chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax; devel fever & a local rxn of soreness, swelling & rash at inject site
It was reported that a male pt received a Fluzone SV '99-'00 vaccination on 11/11/99. On 11/15/99, the pt reports deafness in his left ear. Also, on 11/18/99, the pt reports hearing echoes and at this time is started on steroids. From correspondence received on 2/8/00, it was reported that the pt has partial recovery. Additional pt, vaccine and responsible physician information was also provided.
Client received a pediatric Pfizer COVID vaccine, rather than an adult Pfizer COVID vaccine.
Chill before bed; Threw up and dry heaved for 4 hours.; Threw up and dry heaved for 4 hours.; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm (also reported as left shoulder) on 08May2021 at 11:15 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included, ethinylestradiol/ferrous fumarate/norethisterone acetate (LOESTRIN FE) and spironolactone (MANUFACTURER UNKNOWN) and unspecified multivitamin; all for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 08May2021 at 23:30 the patient experienced chill before bed, threw up and dry heaved for 4 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events threw up and dry heaved for 4 hours was resolved on 09May2021 at 03:30, while that of the event chill before bed was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt contacted Merck first to report adverse effects.  Merck faxed notification to agency and nurse called to follow up with pt.  Pt had reported to Merck blister-type rash on arms, back of legs and trunk - did not seek treatment.  Also stated that "entire family came down with symptoms of chicken pox after receiving the injection."  At time of nurse follow up, pt's blisters had dried up, no new blisters noted, but still some pain at injection site.  (Nurse called pt on 5/21/09 - 23 days after injection).  Progress note from 4/28/09 (when immunization was ordered for pt) states that pt's 38 yo son had recently been diagnosed with shingles.
Near syncopal episode, with nausea, dizziness, and change in vision lasting 5 mins. Pt was placed in reclined position and given water to drink.
Approx. 5 hrs. after receiving shot had extreme chills which lasted several hours. Arm began to ache and I am unable to lift my arm without pain. When the shot was given it felt as though the serum was running inside my arm, like fluid running between a wall.
Stomach cramps, nausea, diarrhea (9 days); Elevated temperature (99+°, 4 days); sore throat (6 days); 2 asthma attacks within week following vaccine (increase from zero attacks in previous 3+ months); extreme fatigue (8 days).
She was in this state of health until 5/14/2021 at 11:30 AM when she noticed acute onset of right 1-3 digits numbness & weakness. This sensation subsequently traveled up the hand, arm and right face. This sensation lasted few minutes and spontaneously resolved. Subsequently she presented to urgent care center (5/14/2021) AM. Notably patient received her first dose of the Pfizer vaccination on 5/12/2021 on the right arm. In the urgent care center evaluated for the transient paresthesia that completely resolved with preserved motor strength. Subsequently patient was discharged home without neuroimaging and given return precaution instructions.  However, while having dinner 5/14 PM the patient again started to develop numbness & weakness of the same digits that quickly spreading to the face. This time however her digits start to jerk involuntarily & violently (not suppressible), subsequently spread to affect her hand more proximally. Episode lasted few minutes as per patient's recollection. Following the jerking the patient's arm felt weak for ~ 1 hour thereafter and feels currently improved but not fully back to baseline.
Reported SOB, weakness, fatigue. Patient return back to the clinic. Dr. consulting the patient at 10:00AM. Patient stay additional 30 min. She was stable and doctor sent her home 10:30 AM.
C/o Dizziness and itching all over body after receiving influenza vaccine. Alert, oriented Treatment Dexamethasome IM, Benadryl IM
fatigue; chills; not feeling well; during the night woke her up; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fatigue, chills, feeling unwell and sleep disturbance. On an unknown date, the outcome of the fatigue, chills, feeling unwell and sleep disturbance were recovered/resolved.   It was unknown if the reporter considered the fatigue, chills, feeling unwell and sleep disturbance to be related to Shingrix.  Additional information was provided as follows: The reporter reported for her sister. The age at the vaccination was not reported. The batch details and injection date not available. The patient received Shingrix a year ago and experienced fatigue, chills, and not feeling well which during the night woke her up.  The symptoms resolved within 48 hours. The reporter did not consent to follow up. Medical doctor follow up consent was not provided. This case is linked to the case US2020075692, reported by same reporter.
This spontaneous report as received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 03-JUL-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot# M041511, expiration date 08-JAN-2018 (dose, route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 15 degrees Fahrenheit and 46 degrees Fahrenheit (also reported as 32.5 degrees Fahrenheit) for 30 minutes. Data logger was not involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-00507513-1708USA001511: US-00507513-1708USA001605:
pt stated that about 15 minutes after getting his first dose of the covid vax that the left side of his face went numb, then his body went numb, he had short of breath and heart palpitations.   He felt like he was in a panic and he like he was dying.  He was vaccinated on Friday and his face started going numb and by Saturday the numbness was moving to his extremities.  By Tuesday he went to the local Hospital ER.  He had blood work and EKG. Test Results were normal.  He was told to FU w/ PCP and is scheduled for Heart Stress Test.  He currently can only do 20 or 30 %  of what he used to be able to do. Since he is active for his work this has changed his daily activities.
Case number PHEH2014US003636 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a male patient whose age was not reported. His medical history and concomitant medications were not reported. It was reported that this patient under 18-years of age was vaccinated with a dose of FLUCELVAX 2013/2014 (batch number: not reported) at a doser of 0.5 ml intramuscularly on an unknown date. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 13 JAN 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Fever, rash maculo-papular, occasional cough, mild conjunctivitis, redenss, submax glands +1, rt drum red;
Shortly after my booster I started having a sore throat, persistent dry cough and fatigue. Shortly thereafter on 01/29/2023 I started getting symptoms of conjunctivitis since I was exposed to my partner, heart racing. Extreme pain in my side so painful I was not able function normally, low HR. Had an extreme left side pain. ECG was normal clear. I was prescribed prednisone and tetracycline at that time.
Presented with shortness of breath and cough admitted to ICU for treatment of severe COVID-19 pneumonia and acute hypoxic respiratory failure. Had evidence of cytokine release syndrome and bilateral pneumonia. Decadron, Remdesivir, tocilizumab, Zn, VitC, Vit-D,cefepime,ceftriaxone,BiPAP. Discussed with patient's daughter. Who requested patient remained DNR, DNI. And wanted to pursue comfort measures. Eventually transitioned to comfort care and started on morphine drip.Time of death:  1150
Feels sick similiar to when she had Covid; Body Aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feels sick similiar to when she had Covid), PAIN (Body Aches) and HEADACHE (Headaches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (January).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MALAISE (Feels sick similiar to when she had Covid), PAIN (Body Aches) and HEADACHE (Headaches). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) for Headache and Pain, at a dose of 1 dosage form. At the time of the report, MALAISE (Feels sick similiar to when she had Covid), PAIN (Body Aches) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided
tingling, prickling bottom of right foot; progressed to intermittent paraesthesia/ prickling come and goes; burning sensations in limbs; tightening like a band around right calf, upper left arm, various nerve type issues like this; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161), via unspecified route of administration in the left arm on 10Apr2021 at 14:45 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient had a history of allergy to sulfa drugs. Concomitant medications were not reported.  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 11Apr2021 at 09:00, 18 hours after the vaccination the patient experienced tingling, prickling bottom of right foot, progressed to intermittent parasthesias, burning sensations in limbs, tightening like a band around right calf, upper left arm, various nerve type issues like this and prickling that comes and goes. The clinical outcome of the event tingling, prickling bottom of right foot, progressed to intermittent parasthesias, burning sensations in limbs, tightening like a band around right calf, upper left arm and  various nerve type issues was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a registered pharmacist concerning a female facility employee with no medical history or drugs allergies, who on 06-Apr-2009 was vaccinated with a first doe of RECOMBIVAX (lot # 663280/1677X), intramuscularly. There was no concomitant medication. On 06-Apr-2009 and within 45 minutes the patient became "violently ill" with nausea and vomiting for 3-4 hours. The pharmacist was asking for a lot check. It was also reported that the employees health nurse will not continue to use this particular lot until it has been verified that there is no problems with this lot. No laboratories studies performed. The patient recovered on 06-Apr-2009. The patient did not seek medical attention. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation had Research and was released. Additional information has been requested.
2/3/10-Patient sent home per school nurse-febrile 101. 2/3-seen per PMD-febrile 101.2-admitted to hospital-3 days-IV fluids-c/o headache; antibiotic-Rocephine; no rash.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: En6203), in left arm, on 29Mar2021 as dose 2, single (Lot number: En6207), in left arm, on 09Nov2021 as dose 3 (booster), single (Lot number: Fh8020), in left arm and on 10May2022 as dose 4 (booster), single (Lot number: Fk9729) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: TYSABRI, start date: 31May2022, stop date: 31May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (07Jun2022) Negative; (11Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient took Paxlovid for Treatment of COVID-19 on 02Jun2022 to 07Jun2022. The patient took other medication in 2 weeks. The patient reported felt better after 5 days of paxlovid, tested negative, then 4 days later felt sick again and tested positive.
Day after injection lymph node under right arm pit swelled to size of a small lemon, This reaction didn't occur after my first injection.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. Medical assistant reported that the patient received dose 1 of GARDASIL (injection, strength, lot #, dose, route were unspecified) on 31-AUG-2009 and dose 2 (injection, strength, lot #, dose, route were unspecified) on 09-FEB-2010, would be receiving dose 3 (injection, strength, lot #, dose, route were unspecified) today on 27-NOV-2013. No symptoms reported. Additional information has been requested.
This spontaneous report was received from a nurse prescriber concerning a 18 year old female patient. The patient had no relevant medical history. The patient's drug reactions/allergies included aloe vera. The patient's concomitant medications included ZOLOFT, ORTHO EVRA and albuterol. On 18-APR-2018, the patient was vaccinated with GARDASIL 9 (lot # N021732 and expiration date of 01-FEB-2020), for vaccination (dose, route of administration and anatomical location were not reported). On 28-APR-2018, the patient developed a rash, a hard lump (injection site mass) and bruising 1 centimeter in diameter at the injection site. On the same date (reported as around the same time), she developed diarrhoea. The patient called the nurse prescriber and she advised her to take BENADRYL (unknown dose and frequency) and topical heat to alleviate the symptoms. No laboratory diagnostics or studies were performed. On 02-MAY-2018, the patient recovered from diarrhoea and injection site rash, but did not recover from injection site mass. The outcome of injection site bruising was unknown. The causal relationship between the aforementioned events and therapy with GARDASIL 9 was not reported.
Red itchy rash at vaccine site (upper left arm) Symptoms devoped 6 days after getting vaccine and are slowly diminishing after 4 days
Patient reports dizziness and ear pain. After receiving the second dose of FLUZONE HD (first dose 9/25/17) at approximately 9:30 AM on 11/3/17 patient reports to have experienced dizziness starting later that night. Did not hear back from the patient or caregiver until the morning of Monday 11/6/17 and asked if the pneumonia vaccination can cause dizziness. This is the moment the Pharmacist realized that a second FLUZONE HD was administered to the patient. Recognizing Pharmacist immediately let the patient know what had occurred and called the patient's primary care physician to let them know what had occurred. Dr. prescribed the patient Meclizine 25 mg tab four times a day to treat the symptoms of dizziness.
After receiving vaccine (4/24/18) for HAVRIX and SHINGRIX pt reports being disoriented for almost 2 days. Around 9PM after vaccine was given patient developed sudden chills, intense nausea, intense headache, teeth chattering, and disorientation. Reports being unable to sleep and violently tossing and turning. Reports being so disoriented that he lost 2 days of time. Unable to brush teeth or do normal daily activities of living. He reports that he was so disoriented he had trouble walking. Reports that wife said he had a fever, but cannot recall what the number was. Today (4/27) pt reports waking up and feeling fine. Did not seek outside treatment and feels fine now, however did have some arm pain and feeling of warmth at injection site today.
Child received vaccine 8-9-13 at approx 1:30 pm. Approx 4:00 pm left arm swelled to twice the normal size was bright red, hot to touch. Parent took child to ED. Child was given BENADRYL 25 mg po, epinephrine 1 mg IM and a script for prednisone 10 mg 1 daily for 5 days. Child had no fever.
Severe chills, High fever, shivering, headache, body aches, light sensitivity , blisters all over mouth
states onset of pain, discomfort in hands, fingers, knees, shoulders on and off twenty four hours after administration of second injection of Hepatitis B.
I almost 18 hours post vaccine developed chills. Had a low-grade headache all day. Super fatigued. Took Tylenol at 12:30 without headache relief. Took Tylenol again at 5 PM without headache relief. Also had a temp of 100.3 at this time. Took ibuprofen at 9 PM with some mild relief. Woke up In the morning feeling OK. Around 3 PM had a temp of 100.0 and I felt dizzy. Had drank 50 ounces throughout the day..
Swollen arm with Goose Egg, generalized arthralgia. Maybe fine sandpaper rash. Rash felt to be due to antibiotic. Symptoms reported over the phone. Pt asked to return to clinic, but never returned, therefore, not actually seen to have any symptoms.
(L) arm very tender & sore to movement or touch. No redness or swelling. Pt has no fever or any other S o Sx. Pt has routine MD appt tomorrow 3/18/10 and will consult with MD at the visit arm tender since 3/11 w/out worsening on oral antibiotics. 4/7/10 better but still pain & slightly swollen. Seeing improvement.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the new shingles vaccine approximately two months ago before the date of reporting. The patient was about to receive the 2nd those when he contracted shingles. The patient was apparently had a mild case with no serious outbreak or pain. The patient wanted to know could he receive the 2nd dose.
Patient mentioned fever, soreness at immunization site, redness and swelling at site. MD gave prescription for MONODOX 100 mg BID for 10 days as a preventative in case of infection. Patient also stated MD mentioned could be a possible blood vessel issue. Patient was getting much better when presenting to the pharmacy on 10/07/2017. On this date he still had some redness and heat at the site of injection. Patient said he does not feel bad. Patient stated on 10/09/2017 that the arm is nearly clear and doesnt have any complaints.
Pt received 2 doses of flu vaccine within 18 days. No symptoms reported. Parent will monitor and call back if symptoms develop.
Severe left armpit pain with lymph node swelling. It radiated to left chest causing chest pain and severe nausea. Brain fog, severe fatigue,  lasted for a week. It is now 2 weeks and the armpit swelling briefly went down but the pain is still there along with the left chest pain. Nausea, brain fog, and fatigue are also still happening.
Rash on inner legs at the knee level. Burning sensation, mild itchiness. Resolved a couple of hours after taking over-the-counter antihistamine. I did not seek professional help.
less than 12hr p/vax pt devel fever up to 101 & c/o gen aching;approx 24hr p/vax given pt has 1 episode of vomiting & nausea x 24-48hr;pt was seen in clinic 72hr p/inj given;no tx given;also had local redness @ inj site 48-72hr p/inj;
patient is a 78 year old female presenting with shortness of breath. Patient tested positive for covid on Thursday 12/2/21 and has had shortness of breath on and off since then.
extreme fatigue; aching nerve pain in hands and calves; aching nerve pain in hands and calves; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer or other non hcp reported that a patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration in May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient previously received first dose of bnt162b2, via an unspecified route of administration, administered on an unspecified date as dose 1, single for covid-19 immunisation. The patient's concomitant medications were not reported. The patient experienced extreme fatigue, aching nerve pain in hands and calves on Jul2021. It was stated that, had pfizer second shot in may. Now since July extreme fatigue and aching nerve pain in hands and calves. Outcome of the events was not recovered.  Information about lot/batch number cannot be obtained. No further information expected.