chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Regular fever symptoms and tiredness Abdominal pain kept me awake the whole night Doctor prescribed Prilosec Hours later I started vomiting and had severe abdominal pain Diagnosed with pancreatitis and splenic artery aneurysm  Treatment: An anti-nausea medication and a shot of Toradol I was recommended to do a one week clear liquid diet
pt described pain that kept them in bed for 2 days could not perform usual activities of daily living took 2 naproxen
left arm pit really swollen; Really hurting bad; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm pit really swollen) and PAIN IN EXTREMITY (Really hurting bad) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced PERIPHERAL SWELLING (left arm pit really swollen) and PAIN IN EXTREMITY (Really hurting bad). At the time of the report, PERIPHERAL SWELLING (left arm pit really swollen) and PAIN IN EXTREMITY (Really hurting bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Menstrual cycle started 7 days early. Menstrual cycle lasted @ 11 days. I always start on the same day and have a very regular period so it was very unusual to start a week early and to last so long.
headache; very exhausted; sore all over the body; Feels like his son was on fire/high fever but not measured; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEADACHE (headache), FATIGUE (very exhausted), MYALGIA (sore all over the body) and PYREXIA (Feels like his son was on fire/high fever but not measured) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical History information was reported.    On 02-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced HEADACHE (headache), FATIGUE (very exhausted), MYALGIA (sore all over the body) and PYREXIA (Feels like his son was on fire/high fever but not measured). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), FATIGUE (very exhausted), MYALGIA (sore all over the body) and PYREXIA (Feels like his son was on fire/high fever but not measured) outcome was unknown.            No concomitant medication was reported.    This case was linked to MOD-2021-209017 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEADACHE (headache), FATIGUE (very exhausted), MYALGIA (sore all over the body) and PYREXIA (Feels like his son was on fire/high fever but not measured) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical History information was reported.    On 02-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced HEADACHE (headache), FATIGUE (very exhausted), MYALGIA (sore all over the body) and PYREXIA (Feels like his son was on fire/high fever but not measured). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), FATIGUE (very exhausted), MYALGIA (sore all over the body) and PYREXIA (Feels like his son was on fire/high fever but not measured) outcome was unknown.            No concomitant medication was reported.    This case was linked to MOD-2021-209017 (Patient Link).
Injection Site Reaction Day 2:  Soreness in shoulder/arm Day 8:  Small, itchy knot at injection site Day 9-11:  Knot has swollen to approximately the size of a half dollar, and seems to be getting worse, not better.
Patient noticed redness, swelling, and hot to touch to left arm on 9/26/15. Patient did not take any ibuprofen or apply cold packs to arm. On 9/28/15, patient reported reaction to nurse. Patient states her reaction lessened since then, Area was noted to be redenned and slightly swollen only.
Aches; Sore arm at injection site; This case was reported by a nurse via call center representative and described the occurrence of pain in a 65-years-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain and injection site pain. On an unknown date, the outcome of the pain and injection site pain were recovered/resolved.   It was unknown if the reporter considered the pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporting nurse was the concerned patient. The patient experienced aches and sore arm at injection site for 36 hours.  The patient did not experience hives. The reporter consented to follow up. This case has been linked to US2020056774 and US2020AMR057294, reported by the same reporter.
Was out of the country for 8 days and started feeling bad, went in and tested Positive for COVID-19. Was prescribed Paxlovid. Tested negative after 5 days.
Pt received Pneumo shot 10/22. Noticed arm swelling and red, went to MD and came in to show pharmacist 10/24/14.
This serious spontaneous case, initially received on 22-Oct-2018, reported by other non-health professional, concerning a male patient of unspecified age. On an unspecified date (few weeks ago as reported), the patient was administered influenza vaccine [dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported]. On an unspecified date, after vaccination, the patient was hospitalised for an unknown reason and he almost died. At the time of this report, the outcome of the event was not reported. The reporter assessed this case as serious (hospitalisation).
I had a really bad sore throat and thought it would go away by the next morning. So, the next morning when it got worse, I took a rapid COVID-19 test and it came back positive. The next day, I had a really bad cough and fever and body chills that caused me to vomit. I started to take DayQuil and NyQuil to help my symptoms. So I went to my doctor and told them I had COVID-19, and the nurse practitioner prescribed Molnupiravir; when I was taking it the prescription, I had a bad rash and reaction to it so I stopped taking it and went back to DayQuil and NyQuil. By day 5 or so of quarantining, I was feeling better.
Patient was given the booster shot for Pfizer vaccine 22 days before he was eligible.
Patient presented to pharmacy 1 week post-COVID vaccination with severe bruising and skin discoloration below the injection site. Patient stated only painful in center of bruise but was itching. Patient's primary care provider is aware of the reaction and has advised to use warm compress to ease symptoms.
Pt stated that itching, redness, and swelling started approximated 3 to 4 days after receiving her vaccinations. Pt stated that the spot started small and has spread to wrap around her arm.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Moderna vaccine on 2/20/2021, 3/23/21 and 10/22/21. Presented to ED with fever, weakness and incontinence. Pt was no longer receiving further Ca tx. Workup in ED significant for UA without evidence of infection, BUN 34, creatinine 1.91, AST 424, ALT 892, lactic acid 1.4, procalcitonin 0.40, INR 2.5, PTT 28.7, hemoglobin 11.7, hematocrit 35.7, platelets 146, COVID-19 positive, CXR w/LLL PNA. Admitted for covid 19 PNA, liver failure, general debility. Transitioned to comfort care/ hospice. Pt expired on 9/15/22. Pt treated with zosyn, ceftriaxone, and azithromycin.
Jynneos administered intramuscularly; Case reference number US-BN-2022-001673 is a spontaneous case report initially received on 27-Jul-2022 from other health care professional via Communication (reference number: USBAV22-0690) and concerns a *29-year-old male patient.*  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), at dose of 0.5 mL, administered intramuscularly (IM) in the *left deltoid region*, for pre-exposure prophylaxis (PrEP) (explicitly coded as 'Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.  At the time of this report it was known that the patient did not experience any adverse event due to Jynneos vaccination.  Additional information received on 27-Jul-2022 from Bavarian Nordic included local BN case ID.  This case is linked with cases no. US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a health care professional via Bavarian Nordic on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 29-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis (PrEP), which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product, but to human factor. The case is non-serious.; Sender's Comments: A 29-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis (PrEP), which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product, but to human factor. The case is non-serious.
Large, warm, red, swelling at site.  Approximately 10cm long, 6cm wide.
Conjunctivitis (swollen eyelids, red eyes), painful bilateral parotitis with edema, chills.
Patient came in for booster dose of covid vaccine. RN, administered .5mL of the moderna vaccine instead of .25mL as was supposed to be given. Patient had no adverse reaction to vaccine, tolerated vaccine dosage.
Pt. seen in office 3 days after receiving injection with red & swollen, tender area where received injection. Doctor advise ice, elevate & give 24 hours to rule out reaction vs cellulitis. Next day pt arm somewhat less red/swollen, dx reaction localized to vaccine.
Moody, low grade temp x few days. Waking at noc. Not napping well. Rash broke out Tuesday or Wednesday.
Itchy red rash on both upper arms, shoulders, upper and lower back, stomach area, both knees. Began after first shot 22 Jan 2021 and got really bad after 18 Feb. 2021 second shot.  Saw skin Doctor on 1 March 2021 and got script for rx cream.  Rash continues of this date, but to lessor degree.
Pt is the high school nurse and she received her flu vaccine at the school 11/05/2002 at 08:30. Apprx. 1 hour later she began to break out and itch all over. She took Benadryl that day and didn't report for work the following day. The rash was much better by 11/07/2002. She states she has been on a increased carb. diet and eating lots of eggs and had a earache the night before (11/04/2002) and used Floxin ear drops. Denies allergies
Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 15-MAR-2021, the patient was vaccinated with one Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number R036176, which has been verified to be valid, the expiration date was reported and validated as 08-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001297:
I had agonizing left hip pain going into the lower back. I couldn't walk. During the night, it's more uncomfortable. When I move, it's better. When I don't move, it's more painful. I am currently undergoing physical therapy.
Warmth at the injection site; Redness at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE WARMTH (Warmth at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE WARMTH (Warmth at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site). At the time of the report, INJECTION SITE WARMTH (Warmth at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used includes blood pressure medicine NOS and cholesterol medicine NOS. Treatment for the events included ice, which didn't do anything. It's starting to fade away.
Within 15-minutes of vaccination, the patient reported pruritus at site of injection. EMS managed the patient's condition on-site.
Today is March 10 - 10 days after the vaccine - my eyes are red, I have some rash on my face and my throat is red and sore.  It?s very painful. I went to the doctor gave me cough medicine. I only cough 2-3 times. But the pain and redness in my throat  is constant. Day 2 - I have shorthness of breath ( that was one morning only) a d I could not move my arm until day 3 . It?s was painful and sore.- I need to know if I t is safe to take the second dosis
Dizziness, numbness, nausea/vomiting, felt lightheaded, flushed, sweating   We monitored her till her symptoms resolved
Pain at injection site, right shoulder right side of neck. Right side of back, burning sensation. Chemo Tx earlier injections 11/10/04.
Immediate burning and pain at injection site followed by swelling. Severe aches from shoulder to fingertips, neck and back. Ear fullness, jaw pain, and eye pain. Fever, side effect peaked 12 hours post-injection and began to subside. Full recovery within 2 days.
getting over shingles and I had two shots/suspected vaccination failure; getting over shingles; painful; 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.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient was just getting over shingles and he/she had two shots.  The patient got the shot, then pharmacy told that the patient could still get shingles and the patient did but not as bad as it would had been because of the shots. It was still painful. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients (gender/age unknown). The patient's concurrent/historical conditions or concomitant therapies were not reported. Since 20-APR-2015 the patients were vaccinated with VAQTA (lot # K008254, exp. date 12-NOV-2015) (dose and route were not reported), which was exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a MA concerning a 10 year old male with no known allergies who on 04/27/04 was vaccinated with a dose of varicella virus vaccine, live. On 04/27/04 was vaccinated with a dose of varicella virus vaccine, live. There was concomitant therapy or other vaccinations given that same day. The MA  reported that on 04/29/04,  developed a rash with tried papules of varying size. Some with some with ruptured cyst heads. There was no itching or fever noticed on that same day the pt was seen in the PMD's office and acyclovir was rx;S but no laboratory or relevant diagnostic tersxts were performed. At the time of this report, the outcome was iunknown. NOr further information is agailable
Menstruation began a full week early (I have very regular cycles) 3 weeks from shot, on the day of my 2nd dose.  The cycle after that was longer by several days,  and now I have begun Menstruation again only 2 weeks after my last cycle.
The pt's mom reported a 2" diameter area of red welts below injection site. Pt complained of pain at site but able to walk without problems. Using Tylenol and Benadryl as needed. The next day, the pt's mom reported overall improvement but noted small welt above injection site, on the right leg.
Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 27 months old female patient who was vaccinated with 0.5 ml dose of suspect ACT-HIB lot number UI895AAA (Expiry date 21-Feb-2019) via intramuscular route in the left thigh on 05-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was reported that doctor inadvertently gave a ACTHIB to a patient that expired on 21-Feb-2019. It was not reported whether the patent experienced any adverse events. 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
I noticed when I urinated about 09:15 am on 17th, the toilet paper looked pink after I wiped myself. I went again an hour later and I was experiencing irritation and issue with not urinating. This time there was a trickle of blood down the toilet. This is very unusual for me -  have not experienced it before. The pink color on the toilet paper continued for about 4 hours. I was having to go to the bathroom frequently. I upped my fluid intake knowing that it may be a bladder infection. I made an appt with doctor - on the 17th -  by the time I got to see her in the afternoon I saw a physician in the same office as my normal doctor - I saw Dr. - the pink on the toilet paper wasn't happening anymore. Was prescribed Cephalexin -500 mg - twice a day for 5 days. It took until yesterday before I didn't have urgency and irritation and an issue with urinating - at this point - it feels like it may be almost back to normal. We are watching now to make sure if I have any more blood or pink staining, I will get an appt with an urologist.
Had extreme pain in right shoulder starting the night of the vaccination, which was Friday.  Went to my family Dr the next Monday whose office had administered the vaccine.  He followed up with a sonogram.  Then I saw an Ortho Dr who did an xray.  I followed up with Physical Therapy until Dec when I stopped because of CoVid fears - but have started again.  Still having pain (not so severe) after 8-1/2 months.  At first pain was so sever I could not sleep and would get migraines almost every night, and had to get help with household chores, and would drop things.  Now I can do everything - but have to work thru the pain to do them.  At home I do prescribed PT exercises, icing and tens therapy.
Patient had either syncopal vs seizure episode. Mom states patient became limp, pale, diaphoretic, and lethargic.