chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Uneasy stomach; Joint pain; Swollen (left) lymph node; 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: EP6955) via an unspecified route of administration in the left arm on 13Apr2021 at 16:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications included minerals nos, vitamins nos (CENTRUM), taken for an unspecified indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 16:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 10:00, the patient experienced uneasy stomach, joint pain and swollen (left) lymph node. 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. The clinical outcome of the events uneasy stomach, joint pain and swollen (left) lymph node were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
In the early afternoon of 3/25 I noticed pain in my breast while nursing my baby. After the feeding I could feel a hard lump on the underside of my breast that was tender to the touch and warm. I used an ice pack on the area, took curcumin and grapefruit seed extract, and nursed again on our regular schedule. The clog was resolved after the next feeding and after taking the supplements and using ice. Clogged ducts have happened to me frequently in the last ten months of nursing. I don?t know if this was related to the vaccine, but I figured I would report it in case it became a pattern in nursing mothers.
pain to my upper body arms, muscles and shoulders; have a slight problem with my back. This vaccine intensived the problem; pain to my upper body arms, muscles and shoulders; pain to my upper body arms, muscles and shoulders; Knee pain agravated; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (pain to my upper body arms, muscles and shoulders), BACK PAIN (have a slight problem with my back. This vaccine intensived the problem), MYALGIA (pain to my upper body arms, muscles and shoulders), ARTHRALGIA (pain to my upper body arms, muscles and shoulders) and ARTHRALGIA (Knee pain agravated) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Knee pain (Received cortisone shot.) and Back pain.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-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 PAIN IN EXTREMITY (pain to my upper body arms, muscles and shoulders), BACK PAIN (have a slight problem with my back. This vaccine intensived the problem), MYALGIA (pain to my upper body arms, muscles and shoulders), ARTHRALGIA (pain to my upper body arms, muscles and shoulders) and ARTHRALGIA (Knee pain agravated). At the time of the report, PAIN IN EXTREMITY (pain to my upper body arms, muscles and shoulders), BACK PAIN (have a slight problem with my back. This vaccine intensived the problem), MYALGIA (pain to my upper body arms, muscles and shoulders), ARTHRALGIA (pain to my upper body arms, muscles and shoulders) and ARTHRALGIA (Knee pain agravated) had not resolved.            No concomitant medications were reported.  Treatment details included 2 Tylenol pills for every four hours in order to function.
Bilateral, anterior thigh warm, erythematous 2cmx2cm. Discharged Rx, warm compress. Tylenol PRN for fever/pain.
Patient only got half dose as the second dose instead of full dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient only got half dose as the second dose instead of full dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient only got half dose as the second dose instead of full dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient only got half dose as the second dose instead of full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
Itching with redness and raised welts beginning 36 hours post injection, starting bilateral inner thighs and ascending bilaterally along groins, flanks, axilla, to arms and hands over a 36 hour period.
When I got out of bed Saturday morning, Jan. 16, 2021, or Sunday, Jan. 17, both of my hips were extremely painful. I had never felt pain in my hips and was alarmed by it. I didn't associate the pain with the COVID-19 vaccination until Jan. 22, when I heard a doctor in a video from the Health Department talking about the vaccinations. The city communication system had sent the link to me, unrequested, in an email. The doctor listed possible side effects, including hip pain. I searched the internet for lists of side effects, although I had read them in newspaper reports and had heard them in coverage of the pandemic and vaccines. I was unaware of hip pain specifically or joint pain being on the list.
Overactive immune response, itching and welps on areas of skin that are coming into contact with grass (no previous allergies), cat and dog hair (no previous allergies), my own hair, dirt/dust (no previous allergies), heat, as well as welping and red streaking rash when rubbing up against clothing. Will develop and subside quickly, and then show up elsewhere.  Locations: hands, feet, arms, scalp, trunk, legs (pretty much everywhere)
Immunization were administered at the doctors office at there wellness appointment. After leaving office later on that afternoon left upper arm started showing redness, swelling, feverish, hardness and tenderness. Mom called on the symptoms and was told to give him some Advil or Tylenol and Benadryl and observe it. If swelling and redness did not go away to bring him in to the office for us to check it or ER if worsen over night.  Mom brought in to the office the next day and the redness and swollenness had spread from the day before.
Became Cool, Clammy, felt nauseated, BP 120/70 - 62 - 18 Coldpack back of neck, give water then sierra mist. Reports last ate salad about 2 hrs prior. No other hx Recovered after 10 miNs with hydration. No rash, RedNess or respiratory changes
Patient stated she still have soreness/tenderness in the shoulder area of the arm she received the vaccine. Sx started 1-2 days after injection. Sx in upper arm and joint area.
left shoulder painful, overnite and into morning some. painful upon lifting up still into afternoon (3pm). pain in rib area.  Some pain in right shoulder. (reverse replacement March 6,2020).  Upon waking in morning of 27 achy in knees and ankles. that gone after supplements.
vaccine received at 915, nothing during 15 minute wait. returned to clinic. aprox 10:15 felt " a fog come over her, bad headache, and BP 189/110, HR 125 done by clinic infusion RN, muscle tingling, left ear felt blocked. Taken to ER for care
This spontaneous report as received from a nurse refers to a patient of unknown age. On 03-SEP-2014 the patient was vaccinated with PROQUAD, .5 ml, subcutaneous, lot number was reported as K005884 with expiry date of 24-OCT-2015. The nurse reported that PROQUAD was improperly stored and exposed to -6.3 C for 144 hours. No adverse effect was reported. Additional information has been requested.
Client is 12 weeks pregnant and has family history of cardiac issues. Client complained of "heart racing" and complaints of tingling of the tongue. No shortness of breath or distress.  Vitals were taken twice. ECG monitor was placed due to family cardiac issues.  ECG was normal sinus rhythm.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 17-APR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA003078:
I didn't get my period after the second dose of the COVID vaccine. I have always had regular periods so it was very strange to not get one like I expect. My husband and I are trying to get pregnant so there's no chance. So after about 6 weeks it did start, and I had a lot of tenderness and bleeding. There was many more heightened symptoms as usual, back pain swelling. As soon as it started, it just kept going. I usually have a 6 day period and it went on for 6 weeks. I sought medical care after I ended up getting a stomach bug and so I was at the doctor for that. And I told them at that point I had my period with a month. And so they prescribed with progesterone. And it was a 10 day course of progesterone. So it's June 28th, I did 10 days of progesterone, and then my period started again after 3 days. It would continue by then. The end of May now through the end of June. So my doctor referred me to a gyno for a consultation at that point. And so I scheduled with her and saw her in the beginning of July and I had a July 28 ultrasound. They didn't understand why I was still experiencing a period at that point. There was a thickening of the lining but it was considered normal. They prescribed me to go on progesterone for 3 months to reset my cycle. I took it for a week but it made me so tired that I was unable to function. I couldn't work, I needed to take naps in the middle of the day. So I called my doctor and said I needed to stop the progesterone and the doctor that looked at my ultrasound said I could come in and surgically implant an IUD to stop taking oral medication to be sleepy, and I declined. Now I'm 5 months out and I use a tracking app for my periods, I'm currently at 41 day cycle with a 12 day period. It has been getting better. It was 6 weeks and then it was 3 ½ week, then 12 days, and now 8-10 days. But the variations are still not the same as what I'm used to. Also added a recommended biopsy and I declined.
Blood cysts on inner thigh, low back pain, ESBL (did not clear up with ciprofloxacin), diverticulosis, colitis,
Cough. Given Benadryl PO, unspecified dose, x1. Stable, released from vaccination site.
Light headedness 2 hrs after appointment Dizzy. Symptoms gone by the next day.
Narrative: 87yo male died on 1/29/22 at the hospital. Pt had been admitted 1/25-1/29/22. Pt had covid infection, was covid positive and was treated w/ dexamethasone and remdesivir with minimal oxygen requirements. Pt had Hx of: HFrEF pulm htn htn Team had rounded 1/29/22 and pt was doing well/eating breakfast when nurse returned to room after rounds he was found unresponsive. He was dnr and pronounced dead. Pt had received covid vaccines on 3/2/21 & 3/30/21. Vaccine failure leading to pt's death due to covid infection.
Random chest pain starting about 6 days after vaccination.  Has been intermittent but persistent for over a month now. I've been to the er twice and had blood tests, chest x-rays and a CT, but no findings.
PATIENT HAD PVC'S 3 DAYS POST VACCINATION. POSSIBLE MYOCARDITIS PER PATIENT.
It started out with eye lids that were bright hot pink dark red. It continued for 2 weeks. We got rid of that. I used some ointments on it and I used some eye drops. We went through an entire list of eyedrops. My eyes were watering so badly. They prescribed something one day and handed me samples and that continued for a couple of days until we found something that really worked for me. Now I am using Prednisolone eye drop, Epinastine, Refresh Relieva PF. I am going to start a new treatment starting today.
Significant pain and loss of range of motion within an hour after shot. Unable to move arm for ~ 3 days. Significant pain has lingered when arm is tweaked over a month later
08jun90 pt vax hepta b> 4 hrs later pt ex tingling, tenderness and shrp pains from hip to knee of lateral inject leg.  09jun90 pt ex n/ acute diarrhea, abdo cramping and blurred vision.  sx continued for 3 days.  sx tx w/ prednisone.
noticed a huge bubble at the injection site; was given his dose of the Moderna Covid-19 Vaccine subcutaneously; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (noticed a huge bubble at the injection site) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (was given his dose of the Moderna Covid-19 Vaccine subcutaneously) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First two primary doses (First dose)), PFIZER BIONTECH COVID-19 VACCINE (First booster dose) and PFIZER BIONTECH COVID-19 VACCINE (First two primary doses (Second dose)). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 22-Apr-2022, the patient experienced VACCINATION SITE REACTION (noticed a huge bubble at the injection site) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (was given his dose of the Moderna Covid-19 Vaccine subcutaneously). At the time of the report, VACCINATION SITE REACTION (noticed a huge bubble at the injection site) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (was given his dose of the Moderna Covid-19 Vaccine subcutaneously) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Patient had gotten first two primary doses & a first booster dose of the Pfizer Covid-19 Vaccine.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-549475 (Patient Link).
Fever, coughing (lead to bronchiolitis), vomiting, viral pneumonia (+). Azithromycin - 5 day treatment Albuterol syrup - 5 days treatment.
Patient came in with their partner to receive the Moderna Covid-19 Spikevax vaccination. Both patients wanted to get vaccinated together so both came into the vaccination room. After verifying DOB, the names, and what vaccine the patients were receiving- I prepared to give the vaccine to the first patient. While doing so, the patient started a discussion, and it distracted me from what I was doing. I then accidentally gave the patient a second dose of the vaccine (her partner's vaccine). Immediately after, I notified the staff pharmacist who consulted with the patient and had them stay for extra observation. Followed up with the patient same day and the next day to check on them and said they were doing well.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: GH9694) and on 23Apr2023 as dose 6 (booster), single (Lot number: GL2042) at the age of 39 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EN6200), on 10Mar2021 as dose 2, single (Lot number: EN6206), on 15Oct2021 as dose 3 (booster), single (Lot number: FH8020) and on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "PID (primary immunodeficiency, SAD subtype)" (unspecified if ongoing); "PID (primary immunodeficiency, SAD subtype)" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "non-allergenic rhinitis" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing); "Known allergies: lactose intolerance" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 treated with Paxlovid started on 24May2023 and stopped on 29May2023.; Sender's Comments: Based on the available information, COVID-19, Vaccination failure were assessed as related to the suspect product due to a plausible temporal association.
UrticariaPruiritus see next section Narrative: On 12/24/20 9p, day 4, experienced itching torso, chest up to clavicle area, and back, continued for a week, emp used OTC cortisone 10 cream, which did not help. Emp states that he ignored itching for over a month, but it woke them at night, and you took a shower to relieve itching. Itching increased over time. After Dose #2, no change in itching. In April, coworker remarked about a rash. Employees states the they awoke twice per night over several months due to itching. Went to ER 4/23/21 because of itching, skin discoloration, rash moving toward face, was given PO cortisone and topical cortisone cream. Itching decreased, rash still present ,sleep is not disrupted at this time. Saw PCP first week of May, rx for ketoconazole 200 mg po.
Fever; Chills; Arm was sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 29th December 2021, the patient received Shingles vaccine. On 29th December 2021, less than a day after receiving Shingles vaccine, the patient experienced pain in arm, fever and chills. On an unknown date, the outcome of the pain in arm, fever and chills were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fever and chills to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient's arm was sore for the day, and got a fever and chills later in the evening of vaccination day. The patient said all good at the time of reporting. The reporter said the insurance should cover it but he/she had to sign a waiver that he/she would pay the $140 if it did not. The follow-up would not possible as no contact details were available.
Fever (101.6), muscle aches, chills, fatigue, blurriness/cloudiness; headache that has been consistent everyday since
swelling, red and hot at the site, cried continuously for an hour or more, 4 days latter, she started throwing up out of nowhere then that night she started banging her hear repeatedly in her crib and car seat, still to this day does it.  She's also had several ear infections since and now has tubes in her ears.
Estimated due date 06/24/2021. I just had arm pain at the injection site and severe headaches for about 2 days.
Had both shots, shingles breakout/suspected Vaccination failure; Had both shots, shingles breakout; Had both shots, got the "booster"; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine and 6 weeks after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient had both Shingle shots and got the booster dose, which led to extra dose administered. The patient then got shingles breakout 6 weeks later. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Heart elevated 24 hours and did not sleep at all as if I was amped up on some type of uppers.  Same symptoms as first pfizer vaccine.
not long after hot skin/welt at injection site, joint pain all over body, nausea, muscle pain all over body, migraine triggered for 2 days (NOT HEADACHE A MIGRAINE- neurological epsiode), new diarrhea lasting 3 days. back to normal ~4 days later. just this morning the hot skin/welt/itchy at injection site is back (feb 11 just over a week later). no other symptoms yet.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 18-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml)(lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer)(R/F) for each time were 72, 31 and R; 384, 34 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
Patient received FLUZONE HIGH DOSE vaccine in the office, by the time she arrived home she had facial, lip and eyelid swelling. She then drove herself to the ER.