chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extreme amount of stress; vertigo that comes and goes; headache; severe fatigue; severe dizziness; arm hurt; fogginess; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (fogginess), DIZZINESS (severe dizziness), PAIN IN EXTREMITY (arm hurt), VERTIGO (vertigo that comes and goes) and STRESS (extreme amount of stress) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Shoulder surgery) on 22-Mar-2021. Concomitant products included PARACETAMOL (TYLENOL) for Pain, ESTRADIOL (ESTROGEN) and TESTOSTERONE for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FEELING ABNORMAL (fogginess). On 07-Mar-2021, the patient experienced DIZZINESS (severe dizziness) and PAIN IN EXTREMITY (arm hurt). On 08-Mar-2021, the patient experienced HEADACHE (headache) and FATIGUE (severe fatigue). On 08-Apr-2021, the patient experienced VERTIGO (vertigo that comes and goes). On an unknown date, the patient experienced STRESS (extreme amount of stress). On 10-Mar-2021, FEELING ABNORMAL (fogginess), DIZZINESS (severe dizziness), PAIN IN EXTREMITY (arm hurt), HEADACHE (headache) and FATIGUE (severe fatigue) had resolved. At the time of the report, VERTIGO (vertigo that comes and goes) and STRESS (extreme amount of stress) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
No additional AE or PQC reported; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided.  On 20-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml for prophylaxis (lot# W012163 has been verified to be a valid lot number, expiration date: 12-APR-2024; strength and route were not reported) after a temperature excursion (product storage error). The vaccine had been stored at 7 degrees Fahrenheit (F) for 1 hour. It was reported that there was no previous temperature excursion. The outcome of the event was unknown. There was no additional adverse event (AE) or product quality complaint (PQC) reported.
77 yo male with past medical history of diabetes, stroke, aortic valve replacement, sleep apnea and hypertension. Admitted for COVID-19 infection, chest tightness, and acute kidney injury on 2/15/21. COVID was treated with bamlanivimab in emergency room (prior to acute kidney injury finding that led to hospitalization) and supportive care.  Acute kidney injury was treated with IV fluids. Diagnosed with NSTEMI with cardiologist consult, outpatient stress test and conservative management. Patient discharged home on 2/18/21 with no change in home medications.
Extreme tenderness in underarm area followed by a large fluid filled pocket about the size of a small ziplock bag.  This fluid has now moved to the left breast area, and still very tender.  Fluid retention seems to be all over the body at this point.
By the evening of the same day, patient developed a fever which was maintained for 36 hours, reaching 102.3 F at highest point.  Symptoms resolved without intervention and patient did not seek medical care.
Pt was in exam 2 room, I administrated the four years old vaccines DTaP MMR in left thigh and Polio, Varicella in right thigh at 10:40 am. 10 mins later patient had a reaction to vaccines, breaking out in hives associated with wheezing.
This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 77-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th June 2020). Concomitant products included trazodone and zolpidem. On 2nd May 15:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd May 2018, several hours after receiving SHINGRIX, the patient experienced erythematous rash and raised rash. The patient was treated with Ointment. On an unknown date, the outcome of the erythematous rash and raised rash were not recovered/not resolved. The reporter considered the erythematous rash and raised rash to be probably related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that a patient developed a red, raised rash around her neck, shoulders and under her breasts a couple hours after receiving SHINGRIX. The patient did yard work in afternoon of vaccination date as well. The patient was fairly uncomfortable due to the rash and saw her health care professional the day before the reporting date and got an ointment to put on it.
Patient received Vaxelis and ACTHIB during the same visit; This non-serious spontaneous safety report, with case number 02251468/02251464, was received by a partner, on 21SEP2022 and forwarded on 22SEP2022 from a consumer.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Patient received Vaxelis and ACTHIB during the same visit".  Further information is expected.  SIGNIFICANT FOLLOW UP INFORMATION was received on 17-OCT-2022 from the other health professional.  The causal relationship between Vaxelis and the event, "Patient received Vaxelis and ACTHIB during the same visit" is not applicable, due to the nature of the event.  No adverse event was reported.  Further information is not expected.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE HYPOXIA
Viral rash with onset right after vaccine on trunk and extremities. Rash lasted 3-4 wks. Rash was exacerbated within 24 hours of second dose of vaccine. No fever.
Pt received vaccinations at 5:45pm on 01-17-06. Returned home with mother and around 6:30pm c/o H/A, vomitted X 1, weak. Had not eaten before vaccinations. Ate supper around 9:30, H/A improved. Went to school 01-18-06 with no c/o this am.
Developed a 3 inch in diameter lump at the unspecified injection site; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (the dosage regimen information was not reported) for prophylaxis.  On an unknown date, the patient developed a 3 inch in diameter lump at the injection site.  At the time of the report, the outcome of injection site mass was unknown. No causality assessment was provided.
Pt recvd 1st dose of Hep B vax in 1992 & 2 days p/vax devel nausea, vomiting & fever; sx remitted over the next 3 to 4 days but devel a pruritic rash; rash described as erythema multiforme; 2 wks later devel maculopapular rash;
symptoms since her dose of Covid Moderna vaccine on Jan the 25th.  In the first 1-2 days she had the usual soreness at the injection site but nothing else. Then, about a week after it, her arm in the area of the injection site gradually became red and warm and indurated slightly without pain About the same time she noted a sense of fatigue and feverishness. Her temp was 100.4 or thereabouts. This persisted for a couple of days with no fever in the morning or midday but feverishness in the late afternoon /early evening and the temp always between 100.2 100.4. The redness of the upper arm increased to an area of about 2x3 inches. On Feb 2nd or 3rd she began a ten day course of penicillin 500mg qid x 24 hr then 250 mg qid x 9 days. The redness, induration and warmth improved and returned to normal gradually over the next 5 days or so. She stopped the penicillin on Feb 12th. Her temperatures in the late afternoons during the time of taking the penicillin were mostly between 100 and 100.4 and in the final couple of days of taking the penicillin it seemed to be resolving. The day after the penicillin it was 99. However, on the 15th it was 101. and since then it has been about 100.4 Her arm still appears normal  .  Other symptoms she is complaining of bilateral lateral hip pain. She feels quite achy. She believes this started since the vaccine dose I believe she may have had some complaints prior to it. No joint complaints, no upper extremity symptoms other than as above. No HA, ST. She has had what she describes as "spasms in her chest") which has improved but presented about the same time as the arm and temperature did. No Gi symptoms. Her activity has not been curtailed. Neck pain bilat was noted starting the end of December without other symptoms and wo any hx of trauma and did not feel like a typical wry neck.    No travel other than for the vaccine, to the grocery store and rarely to another shop. No exposures to anyone other than our grandchildren, son and dau-in-law who are in our "bubble" (the granddaughter attends an out door preschool where they all wear masks and have had no covid cases.Patient walks weekly out doors with a friend. She sees her mother who at 96 resides at home and sees no one.  She had a NP swab for Covid PCR test yesterday (the 17th) which is reported this am as "undetected".  An evaluation with Doctor led to blood work showing wbc 9.2, hgb 11, plt 546k, ESR 74, CRP 67 a diagnosis of PMR was tentatively made and she was started on prednisone 15 mg /d.  Improvement was seen at 24 hours and persisted. Neck pain is 80% better as well.  Questions: Did the vaccine play a role in exacerbating a preceeding condition of PMR? If the neck pain is a red herring, did the vaccine cause PMR?
client received astrazeneca covid vaccine, no reaction. Previous vaccine unavailable in the , Janssen given as an alternative 9.15.2021
approximately 8-10 minutes after first dose-experienced flushing through head, down throat some sensation in throat, had to take deep breath, went down arms, felt very heavy, improved after about 15 minutes then very mild recurrence about 35-40 minutes after dose Because of throat symptoms took benadryl and pepcid 30 minutes prior to 2nd vaccine.  1hr 40minutes after 2nd, difficulty swallowing water, flowing/flushing sensation then my lips were tingly and eyes itchy briefly.  My HR was 90's which is high, my resting is 40's-50's. Arms would feel heavy with this.  This happened later in the day again,  Very unsettling, was in contact via text with cardiologist I work with ( I am an ARNP) and my Dr that is listed on this form.  They told me I could keep taking Benadryl and Pepcid q 6-8hrs.  I was also given prescription for prednisone if needed.   Following day went about 8 hrs between doses, same symptoms took Prednisone that eve, I believe 10mg this was in addition to Benadryl and Pepcid.  These  episodes kept happening for about 5-6 days.  On Friday, 3 days after 2nd dose, I tried to space out meds. then in afternoon about 4:40 was actually short of breath and felt tight with breathing.  So took meds and actually considered using my son's old inhaler.  Symptoms resided in about half hour after meds.  Last dose of meds was Sunday 8 PM after 2nd vaccine.  Ran in  morning and HR would not come down, stayed in 110's very unusual for me, I felt SOB.  Had EKG when I went to office but just prior to EKG symptoms resolved and I was SR in 70's  Had BMP and Mg these were NL. I run daily and had noted increased SOB and HR after first vaccine this continued until just a few weeks ago.   We feel this was some type of allergic reaction with possible mast cell activation.  I had internal "tightness" no appetite and felt like constant state of adrenaline for about 1-2 weeks.   Concerned if booster needed and for my son who is 18 that has some allergies
feeling woozy; sleeping hard; muscle tenderness; redness; headache; malaise; not sleeping well; This case was reported by a consumer via call center representative and described the occurrence of tenderness muscle in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 12th July 2019, unknown after receiving Shingrix, the patient experienced tenderness muscle, erythema, headache, malaise and poor sleep. On 13th July 2019, the patient experienced trouble falling asleep. On 14th July 2019, the patient experienced woozy. On an unknown date, the outcome of the tenderness muscle, erythema, headache, malaise, poor sleep, trouble falling asleep and woozy were recovering/resolving.   It was unknown if the reporter considered the tenderness muscle, erythema, headache, malaise, poor sleep, trouble falling asleep and woozy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the 1st dose of Shingrix, the patient experienced muscle tenderness, redness, headache, malaise, she was not sleeping well, had sleeping hard and felt oozy. There was a discrepancy in the reported outcomes of the events tenderness muscle, erythema, headache, malaise, poor sleep, trouble falling asleep and woozy. Outcome was mentioned as fatal, it was autoloaded as recovering/resolving. However outcome of all these events is captured as autoloaded. This case has been linked to the case US2019127914, reported by the same reporter.
Itchy, 5cm x 5cm wheal around injection site that began one week after injection Applied topical cortisone cream (OTC) and took one Benadryl for two nights in a row.   Cleared up with no further issues.
Patient called yesterday, 1/20/2021 and stated since getting the vaccine she has been overwhelmingly tired and is sleeping all the time.  No  other symptoms stated.
Red, raised, bumps on chest causing slight itching. Also a few spots on left hand/thumb area.
After second dose, I had a fever, and continue to experience shortness of breath, chest tightness and heart palpitations as of June 18th.
65 y.o. female who presents with possible stroke-like symptoms.  Patient reports a prior history of a CVA approximately 6 months ago.  Patient states she has been left with some mild decreased grip strength in the right hand due to that stroke.     Patient reports she went to bed feeling weak and fatigued last night.  She reports she woke up at 3:00 a.m. and noticed her lips were numb and tingly.  She stated she then noticed her right hand was slightly tingly as well.  She states she went into the bathroom and looked at herself in the mirror.  She did not observe any facial droop or slurring of her speech.  Patient denies any headache, chest pain, or palpitations.  Patient reports her symptoms are improving.  Her right hand tingling has resolved and the numbness and tingling to her lips are much better.   Patient does report she has been under a lot of stress and worry lately.  She is uncertain that the symptoms are stroke related or due to stress and anxiety.
Client was initially seen at Hospital on 10/19/23 and transferred to another Hospital. He was admitted that same day and required intubation on 10/23/23. He was then transferred to third hospital on 10/27/23 for escalation of care and Neuromuscular evaluation and EMG.   Per medical records client presented at hospital emergency department as a transfer from another hospital secondary to abrupt onset of lower extremity weakness upon awakening on 10/19/2023. Patient initially reported mild drift of the lower extremity. Per Telehealth neurology, he was recommended to be seen at hospital for possible anterior spinal artery syndrome and requested MRI brain and spine. Upon arrival to hospital patient was noted to have bilateral lower extremity weakness, absent DTR?s, eventually developed dyspnea and required intubation. He was reportedly also complaining of paresthesias in the distal upper extremities. Weakness rapidly progressed and is now currently involving cranial nerves. Prior to leaving facility, patient was able to move his head and open eyes.   A LP was completed on 10/27 which was ?unremarkable?: protein 61, RBC 1400, WBC normal, glucose 102. Five rounds of plasma exchange with no significant improvement. Negative for HIV, Lyme IgG and IgM, paraneoplastic panel, anti-VG CCR antibodies, and anti-ACH receptor antibodies. ?Per report MRI and spine unremarkable in facility.?   A neurology consult was placed for ?ascending paralysis with concern for GBS.? Most recent neurology note from 10/30/23 states, ?suspect AIDP variant, likely AMSAN. EMG consistent with diagnosis.? Neurology note from 10/30/23 also reported, ?In bed, not on sedation chronically ill appearing. Patient is unresponsive to verbal, tactile, and noxious stimuli. Breathing synchronous with the ventilator. Pupils are equal and sluggishly reactive to light. Oculocephalic reflex absent. No gaze preference or pathologic nystagmus noted. No corneal reflexes. No facial asymmetry noted. No gag/cough reflex per RN. No spontaneous movements. No withdrawal to noxious stimuli applied to any extremities. No posturing. No tremors, myoclonus, adventitious movements noted. Tone is decreased throughout. Reflexes absent throughout. Plantar responses are mute bilaterally. Prognosis for a functional neurologic recovery is poor.?  Multiple other medical conditions being monitored.
Blurry vision beginning 6/27/21. Ended up at retinal specialist, diagnosed 6/30/21 with APMPPE -- a rare condition where virus from liver inflames the lens of the eye, resulting in inability to focus or see.
Skin problem: Facial swelling 1 hour after vaccine yesterday. Symptoms reported: eyes swollen shut with slow improvement overnight. Decreased ability to nurse (took an hour to complete a 4oz bottle last night) better, but not completely resolved this morning and fussy.
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient (age and gender not reported) who was administered with a vaccine ACT-HIB (lot number, expiry date, dose, dose in series, route and site of administration was not reported). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique since the nurse has administered the ACTHIB vaccine diluted with sterile water instead of the supplied 0.4 percent saline. It was not reported whether the patient experienced any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
8/31-Present Fever ranging from normal 98.6 to as high as 104. Spiking high fevers.  Loss of appetite. Not as active. Child was placed on antibiotic for 48hrs and taken off. Treatment now includes motrin and tylenol.  There was a rash on my daughter's arms and legs and vomiting, but it may have been an reaction to the antibiotic.
Puffiness to fave, looks like he had mumps - denied shortness of breath - trouble swallowing, sweats, Rx - Medrol and Claritin.
pt recvd vax & devel redness & swelling at inject site; site was tender & slightly itchy;
couldn't lift my arm because it was extremly painful; couldn't lift my arm because it was extremly painful; bruising; arm started swelling really badly into my back; red rash from my elbow up my arm into my back; extreme fatigue; vomiting; pain in head; fever; This spontaneous report was received from a 67-year-old female patient, who was referring to herself. Her concurrent condition included allergy to sulfa and neosporin and adhesive allergy. On an unknown date in 2020 she was vaccinated with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) administered perpendicular to the arm and did not experience any adverse reaction.  On 27-FEB-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered at an angle in arm (exact dose, frequency, lot #, expiration date and route of administration were not reported) as prevention of pneumonia.         On the same day, about an hour after vaccine administration, the patient experienced a very sever reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). Her arm started swelling really badly into back. She got a red rash from elbow up to arm and into back. Additionally, she experienced fever, extreme fatigue for day, could not lift her arm because it was extremely painful. The patient had vomiting one time of short duration, experienced pain in her head and bruising. The patient sought medical attention, she spoke with a physician. However, no treatment was given for the events. She did not expect this reaction because there was no reaction after pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) administration.  The patient recovered from the events on an unknown date in 2021, reported as a few days later. The events were considered to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
patient complained of feeling dizzy, flushed and having a sore arm shortly after receiving vaccine.  she was towards the end of her 30 minute observation when she reported her symptoms to the observation nurse.  her vital signs were stable and recorded.  The doctor on duty was consulted and he cleared the patient to be discharged to home.  the patient did state that she took a Mobic 2 hours prior to coming to clinic.  per the patient, she experienced dizziness when she took Mobic once before.  the patient left the clinic in stable condition.
Patient said after a week the  arm he received the vaccination in was sore and was told to watch arm and report back if any problems. Called back and was told to see his physician in case he had a reaction to the shot. Patient stated he we went to have the arm massaged and is still having problems with arm. States that arm is locking and making a clicking sound and going to doctor for an MRI to see what is the problem.
muscle tiredness; Headache; Injection site swelling; Injection site redness; This case was reported by a consumer via call center representative and described the occurrence of muscle fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received in November 2018, refer case US2019GSK089494).   On 1st May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced muscle fatigue, headache, injection site swelling and injection site erythema. The patient was treated with ibuprofen (Advil) and non-drug therapy (Cold Pack). On an unknown date, the outcome of the muscle fatigue, headache, injection site swelling and injection site erythema were unknown.   It was unknown if the reporter considered the muscle fatigue, headache, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received second injection for shingles the day before reporting. The patient had the majority of side symptoms except for upset stomach.  The patient asked for Advil to alleviate the muscle tiredness, headache etc. and asked for does cold pack also help to alleviate the swollen redness of the injection site. Discrepancy has been provided for the start date of vaccine, as 30th April 2019 should not be yesterday (the day before reporting) date.