chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heavy painful periods 3 months after shot; heavy painful periods 3 months after shot; hip bursitis; nerve pain; hip pain; This spontaneous case was reported by a patient and describes the occurrence of DYSMENORRHOEA (heavy painful periods 3 months after shot), HEAVY MENSTRUAL BLEEDING (heavy painful periods 3 months after shot), BURSITIS (hip bursitis), NEURALGIA (nerve pain) and ARTHRALGIA (hip pain) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 068h21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced DYSMENORRHOEA (heavy painful periods 3 months after shot), HEAVY MENSTRUAL BLEEDING (heavy painful periods 3 months after shot), BURSITIS (hip bursitis), NEURALGIA (nerve pain) and ARTHRALGIA (hip pain). At the time of the report, DYSMENORRHOEA (heavy painful periods 3 months after shot), NEURALGIA (nerve pain) and ARTHRALGIA (hip pain) was resolving and HEAVY MENSTRUAL BLEEDING (heavy painful periods 3 months after shot) and BURSITIS (hip bursitis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular use) was unknown.       Concomitant and specific treatment medications were not reported.  Patient experienced heavy painful periods 3 months after shot. nerve pain and IT/hip pain. Patient needed physical therapy for almost 3 months It was unknown if the patient experienced any additional symptoms/events.  Medication Details and reason for taking the medicine was reported as physical therapy, OTC pain pills, acupuncture.  Lab data/results: Patient got hip bursitis as a result from all the nerve pain and was unable to walk for a couple months.
Mother brought child in on 7/27/17. Redness, swelling and itching to right upper thigh area. Redness measured 12 cm x 10 cm. Mother instructed that she can given child Benadryl and Ibuprofen prn and use cold compresses to area. No complaint of headache, fever, vomiting, or difficulty  breathing. Mother instructed to call or go to ER with any worsening symptoms.
24 hours post vaccine, patient experienced altered and degraded night vision.  In dark and low light environments with the presence of light sources, patient felt vision was not normal.  Abnormal vision was more noticeable when patient was moving and or visually scanning the room.  Daylight vision was normal.
Large Red Raised Hives on Left arm, itching of injection site, Pain from neck down left arm to hand between thumb and index finger, tingling and numbness in hand.  SIRVA.
shot was terrible/shingles are worse/suspected vaccination failure; shot was terrible/shingles are worse; shot was terrible; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: shot was terrible/shingles are worse/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shot was terrible/shingles are worse) and feels awful (Verbatim: shot was terrible). The outcome of the vaccination failure was unknown and the outcome of the shingles and feels awful were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-APR-2023 The case was received from the patient via interactive digital media. The patient stated that shot was terrible but shingles were worse. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
No adverse effect reported; the patient was administered MMRII via the intramuscular route; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.     On 26-JUL-2019, the patient was administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R028523 and expiration date on 04-OCT-2020, for prophylaxis (dose, dose number and anatomical injection were not reported), via intramuscular route (incorrect route of product administration). Besides, the sterile diluent with lot number R032161 and expiration date 18-JUL-2021 (dose, dose number, anatomical injection site were not reported) was used for reconstitution of the vaccine. No adverse effects reported.
pt recvd vax 26AUG92 & ad 4x5 cm induration, fever 101, 2 lt inguinal lymph nodes, 1.5cm ea; following day had 2 suprapubic nodes, 2 cm ea; treatment included DPH & APAP;
This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Health Professional and concerns a female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 16-Oct-2015, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 16-Oct-2015, 4 hours after starting treatment with AFLURIA the patient experienced Severe swollen reaction, (Swelling) extends down the arm down to patient's fingers/Swollen arm and fingers, Swelling started at the injection site. Event treatment: Prednisolone taper. For relevant test results see appropriate report section. Reporter's assessment: The reporter considered events related to suspect drug.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (SICK WITH COVID) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriatic arthritis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced COVID-19 (SICK WITH COVID). At the time of the report, COVID-19 (SICK WITH COVID) outcome was unknown. Not Provided. No concomitant product reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for SKYRIZI for the event(s) of SICK WITH COVID was not provided. Patient had been prescribed with medication by physician as treatment medication. Company Comment: This spontaneous case concerns an adult female patient on concomitant immunosuppressant Risankizumab for psoriatic arthritis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 (reported as Sick with Covid) on an unknown date after receiving a dose of mRNA-1273 vaccine. Latency could not be established as the date of vaccination and the onset date of the event were not provided. A COVID-19 test was not reported. Patient was prescribed unspecified medicine by a physician. Clinical course and outcome are unknown. Information on the primary series of COVID-19 vaccination was undisclosed. Another unspecified dose of mRNA-1273 vaccine was received by the patient on an unknown date. The concomitant immunosuppressant Risankizumab for psoriatic arthritis may decrease the efficacy and immune response to the vaccine leading. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns an adult female patient on concomitant immunosuppressant Risankizumab for psoriatic arthritis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 (reported as Sick with Covid) on an unknown date after receiving a dose of mRNA-1273 vaccine. Latency could not be established as the date of vaccination and the onset date of the event were not provided. A COVID-19 test was not reported. Patient was prescribed unspecified medicine by a physician.  Clinical course and outcome are unknown. Information on the primary series of COVID-19 vaccination was undisclosed. Another unspecified dose of mRNA-1273 vaccine was received by the patient on an unknown date. The concomitant immunosuppressant Risankizumab for psoriatic arthritis may decrease the efficacy and immune response to the vaccine leading. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Hospitalized for hypoxia, COVID pneumonia, acute respiratory failure and sepsis, stabilized
Flushing of the face, increased blood pressure, suffocation, frequent headache, tiredness.
First 3 days swollen and sore, and got better. BUT on 8th day a rash developed, swollen, hot and itchy.  It is now exactly 2 weeks since the vaccine and it?s not better . I was given the vaccine in my left arm because the pharmacist told me it was protocol from the CDC.  I had 11 lymph nodes removed in that arm in 1995  and wanted the right arm.  He did say that if I insisted, he would redo the paperwork, so I reluctantly accepted. The left. I went to see my physician today and he told me not to take the second dose.
Menactra was delivered them the next day.; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old male patient who received 0.5 ml dose of  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot: U6522AA and expiry date: 29-Jan-2021), via intramuscular route in the left deltoid on 12-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Immunisation.  At the time of reporting the patient had no adverse event.  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.  List of document held by sender: none.
26 hours after receiving the vaccine, I experienced what may have been a seizure or syncope.  I do take seizure medicine and have been seizure-free for six years however having this happen right after the vaccine it's hard to believe the two are not related.  My neurologist doesn't think the vaccine had anything at all to do with the seizure/syncope which I believe is an uneducated opinion from a general neurologist (not a seizure specialist).
temp went to 103.7, was limp & pale & poorly responsively; parents took to Er & were told it would be a 1 hr wait so went home; following day temp was down to 101.9;
One week after Yellow Fever vaccine had fever, diarrhea, fatigue, myalgia, headache, and nausea.
Severe pain in left arm; Severe pain in left arm that radiated to neck and shoulder; Severe pain in left arm that radiated to neck and shoulder; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 14:00 (Lot number: FH8027) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Dec2021, outcome "recovering", described as "Severe pain in left arm"; NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 03Dec2021, outcome "recovering" and all described as "Severe pain in left arm that radiated to neck and shoulder". The events "severe pain in left arm", "severe pain in left arm that radiated to neck and shoulder" and "severe pain in left arm that radiated to neck and shoulder" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, neck pain, arthralgia.  Additional information: Patient did not receive any other vaccine in four weeks of vaccination and other medications in two weeks. Patient was not diagnosed with COVID-19 prior to vaccination, underwent COVID nasal swab test with negative result.  No follow-up attempts are possible. No further information is expected.
13 minutes after administration of vaccine patient said she felt a little dizzy.  I attended her with blood pressure cuff and her blood pressure reading at the time was 87/50.  9-1-1 was called and EMS was immediately sent.  The patient seemed tired, but was arousable and maintained consciousness until EMS arrived.  She was then taken to the EMS truck for further evaluation and likely sent on to the hospital
Injection site arm red/left arm is still (4 days later) red; Left arm is still sore/Tenderness and pain at the injection site; This non-serious case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (one episode of shingles 10 years ago).   On 14-APR-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). In APR-2023, an unknown time after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: Injection site arm red/left arm is still (4 days later) red) and pain in arm (Verbatim: Left arm is still sore/Tenderness and pain at the injection site). The outcome of the erythema of extremities and pain in arm were not resolved.   The reporter considered the erythema of extremities and pain in arm to be related to Shingrix.     The company considered the erythema of extremities and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-APR-2023 The reporter (patient) was a retired nurse. The patient did not had the lot number. The patient reports that her left arm was still (4 days later) sore and red and also said she was experiencing tenderness and pain at the injection site.  The patient had not (yet) reported this to her physician. The reporter consented to follow up.
About 1 min after Pfizer injection, pt. c/o "heat" across her chest.  BP was 140/100, pulse ox 95%, pulse 59.  Denied SOB.  Within 20 mins. all sx had abated.  She contacted her doctor that afternoon and was instructed to take BP 3x the next day which she did and reported back to her  doctor.  Her doctor "doubled" her metoprolol.  She has done well since, plans to take the second dose on 3/31/21.
Fever, NauseaVomiting, Body aches, chills, arm pain Narrative: Employee called into Occ Health from home, missing work on 1-27-21, self-administered Tylenol
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). There were no concomitant medications. The patient did not receive any other medications in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: positive at-home test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.
After receiving vaccine pt c/o nausea, then became unconscious with eyes rolling back, stiff body and grunting respirations. After a period of approx. 5 minutes, pt regained consciousness, was alert and orient to person, place and time, able to converse with staff. EMS was called due to family hx of seizures and pt was transported to hospital for further evaluation.
Pt recv vax on 3/6/98; on 3/9/98 pt exp blisters on her lips; dx=erythema multiforme; 3/13/98 problem resolved
This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Massive intestinal distress was really, really bad for 4 weeks), ABDOMINAL DISTENSION (Really bad bloating after every meal/Her main symptoms are bloating and stomach ache) and ABDOMINAL PAIN UPPER (Regularly stomach ached and rumbled/Main symptoms are bloating and stomach ache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 043B21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Massive intestinal distress was really, really bad for 4 weeks). an unknown date, the patient experienced ABDOMINAL DISTENSION (Really bad bloating after every meal/Her main symptoms are bloating and stomach ache) and ABDOMINAL PAIN UPPER (Regularly stomach ached and rumbled/Main symptoms are bloating and stomach ache). At the time of the report, ABDOMINAL DISCOMFORT (Massive intestinal distress was really, really bad for 4 weeks) had resolved and ABDOMINAL DISTENSION (Really bad bloating after every meal/Her main symptoms are bloating and stomach ache) and ABDOMINAL PAIN UPPER (Regularly stomach ached and rumbled/Main symptoms are bloating and stomach ache) outcome was unknown. No relevant concomitant medications were reported. No treatment information was reported.
Developed rash on abdomen - front, back, and sides.  Rash is a little itchy and at times painful.  It feels like I am getting stung by something every once in awhile.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-DEC-2015 at 13:04, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.4 and 5.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
I was in perfect health and didn?t have anything. After I took the first dose, I had a very bad headache every single day. And woke up every single day with a headache. With this headache I had blurry vision that would last a couple of hours then it would disappear. I tried to take Tylenol and ibuprofen to help with the pain. But I felt very weak and when I went walking around the house, I didn?t have any energy to stand up. My heart was beating very fast and I just sat down because I didn?t have energy. One night I was uncomfortable and had uncomfortable pain in my chest. I woke up in the morning and tried to go on with the day and got my son ready for the day to go to school. As I was driving, the school was 3 mins away and it was really cold. I was just standing in line to drop him off and all of the sudden, I had this very weird feeling in my right arm. Numb from my shoulder to my fingers and couldn?t feel anything in my arm. My head was also so cold and I couldn?t see anything in front of me. My car was parked and my son was there with me and witnessed all of it. I couldn?t talk and I couldn?t say anything and my tongue was numb and couldn?t feel anything. He opened the window yelling for help to come help me. They called the ambulance and they pulled me out of the car and tried to make sure I was breathing and they took my son from the car and moved it out of the way. They came and they took me to the ER, they gave me shots in my belly to prevent blood clots and did CT cans and MRIs and they told me I had a stroke. They said it was affecting my speech and memory etc. they kept me at the hospital for 3 days and I had people for speech and massage on my face because my eye was closed and half of my mouth was curved and I couldn?t smile. They said I had the stroke. And they didn?t know if the vaccine had caused this or not. When I got out of the hospital, they put me on a lot of medications and I also applied for CPA. My husband?s friend said that I should file a claim. Still suffering from this, I can?t carry anything and stopped doing medical appointments because they?re wasting time and can?t do anything
No symptoms after the mmr shot. After 6 days my son started a fever. We gave him Tylenol at 7 pm and he went to sleep. At 2 am he woke up screaming. His face was red and he was extremely hot to touch. I took him to the ER right away. We were there from 2 am - 5 am. His temp was 103.2 they gave him Motrin and his fever went down and we were discharged after 3 hours. While there they tested patient for RSV, influenza, and an ear infection which all came back negative. Less than 24 hours later he has a fever of 104.8 and hot to touch. We are not happy about this mmr vaccine.
Pt presented to the hospital  due to confusion and decreased responsiveness.  Pt admitted to alcohol use, she is wheelchair bound from cervical spine injury.  Found to have COVID pneumonia and UTI  Previously vaccinated with Moderna 5/21/21 & 6/21/21.  Discharged 2/8/22
Body rash on arms and legs, especially upper thighs. Two weeks after small clear blisters on wrists and fingers (black dot in center) a couple on legs later and cold sore inside mouth.
3/20/2021 - the next day after vaccination, the side effects were fatigued, c light hills and injection site was swollen.  The fatigue and chills side effects resolved the next day. The swollen arm resolved in 2 weeks However, on 4/9/2021 I developed a rash as of today(4/16/2021) it still has not resolved.