chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nasal Swab (Date:19Jan2022/ Result: Positive); Nasal Swab (Date:19Jan2022/ Result: Positive); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Aug2021 as dose 1, single (Lot number: Ew0167), in left arm and on 20Sep2021 as dose 2, single (Lot number: 301358A) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy to avocado" (unspecified if ongoing), notes: Allergy to avocado. Concomitant medication(s) included: CENTRUM FOR WOMEN. Past drug history included: Took benedryl with first dose, reaction(s): "Took benedryl with first dose"; Zyrtec with second, reaction(s): "Zyrtec with second". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jan2022, outcome "unknown" and all described as "Nasal Swab (Date:19Jan2022/ Result: Positive)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jan2022) Positive, notes: COVID test type post vaccination=Nasal Swab.  Clinical course: Ever since the second dose, Patient had developed a lactose intolerance. Immediately following the dose, patient was puking anytime had dairy. Lasted about 2 weeks. Then noticed if patient had dairy, patient needed to find a bathroom asap. Everything patient read said adverse effects were supposed to wear off after 6 months. It's been a year and patient still can't have a milkshake without blowing up a bathroom or getting nauseous. No COVID prior vaccination. COVID tested post vaccination. No other vaccine in four weeks. Other medications in two weeks Centrum multivitamin.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Body covered in red bumps, hives, completely irritable, unable to eat, cold sweats.
She reports red bumps on the back of her neck and under her eye.  She thought it was from a new makeup.  She went to her Primary Care doctor who through it might be shingles, so patient was prescribed Bactrim and Valacyclovir.  The bumps under her eye resolved quickly, however red bumps developed on her hands and upper arms, which steadily got worse over several days.  On January 13, 2021, the patient went to the doctor and immediately diagnosed the reaction related to her COVID-19 shot.  She stated she had seen this reaction numerous times.  The patient was prescribed Clobetasol Cream 0.05%.  Her hands and upper arms have improved, but her Thumb and fingers.
Itching at injection site. Raised pink firm lump at injection site about 2? by 4? area. Lasted about 5 days.
Approx 5-10 minutes after receiving vaccine, pt developed edema at injection site (upper (L) arm & to (L) wrist).
-headache -joint ache -nausea  -fatigue  -fever  -took tylenol
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 male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 03Mar2021 14:45 (Batch/Lot number: unknown) 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: SOMNOLENCE (non-serious) with onset 03Mar2021 16:30, outcome "unknown", described as "He then fell asleep on the couch around 4:30pm, and woke up at 6pm which is very out of character for him.".Additional information: The patient was wondering if it was due to the vaccine and if it was an allergic reaction. The patient also wants to know what he should be worried about or if he should keep track of symptoms. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse refers to an unspecified patients of unspecified demographics. There was no information about the patients' medical history, concomitant therapies and concurrent conditions. On unknown multiple dates, the patients were vaccinated with improperly stored PROQUAD lot # L047305, expiration date 23-MAY-2017; lot # M004895, expiration date 26-JUL-2017 (strength, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experience the temperature excursion of -12 degrees Celsius till an unknown duration. No data logger was involved. No product quality complaint was reported. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided. This is one of several reports received from the same reporter.
I was really sick to my stomach which resulted in diarrhea. I experienced chills, body aches and was extremely tires. Nausea was the biggest issues. After a few days, I went to the doctor who ran a series of test and treated it for symptoms. He gave me medication to control the nausea and was given Zofran.  The symptoms subsided after 7 days. I saw the provider on day 3.
Chest pain; Shortness of breath; 'shooting' at my left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 21Aug2021 (Lot number: FD7204) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose: 24Jul2021, Batch/lot number: FD7206), administration date: 24Jul2021, for Covid-19 Immunization. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "Chest pain"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; PAIN (non-serious), outcome "unknown", described as "'shooting' at my left arm".  Additional information: Patient had 2nd Pfizer shot on 21Aug and since then this was the 3rd time today, patient been getting like chest pain, shortness of breath and 'shooting' at left arm and was just wondering, patient tried to call family doctor but they are closed at the moment and wasn't just sure if needed to go to a hospital or what the next step should be.  No follow-up attempts are possible. No further information is expected.
Intussusception  12/11/07 Reviewed hospital medical records which reveal patient experienced irritability, decreased oral intake, lethargy & bloody stools.  Had been on antibiotics  & neb treatments prior to admission for respiratory s/s.  Admitted 12/1-12/3/2007 to PICU for observation s/p IS reduction.  Progressed well but had fever of 101. Scheduled to see pcp next day.  FINAL DX: Intussusception, enema reduced.
client complained of numbness to lip  after receiving the 1st COVID  (lot # EW 0150, exp. 4/3/21) at 1150. Client signaled PHN  and informed her she was starting to feel her left lip going numb, pressure to her lower base of the head and palpitations.  First set of vitals:blood pressure 140/80, pulse 80,  oxygen 98%. Client alert and oriented with flushed skin. Client denied shortness of breath , chest pain, no swelling at this time. PHN offered client Benadryl, per client would call friend first if medication was given so she could be picked up.  History of anxiety and hypertension, per client had an allergic reaction to flu shot in the past. Current medication: losartan.  At 1200 client stated numb sensation was radiating to left cheek PHN offered client Benadryl again and client accepted. 50 mg/IM Benadryl administered to right deltoid at 1203. Client informed we would keep her for further observation and would take vitals every 5mins. Vitals at 1205: pulse 94, blood pressure 180/95 oxygen 97%. Numbness to lip and face same, pressure to head same, palpitations same. Alert and oriented. Vitals 1210: blood pressure 120/80, pulse 81, oxygen 100%. Per client previous complaints improving. Client stated could feel cheek again. Vitals 1215: blood pressure 140/80, pulse 102, oxygen 99%. Client stated feeling nausea, emesis bag given and water. Per client also starting to feel drowsy. Palpitations improving and more sensation to lip area. At 1219 client stated having chills, palpitations returning. Per client was not sure if it was her anxiety. PHN offered 911, get paramedics for further assessment and to transfer to hospital for higher level care. Client refused, she felt benadryl was helping at this time. Vitals 1221: blood pressure 140/80, pulse 87, oxygen 99. Client stated all complaints improving. Vitals 1228: blood pressure 142/80, pulse 80, oxygen 100%. Vitals 1234: blood pressure 140/90, pulse 78, oxygen 99%. Per client lip and cheek no longer numb, normal sensation. Nausea had resolved and palpitations improving. 1241 vitals: blood pressure 140/90, pulse 80, oxygen 97%. Vitals 1247: blood pressure 130/90, pulse 75, oxygen 100%. Client stated feeling good. All complaints had resolved. Per client just tired feeling. 1257 vitals: 130/90, pulse 78, oxygen 96. No complaints. Client advised to speak with primary doctor prior to second dose. ER precautions given. Friend arrived at 1300 and would drive client home. last set of vitals 1305: blood pressure 130/90, pulse 75, oxygen 98. All symptoms resolved. Client left facility with a steady gait at 1307
Fever of 101 day 2 and 3 after injection. Red itchy rash down left arm for about a week
Information has been received from a pharmacist referring to a newborn. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 21-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 24Jan2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Feb2021 at 13:00 as dose 2, single (Lot number: FL9267), in left arm, on 01Oct2021 at 14:00 as dose 3 (booster), single (Lot number: 31035BA), in left arm and on 18May2022 at 15:00 as dose 4 (booster), single (Lot number: FN2908) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Milk protein A" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: At Home test became strongly positive after fading to almost gone; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical summary: Other medication in 2 weeks was None. Patient took Paxlovid, starting 31Aug2022 and Treatment stop date was 04Sep2022 for treatment of COVID-19. Adverse event was also reported as at home test became strongly positive after fading to almost gone on 10Sep2022 at 9:00 AM. It was unknown if patient recovered with no treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
got the shingles vaccine then she got shingles; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows:  The case was reported by patient's child. The age at vaccination was not reported. The patient received Shingles vaccines and then got Shingles. The reporter said no thanks. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Generalized rash, Fever.  Rash -varicalla like on 11/25/2002
June 4th: headache, fatigue and Fever of 101F by 5pm, climbing to 102 by 9pm and climbing to 103.8F  by 11pm.  Severe Arm soreness. And muscle aches throughout body. Headache remains all night.   June 5th: headache, nausea, fatigue, muscle soreness, and  fever of between 102.8F and 103.8F throughout the day with Advil. By evening staying steady at 103,1-103.8F even with Advil.  Arm pain at shot location.  June 6th: Fever broke around 6am to 101F and stayed around 100F all day. Arm soreness, headache, and nausea remain. Rash around injection site first noticed around 10am. Fatigue and light headed feeling continues.
This spontaneous report was received from a pharmacy technician, refers to multiple patients of unknown ages and genders. Concurrent condition and medical history were not reported. On an unknown date, the patients were vaccinated with a dose improperly stored of M-M-R II lot # L002873, expiration date 27-JAN-2017 (strength, dose#, dose, route of administration, anatomical location and albumin status were not reported). There was not a product quality complaint (PQC) involved. No adverse effect were reported. This is one of several reported from the same source.  Lot number L002873 has been verified to be a valid  lot number for M-M-R II. Additional information has been requested.
breakthrough bleeding period-wise/this has happened through years; breakthrough bleeding period-wise/this has happened through years; sore arm; extreme fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 42-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6198) via an unspecified route of administration administered on the left arm, on 23Feb2021 09:45, at a single dose, for covid-19 immunization. Medical history included breakthrough bleeding at times through years. There were no known allergies. Concomitant medication included hydromorphone hydrochloride (DILAUDID) and, alprazolam (XANAX) - both taken for unspecified indications, start and stop dates were not reported. Also as reported concomitant medications included "oxymoron" and "flexibility". The patient did not have Covid prior vaccination. The patient did not receive other vaccines in four weeks. The patient stated it was weird because she experienced a breakthrough bleeding period-wise 12 days after shot, on 07Mar2021 11:00. She stated this has happened through years and; a bunch of women on (social site name) were discussing it and majority had a breakthrough bleeding 1-2 weeks after shot and; that they will also be reporting. The patient stated she has no idea if this was a true side effect, but she considered it strange that so many experienced it too. She also experienced normal sore arm and extreme fatigue - both on 07Mar2021 11:00. Her next dose will be tomorrow, 16Mar2021. The patient recovered from the adverse events on Mar2021 with no treatment received. The patient was not Covid-tested post-vaccination.
Vaccine administered on 9//16, and patient reports a rash developed on 9/13/16 on arms and legs. She does not have a PCP and chose not to be seen by an MD.
Left deltoid at injection site red\swollen\itchy area approximately 1" across and 4" down. No rash or anaphylactic reaction noted. Instructed to give BENADRYL 25 mg every 4-6 hrs, office visit if worsens.
a light nose bleed that lasted about 15 minutes; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (patient) .     A 27-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unknown date.   The patient experienced a light nose bleed that lasted about 15 minutes on an unspecified date with outcome of recovered.    Course of the event. Caller stated one hour after receiving the second dose she experienced a light nose bleed that lasted about 15 minutes. Caller stated she just used a Kleenex and only had to switch it out once. Caller states it was not severe and she didn't have to use a washcloth or anything and has not happened since.
1? red spot at injection site until 04/19/2021 when it split and grew. Two 4? spots, one at injection site, one several inches higher. Has been present for a week and is now starting to fade. Slight discomfort when pressure is applied to spots. They are very warm to the touch. Muscles in shoulder have been very sore as well.
This case was reported by a nurse via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female nurse who was administering Herpes zoster (shingrix) (batch number 72P9H, expiry date 9th April 2023) for prophylaxis. On 4th January 2022, the patient received shingrix. On 4th January 2022, unknown after receiving shingrix, the patient experienced occupational exposure while preparing product for administration and exposure via eye contact. On an unknown date, the outcome of the occupational exposure while preparing product for administration and exposure via eye contact were unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Nurse reported while mixing up shingrix, sprayed a small amount into right eye, washed eye out at eye rinse station, which led to occupational exposure while preparing product for administration and exposure via eye contact. The reporter consented to follow up. No additional details regarding reporter available at time of filing adverse event.
pt recv vax;fever & cellulitis at site of inject;;tx/ w/ cephalexin;
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use).    No concomitant medications were reported.  Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 days beyond use date.  The lot number for the monovalent vaccines with their corresponding BUD dates were 027C21A (BUD - 21-May-2021), 053C21A (BUD - 01-Jul-2021), 939902 (BUD - 02-Sep-2021), 011F21A (BUD - 04-Nov-2021), 012H21B (BUD - 23-Dec-2021), 056M21A (BUD - 12-May-2022), 082B22A (BUD - 08-Sep-2022).   The lot numbers for the bivalent vaccines with their corresponding BUD dates and the interval period of administration. 052D22A (BUD - 17-Nov-2022), dates of administration 18-Nov-2022 to 28-Nov-2022, 023H22A, (BUD - 15-Dec-2022), dates of administration 16-Dec-2022 to 20-Dec-2022. It was reported lot 042J21A should have been reported with a BUD of 17-Feb-2022.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live significant follow up contains updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Fever, Headache, dizziness, dry mouth, respiratory problems, loss of appetite, throat swelling, pain in the arm, cold sweat. Hot red face and chest.
Telephone called to MD. Presented at ER 4:50pm with generalized urticaria, angioedema of face, mild respiratory distress. Given Benadryl and breathing tx with ventalin. Quick turn around, sent home on Benadryl x 24hours.