chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in her arm; This case was reported by a pharmacist and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 7F33X, expiry date 11th December 2021) and (batch number 9227H, expiry date 28th February 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 30th December 2020, the patient received the 2nd dose of Shingrix. On 30th December 2020, the 2nd dose was an unknown dose. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on 31th October 2020. The patient did not have any issues with 1st dose. The patient received 2nd dose and experienced pain in her arm. The event was ongoing. The reporter consented to follow up.
Patient received their second dose of the Moderna COVID vaccine on 6/29/2021 (of note, their first dose of Moderna COVID vaccine was given on 5/22/2021, Lot #027C21A). The patient was admitted to the hospital on 10/1/2021 with COVID infection. As of 10/6/2021, the patient remains admitted to the hospital for treatment of COVID-19 infection.
Mild case, pox lesions on trunk spread out peripherally on arms & legs. No fever. Feeling well at this time. No treatment.
Patient tested positive for COVID-19 on 4/23/2021. Patient was asymptomatic and was tested prior to a procedure. Patient previously tested positive on 12/31/2020 for COVID.
Patient with left hip pain starting approximately 48 hours after vaccine administration. Increase in pain and swelling over the following 24 hours. Location consistent with rectus femoris tenosynovitis.  Treated with NSAIDs, ice.
The patient was administered an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional (pharmacy intern) via Global Medical Information (GMI) (Reference number-00510958) and transmitted to Sanofi on 09-Mar-2021.  This case involves a 17 year old female patient who was administered a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6543AA; expiry date: 23-Feb-2021; Strength: standard) via intramuscular route in the left arm for prophylactic vaccination on 08-Mar-2021 (expired product administered).  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  The patient had no other vaccines.   It was a case of an actual medication error due to expired vaccine used (latency same day).  On 08-Mar-2021, the patient came in needing a Menactra vaccine. It was administered without problem, but after administration, it was noted that the product expired on 23-Feb-2021. Therefore, the reporter wanted to know if it was needed to repeat the vaccination. It was decided that they would repeat the vaccination.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
next day- Dizziness, tiredness, pain in the arm, diarrhea next week- skin hives and red swelling on skin
autoimmune condition; Initial information was received on 31-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient) via social media(under reference number US-SA-SAC20211103000618).  This case involves a patient of (unknown demographics) who experienced autoimmune condition (autoimmune disorder) when received vaccine INFLUENZA VACCINE.  The patient's past vaccination included INFLUENZA VACCINE with patient had the flu twice. It was really terrible. But patient got over it. Patient had many flu vaccines and they had essentially ruined life.  The patient's medical history, past medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious autoimmune condition (autoimmune disorder) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Messing with our immune systems is causing more harm than getting the flu. Patient don't get the flu.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome was unknown for the event (autoimmune disorder).  The reporter assessed the causal relationship for event (autoimmune disorder) with the INFLUENZA VACCINE as not reported.  Information on batch has been requested number for this case.; Sender's Comments: This case concerns a patient of (unknown demographics) who experienced autoimmune disorder (unknown latency) after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. The patient's past vaccination included INFLUENZA VACCINE with patient had the flu twice. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Swollen right arm pit area including chest and back with mild pain. Went to urgent care and was prescribed and antibiotic.
Patient received DTAP vaccine on 10/1/2007 and came down with a cold within a couple of days after vaccination. Parent was told by Dr. nurse that kids often get colds after vaccinations and to keep an eye on patient. On 10/9/07 patient suddenly became paralyzed from hips down and was taken to hospital for testing and was admitted to hospital for observation.
Stuffy nose; Stomachache; Chills; Headache; Body aches; Joint pains; fever; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffy nose), ABDOMINAL PAIN UPPER (Stomachache), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body aches) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (He tested Positive for Covid in Feb2021) in February 2021.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced NASAL CONGESTION (Stuffy nose), ABDOMINAL PAIN UPPER (Stomachache), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body aches), ARTHRALGIA (Joint pains) and PYREXIA (fever). At the time of the report, NASAL CONGESTION (Stuffy nose), ABDOMINAL PAIN UPPER (Stomachache), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body aches), ARTHRALGIA (Joint pains) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, COVID-19: positive (Positive) Positive in Feb-2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received :Event outcome updated and declined to further follow-up
Arm sore at the injection site; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0187), via an unspecified route of administration, administered in Arm on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient reported that she received her second dose of Pfizer vaccine two weeks ago and she mentioned that until now from two weeks now her arm was still sore, which was at the injection site. She was just calling because she wanted to know about the side effect. She did not know whether to go through urgent care to have a check out or its just like a normal. The clinical outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested
Employee developed large reddened area at site of injection. Employee completed a telehealth visit with provider who encouraged her to ice and continue to monitor site.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of a improperly stored ZOSTAVAX (lot # K007177, expiration date 21-AUG-2015) (dose and route were not reported). Concomitant therapies were not reported. No adverse effects reported. Additional information is not expected.
Pt was given a second booster, but she does not meet the current CDC guideline requirements (younger than 50 y/o.)
Patient's father reported pneumococcal and Tdap vaccines had been given "yesterday" at a well baby check up.
"Onset vesicular rash 2/23 with itching" over face, torso, arms, legs with >50 eryth discrete macular-vesicular-pustular-crusted lesions.
NUMBNESS IN LEGS; FEELS LIKE EXTREMITIES FALLING ASLEEP; MILD CHILLS; IRREGULAR MENSTRAL CYCLE; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid problems, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination.. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced irregular menstral cycle. On 05-APR-2021, the subject experienced mild chills. On an unspecified date, the subject experienced numbness in legs, and feels like extremities falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild chills, irregular menstral cycle, numbness in legs and feels like extremities falling asleep was not reported. This report was non-serious.
5 inch red swollen patch by shot, severe itchy hives on neck, back chest and down arms, nausea, severe diarrhea, chills but no fever, feel horrible, haven't been this sick in years.
VACCINATION SITE  PAIN; tiredness; viral rash; very sick; lung issues; Weird rash all over my body/around my trunk area at the top of my butt/on the top of my foot; itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), VACCINATION SITE PAIN (VACCINATION SITE  PAIN), FATIGUE (tiredness), VIRAL RASH (viral rash) and ILLNESS (very sick) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced PRURITUS (itching). On an unknown date, the patient experienced VACCINATION SITE PAIN (VACCINATION SITE  PAIN), FATIGUE (tiredness), VIRAL RASH (viral rash), ILLNESS (very sick), LUNG DISORDER (lung issues) and RASH (Weird rash all over my body/around my trunk area at the top of my butt/on the top of my foot). The patient was treated with PREDNISONE at a dose of 1 dosage form and TRIAMCINOLONE (AMCORT [TRIAMCINOLONE]) at a dose of 1 dosage form. At the time of the report, PRURITUS (itching), VACCINATION SITE PAIN (VACCINATION SITE  PAIN), FATIGUE (tiredness), VIRAL RASH (viral rash), ILLNESS (very sick), LUNG DISORDER (lung issues) and RASH (Weird rash all over my body/around my trunk area at the top of my butt/on the top of my foot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was reported.   This case was linked to MOD-2021-294347, MOD-2021-294347 (Patient Link).
1/12/21 around 10:00 reports having nausea, abdominal cramping, weakness, and uncontrolled shaking of hands, chills and present at this time 1/14/21
(L) deltoid swelling 5cm x 5cm warmth to touch, tender.
HA, fever chills cough dizziness, and fatigue 09/24/2021  COVID (+)
Syncope while riding bicycle (multiple serious injuries incurred) exactly 2 weeks after second dose suspected to be related to vaccine. At the time I considered myself exceptionally fit, healthy with no recent history or forewarning of passing out.
Nausea  Fatigue  Headache  Body aches/joint pain Low grade fever
Got pneumonia both lungs couldn?t breathe was hospitalized six days. Not around many people after injection and always wore a mask.
5 x 7cm area of swelling, mild erythema, induration on posterior right upper arm, mildly tender, developed 24 hours after MMR & VZV vaccines were given. No fever.
Patient developed rash on 11/16/17-9d after vaccines. Seen in ER 11/19 and 11/20; office 11/22/17. Widespread rash which looked like measles. According to Red Book, can occur in 2% of patients receiving MMR.
Administration interval error.  Pt was incorrectly scheduled for a pfizer second dose having received moderna as his first dose.  Once we discovered he was a moderna patient, we resceduled as a moderna but did not realize the interval timing discrepancy.  Patient aware.  Spoke with moderna and they indicated not to repeat the dose a third time.  No reaction during post injection observation time.
When client got up the next morning, his left hip, thigh and knee cap were swollen twice the normal size and slightly warm. Mother put cool packs and has been giving salt water baths to decrease swelling. They state no change in swelling. Client has not complained of pain unless someone is pushing on area. Pt went to clinic and they stated it was a counter reaction to pertussis that led to the edema. Recommended DT in the future.
The patient was administered the vaccine and told he had to stay for 15 minutes. He agreed and stayed seated in the vaccination chair. I returned to the pharmacy. Roughly 5 minutes later, we heard a loud crash. patient fell forward to the floor. He was sweaty and pale white. I immediately called 911. They arrived with in 2 minutes. The patient left via ambulance. Medic reported to me that he was hypotensive, bradycardic with a HR in the 30s.
Approximately 8 hours after receiving the shot on 7/10/21, I had tingling that started in my right thumb (the same arm as the vaccine). The tingling spread to my fingers in the same hand, then into my right wrist, right elbow, and up my right arm. It felt like my nerves were very angry. The next day, nerve tingling started in my feet. I had jerking movements in my right lower leg. I started twitching in my arms and my legs and experienced numbness in my hands and feet. It was difficult to cut my husband's hair, because holding the hair clippers was too aggravating to the nerves in my right hand. The nerve irritation moved upward to my hips, upper legs, and low back. By Tuesday (3 days after the shot) I grew increasingly weak and stiff in my legs and back. I was also losing coordination. I went to hospital. They did tests (blood, urine, etc) which were normal. I was sent home. It was difficult to walk very far without feeling stiff. Prior to the vaccine I could walk several miles without problems. The next day, the nerve irritation moved into my upper back and neck. I felt twitching in my face. It was uncomfortable to stand for extended periods of time. Most of the symptoms subsided over the next two weeks, with some mild twitching (arms, legs), numbness (hands, feet), weakness, and coordination loss currently remaining. I took Aspirin on 7/22/21 and it caused my nerves to flare up again, causing tingling in my arms, legs, and lips. Currently on 7/27/21 I still have tingling in my hands, arms, feet, and legs.
Both the patient and her husband had trouble swallowing, severe pain in the vaccinated arm, and redness at the site of administration.
8/16/2021 I started to have COVID symptoms which I think I got from my husband because he wasn't vaccinated at that time. He had tested positive for COVID a day before. I was taking care of him while he had COVID and then I started showing symptoms the night of 8/16/2021. I ordered a online request for a COVID test. Then I went to the local Urgent Care   to do the test on 8/17/2021. I got the results the next day on 8/18/2021, and tested positive for COVID. My symptoms weren't as bad as my husbands. I didn't lose my taste or smell. I had body aches, but I was still able to take care of him because he wasn't doing so well. We did the 10 days of isolation and quarantine. The body aches had died down after a few more days, and now I am fine.
This spontaneous report was received from a health care worker referring to a 13 year old male patient. No medical history was reported. Approximately on 21-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9, dose, route and frequency: unknown, lot number: L016429, expiry date 09-AUG-2017. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Friday the 23rd lost filling in left arm could not make a fist; Saturday 24th very fatigued; diarrhea; itching coming about the body; shortness of a breath; hives all over the body; hot to touch; hard to breathe; Itchy feeling and throat and tongue; Itchy feeling and throat and tongue; Also had bad headaches for 2 days; This is a spontaneous report from a contactable consumer (patient). A 48-Years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in Left arm on 23Jul2021 13:15 (age at the time of vaccination 48-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. Patient had no known allergies. On 23Jul2021 13:15, the patient experienced Friday the 23rd lost filling in left arm could not make a fist; Saturday 24th very fatigued; diarrhea; itching coming about the body; shortness of a breath; hives all over the body; hot to touch; hard to breathe; Itchy feeling and throat and tongue; and also had bad headaches for 2 days. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient received 2 types of medication to help with the hives as a treatment for adverse events. No covid prior vaccination. No covid tested post vaccination. The outcome for all the events was recovering.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 2 month old patient who was vaccinated with the first dose of ROTATEQ.  Subsequently at the four month visit, the patient's mother reported that the infant was gassy, burping and passed gas a lot, and was very, very fussy.  It was unknown whether medical attention was sought.  Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In October 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). In November 2018, not applicable after receiving SHINGRIX and less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. The patient was treated with TAMIFLU. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the influenza to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. It was unknown if the reporter considered the vaccination failure to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The patient received SHINGRIX dose about 2 months ago and a flu shot in early October 2018. The patient reported that about 3 days ago, he developed the flu and was seen by urgent care clinic and prescribed TAMIFLU to treat. The reporter did not consent to follow up. The reporter was unable to verify which flu shot he received.
Patient received booster COVID dose on Friday, 2/18/22. Late Saturday, patient experienced headache, dizziness and arm pain. Patient reports that she took Tylenol, which did not help. On Sunday, patient reports waking up with nausea and worse headache + dizziness. What concerned the patient the most was that she also experienced diarrhea on Sunday. The diarrhea persisted through Monday, 2/21/22. It is only today that she has started feeling better (she has been working on staying hydrated). Of note, patient states her headache turned migraine-like (i.e., had to avoid light and sound) on Monday and persisted until today.
Patient stated exactly 2 weeks after her second dose, she got numbness in both her arms all the way through her finger tips. Additionally, she has joint pain in almost every joint of her body. She reports that it hurts to stand, sit, walk, and move. She has tried OTC medications with no help. As of May 5, 2021, she reports a slow regression of symptoms.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective and COVID-19 with PAXLOVID.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
Irritable bowel systems.  Treatment diet and IB guard. Improving after 2.5 weeks