chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hypertension; Maternal Exposure During Pregnancy, second trimester; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jul2021 08:15 (Batch/Lot number: unknown) at the age of 35 years as dose 2, single for covid-19 immunisation. Date of last menstrual period: 02Apr2021. The patient was 16 weeks pregnant at the time of exposure to bnt162b2. The patient was 17 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 07Jan2022. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Anatomical location: Arm right; Administration time: 08:15;), administration date: 08Jul2021, when the patient was 35 years old, for COVID-19 immunisation, reaction(s): "Maternal exposure during pregnancy, second trimester". The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 29Jul2021 08:15, outcome "unknown", described as "Maternal Exposure During Pregnancy, second trimester"; HYPERTENSION (non-serious) with onset 30Jul2021 11:00, outcome "not recovered", described as "Hypertension". The event "hypertension" was evaluated at the physician office visit. Therapeutic measures were taken as a result of hypertension.  Additional information: The patient had no known allergies. The last menstrual period of the patient was 02Apr2021. 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. On 30Jul2021 at 11:00 (also reported as about 24 hours after second dose), the patient had hypertension. At the time of report, hypertension had not yet returned to normal levels. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of hypertension which included treatment with nifedipine (MANUFACTURER UNKNOWN). The clinical outcome of the event hypertension was not recovered at the time of this report.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Office manager responsible for storage and handling of vaccines reported patient administered MMRII and VARIVAX that experienced supported temperature excursion.  See related AE 02151018 and AE  02151019.  No additional AE information.  No PQC.; Office manager responsible for storage and handling of vaccines reported patient administered MMRII and VARIVAX that experienced supported temperature excursion.  See related AE 02151018 and AE  02151019.  No additional AE information.  No PQC.; This spontaneous report was received from an office manager referring to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant therapies, concurrent conditions and previous drug reactions or allergies were not reported.   On 13-APR-2022, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rha) (M-M-R II) 0.5 milliliters (mL), once (lot number  T027937 has been verified to be valid, expiration date reported and established as 18-AUG-2022 ) and one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (mL), once (lot number U019904  has been verified to be valid, expiration date reported and established as 24-JUN-2023) (routes of administration, anatomical sites of vaccination, and vaccine schemes were not reported). Both vaccines were administered as prophylaxis.   It was reported that the vaccines were exposed to supported temperature excursion before being administered. No additional adverse event was reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA007163:
SOB and chest tightness. Discharged in stable condition.  Monitor symptoms.  Expect improvement.  If worsens need to call us.  Keep hydrated.
The day following administration of Recomb pt exp 3 episodes of dizziness to the extent pt went home from work; No other sx noted; The 3rd day pt was improved & back to work;
In June, I noticed bleeding around time frame of when I ovulate. With each passing month the bleeding increased with ovulation to the point where the flow was as much as my normal period. So from June until now I am having 6 days of bleeding every two weeks. This is NOT normal. I usually menstruated every 28-30 days. I have never experienced abnormal bleeding within a cycle ever until I had the last dose of the Covid vaccine.
c/o eyes feeling tired and burning. left side of face felt "tight" and tongue felt thick. BP 188/91, HR 88,R 16, O2 sat 97. Known borderline HBP. Administered Benadryl 50 mg.  1107 BP 177/90, HR 82, R 16, O2 Sat 98. States feels much better. No more tightness in face and eyes better. No feeling of tongue thickness. Swallows well. No c/o rash, itching and none noted.
Severe pain left arm from shoulder down and tingling in hand and fingers. Referred to Orthopedic MD Dr. who administered Cortisone injection in left shoulder and instructed her to apply ice, to exercise arm, and to take Ibuprofen 600mg q6h as needed.
Exactly 2 months after last vaccine I had a major psoriasis flare up from my scalp ,torso and groin areas. I have never had a flare like this  and it was more extensive than  when diagnosed  4  years ago. . I have been on Humira for at least 3 years. I wonder if COVID vaccine rendered Humira ineffective for me. I am going to be started on a different biologic medication soon.
I was fine after the shot. About 10pm, I woke up from a nap and my arm hurt so bad. I was very dizzy feeling like vertigo and nauseous. I took off work. The next day about 3 pm my arm felt so bad like it was broken and ribs starting hurting and down my back. I took Tylenol, at 12-1am my arm kept hurting until I starting feeling around and noticed under my armpit was so swollen. I couldn?t close my arm and to try and do so hurt so bad! I was crying. I stayed in bed and took some Advil Thursday, fell asleep and the swelling went down somewhat but it still was in excruciating pain. Went to  E.R., they done and EKG on me, gave me steroids and sent me home with a prescription for Prednisone.
Swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient). A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 17Jul2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 18Jul2021, the patient experienced swollen lymph nodes (which started on a day later, as reported). Reportedly, she is asking if there is a guideline on receiving the second dose of the vaccine. She also wants to know if this is a side effect of the vaccine and if it is considered severe. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Fully vaccinated with Pfizer x 2. Tested positive for COVID 19 on 2/24/2022. Admitted to hospital on 02/24/2022. Expired on 03/03/2022 while still hospitalized.
cataracts; foggy vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2, solution for injection), administered in arm right, administration date 27Apr2021 11:00 (Lot number: EW0153) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Really high eye pressure", start date: 2008 (ongoing). Concomitant medication(s) included: LATANOPROST taken for eye pain. Vaccination history included: Bnt162b2 (First dose: 06APR2021 , Lot: EP6955, NDC: Unknown , Expiration: Unknown , Route of administration: right shoulder), administration date: 06Apr2021, when the patient was 54 years old, for COVID-19 Immunization, reaction(s): "foggy vision". The following information was reported: CATARACT (medically significant), outcome "unknown", described as "cataracts"; VISION BLURRED (non-serious) with onset Apr2021, outcome "unknown", described as "foggy vision". The events "cataracts" and "foggy vision" were evaluated at the physician office visit.  Follow-up attempts are completed. No further information is expected.
Patient has history of fainting after vaccines,blood work,or steroids shots.  Patient started feeling nauseous after about 4 minutes then started to loose color in skin.  Placed cool compresses to patient neck and forehead.  Had patient lie down in supine position with feet elevated with cold compressed still applied.  Patient stayed in this position until started feeling better, then had patient sit for a few minutes then gradually moved patient to chair.  Observed patient in chair for around 30 minutes before patient facility.  Patient never fainted just had the feeling.
About 3 days after the vaccination her her arm turned Black and Blue in a small area. After about 2 more days the bruise got larger. Then on February 12th she came to me about 4:00 pm and showed me that around the black and blue area was a 1 in area of very red  itching area. I took her to the Express Care near us. the nurse checked her arm and gave her 1 tablet of Benadryl and gave her prescription for more.
Today, 8 days after vaccination, the injection site was itchy with a large red oval on the skin
After administration of albuterol nebule, hepatitis a and varicella vaccines, patient developed rash on body and tingling in the back of her throat 06/10/2009 at 11:45.Itching denied by patient. Patient was given 10mg PO Benadryl.(Also with rx to benadryl and claritin). Mom called two days later to report continued use of albuterol and 30 hours after rash presented it has gone away. Mom denied any problems with breathing or throat/tongue swelling.
Sever muscle spams and joint pain  in my entire body felt for over 24 hours
Case number PHEH2013US023747 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 71-year-old female patient. She was vaccinated with expired vaccine of FLUVIRIN 2012/2013 (batch number 123303, expiry date: JUN 2013) at a dose of 0.5 ml intramuscularly on 18 OCT 2013. No adverse event was reported following this medication error (expired vaccine used).
The patient fainted and then had seizure-like activity. He came to, sat up, and then fainted again. The physician is not certain if this event was related to vaccine.
Initial report received on 15 March 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3362AA received on 14 August 2009, lot number C3471AA received on 12 October 2009, lot number C3545AB received on 13 January 2010 and 1 dose of DAPTACEL; lot number C3473AA received on 20 September 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 01 February 2012, approximately 16 months after the last dose. On 13 February 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 15 February 2012 for 8 days. The subject was not hospitalized. According to the reporter, the case is epidemiologically linked directly to a laboratory-confirmed case. At the time of the final contact on 24 February 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
This spontaneous report was received from a licensed nurse practitioner, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 03-OCT-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength, dose, route of administration, anatomical location were not reported), involving lot # N002720 with expiration date on 12-MAY-2019, or lot # N001533 with expiration date on 16-OCT-2019; for prophylaxis. The storage temperature was 32.54 degrees Fahrenheit (F) for a time frame of 25 minutes. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA011217: US-009507513-1710USA011216: US-009507513-1710USA002653: US-009507513-1710USA011215.
She got anaphylactic shock from it/She was allergic to the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC SHOCK (medically significant), outcome "unknown", described as "She got anaphylactic shock from it/She was allergic to the first dose". Clinical course: She got anaphylactic shock from it. Yet no one told her from the first time it happened not to get the second one.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300156967 Same reporter/drug, different patient/event;US-PFIZER INC-202300156966 Same reporter/drug, different patient/event;US-PFIZER INC-202300156965 Same patient, Same product (DOSE 2), different events;
Patient called stated that she had a shingles break-out several days after injection give but just called us today.  Patient could not remember exactly what day.  She states that her left arm (injection site) had shingles outbreak. She has a history of having shingles.
Extreme fatigue; Temp of 101.2; Chills; Severe headache/ headache secondday after; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 14Apr2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and nature's bounty immune 24h (MANUFACTURER UNKNOWN); both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 24Mar2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 01:00, the patient experienced temperature of 101.2, chills and severe headache from "1am to 3pm" after shot, extreme fatigue and headache second day after. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 14Apr2021 patient checked her body temperature and it was 101.2 (unspecified units). 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 temperature of 101.2, chills, severe headache and extreme fatigue was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Influenza vaccine information is not available.  10/14/19 Patient presented to the hospital with rapidly progressive bilateral lower extremity weakness s/p flu shot one week prior.  Received IVIG, changed to plasma exchange.  10/23 slightly more movement of fingers
This is an 86 year old male with PMH of HTN, HLD, CVA, CAD s/p CABG, BPH and stents, prosthetic left eye, right eye cataract removal, BPH, and anxiety brought to the ED for evaluation of possible worsening of neurological symptoms. Patient's daughter reports patient has been intermittently confused for the past 2 weeks. Daughter reports past few days he has been experiencing more weak, worsing facial droop, less appetite. Found to be COVID-19 Positive
Two days after the vaccine, I developed a rash on my arm and severe pain. Then the day after I was having horrible chest pain and heart palpitations. I was given heparin directly to my heart to treat a possible blood clot.
Strabismus of right eye that progressed over next several months to include ptosis of that eye with the resulting diagnosis of oculomotor nerve palsy, incomplete of the right eye.
The Saturday after receiving the vaccine patient started that she was having a tightness in her chest. Through  out the day her arm started swelling. Patient received a fever of 104. Patient stated the swelling is tryin to come around to the inside of her arm. Under the  swelling is hard. Patient also stated that she received a blister.
1st dose. Normal symptoms that were expected. Fine following day.  2nd dose swollen arm, hives appeared the following day and rash stayed for a few days. No other symptoms 3rd dose.  Experienced sensation in chest area. At 8pm I went to lay down and when I got up a short time after I had severe dizziness which made me nauseous. I laid back down and was unable to move my head without dizziness occurring. Upper body became itchy.  Following morning I felt like I was in a fog for the whole day but dizziness was gone. Rash on my arm. Seems to be getting better now (2 days after)
Seizures. Did not want to wake from nap. Low blood sugar - 40 - per school nurse.
I had a severe reaction of half-face paralysis (left side)/Bell syndrome; This is a spontaneous report from a contactable consumer (patient) reported for self. A 33-year-old patient of an unspecified gender received bnt162b2 (Pfizer COVID vaccine), dose 1 via an unspecified route of administration on 21Mar2021 at 33 years old (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Mar2021 patient took the first Covid vaccine (Pfizer) and immediately after 10 minutes had a severe reaction of half-face paralysis (left side). Patient rushed to the doctor who told to wait it out and see if it faded the next morning. Unfortunately, it worsened! Patient rushed to the ER where patient got treated for Bell syndrome. Today, seven months after, it had not fully passed and patient could still feel the paralysis in certain spots. Therapeutic measures were taken as a result of the event. The outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I EXPERIENCED A VERY HIGH CONTINUOUS PULSE RATE - OVER 250BPM.  I WAS ADMITTED TO THE ER AT HOSPITAL.  I WAS ADMITTED AND PUT ON AMIODARONE IV.  AFTER 3 DAYS I HAD CARDIOVERSION TREATMENT AND WAS DISCHARGED WITH A NORMAL (60) PULSE RATE.
Information has been received from a consumer concerning his 34 year old wife with no past medical history who on approx. 9/19/00 or 10/05/00 was vaccinated with 1 dose of MMRII (lot 05821L invalid). There was no concomitant medication. The consumer stated that his wife was approx. 5 days pregnant at the time of vaccination. Follow-up information from a physician stated, "(The pt was) lost to follow-up" and "probably had an abortion". No further information is expected.
Diarrhea that occurred 5 times between 1-8 PM on 10/6/11 followed by a day (10/7/11) with one tiny normal bowel movement and another day of 4 bouts of diarrhea (10/8/11). I will take my child to the hospital or doctor at the first sign of dehydration, and I will follow up with the doctor on Monday, October 10th.
Completely covered with erythemia multiforme ? 20 to MMR #2. No other symptoms.
This spontaneous report as received from an office administrator (also reported as: medical assistant) refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 20-APR-2015 the patient was vaccinated with first dose of vaccination series with GARDASIL HPV-4 (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. On 13-AUG-2018, the patient was vaccinated with second dose of vaccination series with GARDASIL 9 0.5 ml/once (lot # R001263, expiry date: 10-NOV-2020) intramuscularly for prophylaxis. No adverse effects were reported. No product quality complaint was involved. Lot number [R001263] has been verified to be a valid lot number for GARDASIL 9.
Information has been received from a medical assistant concerning a 16 year old female with no drug reactions/allergies and no pertinent medical history who was vaccinated with the first dose of GARDASIL on 15-OCT-2009. There were no concomitant medications. The patient was several days later in her menstrual cycle. The patient's last menstruation period was 28-SEP-2009. The patient had sought medical attention by phone call. There were no lab diagnostic studies performed. At the time of report the patient's status was not recovered. Additional information has been requested.
Sore throat, achiness, congestion, headache, hot at night, symptoms disappeared 10-23-12. Patient took BENADRYL and ADVIL for symptoms. Redness and soreness/rash x1 day rt upper arm injection site.
3/8 at 2:30 pm noticed hives on hand but did not pay attention to it at 6:00 pm hives all over arms all the way to elbow, itching a lot during afternoon felt tired/exhausted for no reason, took nap. 3/9 nurse that was contacted suggested to come in but no shortness of breath given chlorpheniramine (over the counter) 4 mg every 6 hours within 1 hour itching subsided, no more hives. 3/10 hives gone except for ones that scratched.
Headache, Fever, NauseaVomiting, Body ache Narrative:
15 min after receiving the H1N1 vaccine, pt returned, stating he was dizzy. There was no improvement after drinking Gatorade, sitting w/feet up.
Pt was injected w/ ADACEL when she was requesting TB testing. Pt.'s mom said pt received all her shots already but didn't clarify which & when pt was fine physically when they left the pharmacy.
Fetal arrhythmia; congenital ASD; congenital ptosis of right eye with Marcuss Gunn jaw winking syndrome; duplex kidney
On 11/1/06 Patient noted raised, slightly pink rash develop on Right side of back. Complained of "severe itching", stated rash "not open". Stated rash continued to develop to behind ear and to scalp, progressing to chest. Instructed to notify MD
Patient stated she was not feeling well immediately after administration. We offered her water and to put up her legs. She did then started panicking and saying she was seeing  stars and felt like she was going to faint. I went to get the machine to take her blood pressure and she said she could not breathe and needed an EpiPen. I administered an EpiPen and we called 911.
COVID vaccine breakthrough case. Pfizer Dose 1- 3/9/21 EN6206, Dose 2- 3/30/21 ER8730 and boosted Dose 3- 10/06/21 EW0186.