chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; vomiting; low grade temperature; This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported similar events for 2 patients. This is the 1st of 2 reports. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. Two days after vaccination the patient experienced nausea, vomiting and low grade temperature. The outcome of the reported events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020139838 same reporter/drug/event, different patient
No adverse event; drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy).    No Concomitant and treatment medication reported.  Patient was 9 weeks pregnant and did receive the vaccine on 23-Sep-2023. Patient had not any problems and had no adverse event. Company comment This spontaneous case concerns a female patient of an unknown age with no medical history reported, who experienced the unexpected, non-serious, event of maternal exposure during pregnancy and no adverse event was reported. The patient received a dose of mRNA-1273.815 (SPIKEVAX 2023-2024). The event onset date was not provided, thus, exact latency between vaccination and onset of the events could not be assessed. It was reported that the patient was 9 weeks pregnant and received the vaccine. Last menstrual period and estimated date of delivery were not provided. No further clinical information was provided. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) is not affected by this report.
Patient states she was not able to sleep night of vaccination, felt like knife sticking in her arm. She states she had a low grade fever, headache, no energy and nauseous. Patient states she had pain on her right side from her neck to her waist.
Shingles/ came down with shingles after my 1st dose; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient came down with shingles after vaccination.
Information has been received from a physician concerning a female who was vaccinated with the first dose of GARDASIL (date of vaccination and lot number not provided). Subsequently, the patient experienced pelvic pain one day after vaccination. Subsequently, the patient recovered from pelvic pain. It was reported that the patient sought unspecified medical attention. Additional information has been requested.
One week after receiving the first Moderna vaccine a raised square rash appeared at the site of injection. Rash appeared raised for about 2 days before becoming flat. The rash is red and still spreading down the arm at least 6 days later. The rash is mildly itchy.
feeling severe tightness in my chest; shortness of breath; diarrhea; ears popping; few shooting pains (cramps) in chest (not constant); few shooting pains (cramps) in chest (not constant); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 19:30 (Lot number: FC3180) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid cancer" (unspecified if ongoing); "total thyroidectomy" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Product=COVID 19, Brand=Pfizer, Lot number=FA7484, Lot unknown=False, Administration date=31Jul2021, Administration time=03:00 PM, Dose number=1, Vaccine location=Left arm), administration date: 31Jul2021, when the patient was 29 years old, for Covid-19 immunisation. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 26Aug2021 22:00, outcome "not recovered", described as "feeling severe tightness in my chest"; DYSPNOEA (non-serious) with onset 26Aug2021 22:00, outcome "not recovered", described as "shortness of breath"; DIARRHOEA (non-serious) with onset 26Aug2021 22:00, outcome "not recovered", described as "diarrhea"; EAR DISCOMFORT (non-serious) with onset 26Aug2021 22:00, outcome "not recovered", described as "ears popping"; PAIN (non-serious), MUSCLE SPASMS (non-serious) all with onset 26Aug2021 22:00, outcome "not recovered" and all described as "few shooting pains (cramps) in chest (not constant)". The events "feeling severe tightness in my chest", "diarrhea", "ears popping", "few shooting pains (cramps) in chest (not constant)" and "few shooting pains (cramps) in chest (not constant)" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest discomfort, dyspnoea, diarrhoea, ear discomfort, pain, muscle spasms.  Additional information: The patient did not have any other vaccine in four weeks and the did not have any known allergies. The patient tested negative for Covid test on 27Aug2021 done by nasal swab. Clinical course: It was reported that patient received the second dose of the vaccine around 7:30pm Thursday 26Aug2021. Around 10pm started feeling severe tightness in her chest and shortness of breath. Woke up the next morning a bit worse. Went to walk in sent to ER. Vitals and test look ok but no explanation for chest tightness and SOB. Still feeling it was of 28Aug2021 12pm. Other smaller symptoms were diarrhea, ears popping and few shooting pains (cramps) in chest (not constant).  No follow-up attempts are possible. No further information is expected.
Rash on right inner arm, started the size of finger print, grew to larger than a baseball. Biopsied and determined to be granuloma annulare. 16 months later, the rash is still there and there are 6 similar spots (left bicep, front of right thigh, back of left thigh, inner right thigh, lower stomach, and right elbow).
Patient experienced dizziness, loss of balance, neck pain and headache two days after receiving her vaccine. She also experienced eye twitching two days after the vaccine as well. All symptoms have resolved excepty the eye twitching. Patient went to the emergency room for treatment.
Menstrual spotting; Sore arm; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 13Sep2021 at 14:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid imbalance. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), fexofenadine hydrochloride (ALLEGRA), and vitamin d nos (VIT D); all for unknown indications from unknown dates and unknown if ongoing. On 14Sep2021 at 07:00, the patient experienced menstrual spotting, sore arm, and fatigue. The events 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 events. The clinical outcome of the events menstrual spotting, sore arm, and fatigue was not recovered at the time of this report.
Narrative: pain at the injection; resolved within 48 hours  Other Relevant Hx: Symptoms:  & arm pain Treatment:
Patients (mine) arm swelled from the shoulder to the elbow, was itching, very red & hot. I had hives, trouble breathing, my tongue swelled as my lips & eyes did. My fingers were itching. I had trouble sleeping the 1st 2 nights. It took 8 days for the swelling & redness to finally subside and be gone. I used 3 EPIPENS, MEDROL Dose pak & BENADRYL for several days (the 1st day). The arm stayed sore until the 7th day and then on the 8th day the swelling started & quickly reduce but stayed swollen another 2 days & then it was all over. The onset of symptoms began as soon as I got the shot. By the time administrator took the needle out of my arm I complained my arm hurt & itched. She agreed it was red but would go away soon. Just use my arm. This is the 1st flu shot I have ever gotten a reaction to & this is the 1st time I had the H1N1 mixed in. My main concern is because I had this type of reaction this year, will I be able to get the flu vaccine next year? Or is it just not safe? This is the only reason I am reporting this. My doctor, nor his office did anything wrong. They have been very helpful & concerned. Please do not make them feel like they did anything wrong.
tested positive after taking the 1stdose/tested positive for Covid/they got a result for asymptomatic employee that tested positive with COVID 19; tested positive after taking the 1stdose/tested positive for Covid/they got a result for asymptomatic employee that tested positive with COVID 19; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A contactable Nurse reported similar events for 3 patients.This is 3rd of 3 reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan202 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid after taking the 1st dose/got a result for asymptomatic employee that tested positive with covid 19 on 11Jan2021. The nurse reported that got the first shot on the 05Jan2021 for all of the 50 employees and 70 residents. On 11Jan2021, they got a result for asymptomatic 3 employees that tested positive with COVID 19. HCP had questions about 2nd dose guidelines, if they can take the second shot after testing positive. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021049693 same reporter/ drug/ event, different patients.;US-PFIZER INC-2021049694 same reporter/ drug/ event, different patients.
This case was reported by a consumer via call center representative and described the occurrence of uveitis in a 57-year-old male patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 7 days after receiving SHINGRIX, the patient experienced uveitis (serious criteria GSK medically significant), erythema, tiredness, swelling and muscle pain. In April 2018, the outcome of the erythema, tiredness, swelling and muscle pain were recovered/resolved. On an unknown date, the outcome of the uveitis was not recovered/not resolved. It was unknown if the reporter considered the uveitis, erythema, tiredness, swelling and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. About one week later after receiving SHINGRIX, the patient experienced uveitis. Less than a day after receiving SHINGRIX, the patient experienced redness, tiredness, swelling and muscle pain, which lasted for about two days. The patient was questioning if the vaccine could have caused the condition. The patient was asked for the name and number of his physician or a form could be sent requesting additional information about his situation, but the patient did not answer the question. Follow up received from consumer on 23rd July 2018: The reporter details were updated. On 24th April 2018, the patient received SHINGRIX. The reporter provided updated information regarding uveitis. The reporter stated that it develeoped around 15th May 2018, which was about 2 weeks after 1st dose of SHINGRIX. The caller also provided ophthalmologist contact information and permission to follow up.
Febrile seizure for @ 3 minutes. Took to hospital via ambulance, fever at hospital 101.5. Given motrin and sent home. No fever thereafter.
The 5-11 year old Pfizer vaccine was not reconstituted with the 1.3 ml of diluent
Hives (all over body) Spent the day outside on a high-pollen-count day. At 6PM noticed itchy/tingly  and upon inspection noticed hives all over body. I have had Hives at least once  before while on high-dose (400-600mg) ibuprofin, but never from allergies. Not certain this is related to J&J shot, but doctor said it wouldn't hurt to report.  Next day stayed indoors. Hives are less common, but still present.
Myalgia, NauseaVomiting, chills, malaise, pain in injection arm Narrative:
Rt upper arm swollen, tender, hard and warm, not red.  Woke up this morning this way.  So far, it's been 7 hr.  Use cool pack.  Let us know if not better.
Within an hour of this first shot, my entire body from neck down was covered in wheals (hives), too many to count.  I was up most of the night with excruciating pain, wanting to tear my skin off!?!  The itching gradually subsided during the following 36 hours but the enormous number of wheals lasted several days.  The study doctor for the clinical trial where I am currently a participant  prescribed that I take the following within a couple hours prior to my second Covid-19 vaccine on April 7 (and, if needed, up to 12 hours afterwards): ? Cetirizine 10mg x 2 ? Pepcid 20mg x 2 ? Prednisone 10mg x 2
1/25/21 - numbness and tingling, feeling of nerve tension began in right arm  and hand with no clear peripheral nerve pattern; next day in both arms with twitching of R middle finger; third day afternoon began in R foot and spread up into calf as well as L foot; went to the ER on 1/27/21; clear ECG, chest XR, brain and cervical CT, and bloodwork; referred to neurologist with concerns of MS or transverse myelitis;  saw neurologist on 2/3/21 - he found mildly hyperactive reflexes and a (+) hoffman's reflex; ordered MRI of brain and cervical spine with and without contrast and more bloodwork; MRIs performed apx 1 1/2 weeks later and bloodwork done same day (2/3); bloodwork revealed elevated C-reactive protein of ~14 and ESR of 14 (higher than previous baseline of <2) but all else clear; MRIs came back clear 2/8/21 - 9 days after second dose woke up with throbbing headache, body aches, and overall feeling of being ill; on the third day of this went to go get tested for COVID and flu to be safe; both rapid and PCR came back negative; sx resolved by the weekend;  2/15/21 - began getting frequent headaches, inability to take a deep breath and sharp retrosternal chest pain up into the back of my throat when I would try; difficulty breathing with a mask on; significantly elevated heart rate; SOB at work esp with mask on; symptoms worse with mask and then eased on weekends without mask; then became able to take deep breath but with chest pain then began to need to cough with a deep breath then more frequent coughing esp after long days of mask wearing; several occasions of waking up at night unable to breath esp when lying on either side with racing heart; symptoms vary in intensity but on days when they would act up, heart rate is consistently elevated (normal resting heart rate ~55, would be up at 90 while lying down, 120 while standing making coffee) 3/9/21 - went to ER in the evening due to symptom increase of chest pain, SOB, and elevated heart rate; ER ran bloodwork and found elevated D-dimer of 0.6, WBC of 27,000, high neutrophils, and low lymphocytes; CT angiogram to r/o PE came back negative; (-) chest XR other than minor atelectasis; abnormal ECG with incomplete RBBB and prolonged QT interval; tachycardia; admitted to hospital; blood cultures, urine cultures, and respiratory pathogen panel including COVID test negative; started on albuterol breathing treatments and 40 mg of steroids 2x/day which normalized WBC count and eased sx significantly; consult with pulmonology and cardiology; 2nd chest x-ray (-) and transthoracic ECHO (-); started on beta blockers 12.5 mg 2x/day which helped heart rate some; second ECG found no RBBB and normal QT interval but unable to rule out anterior MI or inferior ischemia. D/c on steroid dose pack, beta blockers, cough suppressant. Follow up with cardio and pulm. Now seeing immunologist as well who started me on corticosteroid inhaler, monteleukast. Running more blood work soon. PCP gave albuterol inhaler, did round of antibiotics, orders to use incentive spirometer for breathing capacity. Waiting on pulmonology follow up and 30 day holter monitor, stress ecg, and other cardiac tests.
Patient received second dose of COVID-19 vaccine on DAY 9. Patient's command notified.
Information has been received from a physician concerning a patient who on approximately 30-OCT-2006 was vaccinated with an oral dose of Rotateq. On 10-DEC-2006 the patient was referred to the hospital for intussusception. The patients outcome was not known. There was no product quality complaint involved. The patient's intussusception was considered to be life threatening. Additional information has been requested.
Passed out after receiving vaccines, while sitting on exam table. Had 48 hours of headache, nausea, fatigue, malaise, slurred speech, Rt arm pain, lower lip laceration; monitored by phone daily and seen in follow up 4/10/15 by CRNP.
Headache, nausea, loss of appetite, fatigue, muscle aches (legs and arms), burning feeling in lungs when breathing.  This is still occurring on Day 8 after vaccine.
This infant had periorbital edema, hives on his arms and legs, and lip edema.
This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 56-year-old female patient who received BOOSTRIX. On 15th June 2015, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced muscle weakness and weakness. On an unknown date, the outcome of the muscle weakness and weakness were unknown. It was unknown if the reporter considered the muscle weakness and weakness to be related to BOOSTRIX. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the patient herself. The patient received a vaccine and she believed that it was BOOSTRIX. Later that summer, the patient began to experience weakness on her left side which has progressed to include both arms, both legs and her mouth. In December 2015, the patient had an MRI (Nuclear magnetic resonance imaging) performed and the results were negative.
Patient hospitalized after fall. COVID positive 10/4/22. Vaccines: COVID-19  01/08/2021  1 of 3  Spikevax-MOD 100mcg  Full  COVID-19  02/04/2021  2 of 3  Spikevax-MOD 100mcg  Full    COVID-19  04/19/2022  3 of 3  Spikevax-MOD 100mcg  Full
Temp to 103.1 x 2.5 days. Severe achiness. Lethargy. Unable to work.
Fever as high as 104.3 f lasting for more than 5 days. Severe fussiness.
Mom noticed "redness and little swollen" last evening with c/o pain. Tylenol given with relief-no fever. Picked child up after school at 3:30pm with child c/o pain Rt arm. Tylenol given and noted reddened, swollen Rt upper arm on deltoid region. Local reaction "superficial reaction."
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding drug reactions or allergies and medical history was not reported. The nurse reported that on 13-FEB-2015 the patient was inadvertently administered PNEUMOVAX 23 (dose, route of administration, anatomical location, lot# were not reported) that had expired on 12-FEB-2015. Concomitant therapies were not reported. No adverse effect was reported. Additional information has been requested.
p/ being vax the pt subsequently exp headache, temp 100.0f lasting 3-4 hrs & a papular rash described as itchy & lasting approx 6-10 days.
Itching and swelling of muscle below injection site. Matches symptoms of "COVID arm" as described by health.com article.
Fever, Nausea, extreme redness, bruising, swelling, and itching in arm at injection site.
After several hours of administration of the vaccine I began to feel a tingling sensation in the head specifically on the right side, then I began to notice swelling on this side of the head which lasted for 6 days.
48 hours past injection pt has edema of the upper left arm, erythema of the injection site, pain with touch a palpable area of induration and pain when lifting the arm.  Edema resolved with ice and ibuprofen.   PT examined 7 hours later approximately 3 cm area of induration surrounding injection site. very faint erythema about 2mm at injection site itself. No streaking redness, no fluctuant mass. PT is able to move her arm with normal ROM but is hesitant due to pain
DTaP & MMR administered approx 48 hrs ago. 24 hrs ago upper left arm red & swollen now 2x2 inch erythema, no fever child active & playful.
Patient received first dose of Moderna Covid 19 vaccine and neglected to inform staff that he had all ready received first dose of Pfizer vaccine prior to this dose.
I received the vaccine on 10/11/17 around 9 am and at 7 am on 10/12/17 I woke with a tightness in my chest and a sore neck. Pain of 5/6 on scale of 1-10.
Child had hives back of hand, neck red, 1 red spot by left eye and mouth, groin red, Awoke crying, Child had Enfamil with iron, 4 oz 7 pm 5/19/02 instead of Alsoy. -ER, Diagnosed -allergic reaction, No meds given, Treatment-switch back to Alsoy formula.
Patient complains of headache post vaccination, no other symptoms . Did not eat breakfast / hydrate. pulse 66, 98% RA, EMS not needed. Symptoms resolved. observed for 15 minutes
Patient said that later that day she started to feel like she had cellulitis.  She was warm to the touch, and had chills and a fever.  She also felt very swollen and sore in the arm.