chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per client: "Two hours after the vaccine I started feeling pains in my arms the next day the pain continued also spreading to my sides and legs. The area where I got the shot was very swollen, hot to touch and very painful. The next day pain continued and area spreaded, Will be going to urgent care." This CHN observed erythema approx. 70mm x 70mm, warm to the touch. Client advised to seek medical attention, continue taking medication for discomfort (taking Ibuprofen) apply cool compress to area. Client states is going to urgent care.
Started with headache, arm soreness and right hip ache ( artificial hip joint) on Friday, sneezing a lot and itching on Saturday and now on Sunday right shoulder and Neck are so sore that I want to stay in bed, but I can't because we have a week to move!
already taken the doses of the covid-19 vaccine and contracted the disease; already taken the doses of the covid-19 vaccine and contracted the disease; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "already taken the doses of the covid-19 vaccine and contracted the disease". Verbatim and Event Description: The patient mentioned that he had already taken the doses of the covid-19 vaccine and contracted the disease. He also shared that he uses Pfizer products.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Pt with a PMH of COPD, asthma, and heart failure. Pt arrived with increasing shortness of breath, fever, and headache. Pt admitted due to COVID-19 positivity, COPD exacerbation, CHF exacerbation, and dyspnea.
pt had injection site reaction.  Red/soreness     referred pt  pcp if problem persists.   I contacted PCP office and made them aware of the situation.
pt vaxed 27MAY92 & on 29MAY seen by MD for fretfulness & severe rhinitis; following day, devel fever of 103, h/a, neck pain & white blotches on tonsils; 30MAY pt still febrile, temp less than 102;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. Reporter classified events as non serious. Patient did not have known allergies. But my mouth tasted like pennies the whole time taking Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID rebound at day 8 (COVID-19 recurrent); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID rebound at day 8 (COVID-19 recurrent)) in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-May-2022, the patient experienced COVID-19 (COVID rebound at day 8 (COVID-19 recurrent)). At the time of the report, COVID-19 (COVID rebound at day 8 (COVID-19 recurrent)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Tested negative on day 7 on multiple rapid tests.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       It was reported that patient had unknown drug, start date of the drug was on 01-May-2022 and last administration on 05-May-2022 for COVID-Treatment as an indication.  No concomitant medication information was provided.  Company Comment: This spontaneous case concerns a 28-year-old male patient, with a no medical history reported, who experienced the unexpected AESI of COVID-19 recurrent. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. The patient was treated with an unspecified drug for COVID-19. However on day 8 of treatment, the patient had COVID rebound. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 28-year-old male patient, with a no medical history reported, who experienced the unexpected AESI of COVID-19 recurrent. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. The patient was treated with an unspecified drug for COVID-19. However on day 8 of treatment, the patient had COVID rebound. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Shortly after injection started itching. Then when  she got home she started a rash on face, chest.
Within 3 hours, unable to lift arm., unable to sleep. Severe arm pain for three days, then started vomiiting and vomited for 2 days.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (on an unknown date in April 2019 had a mild case compared to mother-in-law) and shingles (Family History) (mother in-laws, had them at the same time). In June 2020, the patient received the 2nd dose of Shingles vaccine. In January 2020, the patient received the 1st dose of Shingles vaccine. In March 2021, between 8 and 10 months after receiving Shingles vaccine and between 1 and 2 years 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 and Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was 49 years old when he/she got Shingles in April 2019, so doctor suggested to get the vaccine. In March 2021, the patient got shingles again and this time they were much worse. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
hasn't been feeling feel; haven't been able to eat much other than liquids and Jello; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (hasn't been feeling feel) and FEEDING DISORDER (haven't been able to eat much other than liquids and Jello) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TUCATINIB (TUKYSA) for Malignant neoplasm of lower-outer quadrant of female breast.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and TUCATINIB (TUKYSA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (hasn't been feeling feel) and FEEDING DISORDER (haven't been able to eat much other than liquids and Jello). At the time of the report, VACCINATION COMPLICATION (hasn't been feeling feel) and FEEDING DISORDER (haven't been able to eat much other than liquids and Jello) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided  Action taken with mRNA1273 Moderna vaccine was Not Applicable
Consumer stated he is unsure if it is still viable and if he can administer it since it was left in his car.; Consumer stated he has the vaccine, GARDASIL 9 and is unable to administer it. Consumer stated he was given the vaccine, not administered, from the pharmacy.; Consumer stated he has the vaccine, GARDASIL 9 and is unable to administer it / he was given the vaccine, not administered, from the pharmacy. Consumer stated he is unsure if it is still viable and if he can administer it since it was left in his car; This spontaneous report was received from a male consumer of unknown age who was reporting on himself. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication and previous drug reactions or allergies was not provided.  On unknown date in February 2021, the consumer was given from the pharmacy a not administered dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (formulation, dose, and vaccination scheme frequency were not reported, lot number and expiration date were unknown) and he still had it but was unable to administer it. Additionally, the consumer stated he was unsure if hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was still viable and if he could administer it since it was left in his car (product storage error, product dose omission issue and circumstance or information capable of leading to medication error).
Patient experienced rash on injected arm with 24 hours. Progressed to stinging and itching. Next day experienced extreme redness and stinging on face and low grade fever. Patient went to ER and was diagnosed with Cellulitis. Was given  Rx for Prednisone and Doxycycline. Followed up with patient on 10/25. Reports that symptoms have improved.
01/06/22 presents to ED for "fatigue, dyspnea, cough" "increasing shortness of breath and anxiety". "history of smoking and obesity"
Patient signed up for pfizer booster through our pharmacy, went through process, when I gave shot told her she was getting pfizer booster, after the fact she showed us card she had gotten moderna as first two. Did not get first two doses at our facility. We told her to monitor side effects and let us know if any issues/adr.
No Adverse event; patient received a half dose of the Moderna Covid-19 bivalent booster dose vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received a half dose of the Moderna Covid-19 bivalent booster dose vaccine) and NO ADVERSE EVENT (No Adverse event) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Dec-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient received a half dose of the Moderna Covid-19 bivalent booster dose vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient received a half dose of the Moderna Covid-19 bivalent booster dose vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (patient received a half dose of the Moderna Covid-19 bivalent booster dose vaccine).    No concomitant medications were reported.   Patient received additional booster.  No treatment medication was provided.
Received shot at 08:20 on Thursday. By 12:00 I was feeling sluggish and rundown. At 06:00 (Friday), I woke with a massive pressure headache, malaise, very sore left arm (where the injection was), and a fever of 100.2. Tylenol at 06:20 seems to have broken fever, still feel very rundown and the headache is debilitating.  It is 10:00 hrs. as I fill this out. The Tylenol made no difference to the headache.
Alternating diarrhea and constipation for 2 months following second dose of vaccine.
high fever; extreme fatigue; patient had allergies, but it was unknown what the allergies are to; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the sixth of eight reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer version of the vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 vaccination. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine on Dec2020. The patient had allergies, but it was unknown what the allergies are to. The outcome of events was unknown.  No follow-up attempts are possible. Information on batch/Lot number cannot be obtained. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520682 same reporter/drug/AE, different patient
My arm is swollen and red around the injection site.  It has heat in the injection site.  It has been two weeks after the first injection and the injection site it itches.  The swelling is getting larger and it hurts sometimes.
The day following the 2nd vaccine her arm had some swelling, soreness that radiated down the wing of her back.  She was achy, doesn't believe she had fever, but had chills and just slept a lot, just didn't feel good.   This reaction lasted 24 hours and then all went away.  She took Ibuprofen for the symptoms.
I went in for a routine mammogram. They found an enlarge lymph node in my arm pit. They did an ultra sound on it and now I need a biopsy.
Nausea; Fatigue; Diarhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) as dose1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose of covid-19 vaccine.), administration date: 12Mar2021, for Covid-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 01Apr2021, outcome "unknown", described as "Nausea"; FATIGUE (non-serious) with onset 01Apr2021, outcome "unknown", described as "Fatigue"; DIARRHOEA (non-serious) with onset 01Apr2021, outcome "unknown", described as "Diarhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Skin rash The pt also had an IPV/Aventis/U04522/RL/2.
Patient received pfizer vaccine on 1/4/22 and 1/25/22. COVID positive on 3/4/22 Presented to ER on 3/11/22 for intraabdominal abscess. Found to be COVID19 positive without symptoms. Discharged on 3/15/22
Typical side effects began next day(4/18), Arm soreness at injection site, headache, feeling of fatigue, breathing feeling slightly off,  but subsided after the second day (4/19).  Third day was completely fine (4/20), Morning of fourth day (4/21) wave of dizziness and fatigue began accompanied with feeling of pressure in ears with occasional ringing. Also headache at the back of the head and where the cervical spine meets the skull. Occasional congestion. Hard to concentrate and occasional lightheaded feeling. Going on one week since injection and 3rd day of dizzy spells. (4/24)  Treatment: Drinking mostly water. Diet consisting mostly of vegetables and grains (no changes have been made to my diet) Ibuprofen 200mg seems to alleviate earache which in turn relieves some dizziness but feeling of being off balance remains.  No previous history of any sort of vertigo or ear infections.
Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.  Excursion from the freezer occurred on 01-Oct-2021
Rash/whelts and much itching,  first on left arm where injection was given and then on the right arm.   She used anti-itch ointment and within about 1 hour the rash went away and the itching stopped.
Child woke up to a 8 mm blister on injection site where varicella was given.
I received the vaccine at 1:10 pm in the afternoon. Around 8:30 pm I started to develop cold chills, body aches, cough/sore throat, headache. I felt this way Saturday, 3/20/2021 at 8:30pm until Monday, 3/22/2021 11am.
I had severe abdominal pain, vomiting, diarrhea, I was passing blood clots in my stool. My husband took me to the emergency room, where they ran a CAT scan and did a stool culture. The diagnosed me with colitis and norovirus, I was given two different antibiotics to take. I am feeling a lot better, but I am not one hundred percent yet.
Broke out in rash on left arm and swelling up to knuckles. Began the same day as administration about 1 or 2 hours after. Very warm to touch and looks swollen compared to right arm. Pain throughout arm since 1/29 but has improved.
patient received their 3rd dose of PENTACEL 2 weeks after their 2nd dose with no reported adverse event; Initial information received  on 03-Mar-2022 regarding an unsolicited valid non-serious case received from a physician via call center.  This case involves a 6 months old female patient who had experienced patient received their 3rd dose of pentacel 2 weeks after their 2nd dose with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar); and rotavirus vaccine (Rotavirus Vaccine) both for Prophylactic vaccination.  On 29-Oct-2021, the patient received a 0.5 ml third dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine (frequency: once, Strength: standard) (formulation: unknown) lot UJ494AAA via intramuscular route in the right thigh.  On 29-OCT-202, the patient developed a non-serious event patient received their 3rd dose of pentacel 2 weeks after their 2nd dose with no reported adverse event (inappropriate schedule of product administration) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (inappropriate schedule of product administration).  At time of reporting, the outcome was Unknown for the event inappropriate schedule of product administration.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient presented with urticarial rash to neck, trunk, arms and upper left thigh. Mother reports she noticed 2-3 "spots" on his left thigh and hip area earlier this morning when changing his diaper. Since that time mother reports it has gotten worse. Patient is irritable.
within 24 hours:  blistering lesion with surrounding erythema on R buttocks and herpes simplex (cold sore) on lip
headache; muscle aches; pain; This is a spontaneous report received contactable female consumer via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch /lot number not reported), via an unspecified route of administration on 25Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date the patient experienced a headache and has muscle aches and pain. she wants to know if she can take tylenol. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Employee reported, on Jan. 14, 2015, that on 10/23/14, a few hours after receiving her flu shot at work, she noticed a red, bumpy, itchy rash on her left arm and left side of her chest. Rash lasted < 24 hours and resolved without treatment. She denies any known allergies. Flu shot was given in left arm.
Felt like  passing out for 2 minutes.  Patient states he was anxious because he don't like taking shot. He states he has history of passing out with shots. VSS: BP 92/61, Heart rate 86 bpm, 02 sat 97%, Blood Sugar 128
Woke up in the early morning hours after receiving the shot midday with extreme chills,  teeth chattering and feeling feeling totally drained.  Went back to bed, could not stop shivering and teeth chattering but eventually fell back asleep, albeit fitfully.  That morning, I woke and the chills had gone but I  still felt totally drained and spent the remainder of the day -- until about 3 pm -- in bed, sleeping on and off.  Felt better -- though still weak.  Took two days, but am now feeling pretty normal.
After both of these shots my arm was exceptionally sore (more so than with the usual flu shot), I was tired, had chills, diarrhea, felt ill. With both doses, slept most of the next day, unable to do much of anything else. Difficult to sleep as even a sheet on my arm was painful. Day 2 after shot, feeling OK to do activities but arm is still very sore.