chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lips swelled up; Blisters; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 26Apr2021 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Medical history included uveitis in left eye and penicillin allergy. Concomitant medications included prednisolone (MANUFACTURER UNKNOWN) eye drops and birth control (MANUFACTURER UNKNOWN). 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 01May2021, the patient experienced lips swelled up and blisters. Treatment received for the events was steroid cream (unspecified drug) and antibacterial cream (unspecified drug). The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lips swelled up and blisters were not recovered at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the arm right on an unknown date in 2021 (at the age of 20-year-old) as a single dose for COVID-19 immunisation.
Weird tearing pain in center of left armpit when i lift my left arm (arm i got booster shot in) a couple days after getting the 1st covid pfizer booster.; Also feel pain in left lat muscle that feels related to main pain described above.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old male patient received BNT162b2 (BNT162B2), on 02Aug2022 at 15:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization completed , Unknown Manufacturer), for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: MYALGIA (non-serious) with onset 04Aug2022 at 17:00, outcome "not recovered", described as "Also feel pain in left lat muscle that feels related to main pain described above."; AXILLARY PAIN (non-serious) with onset 04Aug2022 at 17:00, outcome "not recovered", described as "Weird tearing pain in center of left armpit when i lift my left arm (arm i got booster shot in) a couple days after getting the 1st covid pfizer booster.". Therapeutic measures were not taken as a result of axillary pain, myalgia.  Additional Information: The patient was 21 years old as reported. It was reported that other vaccine in four weeks and other medications in two weeks was reported as none and the patient had no known allergies. COVID prior vaccination and COVID tested post vaccination was reported as none. The patient stated that weird tearing pain in center of left armpit when he lift his left arm (arm he got booster shot in) a couple days after getting the 1st covid pfizer booster. Had pain for few days thinking it must be from booster shot so just wanted to tell. Also feel pain in left lat muscle that feels related to main pain described above.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt entered a SNF in July 2021 following a hospitalization related to peripheral vascular disease with amputation.  The pt slowly deteriorated and tested positive for COVID in September 2021.  Per the doctor's statement and the death certificate, she died in the SNF of COVID pneumonia
Patient had itching/rash/hives within 15-20 min after vaccine on 1/29/2021. Sent to emergency center by observation but rash was improving. She opted to not stay at emergency center and went home. Took Benadryl 25 mg PO x2, rash resolved. 2nd dose deferred.
Moderate generalized headache and body aches 12 hours after 2nd dose of vaccination lasting one day. Managed with Acetaminophen at home. Left axillary lymphadenopathy 36 hours afer 2nd dose, currently subsiding. No care sought
wheezing; coughing; bringing up blood when coughing; nose is running; eyes are running and it never stops and makes it hard for him to see; This is a spontaneous report from a contactable consumer reporting for her husband. A 77-Years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EP7533; Expiration date: Unknown) on 27Apr2021 at 13:05 via an unspecified route of administration as DOSE 1, single for covid-19 immunisation (age at vaccination: 77-Years-old). The patient medical history includes While probing for the patient weight it was reported that his weight was fluctuating. He used to be 250lbs about 7 months ago, now he was about 185 lbs. In the last 2 years patient had two heart surgeries, four heart stents, and underwent chemotherapy for six months. Patient had colon cancer, liver cancer and lung cancer from an unknown date and unknown if it was ongoing. He got rid of the colon cancer and now the lung cancer was getting treated. He used to be a type 2 diabetic but after he lost all the weight the diabetes was gone. The patient was allergic to Penicillin. He swelled up like a balloon and turned bright red and his allergic reaction happened in 1965. The reporter does not have the NDC/Lot/Expiry for Penicillin. The patient was not taking any concomitant medication of concern. The patient did not receive any other vaccine on same date with the Pfizer vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient did not have any AE (s) prior vaccination. On 27Apr2021, the patient experienced wheezing, coughing, bringing up blood when coughing, nose was running, eyes are running, and it never stops and makes it hard for him to see. The reporter mentioned that the blood that patient bringing up when coughing was not a lot of blood but it's still a concern. The reporter was trying to give him a lot of water because that's what the paperwork says to do. The reporter and her husband were scheduled for their second Covid 19 vaccines on 18May2021. The patient did not visit emergency room or physician office due to events. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Day 1 - 5  Shot, soreness in arm. Day 2- present - Fever, treatment Tylenol or Advil. Day 2-5 sore arm and body soreness (getting better). Day 2- present: Headache (Tylenol and Advil not provide relief). Day 4-present: Behcet symptoms appear, ulcers in the mouth and vulvitis.
I tested positive for COVID-19 on 12/15/22. I had a lot of congestion, throat phlegm, headache, fatigue, nausea, body aches, and diarrhea. I didn't register a fever, but I felt feverish. I contacted my doctor and was told to take Robitussin DM and Afrin. He also told me to take Tylenol for pain and discomfort. I am feeling better now. It took a couple weeks, but I am much better now.
last week he has been experiencing skin sensitivity all over his body; This non-serious case was reported by a consumer via call center representative and described the occurrence of sensitive skin in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). In OCT-2023, an unknown time after receiving Shingrix, the patient experienced sensitive skin (Verbatim: last week he has been experiencing skin sensitivity all over his body). The outcome of the sensitive skin was not resolved.   It was unknown if the reporter considered the sensitive skin to be related to Shingrix.     It was unknown if the company considered the sensitive skin to be related to Shingrix.   Additional Information: GSK Receipt Date - 30-OCT-2023 The reporter was the patient. The patient received Shingrix shot.  The patient did not recall which arm the injection was given in. He did not have the lot number but did provide his physician's contact information. He received the injection at his physician's office (not at a pharmacy). He reports that from reporting last week he has been experiencing skin sensitivity all over his body. He stated that when his clothes touch his skin or when he touches his skin it was kind of sensitive. The patient was wondering if that was a side effect from Shingrix. The reporter consented to follow.
Awakened at 4:00 am with extreme burning in upper chest. Transported to hospital by emergency squad. Approximately 3 hours after arrival at "ER" I was paralyzed from waist down. "Transverse Myelitis". Treated with steroids.
PT GOT JANSSEN SHOT 3/20/21; WAS GIVEN PFIZER SHOT 8/7/21
This spontaneous report as received from a pharmacist refers to a 55 year old female patient. On 03-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000436, expiration date 10-APR-2014) (0.65 ml dose, once, subcutaneous route). Concomitant therapy was not reported. In 2013 after received the ZOSTAVAX, the patient experienced bad swelling, warm to touch and redness of upper arm. It was not known if the physician could be contacted. The patient had a treatment with ice topically and BENADRYL. At the time of the report the patient's outcome was unknown. Additional information has been requested.
At 1 week frontal H/A, nasal congestion, extreme exhaustion & general aches, spont. resolved approximately 36 hours.
Within 24 hours of the injection, healthy and well (aside from pre-existing reflux condition being managed holistically)Patient suffered from persistent and SEVERE diarrhea (profuse 3-5 times daily complete lose and watery bowels) for 10 days consecutive, without resolve at any point. Taken to the Emergency Room 3/11/2019 for severe bloated hard abdomen. ER diagnosed with influenza A, and found no obstruction with GI (Test:XR ABDOMEN 2V ROUTINE SUPINE W UPRIGHT/DECUB/CTL). 3/12/2019 office visit with pediatrics to follow up- The b.r.a.t. diet was recommended and implemented, diarrhea persisted for at least 4-5 more days, then subsided naturally.
Emesis 7/20/07 at 12:00. Redness to right thigh 7/20/07 8pm. Large red circular area covering right thigh 7/20/07 at 8.
Pt recvd vax & 2-3 wks later sudden onset of weight loss, polyuria, polydipsia, FB sugar 318; acute diabetes;
Pt was seen in our office on 8/19/09 with symptoms of fevers, cold symptoms, lethargic, decreased appetite, irritability and vomiting. The parents took her to the ER the next day and was provided with a full septic workup. Her blood culture showed Haemophilus influenza B. She was admitted to the ICU for H-flu meningitis. See attached paperwork regarding hospital/discharge.
meets criteria for break through. Employee vaccinated on 12/31/20 and 1/21/21 with Pfizer vaccine but symptomatic on 3/17/21 and positive same day.
FEELING DIZZY; CHILLS; HEAD PAIN; FEVER; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 at 11:00 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021 20:00, the subject experienced feeling dizzy. On 03-APR-2021 20:00, the subject experienced chills. On 03-APR-2021 20:00, the subject experienced head pain. On 03-APR-2021 20:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling dizzy, head pain, fever, and chills. This report was non-serious.
sore arm; lightheaded; not feeling very well; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DIZZINESS (lightheaded), MALAISE (not feeling very well), FATIGUE (fatigue) and CHILLS (chills) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Positive) on 17-Dec-2020 and Heart attack.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), DIZZINESS (lightheaded), MALAISE (not feeling very well), FATIGUE (fatigue) and CHILLS (chills). On 21-Jan-2021, PAIN IN EXTREMITY (sore arm), DIZZINESS (lightheaded) and CHILLS (chills) had resolved. On 22-Jan-2021, MALAISE (not feeling very well) had resolved. At the time of the report, FATIGUE (fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Admission Date: 8/18/2022 Discharge Date: 08/21/2022 Patient is a 86 y.o. female past medical history chronic obstructive pulmonary disease, type 2 diabetes mellitus, hypertension, dementia, CKD stage 4 who presents today with altered mental status and shortness of breath.   History obtained from Daughter at bedside as patient with dementia would default to "I don't know" to all questioning.  Daughter stated that on Saturday 8/13 there was a family party and some in the attendees had recently gotten over COVID-19 infection.  Daughter endorse that multiple family members tested positive for COVID-19 thereafter including patient spouse.  Patient was feeling unwell the day after with significantly elevated blood sugars in the 360s, low-grade temp 99.6° by forehead, cough, chills, progressing to shortness of breath.  Patient had pulse ox 88-91%.  Daughter called patient's PCP on Tuesday and was offered Hecksel did but family ultimately declined due to risk of side effects.  Daughter bleed patient was improving but morning of admission 8/18 patient was found acting odd, diaphoretic, and not following commands as she usually does.  Daughter was setting up patient's medication and noted that patient took Thursdays and Fridays medications.  Patient's blood glucose was then checked by daughter was noted to be 14 associated with sweating and confusion but no tremors.  Daughter stated that patient looked ?really out of it?.  Daughter endorses patient's eating habits have been stable and not significantly decreased as she eats sweets, glue large, sandwiches throughout the day.   In the Emergency Department, patient was administered D50 W and D 10 W. Serum studies with improved blood glucose, AKI on CKD 4, acute on chronic anemia, hyponatremia and moderate electrolyte abnormalities.  Patient tested positive for COVID-19 on 08/15.  She was administered 1L IVF and continue on maintenance fluid. Patient was noted to be hypoxic pre-hospital with no documented hypoxic values in ED. Hospitalist service consulted for admission and further evaluation.
shingles; Subsequent to the ZOSTAVAX inoculation, the pt was treated by a physician at a healthcare center for shingles.; This initial spontaneous report was received from a lawyer regarding a case in litigation involving a male patient (pt) of unknown age. There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2018, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) at a hospital as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions. On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (herpes zoster). The pt was treated by a physician at a healthcare center due to herpes zoster (vaccination failure). It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the herpes zoster and vaccination failure was not reported.   The reporter considered the herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
DTap administered inadvertently as adolescent dose of tetanus/diphtheria/pertussis vaccine (instead of Tdap). No known adverse event associated as of 12/7/2007.
Intermittent swelling and pain of ankles, knees, fingers and knuckles started approx 8/4/13. Previously rash. Rash and fever 6/26 (PROQUAD on 6/17/13) lasted 3 days.
almost blacked out; Dizzy; sweating; turned very pale; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: LE9267, expiration date unknown) via an unspecified route of administration in the left arm on 13Feb2021, 09:45AM (at 50 years old) at a single dose for COVID-19 immunization. The patient was not pregnant when vaccinated in Other Vaccination Facility Type. Medical history included high blood pressure and allergies to Biaxin and Amoxicillin; all from an unknown date and unknown if ongoing. Concomitant medications included calcium, lisinopril, colecalciferol (VITAMIN D) which were received within 2 weeks of vaccination. At 50 years old, the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL1283, expiration date unknown) via an unspecified route of administration in the left arm on 23Jan2021, 09:00AM at a single dose for COVID-19 immunization. The patient was not diagnosed with COVID prior to vaccination, did not receive any other vaccines within 4 weeks prior to BNT162B2, and was not tested for COVID post vaccination. On 14Feb2021 09:45, the patient experienced dizzy, sweating, turned very pale, and almost blacked out. No therapeutic measures were taken as a result of the adverse events. The patient recovered from the events on an unspecified date.
Respiratory difficulties including severe asthma/COPD-like symptoms, mild cough, lethargy, headaches starting within 36 hours of vaccine and continuing to present day though symptom severity diminishing over time with medications.  Also experienced marked decline in ability to exercise, run, and complete tasks such as simple conversations without breathing struggles and close to losing consciousness.  These symptoms were much worse and much more prolonged then when Covid positive in January.
dizziness, gastro intestinal  upset, belching, nausea, headache, body aches
devel lightheadedness, tremors, anxiety, numbness, diaphoretic, cyanotic, tachycardia, inc BP 10 mins p/vax;SOB;grey pallor, blue mottling, tingling, lightheaded, cold, diaphoretic, runny eyes, bilat heavyness/numbness, cold clammy
Unable to make the second appointment; missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Unable to make the second appointment) and PRODUCT DOSE OMISSION ISSUE (missed second dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder NOS. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), ANAGRELIDE, VITAMIN D3, ZINC, OLMESARTAN MEDOXOMIL (BENICAR), NIFEDIPINE, ATENOLOL and LORAZEPAM for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Unable to make the second appointment) and PRODUCT DOSE OMISSION ISSUE (missed second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Unable to make the second appointment) had resolved and PRODUCT DOSE OMISSION ISSUE (missed second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated no side effects were experienced due to the vaccine. The patient also reported having heart issues for years and was unable to make the second appointment.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: Significant follow-up information received. Added missed second dose as an event.
Redness at injection site. Redness and swelling going down arm just past the elbow. Hot and tender to the touch. Went to hospital and started taking BENADRYL.
headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM, ASCORBIC ACID (VITAMIN C ASC ACID), VITAMIN D3 and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PYREXIA (fever). On 21-Jan-2021, the patient experienced HEADACHE (headache). At the time of the report, PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 100.4. On 21-Jan-2021, Body temperature: 100.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took acetaminophen to relieve her symptoms
Dizziness Fatigue Narrative:  Patient developed vertigo and general fatigue following administration of covid vaccine. Resolved as of 1/5/21.
Pt recvd vax & exp arthralgias in knees, lt shoulder, neck & lt elbow; seen by MD & treated w/non-steroidal anti-inflammatory drugs;
Somnolence & fever of 103 which resolved w/fluid; APAP given; This occurred 1 hr p/receiving immun;
Approximately 24-36 hours post vax, the parents observed that the infant no longer responded to noise. No further information was available at the date of this report. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of IPOL.
Slight light headed ness, but major flushing and the beginnings of hives.  I got myself up and ate 2 Benadryl.  Made it home, fell asleep for 3 hours, seems okay now.
1) headache starting on the second day. Progressively worsening. After 2 months I took butterburr and the cycle of CONSTANT headache stopped but still was severe and daily. Still continues - severe head pain - feels like a seizure is coming. Saw numerous doctors that had no idea what it could be. Temple area. Feels like throbbing and quite a bit of pressure. 2) muscle twitching and pain through my body started after a week. still continues. 3) chest pain and pressure started two weeks after first dose. multiple ER visits... stress test.  scans for clots... no problem found. Constant chest pain slowly subsided after 3 months- still present but not a major concern.