chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 9:15 that night, I started getting severe generalized body aches. At 2:15AM on 12/15/2021, I woke up in excruciating pain in my right ankle joint and in my left hip. In my left hip, it was so painful that when I got up out of bed, I could not weight bare at all on my left leg. It felt like severe joint pain with neuralgia type pain. It felt like nerve pain and it radiated into my groin into my hip socket and down to my left thigh on the top. Didn't go beyond my knee, but confined to the groin, hip and thigh. It was severe, and by far the worst pain I've ever experienced in my life. I called my doctor, morning of 12/15. I could not get out of bed and could not walk on my left leg. I had a telehealth visit and they wrote a prescription for a muscle relaxer and order suggested that I see a physical therapist. I have been having lower back pain for a couple years, so they thought it may have had something to do with that. And so that day, I could not work at all and couldn't take care of my animals or myself for the whole day. The next day, 12/16/2021, it was better to the point where I could weight bare on the leg but I have continued to have problems and have moderate pain in that leg and in the hip joint. Still to this day. I saw a chiropractor and that was not at all helpful to me. I have an appointment with another chiropractor to see if we can try to get this under control. It feels like a nerve or neuralgia type pain. I haven't fallen or hurt myself, so I don't know what's caused this sudden flare up. I did have the same thing happen after the 2nd vaccine, but not nearly as bad. And that happened with my right hip, not my left. I couldn't get out of bed and take care of myself. I couldn't work. April 8, 2021 I had the bad problems and I got my 2nd Pfizer on April 7, except this has resolved. After this booster, I'm still having difficulty walking on the left leg.
Case previously recorded as MA2009-6264. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Agency reference no. NA09-008851.
Patient states she had typical sore arm starting within a day after injection. However, on late Sunday/Monday she noticed the underside of her arm hurt more significantly than the injection site. She states that the injection site soreness has gone down significantly but is still tender, while the underside of her arm is still significantly sore and hurts with movement. Denies any redness or hotness to the touch. Advised patient to reach out to provider if it does not resolve or worsens.
Patient reports rash on Wednesday/Thursday on back of right arm that has been getting worse, has been taking Zyrtec and Motrin and applying Benadryl cream - recommendations per pharmacist. Reports intermittent mild itchiness at site.  States the redness is getting worse.  Advised that this is a common side effect with any vaccine.  Recommended he continue current regimen and applying ice pack to the area.  Recommended if his symptoms persist or worsen over the next day, advised that he follow-up urgently at urgent care or ER for further evaluation.  States he is currently out of town but advised if he is back in town sooner, we'd be more than happy to take a look at his arm.  He  verbalized understanding.
Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case is linked to case 2018SA331473 (same reporter). This case involves a nine years old female patient who was vaccinated with a 0.25 ml dose instead of 0.5 ml dose FLUZONE QUADRIVALENT lot UT6259NA and Exp. Date 30-MAR-2019 via unknown route in the left deltoid on 09-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to vaccine underdose. It was unknown whether the patient had any 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 documents held by sender: none.
Information has been received from a licensed practical nurse concerning a patient who on an unspecified date was vaccinated IM with 0.5 ml of PNEUMOVAX 23 (lot# 667913/1021z). It was reported that the patient experienced extensive redness, pain and feeling of heat at injection site. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Accelerated decline in condition with decreased input, decreased responsiveness, somnolence, and death
Patient complains of prolonged injection site pain. Given Tetanus Diphtheria vaccine in left upper arm - deltoid. Pain started 3 days later. + ROM to left arm/hand, no bruising, no swelling, no erythema, denies numbness/tingling down arm. Reports "its just weak and painful in the morning." Reports decrease in symptoms in past 4 days. No PO analgesic use. Topical analgesic use 1 time with relief. Still reports some pain at site.
FLUARIX 35 month and older dose was given instead of PEDIARIX at 2 months of age.
fatigue began one month after  second covid 19 vaccine. can not complete daily routine. Ongoing for 2 months
No side effects of any kind for the first 24-36 hours (this is for the first vaccine) No rash at injection sight. Then pretty strong reaction in terms of fever, nausea, headhace and body aches; congestion and breathing issues lasted for at least 2-3 days. Difficutly with breathing and congestion are still an issue almost a week later.
Patient received a third dose of vaccine. Patient had no adverse signs or symptoms, parent was counseled.
After getting the first two Vaccine shots with in a month I noticed a huge drop in my weight. I have weighed from 220 to 230 lbs for over 10 years. I was lost to why I had lost the weight so fast until I got my booster shot and I lost 15lbs within a week to two weeks after the shots just like it was after the first two shots. So now all together I have lost about 50 lbs. 30 lbs was about two weeks after first two shots then 15 right after third shot and it's still going down. I also within 24 hours of getting shots would get uncontrollably trimmers from feeling so cold and couldn't get warm and after going to sleep this way my teeth chattered so badly it cracked most of my teeth and had 3 fall out so far.
Patient has had chronic constipation since she was 3 years old. I wanted to test my daughter and we were doing blood test for the Autism diagnosis and did the test for Celiac Disease at the same time because I was diagnosed years ago. It did come back as positive for Celiac Disease. There has been no change in her health. She is doing good.
Soft, apple sized swelling in left armpit; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 20Jul2021 at 10:30 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (ADVIL), paracetamol (TYLENOL) and gabapentin (MANUFACTURER UNKNOWN); all from an unknown date, for an unknown indication, unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 29Jun2021 at 15:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 21Jul2021 at 21:00, the patient experienced soft, apple sized swelling in left armpit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event soft, apple sized swelling in left armpit was not recovered at the time of this report.
Premedicated with Ibuprofen 400mg  about 2 hours before injection yesterday.  Woke up this morning with chills, low grade fever, mild nausea, a headache, and a very sore arm.  By late morning I had a fever of 100.9 and a severe headache.  Early afternoon fever went up to 102.1.  At this time I took ibuprofen 400mg and sumaptriptan 100mg.  Fever came down and heaeache lessened.
Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 at 12:15 as dose 1, single (Batch/Lot number: unknown), in right arm and on 03Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 82 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2022 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Macular degeneration" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Doxycycline-dizzy, reaction(s): "Known allergies: doxycycline-dizzy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Prior to vaccination, was the patient diagnosed with COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (05Oct2022) Normal; Body temperature: (05Oct2022) Normal; Heart rate: (05Oct2022) Normal; Oxygen saturation: (05Oct2022) Normal; SARS-CoV-2 test: (04Oct2022) Negative, notes: Home covid tests 04Oct and 05Oct were normal; (05Oct2022) Negative, notes: Home covid tests 04Oct and 05Oct were normal. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported event Drug ineffective and Covid-19 cannot be completely excluded.
Patient is a 79-year-old male with history of diabetes not on medication and renal cell carcinoma of the left kidney presenting for altered mental status. He is accompanied by his daughter, an internal medicine doctor, who provides the history. She states that 3 days ago she was noted to be rigid and unresponsive. Subsequently yesterday he exhibited the same symptoms while sitting at the table. He was noted to be rigid, diaphoretic, unresponsive. He was not exhibiting tonic-clonic movements but he was noted to have shaking of the hands. He has urinary and bowel incontinence at baseline and has worsened over the past month. The rigidity lasted for 30 minutes and he was also exhibiting dysarthria. Denies history of stroke or childhood seizures. At the time of symptoms yesterday he was noted to be hyperreflexic. He is noted to have new onset tremors at rest as well as shuffling gate. No known history of Parkinson's. He had a nephrectomy for his renal cancer and was receiving chemotherapy for 2 years. Due to the chemotherapy side effects he refused chemotherapy and has not received since March. He does not have follow-up with the oncologist due to refusal of chemotherapy. He is currently not being treated. Daughter states that prior to current episodes he was experiencing similar symptoms of diaphoresis and rigidity 2 years ago. At that time the daughter stopped his Mirabegron to see if symptoms would improved but experienced similar symptoms approximately 6 months later. Patient is experiencing worsening of baseline urinary bowel incontinence. He is not currently complaining of abdominal pain or pain with urination or defecation. Denies chest pain, shortness of breath, numbness or tingling. Patient is fully COVID vaccinated.
Information has been received from a consumer concerning her daughter who on 07/07/2001 was vaccinated with varicella vaccine. On approx. 07/17/2001, the pt experienced redness and bumps around the injection site. The pt's mother also reported that her daughter developed 100 slightly raised red bumps which never blistered on her body. The rash subsequently resolved. The pt's mother reported that rash "came and went fairly quickly." Additional info is not expected.
Got flu shot Tues. 9/29 right deltoid; Thursday right should got severe joint pain which progressed to bone and muscle aches all over.  Felt achy all over, similiar to his first episode of rheumatoid arthritis.   Lasted 24 hours.
I skipped 2 periods after having one light period. I have now been experiencing heavy vaginal bleeding for a month straight.
Moderna COVID-19 Vaccine EUA Vaccine administered at 8:30 am on 2/11/2021. Left arm started becoming sore about 8 PM that night. Patient took 325 mg aspirin po to relieve inflammation. Chills began at 1:30 and persisted for 3-4 hours. Patient collapsed about 6:30 PM on 2/12/2021 and  EMS responded to home within minutes. Vitals were WNL. EKG showed no significant problems. Blood glucose was 144 mg/dl.
initially felt awful for one week, and again after 2nd shot but after 2nd shot have had persistent metallic taste in mouth
painful rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (patient).   A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Aug2021 12:24 (Lot number: EW0167) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 02Sep2021, outcome "not recovered", described as "painful rash". Therapeutic measures were taken as a result of rash.  Additional information: She is calling about the Pfizer Covid19 vaccine. She took the first dose on 30Aug2021. This past week she developed a serious rash on her back and it is now coming up underneath her breast and it is very, very painful. It is hard for her to keep her clothes on. It is not worse but worse than when it started, clarified it is worsened. She is skeptical about getting second dose on 20Sep2021. Advised to consult with hcp. Treatment: She is putting something over it like Neosporin but it is not working.   No follow-up attempts are possible. No further information is expected.
Has red circular rash at vaccine site in both the right and left arm. The left arm site is larger (7 cm x 5 cm) and is warm to touch, with itchiness. Right arm is not warm to touch and is smaller.  Still not resolved at time of appointment.   Benedryl 25 mg prescribed, advise to apply ice.
Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Date the vial was initially stored in the refrigerator reported as unknown and the vial did not undergo any temperature excursions. The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Non Significant FU - Primary Reporter address updated
bit of a sore arm; DOSE 5 (BOOSTER); DOSE 5 (BOOSTER); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  An 81-year-old female patient received bnt162b2 (COMIRNATY), as dose 5 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1st), for Covid-19 immunization, reaction(s): "sore arm-no big deal"; Bnt162b2 (DOSE: 2nd), for Covid-19 immunization, reaction(s): "sore arm-no big deal"; Bnt162b2 (DOSE: 3rd), for Covid-19 immunization, reaction(s): "sore arm-no big deal"; Bnt162b2 (DOSE: 4th), for Covid-19 immunization, reaction(s): "DOSE 4 (BOOSTER)", "DOSE 4 (BOOSTER)", "sore arm-no big deal". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "bit of a sore arm"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "DOSE 5 (BOOSTER)".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Patient received her second dose of Shingrix vaccination on 9/10/19.  By the time she was at home she had to use the bathroom almost every 5 minutes,  started to develop a migraine, felt nauseous, groggy, fatigue and extreme pain upon touch.  The next morning, 9/11/19, she decided to work from home from 8am but had to stop working at 11am because she did not feel well.  She decided to take a nap and woke up with a fever drenched in sweat.  Today, 9/12/19, she did not feel well enough to drive or work and  called in for work today as well.  She is still experiencing headaches and extreme fatigue.  She will be making an appointment to be seen by a physician.
Fever began on 9/30/2021 at 0426 of 99.4. Throughout the day of 9/30/2021 continually increased to 103.0 at 2120. Given tylenol and fever has subsided. 10/1/2021 at 0823 98.1.
diagnosed covid positive/coughing, congestion, body aches all like a common cold and lost sense of taste; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 19 year-old male patient received bnt162b2 (COMIRNATY), administration date 11Apr2021 (Lot number: EP7533) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "vitiligo" (unspecified if ongoing), notes: diagnosed with vitiligo in 8th grade; "mild cough" (unspecified if ongoing); "post nasal drip" (unspecified if ongoing); "stuffy nose" (unspecified if ongoing); "skipping heart beat" (unspecified if ongoing). Family history included: "high blood pressure" (unspecified if ongoing), notes: maternal; "diabetes" (unspecified if ongoing), notes: paternal. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 23Dec2021, outcome "unknown", described as "diagnosed covid positive/coughing, congestion, body aches all like a common cold and lost sense of taste". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Prior to covid symptoms the patient experienced mild cough, post nasal drip, stuffy nose during the start of winter season. It was reported that symptoms (included coughing, congestion, body aches all like a common cold and lost sense of taste) started on 20Dec2021. Coughing, congestion, body aches all like a common cold resolved in 1-2 days and lost sense of taste recovered in few days. Taste recovered most but still was slightly off at the time of the event. Quarantine was required and ended on 30Dec2021. The patient might have spread covid to his biological father. It was unclear where did he got COVID. The patient did not receive booster. It was reported that event did not take place after use of product.  No follow-up attempts are possible. No further information is expected.
Heart symptoms; broke out sweating like he had just got out of the shower; Achy; Felt run down; heart palpitations that were stronger and more frequent than normally; This is a spontaneous case from a contactable consumer (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot, Expiration date and NDC number: Unknown), via an unspecified route of administration in left shoulder on 25Mar2021 (at age of 54-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation at grocery store. Vaccine was not administered at facility. No other vaccines were received within four weeks prior to the administration of bnt162b2. The patient stated he has a history of a heart condition. Verified with patient, his heart condition was ongoing heart palpitations. Concomitant medications were not reported. The patient received his first Pfizer COVID vaccine yesterday on 25Mar2021. Last night patient had to go to the emergency room because patient was having heart symptoms, patient reported he had broke out sweating like he had just got out of the shower, patient was achy, and felt run down. The patient stated he has a history of a heart condition. Verified with patient, his heart condition was heart palpitations. Last nights event of heart symptoms included heart palpitations that were stronger and more frequent than normally. The patient asked the emergency room doctor if he should get his second Pfizer COVID Vaccine. The emergency room doctor told him yes. The patient was asking for Pfizer's opinion as well, if he should get his second Pfizer COVID Vaccine. The patient stated he believed the Pfizer COVID Vaccine triggered these symptoms. No investigation assessment reported. Outcome of the events was unknown.  No follow-up attempts are possible. Information on lot/batch cannot be obtained.
Sinus headache would not go away with medicine, Sluggish, Dizzy, Light headed, Tired,
Tinnitus in right ear. ENT prescribed methylprednisolone pack but it did not help.
Patient complained of headache, back pain, nausea, and cold sweats about 5 minutes after getting 2 vaccines listed above.  Patient was told to sit down.  Her BP and pulse was monitored for about 15 minutes after onset of symptoms.  Patient gradually began feeling better after about five minutes with all symptoms resolving within 30 minutes
1 week after vaccine received, injection site itching and noted to be red, hot and firm to touch in an area 2.5 x 3.5 inches.  Within 24 hours area spread to 4 x 6 inches.  Dissipated after 4-5 days.
I have been getting headaches and body aches since Friday the 22nd and then today I woke up with my left arm around the deltoid being erythemic, raised and itching.
Irritable and triggered behavior 2-3d followed by ataxia x1 month.