chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt like someone hit his arm; fatigued a little; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "felt like someone hit his arm"; FATIGUE (non-serious), outcome "unknown", described as "fatigued a little".  Additional information: The caller had a friend who had their second Pfizer shot. The patient was older than the caller. The patient was fine, he said it felt like someone hit his arm and was fatigued a little. The caller declines to file a safety report, no further information or details were captured at this time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Reason for admission: Pt received flu shot 10-18-08 at approximately 0815; came to Emerg Dept on 10-18-08 at 1645 c/o itching and rash, was given diphenhydramine 50mg IM at 1758; returned to Emerg Dept 10-19-08 at 1038 w/complaints of rash all over body and blisters and whelps, was given methylprednisolone 125mg IM and hydroxyzine 50mg IM; Returned 10-20-08 to Emerg Dept w/complaints of CP mid/lt sternal on a scale of 8/10 along with lightheadedness and SOB; reports on admission that he is pain free but rash and blisters are returning. The Pt was admitted due to his hx of CAD, but it is felt he had an anxiety reaction to his continuing circumstances, as his chest pain resolved quickly upon admission without any actual treatment of the chest pain itself. Pt also received diphenhydramine 25 mg IV q 8 x 2, prednisone 20 mg q am and cetirizine 10 mg q am as an inpt.
difficulty breathing; feeling dizzy; feeling ball in throat; cold sweet; feeling blackout; headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), DIZZINESS (feeling dizzy), OROPHARYNGEAL DISCOMFORT (feeling ball in throat), COLD SWEAT (cold sweet) and DIZZINESS (feeling blackout) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced DYSPNOEA (difficulty breathing), DIZZINESS (feeling dizzy), OROPHARYNGEAL DISCOMFORT (feeling ball in throat), COLD SWEAT (cold sweet), DIZZINESS (feeling blackout) and HEADACHE (headache). At the time of the report, DYSPNOEA (difficulty breathing) had not resolved and DIZZINESS (feeling dizzy), OROPHARYNGEAL DISCOMFORT (feeling ball in throat), COLD SWEAT (cold sweet), DIZZINESS (feeling blackout) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2021, Heart rate: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported. Patient states that the adverse event fast heartbeat is still unresolved.
Patient fainted 5 minutes after getting the vaccine. The patient had hit her head during the fall and has a big bump/bruise. EMS was called and cleared the patient from any sort of concussion.
Delayed getting their second dose of the Moderna COVID-19 vaccine; Did not have a lot of reactions; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed getting their second dose of the Moderna COVID-19 vaccine) and UNEVALUABLE EVENT (Did not have a lot of reactions) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed getting their second dose of the Moderna COVID-19 vaccine) and UNEVALUABLE EVENT (Did not have a lot of reactions). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed getting their second dose of the Moderna COVID-19 vaccine) and UNEVALUABLE EVENT (Did not have a lot of reactions) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.
10/14/2011 Flu shot injection into right shoulder. 10/14/11 to 10/28/11 Right shoulder pain increasingly severe, to point of tears. 10/28/11 Phone call to Dr. with complaint of severe right shoulder pain. 11/10/11 Another call to Dr. with same complaint. I was prescribed Prednisone 5 mg/day for 6 days. 11/11/11 Call to Dr.'s office - pain gone. 11/17/11 Call to Dr. - right shoulder pain is back. Dr prescribed 2nd round on Prednisone, 5 mg/day for 6 days, and physical therapy. 11/23/11 and 11/25/11 PT - pain so intense I could not continue PT. Pain continues, severity varies. 3/5/12 Office visit to Dr. - right shoulder pain has been tolerable, but continuous. She suggested appt with sports orthopedic doctor. 3/30/12 Office visit with Dr. Received steroid injection. Pain relieved for a few weeks, but returns. Enough pain to make another appt with Dr. 10/5/12 Office visit to Dr. - X-ray, suggested MRI. 10/15/12 MRI. 10/19/12 Office visit with Dr. - MRI indicated nerve impingement in right shoulder. Steroid injection given and physical therapy recommended. NOTE: The flu shot was administered at the point of my right shoulder. During the flu shot injection administration, I stated loudly "It feels like you went right in my joint". The injection hurt! She responded by saying "I'm supposed to give it to you that high". After the injection, the pain escalated to the point it was severe enough to make me cry and I could not lift my arm, or sleep on my right shoulder. After a year, I still cannot reach backwards without pain and cannot sleep on my right shoulder without pain waking me.
Pt received 2 mo vaccinations on 1/3/2014. Presented to ER on 1/4/2014 at approx 2230 with "whole body jerking movements" vomiting x1, 1 period of apnea. No fever.
Gave me the shot  closer to my elbow rather than my shoulder; Swollen, it started swelling but it was red, it's still red and it's swollen but it's swollen quite a bit; Swollen, it started swelling but it was red, it's still red and it's swollen but it's swollen quite a bit; Have swelling and it has increased quite a bit and it's warm; Have swelling and it has increased quite a bit and it's warm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number W7602805, Expiration date: was not reported), via an unspecified route of administration on 05Jul2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had the Pfizer shot on 05Jul2021 and I didn't pay much attention as to where she gave me the shot but it's closer to my elbow rather than my shoulder. So, I'm just wondering if and then I have, it was swollen, it started swelling but it was red, it's still red and it's swollen but it's swollen quite a bit, it's actually right across my shoulder like a band halfway around my arm. And I was wondering if I could send you a picture for you to see it. When confirmed about the swelling around shoulder, consumer stated, It's not on patients shoulder, it's down by patients bicep it's not up on patients shoulder at all. It's closer to patinets elbow maybe like 2 inches away from my elbow. She gave it to me at the wrong spot, so I'm just trying to find out if that's okay or was she supposed to do it higher or what to do. And my sister in the hospital and she's having Chemo therapy and one of the nurses, I sent her a picture so she could see because I wanted to go and visit her and the nurse said that, that was really strange as to how or where I've had the shot. And she suggested why don't you better call on the website and know if there's a problem with that. I do have swelling and it has increased quite a bit and it's warm. And that's one of the side effects that I'm just concerned as to where she gave me the shot. Hopefully on the shoulder, above my elbow, on my arm up high and it's down near my elbow almost. I wasn't watching her do it because I can't stand needles so I was looking the other way I didn't see where she put the shot and she's rubbing alcohol on my arm it feel like a little higher than where she gave me the shot. The outcome of the events was reported as not recovered for vaccination site erythema and vaccination site swelling, while for the other events its was reported as unknown.
Patient developed itching (felt like bugs crawling all over skin), no rash, redness, edema, nausea or warmth at injection site.  Rx'd with PO Benadryl
3cm distal to injection site developed cellulitic area. Improving on oral Keflex
patients administered Moderna vaccine while temperature excursion assessment was ongoing; Possible Product temperature excursion issue; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (Possible Product temperature excursion issue) in a 51-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (Possible Product temperature excursion issue). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (Possible Product temperature excursion issue) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were reported. No treatments were reported.
pt recvd vax 18OCT94 4PM; by 7PM noticed neck sore & by the next morning could hardly mve head w/in-pain; then felt approx a quarter size lump under lt jaw;
I just had sore arm; 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 an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-Jul-2022. Reporter's Comments: This case was reported by the patient via interactive digital media. The patient had completed 2 shots and he/she did not get sick.  The patient just had sore arm. Additional Supportive Information: The follow-up would not possible as no contact details were available. From  the narrative it was not clear after which dose patient had sore arm  hence only 1 suspect without dose number was captured in the case.; Sender's Comments:  US-GSK-US2022AMR117884:Same reporter
Swollen lymph nodes both sides of neck developed 2 days after administration. The day of administration patient experienced extreme fatigue, right arm pain. Patient took tylenol for pain relief.
Post vax, this pt experienced local reactions with swelling, redness and soreness around the injection site to the elbow. No systemic effects occurred. The pt was instructed to use warm moist packs for 15 minutes several times daily and to take acetaminophen. Follow-up information was received which indicates that the event was resolving.
Day 1-4  soreness in arm. Day 5-6 no problem s. Day 7 wake up nauseous, headache, injection site red swollen and hot. Day 8 arm site is larger with a rash. Itching. Day 9 itching severe. Rash on chest, shoulders, back. Went to health center. My provider. I have been taking benedryl. Still itchy but is better. Injection site is also improving but is still red and swollen some. Not on fire anymore,
Information has been received from a physician concerning a pt who was vaccinated with the first dose of rotavirus vaccine. The physician reported that the pt subsequently stopped breathing. It was unk if medical attention was sought. The pt was considered to be recovered as they were noted to be ok and fine. Upon internal review, stopped breathing was determined to be an other important medical event (OMIC). Additional information has been requested.
Golf-ball size redden area, elevated, warm to touch, pain to touch. Given Xyzal 5mg (antihistamine).
Presented to Emergency Department at hospital with complaints of dyspnea and AMS. Discharge Diagnoses: COPD with acute exacerbation Notes stated he required HFNC and developed progressive multi-system organ failure.
14 weeks pregnant at town of vaccine. Due date 11/4/2021. Found out 5/26/2021 at 16 weeks 6 days that there was fetal demise. No heartbeat found on ultrasound. No other symptoms noted. No bleeding, spotting, or cramping. Fetus measured 16+ weeks on ultrasound. Last fetal heart tones heard on at home doppler on Monday 5/17 at 15 weeks 4 days.
Patient with 2 Moderna COVID vaccinations, last dose 06/01/21, who admitted with complications from COVID.  Provider note:    "Reason for Admission: Ground level fall   Brief Summary of Hospital Stay:  76-year-old female presenting for evaluation of a ground level fall after having syncopal episode. She was found by her husband who subsequently called EMS. She reported to have  subjective fevers and was evaluated by her family doctor day before the ED arrival, via telemedicine and was placed on doxycycline for suspected sinusitis. Pt was tested COVID pos on arrival. Patienthad received both of her COVID vaccinations. CXR revealed suspicious for covid pneumonia. Pt's symptoms was started 10 days prior to arrival and she was not eligible for remdesivir or regeneron. Pt became hypoxic and dexamethasone initiated. Patient with significant middle back pain for which  scheduled Tylenol as well as PRN  Norco/fentanyl later switched to Toradol with Tylenol PRN. Lack of food intake prior to arrival , therefore, IVF initiated. Pt's condition was deteriorated for a day during the stay, however, she recovered well with passing neuro exam without abnormality. Pt was initially paced on 2L oxygen and weaned off yesterday. However, pt de-satted to 85% during the walk test prior to discharge and ordered oxygen at the discharge. Pt's BP was soft during the stay. But pt was asymptomatic and BP has been stable. Pt confirmed that her BP normally runs low. Her BUN was mildly elevated this AM. Few hours of Normal saline  At 100ml/hr was given prior to discharge. Pt was discharged with oxygen, home care on 12/22/21. Pt was hyponatremic on admission (Na 132) and it was resolved prior to discharge. Pt to finish her dexamethazone dose and use tessalon Pearls as needed for her cough. Pt to f/u with her PCP for her ongoing covid issues and also discuss about possible trial of bisphosphonate for her compression fractures. "
Information has been received from a physician concerning a 4 yr old female who was vaccinated at 12 months of age with a dose of varicella virus vaccine live. In Nov 2005, the pt developed a case of breakthrough varicella. It was unk how many lesions the pt had or if fever was present. Unspecified medical attention was sought. The pt subsequently recovered. A product quality complaint was not involved. Additional information has been requested. The physician also reported a case of varicella in the pt's 2 month old female sibling (WAES0601USA01414).
Information has been received from a Licensed Practical Nurse (L.P.N) concerning a 17 year old female with allergy to CECLOR with no pertinent medical history, who on 03-SEP-2009 was vaccinated with a first does of GARDASIL (Lot number not reported), IM. There was no concomitant medication. On 27-JUL-2010, the patient received the second IM dose of GARDASIL (Lot number 666121/0597Z) (Expiration date: 13-AUG-2012) and on 30-JUL-2010 "several days after receiving the second dose" she fainted. No laboratory studies were performed. On 30-JUL-2010 the patient had recovered from fainted. The patient sought unspecified medical attention. Follow up information has been received from the Licensed Practical Nurse who reported that the patient's grandmother stated that on 30-JUL-2010 three days after vaccination, the patient had a fainting spell. It was reported that the patient recovered consciousness quickly. The Licensed Practical Nurse stated that the grandmother's patient did not take the patient to the doctor. The Licensed Practical Nurse advised and reinforce her to take the patient to evaluation. The patient did not seek medical attention. Additional information is not expected.
little bit tired; tenderness in her right arm; This is a spontaneous report from a contactable consumer (patient).  A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: ER8737, Expiration Date: 20Jul2021), via an unspecified route of administration, administered in right arm on 20Apr2021 at 16:00 (at the age of 73 years old) as first dose, single for COVID-19 immunisation. Medical history included being hyperallergenic from unspecified date in 1963, since when the patient was 15 years old and unknown if ongoing. However, it was also reported that the patient has no medical history (including any illness at time of vaccination) and family medical history relevant to the adverse event. No additional vaccines administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included glipizide and dulaglutide (TRULICITY), both taken for an unspecified indication, start and stop date were not reported. On 20Apr2021, after the first dose the patient had a tenderness in her right arm, where she received the vaccine. Then on 21Apr2021, the patient felt that she was a little bit tired. Events did not result to Emergency room and Physician Office visit. Outcome of all events was recovering.   No follow-up attempts are possible. No further information is expected.
I felt back pain and arm pain around 21:30 on Friday. I could not raise my arm on Saturday.
Rash on her arm and chest, which looks like large spider bites; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her arm and chest, which looks like large spider bites) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced RASH (Rash on her arm and chest, which looks like large spider bites). The patient was treated with TRIAMCINOLONE for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash on her arm and chest, which looks like large spider bites) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Myalgia & CoughWheeze Narrative:  Employee reports she has body aches, runny nose, sore throat, and mild cough. She said he had her 2nd dose on 1/22/2021. She doesn't know if this is a delay reaction from the vaccine or she's having COVID-19 symptoms, and would like to speak to someone.
Afternoon of day HEB B# 3 received Pt developed hives on arms/face/stomach. No resp distress. Pt takes allergy shots weekly. Pt has taken Benadryl and has epi pen. Will contact PMD if warranted. Pt did not return F/U telephone calls.
Hearing loss; This spontaneous case was reported by a nurse and describes the occurrence of DEAFNESS (Hearing loss) in a 55-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Adenocarcinoma (Lobectomy for adenocarcinoma) in 2017.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Hearing loss) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  Within a few weeks of first shot with Moderna vaccine, patient had some hearing loss. Some of the patient's friends experienced the same thing.  Company Comment: This spontaneous case concerns a 55-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of deafness. The event occurred unknown number of days after receiving the first dose of the mRNA-1273 original vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that within a few weeks after vaccination, the patient had some hearing loss. No further details were provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 original vaccine is not affected by this report.   This case was linked to MOD-2022-660854 (Patient Link).; Sender's Comments: This spontaneous case concerns a 55-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of deafness. The event occurred unknown number of days after receiving the first dose of the mRNA-1273 original vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that within a few weeks after vaccination, the patient had some hearing loss. No further details were provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 original vaccine is not affected by this report.