chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within hours of vaccination, left deltoid area became inflamed, swollen and painful. Area was about 3 inches x 4 inches. Pt used ice and took 2 ADVIL in order to sleep. She presented morning of 9/11/18 and are was still pink and very warm to the touch. Some edema was noted. Injection site was within the boundaries of the deltoid vaccination area. Pt will continue to monitor, use ice and take ADVIL if necessary. Symptoms are improving.
Influenza vaccine 6-35 month ordered, influenza vaccine 3+ given to patient. Dr. notified parent unaware attempted to contact parent after inceident. Will continue to try to contact parent.
No additional AE/PQC reported; HCP calling to report an AE regarding the VARIVAX vaccine. HCP reported that two 4 month old patients received VARIVAX instead of VAXELIS. HCP stated that they administered the wrong vaccine. HCP administered the vaccines due to product confusion bec; HCP calling to report an AE regarding the VARIVAX vaccine. HCP reported that two 4 month old patients received VARIVAX instead of VAXELIS. HCP stated that they administered the wrong vaccine. HCP administered the vaccines due to product confusion bec; This spontaneous report was received from a physician referred to a 4 month old patient of unknown gender. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.     On 31-OCT-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # X000532, Expiration date 04-JAN-2025, (strength, dose, dose number, frequency, route, and anatomical location were not reported), for prophylaxis; the dose of varicella virus vaccine live (oka/merck)(VARIVAX) was administered instead of a dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(VAXELIS). The reporter stated that they administered the wrong vaccine due to product confusion because "the vaccines sounded similar" (wrong product administered and product confusion). The patient did not experience any adverse event.  This is one of two reports from the same reporter.
Nose started bleeding big fat drops of blood very, very quickly.; This is a spontaneous report from a non-contactable consumer, the patient. A 12-year-old male 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 on 12Sep2021 at 00:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, and known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Sep2021 at 20:15, the patient had experienced a small bloody nose the previous day to the day of report (day of vaccination), but it stopped in 5 minutes. On the day of the report, the patient's nose started bleeding big fat drops of blood very, very quickly. It was reported that the patient did not have a bloody nose in a year and his nose continued to gush for 30-40 minutes. During this time, it got under control. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event nose started bleeding big fat drops of blood very, very quickly was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 18JUN97 & 3mo post vax pt devel a gen chickenpox rash, sore throat & swollen glands;
Note I am a healthcare provider. This was my third dose of the pfizer vaccine (the second dose was in January 2021; I also had covid 19 infection in January before second dose).  I had shaking chills with significant fever (measured on forehead at 101) for about 24 hours associated with nausea and muscle aches.  This was worse than my prior pfizer vaccines and actual covid.
3 shots given in R arm @ 12:00. Parents left & came back. Presented @12:50. BP 120/60. Hives all over body. Facial swelling. No respiratory distress. Injection site red but not swollen. Benadryl 50mg PO given(25mg & 25mg) ? Orapred 40mg po given @ 1:45pm. Observed pt for 1 hr. EMS called to transport pt to Hospital for observation.
pt recv vax & appears that the vax may have been r/t sz or the child was prone to febrile sz;
Approx. 24 hrs after injection patient developed redness around arm about 2 inches wide around 3/4 of the upper arm. Pt. went to see urgent care clinic and they suggested ice packs, CLARITIN, and Ibuprofen. 2 days later arm completely back to normal.
Temp 100F- possible seizure/ choking while sitting in car seat foaming at mouth-mouth clenched shut.  12/20/06 Received medical records from PCP which included ER records which reveal patient seen in ER for febrile seizure following a week long hx of cough & congestion.  Temp 102.7 in ER.  PCP record on 11/28 day of vax reveals patient was well. Final DX: benign febrile seizure & URI per ER physician.  PCP note stated probable MMR febrile reaction.
4/8 child had rash on arms.  Started with itching 4/9.  Rash spread over body, warm to touch.  sent to doctor. Information from 60 day Follow-up report states 4/23/04 Called mom at number listed. States wrong number. 4/27/04 - No answer at number. 5/24/04 Mom in clinic for TB skin test with child. Mom reports child had been diagnosed with Kalasawki Disease.  Client was currently on meds and doing better. Mom states client was hospitalized and released.
Generalized body aches began mild and progressively worsened  Generalized joint pain began mild and progressively worsened-most severe in lower back, arms/fingers
Per the patient report: "I recieved COVID and Flu shot at employee vaccine clinic the evening of Thursday 9/29, within a few hours I noticed some tingling/numbness in the pinky and ring finger of my left hand. Tingling got gradually worse over the next several days.    Shot was received in same arm.  This was a covid booster. "
Patient is a 82 y.o. female who presents with worsening of cough, fevers, shortness of breath, and chills for the past two weeks. One week ago she was diagnosed with covid. The patient stated that she was vaccinated for COVID-19 in February of 2021.  She was admitted on 8/31/2021 with acute hypoxic respiratory failure secondary to COVID-19 pneumonia. Patient required heated high flow nasal cannula oxygen and BiPAP support.  She also received dexamethasone x 10 days.  She showed gradual progressive improvement and weaned to regular oxygen per nasal cannula and currently on 4 L.  Patient has been stable on 4 L and seems to be comfortable at this time and overall improved.   On 9/11/2021, she was transferred to extended care facility to continue with rehab and wean down/off oxygen as tolerated.
First dose of Moderna: received vaccine April 23,2021 woke up April 24th my lips were swollen, blue and itchy. I had hives all over. I called my aunt that?s a doctor she told me to take Benadryl which helped. The swelling on my lips lasted until April 27th, and only one side swelled up . 2nd dose of Moderna: I had a fever, chills, swollen lips, itchy tongue, my lips also turned blue. This time the opposite sides of my lip swelled up and it?s extremely painful when rubbed against. I can breathe so I?m not worried.  Allergy medicine seems to help with the swelling and itchiness. My nose is stuffy and i have a lot of abdominal cramping.
BLOOD CLOT; This spontaneous report received from a consumer via media via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) 1 total, dose was not reported, administered on an unspecified date on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in  APR-2022, the patient experienced blood clot. Reporter stated that, "My Great Aunt had the 1 Shot Covid Vaccine in 2021. She suffered a blood clot last week, That forced her electric chair to maneuver onto a major highway. Update, My Great Aunt  is recovering from her 1 shot blood clot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220513851-covid-19 vaccine ad26.cov2.s-blood clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Immunizations administered on 06May06. On 07May06 pt experienced severe headache and vomiting that lasted through 08May06.
I got a mild fever the night of the vaccine of 100 and a little bit of discomfort. Then 3 or 4 days after the vaccine I noticed an area of 3 or 4 red bumps and then it became painful. I booked an appointment at the doctor and they confirmed it was shingles. This lasted about 2 weeks.
When shot was administered, I was itchy for about 5 minutes.  Later, I got black & blue where administered.  Then there was swelling, redness, the area is warm.  The redness is spreading on my arm but the black & blueness is disappearing. I called my physician on 1/23/13, was told that there is really nothing that can be done and to apply warm compresses.  Also, was told it could be a week before all symptoms may disappear.
Narrative: 71 yo male presented to the Emergency Dept on 9/7/2021 with complaints of of fatigue and fever x1 week. Patient has history of mild-moderate aortic stenosis w/ mild aortic insufficiency, non-obstructive CAD (LHC '19), HFpEF, PVCs/NSVT, HTN, HLD, OSA, CKD, hypothyroidism and peripheral neuropathy. Tested COVID+ on 9/7/2021 despite being fully vaccinated with Moderna Covid vaccination on 1/20/2021 and 2/19/2021. He received monoclonal antibody on 9/7. He felt better, but then developed worsening fevers, cough, and dyspnea. He presented to the ED on 9/11 for further evaluation. He had oxygen desaturation to the 80s and was placed on supplemental oxygen by nasal cannula. CXR demonstrated evidence of COVID pneumonia. He was given dexamethasone, ceftriaxone, and azithromycin and admitted for further management. He had acute hypoxic respiratory failure and no clear evidence for bacterial superinfection. He was discharged after 2 days at his request, in stable condition.
Pt developed rapid numbness/weakness diffusely, requiring ventilator support over period of days. Currently treated with IVIG
my left lymph node (shot was received in left arm), was hurting and my underarm is swollen and painful; my left lymph node (shot was received in left arm), was hurting and my underarm is swollen and painful; By 530 I started sweating; I woke up at 3am the morning of the 24th with uncontrollable chills; I then determined that I had a fever of 101.2; I got out of bed and noticed my body was aching all over; My arm that received the shot was tender/my underarm is swollen and painful; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in left arm, on 23Mar2021, at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. The patient woke up in the morning with uncontrollable chills, had a fever of 101.2 on 24Mar2021 03:00, on 24Mar2021 05:30 he started sweating, on 24Mar2021, he got out of bed and noticed the body was aching all over, arm that received the shot was tender. On 25Mar2021, left lymph node (shot was received in left arm) was hurting, underarm is swollen and painful. The patient underwent lab tests and procedures which included body temperature: 101.2 on 24Mar2021. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash on bilateral upper extremities, chest, back and neck. Took 50mg of Benadryl PO.
Pt received 2nd dose of H1N1 preservative free vaccine at 1145 AM in R thigh IM. Pt experienced "hives" later that evening and was taken to local ER. at approx 9 pm. Pt was discharged with Dx of scattered urticaria with Rx of children's BENADRYL PO 12.5 mg/ml, 2 ml q6h.
pt recvd flu vax 3OCT92 & on 17OCT92 reported progressive numbness & weakness in lower extremities; adm to hosp 19OCT92 w/ascending paralysis, thought to be GBS;
Headache, described by patient as worse headache of their life. Patient was referred to the emergency department where they were diagnosed with left-sided occipital nerve pain (possible cluster headache). Physical and neurologic exan normal. Labs within normal limits. Gave patient IV fluids, diphenhydramine 50 mg IV, ketorolac 15 mg IV, and ondansetron 4 mg IV with limited improvement. Gave occipital nerve block using bupivacaine 0.5% 1.5 mL and lidocaine-epinephrine 1% 2.5 mL, which resulted in significant improvement. Prescribed gabapentin 100 mg TID x1 week upon discharge for patient to use if symptoms recurred.
pt recv vax 7OCT96 & 1NOV96 pt exp a rash of 6-10 lesions on the arm 7 face;the rash was red & raised & was on the opposite arm as the vax;
Pt had a blotchy rash on scalp, neck, forehead and cheeks that increased from 2 days prior to vax. Pt was treated with hydrocortisone.
It started around 2 am the next day. I woke up in the middle of night, feeling dizzy and nauseous and body aches all over. My left arm was numb and tingly. I overall felt like I had the flu, but as if I was having an allergic reaction. It felt similar to the past reaction to a medicine I'm allergic to. I felt fatigue, and unable to do anything. I had a migraine and lower back pain.  This lasted about 2 to 4 days. It was very similar to the Sectrum medicine I mentioned under my allergies.  I had a couple of doctor appointments. No lab test just the doctors thought I had nerve damage. They put me in a vitamin called alphalypoticacid. This has been helping me. I'm still experiencing the numbness in my arm but most of the symptoms have gone away. This was my first pregnancy, I found out on October 30th that I was pregnant.  I was about six weeks pregnant. I had cramping on Nov 1st. My htg levels were going down and being monitored by my doctor and with bleeding on Nov 5th
Initial swelling at injection site on 4/20/2011. On 4/21/2011 pt. experienced vomiting, numbness on left side (arm, face, tongue). Vomiting was projectile. Experienced unsteady gait, fine motor issues on left side of body/hand. Weakness in left hand x 7 months re mom. Double vision x 2 months re mom.
25-30 min post injection patient reported feeling itchy and became flushed.   Reported mouth tingling and difficulty swallowing.   No difficulty breathing.   Monitored the patient, sats were wnl BP was elevated.   Cool pack placed on forehead, and patient took oral benedryl.   After about 20 minutes color and BP had normalized, itching and tingling resolved.   Patient ate and drank and felt well enough to leave on her own.    No further issues.
Woke at 12 AM with cold sweats, dizziness, 101 fever, nausea, body aches, headache. Treated with fluids and 500 mg of Tylenol for fever/symptoms. Fever and symptoms sustained through 10/5/2014.
Fever, extreme shaking/chills, extreme malaise, heat swings. Symptoms dampened by applying ice to the forehead for 1 hour+ but still persist. Had similar symptoms with 3rd dose (booster).
L arm swelling, pain, redness, and warmth.  Symptoms worsen and patient went to ER on 4/9/2013.  Patient was diagnosed with cellulitis and started on 10-day course of Clindamycin.
After giving Varivax in (L) arm SQ, pt went to leave through the waiting room. She fainted while in waiting room. We brought her to lie down on exam table - normal BP - given water to drink. Pt went home well.
Make me sick; Muscle and body aches; Muscle and body aches; Nausea; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-713740 (Moderna).  A 69-year-old female patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 06Feb2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "sick", "muscle and body aches", "muscle and body aches", "nausea", "headache". The following information was reported: HEADACHE (non-serious) with onset 28Feb2021, outcome "unknown"; ILLNESS (non-serious) with onset 28Feb2021, outcome "unknown", described as "Make me sick"; MYALGIA (non-serious), PAIN (non-serious) all with onset 28Feb2021, outcome "unknown" and all described as "Muscle and body aches"; NAUSEA (non-serious) with onset 28Feb2021, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated that all vaccines make her sick, muscle and body aches, some nausea, headache the next day after the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Case number PHEH2013US016741 is an initial spontaneous report received from nurse on 06 Aug 2013. This is also a quality complaint report (reference number: 238867). This report refers to a 23-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with RABAVERT (batch number: 467011C) at a dose of one ml on 03 Oct 2011 (day 0), 10 Oct 2011 (day 7) and 24 Oct 2011 (day 21). On 14 May 2013, she had equivocal rabies titer, which was an insufficient result. She required a rabies booster. Reporter assessed the case as serious (significant). No other information was provided.
Existing patient presented for flu shot. Has had flu shots in past with no problems. Flu shot FLUARIX QUAD given about 0930. Pt walked to transit center: noted increasing itching at injection site gave self an EPIPEN she carries secondary to allergy to insects and Sulfa. Called pharmacy at 10:30 and advised to stop back. Pt stopped in at 1500. Advised she was ok, but would take BENADRYL upon return home.
On January 14, 2021 a parent came to clinic to obtain COVID vaccine. The father is a dentist and he brought his teen-aged daughter with him to get the COVID vaccine, stating that she worked in the office and had patient exposure. The parent filled out the screening questionnaire for the daughter using a false date-of-birth in order to qualify the girl for the vaccine. When the parent & daughter returned for the second dose 3 weeks later on 2/2/2021, the daughter filled out her own screening questionnaire using the correct date-of-birth, which is when we became aware of the situation. The daughter was not allowed to get the second dose.
Felt in my head within seconds. My body was overheated to the point nurse applied ice on my back, neck, head. sweating. I was shaking. Felt like I was going to pass out. Felt dizzy  which I an still experiencing. Vision was blurred, still experiencing.  Was having sob.
I had a severe case of Covid-19 in December of 2020 and was hospitalized for twenty days. The day after the vaccine I got swelling in my left leg which was severe and painful. Testing revealed that there were blood clots in my legs. I have been having problems with bold clots since having Covid-19. My blood Sugar was over 500 the day after the shot and my blood pressure was very high. My blood sugar has been under control for a long time, and it is never this high. I also started to get headaches daily which I am still getting but they are not as often. I now only get headaches two to three times a week especially toward the end of the work week. Before the vaccine I was getting the occasional headache, but they were controlled with Excedrin. The new headaches are only controlled with prescription medication. The swelling in my left leg is still happening on occasion. I had been experiencing Long Covid-19 symptoms before the vaccine but they were much improved and the vaccine seemed to cause all of the symptoms to regress.
Information has been received from a registered nurse concerning a female who was vaccinated with a first dose of HPV. Subsequently the patient experienced nausea and vomiting. At the time of the report the patient was recovering. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # reported as K022995 exp date 22-JUL-2016 and lot # K020181 exp date 24-JUN-2016) (dose not reported) orally. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacist who refers to a patient of unknown age and gender. No information regarding the patients's pertinent medical history,concomitant therapies and drug reaction or allergies was provided. On 24-SEP-2018, the patient was vaccinated with PROQUAD (recombinant human albumin) lot # R001540, expiry date 15-JUL-2019, albumin status rHA (exact dose and route of administration were not reported) reconstituted with properly stored sterile diluent (lot and expiry date unknown) for prophylaxis. The dose of vaccine was stored between -14 and -10 Celsius degrees (C) for 53 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
had an arm sore, lasted 3 to 5 days; Head ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had an arm sore, lasted 3 to 5 days) and HEADACHE (Head ache) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had an arm sore, lasted 3 to 5 days) and HEADACHE (Head ache). At the time of the report, PAIN IN EXTREMITY (had an arm sore, lasted 3 to 5 days) and HEADACHE (Head ache) outcome was recovered/resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes Tylenol   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.