chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for COVID19; tested positive for COVID19; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for mother. An 84-years-old elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Feb2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient past medical history and concomitant medication was not reported. On an unspecified date It was reported that after the administered of first dose the patient tested positive for COVID-19 and her 2nd dose was scheduled on 24Feb2021. Eventually 2nd dose was not successfully given due to the positive result to COVID19 test conducted. Her physician advised her to get a monoclonal antibody and had to wait 90 days to get her 2nd dose. Reporter has been getting conflicting information from their physicians regarding the number of doses to be administered following a monoclonal AB administration. The patient underwent lab tests and procedures which included covid-19: positive in Feb2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested. further information has been requested.
started with tongue swelling and then felt like her throat was starting to close in. Placed in Wheelchair and taken up to ED. Gave her 50 po Benadryl on our way up to ED.  In the ED was given the following medication  Medications Administered During Visit diphenhydrAMINE, 25 mg, IV Push EPINEPHrine Soln 1 mg/mL, 0.3 mg, IM methylPREDNISolone sodium succinate, 125 mg, IV Push sodium chloride 0.9% bolus *, 500 mL, IV Piggyback Medical Decision Making 1249 Tongue back to normal. VS stable. Home. See instructions
Intense heart palpitations on the third night; only happened once for about a minute, but felt very scary at the time. Had a fever the first night of vaccine and no sleep. Consistent and then intermittent fatigue the first few weeks after initial injection.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (A hot sensation on the skin with a cold sensation on top of it), FORMICATION (It's almost like skin crawling), BURNING SENSATION (Razor burn with a chill on top), PAIN IN EXTREMITY (Arm pain) and HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (A hot sensation on the skin with a cold sensation on top of it), FORMICATION (It's almost like skin crawling), BURNING SENSATION (Razor burn with a chill on top), PAIN IN EXTREMITY (Arm pain) and HEADACHE (Headache). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (A hot sensation on the skin with a cold sensation on top of it) had not resolved, FORMICATION (It's almost like skin crawling) and BURNING SENSATION (Razor burn with a chill on top) outcome was unknown and PAIN IN EXTREMITY (Arm pain) and HEADACHE (Headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) tested positive in Decemebr-2020..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
reconstituted with saline solution; reconstituted with saline solution; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number Y44ZT, expiry date 10th July 2023) for prophylaxis.   On 8th August 2022, the patient received the 1st dose of Shingrix. On 8th August 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-Aug-2022 Reporter's Comments: The patient received Shingrix and the lyophilized portion was reconstituted incorrectly with Saline solution instead of the accompanying adjuvant. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The Shingrix lyophilized portion was reconstituted incorrectly with saline solution instead of the accompanying adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
This spontaneous report as received from an health care worker refers to an unspecified number of patients of unknown age and gender might have received RECOMBIVAX HB (lot # unspecified) dose, frequency and location unspecified, which were stored improperly on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Stenger test negative 6-8000 Hz, profound high range hearing loss in lt ear; constant tinnitus; dx -immune reactive 8th nerve damage; Annual follow-up states the pt has not yet recovered.
This is a spontaneous report from a contactable nurse received via a Pfizer sales representative.  This nurse reported similar events in two patients. This is the second of two reports.  A 17-year-old female patient of an unspecified ethnicity received the first dose of TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunisation.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the next day after the vaccination, the patient experienced vomiting. The clinical outcome of the event, vomiting, was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016424799 same reporter, drug, event in a different patient.
Fever 100F, Hypersensitivity to left thigh, erythema and edema to left thigh, child crying uncontrollably.
Patient c/o feeling irritation in her throat that starting to make her voice raspy. Patient stated that same reaction when taking pain medications and would take Benadryl to stop. Nurse attended and vital was taken BP 122/084. HR 72. Oxygen 99.  Nurse gave patient 2 Benadryl. Patient left in stable condition.
Narrative:  10/07/2020 COVID swab, result: NOT detected COVID infection following COVID vaccine series 01/26, Pfizer, dose #1 02/17, Pfizer, dose #2 08/04 pt cc: cough, diarrhea, fatigue, fever, headache, myalgias, nausea, rhinorrhea, dyspnea exposure: unknown 08/05-08/15 pt symptoms continue 08/10 COVID swab, result: detected 08/10 SARS-COV-2 LINEAGE B.1.617.2 08/10 SARS-COV-2 CLADE 21A DELTA 08/16 clinically resolved
The patients arm became very red and warm and swelled up to the size of a baseball at the injection site, which was at the lower part of the triicep, much lower than expected administration site. The patient described it as very painful and she could not sleep at all that night. Sh eused ice treatments, motrin, and applied hydrocortisone 2.5% crm topically, six days later, she shill has pain and swelling but is feeing better.  Ultrasound done showed the swelling low in the arm (tricep) and a large knot on the muscle - diagnosis/adverse events said to be due to incorrect administration. Negative cellulitis, negative infection.
Body ache, fever, sore throat, rash all over the body, sore throat and nasal congestion
first dose of Moderna Covid-19 vaccine last 01Dec2021 with lot number 012S21E. Patient failed to get the second primary dose with the recommended dose interval.; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (first dose of Moderna Covid-19 vaccine last 01Dec2021 with lot number 012S21E. Patient failed to get the second primary dose with the recommended dose interval.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012S21E) for COVID-19 prophylaxis.     Patient do not have any relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (first dose of Moderna Covid-19 vaccine last 01Dec2021 with lot number 012S21E. Patient failed to get the second primary dose with the recommended dose interval.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (first dose of Moderna Covid-19 vaccine last 01Dec2021 with lot number 012S21E. Patient failed to get the second primary dose with the recommended dose interval.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (first dose of Moderna Covid-19 vaccine last 01Dec2021 with lot number 012S21E. Patient failed to get the second primary dose with the recommended dose interval.).    The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported.  Patient was still looking for to get the second dose.  No treatment medications was reported.
Patient received vaccine around 330pm. Arm started to hurt around 5p with pain becoming unbearable by 7p. She took ibuprofen at 8p night before but it didn't seem to help. Overnight, she had continued pain with nausea, shakiness and dizziness. She passed out in the am so her husband brought her into an ER. Upon admit, she had a CBC with differential, basic metabolic panel, and ECG. She was given an IV dose of Ketorolac. Per patient report, nothing else was found. She is now home, no longer nauseous, moving arm often, and taking ibuprofen 600mg TID per discharge instructions from ER. She is feeling better and planning on decreasing ibuprofen dose tomorrow.
Was already having long standing (4months +) flare of erythema nodosum nodules on right shin - within 2 wks of vaccine noticed large nodule (quarter size) develop on right lower calf - was not there prior to injection or anytime throughout most recent flare - nodules continue on right shin;  intermittent episodes of dizziness within first week of injection, continued through week 2 post injection - no prior hx of same - seems to have resolved post week 3
Received pneumonia vaccine 11/13/06.  Itching 1st day 11/14/06 left arm deltoid red, swollen.  Site of softball.
received the vaccine on 5/8/2021, awoke 5/9/2021 with significant supraclavicaluar soft tissue/lymphatic swelling that has not resolved in >3 months.
First shot: Excessive thirst for 12 hrs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jan2021 12:00 (Lot number: EL3302) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THIRST (non-serious) with onset Jan2021, outcome "recovered" (2021), described as "First shot: Excessive thirst for 12 hrs". Therapeutic measures were not taken as a result of thirst.  Additional information: The reporter considered the events as t non serious.patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient did not received any other medications within 2 weeks of vaccination.no treatment received for the adverse event. patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, patient has not been tested for COVID-19.patient was not Allergies to medications, food, or other products. Vaccine Facility information was available. Ethnicity information is available. Location of injection information is available for all vaccines received on the same date.  No follow-up attempts are possible. No further information is expected.
Itching, light rash all over body (head, ears, mouth, chest, back, legs, groin) Lasted 8+ hours until I was able to take Benadryl to alleviate
Symptoms started 30 min. after vaccination - dizzy, nauseous, feeling hot/clammy. - Continued same 1 hour later - but had headache/weakness/sleepy. Had fever >100 degrees that evening - tired next day & queasy.
Inappropriate schedule of vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 51-year-old female patient who received HBV (Engerix B adult) (batch number FR334, expiry date 24-AUG-2024) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B ADULT).   On 16-JUN-2023, the patient received the 2nd dose of Engerix B adult (left deltoid). On 16-JUN-2023, an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate schedule of vaccine). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 16-JUN-2023 Registered nurse called to inquire was the dose valid or another dose needed. The reporter wanted to know how to proceed. RN reported an adult was administered Engerix too early. Did not consent to follow-up.
Information has been received from a licensed practical nurse concerning a 68 year old female with no pertinent medical history, drug reactions or allergies who on 14-JAN-2008 was vaccinated subcutaneously with 0.65 mL of zoster vaccine live (Oka/Merck) (Lot # 659403/1825U). There was no concomitant medication. On 28-FEB-2008, the patient broke out in shingles. On 17-MAR-2008, the patient contacted the nurse and reported that she had shingles blisters on her face. The patient was seen by a dermatologist and was being treated with an antiviral. The nurse was not interested in VZV ID program. At the time of reporting the patient's present status was unknown. There was no product quality complaint. There were no lab diagnostic studies performed. Additional information has been requested.
Administration error-- patient reports vaccine running down arm immediately after administration and does not believe he received the full dose.  He did experience arm soreness for a couple days after the vaccine.
I HAD LOWER ABDOMINAL PAIN. DOCTOR SENT ME TO GET CT SCAN IN THE HOSPITAL. THEY DETERMINED I HAVE DIVERTICULITIS.
Over 3 weeks following vaccination had worsening chest pain and shortness of breath, on 10/21/2022 was admitted to the hospital for myopericarditis with moderate pericardial effusion,  new onset atrial fibrillation, and left pleural effusion. Pericardial effusion was treated with pericardial drain in cardiac ICU, then myopericarditis treated with Colchicine, atrial fibrillation treated with Eliquis, pleural effusion treated with Lasix.  Discharged from hospital 10/27/2022 and follows up with Cardiology and PCP.
Right Arm Injection Site extremely sore to touch.  Woke up in the morning puking.  Broken blood vessels in the face, looked like a rash but dissapated over the course of 3 days.  Chills, extreme muscle and joint pain.  Very nauseous throughout the day and most of the night.  Most of the symptoms went away after the first day, but the muscle and joint pain stayed through Sunday and into Monday morning.
Gillian-Barre Syndrome; unable to walk; currently in a wheelchair; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female 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, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Gillian-Barre Syndrome) (serious criteria GSK medically significant), unable to walk (Verbatim: unable to walk) and wheelchair user (Verbatim: currently in a wheelchair). The outcome of the guillain barre syndrome, unable to walk and wheelchair user were not reported.   It was unknown if the reporter considered the guillain barre syndrome, unable to walk and wheelchair user to be related to Shingles vaccine.     It was unknown if the company considered the guillain barre syndrome, unable to walk and wheelchair user to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023. The patient reported this case via interactive digital media. The reporter stated that friend of his/ her was currently in a wheelchair, unable to walk after her first dose of this vaccination. The patient developed Gillian-Barre Syndrome, a side effect.
3/24/2017 Parent contacted clinic after patient called from school regarding an itchy rash all over body. Parent states that reaction started with a local reaction of pain and tenderness at injection site. After a day patient began itching and experiencing the rash all over body. Per Dr., patient may take Benadryl and parent states that she will do an oatmeal bath tonight as well. Parent advised that she can take patient to our clinic after hours or if patient has any trouble breathing, excessive sneezing or coughing to take patient to the nearest emergency room. Parent verbalized understanding. Advised parent that someone from agency or Vaers may contact her and that I would follow up with her on Monday.
62-year-old female, history of hypertension presented to the ED with generalized fatigue. Symptomatic for 5 days.Pt test + for COVID on 10/26.  No chest pain, no cough and no fever. Vitals within normal limits.  Supportive care.  Continue quaratining until result negative.  Told to return if symptoms worsen.  Follow up PCP in 2-3 days.
extreme exhaustion at 10 Wed. night. Upon awakening around 7 AM Thurs. morning, severe vertigo.  Had to crawl because of room spinning.  This continued all day and abated around 6 PM.  Left me feeling tired, and still tired on Fri. AM
This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown gender and age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an inadvertently GARDASIL, lot number J010668, expiration date 29-APR-2016 and lot number K009482, expiration date 06-MAR-2017, which had been improperly stored (incorrect product storage). There was no concomitant medication reported. No adverse effects were reported. This is one of two reports from the same reporter (case # 1511USA008404). Additional information has been requested.
EMPLOYEE HAD RIGHT SIDED LOWER EYELID AND CHEEK SWELLING AND ITCHING AT APPROXIMATELY 0600 PM ON 01/12/21. WHICH HAD MINIMAL CHANGES AT 0600 AM THE FOLLOWING MORNING.    DENIES: REDNESS, THROAT ITCHING, SOB, UPPER EYELID SWELLING, TOOTH PAIN OR DENTAL ABSCESS, LYPMHNODE SWELLING
Patient almost immediately began experiencing severe lower back pain, radiating through both arms and extending into her chest. She felt nauseous, flushed, and light-headed and was experiencing a great deal of anxiety. She was escorted to a chair and the immunizing pharmacist stayed with her until the symptoms subsided. She refused multiple offers to call for EMS. After symptoms subsided, she left the pharmacy and returned a short time later to report a dull headache. I phoned her later in the evening to check on her condition and she reported that she still had the headache, but otherwise, all symptoms had subsided.
Large red painful bump and swelling on arm. Muscle aches, headache, fatigue on first day after shot. Stomach pain and nausea on second day.  Continued headache and fatigue for three days.
Patient's father reports elevated temp at home 4/23/2009, for which he did administer tylenol.  States child woke up approximately 5 am 04/24/2009 w/ complaints of child being "stiff" with blue lips briefly.  Child was examined at local ER upon noting symptoms and was diagnosed with a "febrile" seizure.  Child's temp in ER was 100.4 axillary per ER records.
Pfizer vaccine was administered outside of our facility - reported by patient- ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------- I95.9 HYPOTENSION 5/29/2021 NONTRAUMATIC ACUTE KIDNEY INJURY I95.9 HYPOTENSION 5/29/2021 ATRIAL FLUTTER, UNSPECIFIED I95.9 HYPOTENSION 5/29/2021 CANCER METASTATIC TO RETROPERITONEAL LN I95.9 HYPOTENSION 5/29/2021 HYPOTENSION I95.9 HYPOTENSION 5/29/2021 SAB, UNSPECIFIED W CARDIAC ARREST
2nd vaccine- 01-04-2021; initially started to feel loss of appetite, a lot of weakness and just feeling sick. I got to the point where I could not sit in my wheelchair, literally had no core strength in me. I went to the ER and they gave me a rapid swab for covid. They decided to do blood cultures, were getting ready to plasma when an infectious disease doctor came in and said to that I did not have covid but rather a UTI and my UTI went into sepsis. I was hospitalized, 2 ½ months. I believe that this started with the Pfizer vaccine. I also went to a rehab place to regain my strength.  I continue to have today with weakness to my body and struggle with core strength.  I do not have lot# to provide.
Patient developed headache ~20 minutes after vaccine administration. Vitals at 11:28 AM: O2 98%, HR 91,   BP 156/85. Vitals at 11 41 AM: O2 99%, HR 90, BP 149/90. Patient reported feeling anxious given her history of anaphylaxis to peanuts. Patient was monitored for 60 minutes. She did not develop any new  or worsening symptoms throughout 60 minute observation period and she remained well appearing throughout.   Reviewed s/sx anaphylaxis (facial swelling, throat itching or tightness, shortness of breath, vomiting)   and advised her to call 911 immediately if these occur today.
Dizziness, extreme tiredness ; patient slept over 20 hours; experienced heart fluctuations;  along with body rash especially on torso and legs-rash; low-grade fever for 24 hours (11-6 thru11-7)  dissipated by Monday, 11-8
This is a spontaneous report from a contactable consumer (Patient). A 24-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 22Mar2021 15:30 as second dose, single dose (at the age of 24-years-old); and previously took BNT162B2(Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in Arm Left on 01Mar2021 15:30 as 1st dose, single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to vaccination and not diagnosed with COVID-19 prior to vaccination. Medical history included chronic eczema. Concomitant medication included TACROLIMUS 0.1 ointment topical taken for an unspecified indication, start and stop date were not reported. On 26Mar2021, the patient experienced moderate/severe eczema flare-up. The patient underwent lab tests and procedures which included COVID19SS: negative (nasal swab) on 06Apr2021 after vaccination. No treatment received for event. Patient was not recovered from event. No follow-up attempts needed. No further information is expected.
Post vax, the pt developed a fever of 105 that lasted for 10 days.
11x13cm redness and swelling left arm--onset day after vaccination and has grown over next 11 days. Last contact 11 days after vaccine