently, the patient developed adenopathy on the left side of her neck and a fever of 102F. She was treated with ibuprofen and acetaminophen. She missed one day of school as a result of her symptoms. Subsequently, the patient received in two weeks. Additional information has been requested. This is one of two reports received from the same source.
Developed intractable headache that woke me from a sound sleep and lasted for 15 hours, with body aches and chills.  Left arm sore for three days.
On 05Dec2022 vaccine put in the refrigerator and was given on 09Jan2023; No Adverse Event; 8 patients received doses after the 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date), PRODUCT STORAGE ERROR (On 05Dec2022 vaccine put in the refrigerator and was given on 09Jan2023) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 09-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 05Dec2022 vaccine put in the refrigerator and was given on 09Jan2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date), PRODUCT STORAGE ERROR (On 05Dec2022 vaccine put in the refrigerator and was given on 09Jan2023) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date) and PRODUCT STORAGE ERROR (On 05Dec2022 vaccine put in the refrigerator and was given on 09Jan2023).    Concomitant medications were not reported.  This case contains information for the patient 8 out of 8 adult patients. The vial size was 2.5 ml. The vial did not undergo any temperature excursions. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696087 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696087:Patient 8out of 8 Patients
3 days ago, there was a coloring on her toenail like a blood vessel rupture; facial numbness; Immediate numbness/numbness in left leg/numbness in left arm; tingling; sharp pain like poked with a pin; left big toe is really painful; This is a spontaneous report from a contactable consumer, the patient, received from a program.  A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 03Mar2021 as a single dose for COVID-19 immunisation.  Medical history included chemical sensitivity. The patient's concomitant medications were not reported.  In Mar2021, the patient experienced immediate numbness, tingling and sharp pain like being poked with a pin. She had numbness of her left leg and left arm. She reported her left big toe was painful.  On 07Mar2021, the left side of her face was numb which lasted for 2 hours. On 22Mar2021, there was a coloring on her toenail like a blood vessel rupture. The clinical outcome of the facial numbness was recovered on 07Mar2021, while the outcomes of the numbness, tingling, sharp pain, big toe painful, and coloring of her toenail were unknown.    No follow-up attempts are possible; information about lot number cannot be obtained.
Several abdominal pain upside pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Several abdominal pain upside pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Several abdominal pain upside pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Abdominal pain upper, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Several abdominal pain upside pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Information has been received from a registered nurse concerning an adult (age and gender unknown) patient who within the last six months, on an unknown date, was vaccinated (route unknown) with a 0.5mL dose pneumococcal 23v polysaccharide vaccine (lot # 650329/0747P). Subsequently, within the last six months on an unspecified date, the patient developed an injection site reaction which included pain, redness, swelling, and local heat. The patient also developed cellulitis and was treated with antibiotics. Subsequently, on an unspecified date the patient recovered. No product quality complaint was involved. A lot check has been requested. The records of testing prior to the release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
DIZZY; INJECTION SITE PAIN RADIATING TO NECK; ALMOST FAINTED; EXCESSIVE SWEATING AROUND ABDOMEN; FINGERS TINGLING AND JUMPING; CHILLS; SORE ARM AT INJECTION SITE; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced injection site pain radiating to neck. On 07-APR-2021, the subject experienced dizzy. On 07-APR-2021, the subject experienced almost fainted. On 07-APR-2021, the subject experienced excessive sweating around abdomen. On 07-APR-2021, the subject experienced fingers tingling and jumping. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced sore arm at injection site. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, almost fainted, fingers tingling and jumping, chills, nausea, and fever on 08-APR-2021, and had not recovered from headache, sore arm at injection site, excessive sweating around abdomen, and injection site pain radiating to neck. This report was non-serious.; Sender's Comments: V0:MAC comment is not required for nonserious case as per standard protocol.
Patient came in for a 1st dose Moderna vaccine today 08/03/21 @ 9:30am.  She was given vaccine around 9:40am and stated, she started experiencing chest heaviness/tightness  and sensation of having something in her throat, but not being able to cough it up within 15 minutes of getting vaccine.  She was offered some water and stayed seated for an additional 10 minutes or so and decided she was going to leave even though she was not feeling symptoms improve.  She was offered to speak to site's nurse hotline and she refused.  She stated she is a nurse herself and will seek further treatment if necessary.  She called Pharmacy back at 1pm notifying us of symptoms getting worse started feeling itching and broke out in hives.  She took a Claritin and Benadryl and stated the hives were relived after about one hour, but still has itchiness in her throat.  She is concerned about completing dose serious and having a more severe allergic reaction.
Information has been received from a physician concerning a 16 weeks old patient with down's syndrome and gastrooesophageal reflux who on an unspecified date was vaccinated PO with the first dose of ROTATEQ (lot# not reported). The physician stated that after the child had a surgery (unspecified time) and at the time of the report, the child had a gastrostomy tube (G tube). The physician did not believe the surgery and tube had anything to do with ROTATEQ, but due to the patient having gastrointestinal (GI) reflux. At the time of the report, the patient's outcome was unknown. Upon internal review surgery was considered as an other important medical event. Additional information has been requested.
I started to notice intermittent tingling and numbness that would travel from feet to legs to arms, sometimes to lips. It was not constant, some days it was worse that others. No pain, or swelling noted with this. Unaffected by position or movement. Also had very painful sciatica down R leg (something I have had in the past but that was resolved) this lasted for about two weeks and the numbness and tingling has lasted thus far for a month.
Nursing manager was informed of incident. She in turn contacted Patients mother and explained to parent and reassured her of no harm to extra dose. Patient will need to return for Pentacel (18 month immunization
The patient has a history of Parkinson's which was diagnosed in April 2023; currently he is not on medication for this. He was seen in the ED on 8/17/23 for dizziness which he describes as feeling woozy and lightheaded. Additionally, the patient had a worsening tremor and mild confusion. He was admitted on 8/17/23 for this. On admission, he was found to be febrile with a temperature of 101-102F. A COVID PCR test was done which resulted positive. He was discharged on 8/20/23. During admission, he was started on Paxlovid. Of note, the patient has received the primary COVID vaccine series and three boosters.
testing positive; testing positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Former diabetic" (unspecified if ongoing), notes: Known allergies: No; "smoker" (unspecified if ongoing); "obese" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset Apr2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) positive, notes: 4 days after completion of medication, I was symptomatic and testing positive. Was non symptomatic during medication course. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical Course: Anti viral details product=COVID 19 Treatment, brand Paxlovid, treatment start date was on15Apr2022, and treatment stop date was on 20Apr2022. Adverse event: 4 days after completion of medication, he was symptomatic and testing positive. Was non symptomatic during medication course.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1 shingrix box has 1 missing diluent; may received only diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 9DM72, expiry date 28th January 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's comment: Pharmacist reported that 1 box of Shingrix had 1 missing diluent. Pharmacist assumed that the patient might had received only the diluent of Shingrix. The reporter consented to follow-up. Additional Supportive Information: The patient might had received only the diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Aortic dissection, aortic valve partially detached, right coronary artery dissection
Vaccine administered in left deltoid by RN.  Swollen left arm noticed by RN on 2/8/2021 in AM (~0800).  Patient did not notice swelling or complain of ADR.
A RED, ITCHY RAISED BUMP WITH THE SIZE OF THE PINKY FINGERNAIL , NOT PAINFUL  HAS DEVELOPED  AT THE INJECTION SITE ON THE FIFTH DAY AFTER GETTING THE VACCINE. SHE NOTICED IT WAS THERE AT 1:00PM, AND NO MORE ITCHY AT 4:53PM TODAY 9/20/23.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:02 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 53.20. Concomitant products were not provided. On 15-Apr-2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021 and vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.