chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had rash at injection site, little purple dots on both legs, extreme fatigue, migraine headaches, seizures extreme spine pain, hip pain, vertigo, dizziness, extreme exhaustion and a constant case of thrush. The day after the first and only injection she came down with pneumonia, bronchitis, a sinus infection, 2 ear infections, throat infection, a common cold and thrush. This was constant for the first 2-3 months. She had 1 or more symptoms at any given moment after vaccinated. She had never had any of these symptoms EVER before the shot (except for the bronchitis and the cold). All of these symptoms started immediately and slowly got worse and worse. I took her to see her doctor 1-3 times per week for several months.
Initial report received on 08 September 2009 from a Healthcare Professional. A 26 year old female patient, whose medical history was not reported, received a left deltoid intramuscular injection of ADACEL (sanofi pasteur Inc. lot number UF551BA corresponding to sanofi pasteur Ltd. C3159) on 01 September 2009. Illness at the time of vaccination was not reported. Concomitant medications included CLARITIN and NYQUIL. On 04 September 2009, the patient developed a lump at the left deltoid injection site. Corrective treatment was not reported. At the time of the report (08 September 2009), the patient still had a pea-sized palpable lump which was not visible. The patient was reported to have recovered.
03/08 approximately 8 AM: severe headache progressed to fatigue, sweats at night and chills.  03/09 18:00: noticed first sign of red rash, itchy, flat or slightly raised.  On 03/10 there approximately 11 lesions abdomen, back left leg and arms.  Reports itching, temperature 99.  Recovering 03/12/04.
Redness swelling, soreness, hives, 4 inches round area at site of injection treated with Topicort spray Atarax and Claritin.
no adverse event; A medical assistant called to report an expired dose of VARIVAX was administered to a patient.  No additonal ae's and no PQC's were reported.; This spontaneous report was received from a medical assistant referring to an unknown age and gender patient. Pertinent medical history, concomitant medication and drug reactions/allergies were not reported.  On 28-JUN-2022, the patient was vaccine with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T021826, expiration date 25-JUN-2022) to prevent varicella infection (strength, dose, frequency was not reported) (expired product administered). No additional adverse event was reported (no adverse event).
Fever over 101 degrees, muscle aches, and fatigue that lasted for 5 days. Dull pain in the right testicle that lasted for nearly 3 months.
Generalized aching; Headache; Tiredness; Generalized aching; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN (Generalized aching), the second episode of PAIN (Generalized aching), the first episode of HEADACHE (Headache), the second episode of HEADACHE (Headache) and the first episode of FATIGUE (Tiredness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2021, the patient experienced the first episode of PAIN (Generalized aching), the first episode of HEADACHE (Headache) and the first episode of FATIGUE (Tiredness). In February 2021, the patient experienced the second episode of PAIN (Generalized aching), the second episode of HEADACHE (Headache) and the second episode of FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In February 2021, last episode of PAIN (Generalized aching), the last episode of HEADACHE (Headache) and the last episode of FATIGUE (Tiredness) had resolved.     Concomitant product use was not provided by the reporter.  On an unknown date in Jan-2021, the patient experienced tiredness, body aches and headache after first covid-19 vaccinations. In Jan-2021, the tiredness, body aches and headache after first covid-19 vaccination was resolved.  On an unknown date in Feb-2021, the patient experienced tiredness, body aches and headache after second covid-19 vaccinations. In Feb-2021, the tiredness, body aches and headache after second covid-19 vaccination was resolved.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for Humira(Adalimumab) for the events of lymph nodes swollen under both arm pits/more on left arm where shot was given after covid booster shot, fever after covid booster shot, headache after covid booster shot, fatigue after covid booster shot, body aches after covid booster shot, tiredness after first covid-19 vaccinations, body aches after first covid-19 vaccinations, headache after first covid-19 vaccinations, tiredness after second covid-19 vaccinations, body aches after second covid-19 vaccinations and headache after second covid-19 vaccinations was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2021-630288 (Patient Link).
severe chills; Today I am achy; This is a spontaneous report received from two contactable consumer (patient's wife and patient). A 65-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and (Batch/lot number: EM9809, expiration date: 30Jun2021) via an unspecified route of administration on 08Feb2021(at the age of 65-year-old) as a single dose for COVID-19 immunization. Medical history included Cancer (unspecified) treated with Immunotherapy. Concomitant medications included unspecified medications. On 12Feb2021, at 03:00 (after 5 days of vaccination), the patient woke up with severe chills and was achy.The patient enquired was that common.It is odd that it is 5 days late and the patient was having a reaction.Patient received Tylenol for the events. The outcome for the events was unknown.
arm hurt; This is a spontaneous report from a contactable consumer. A contactable consumer reported different events for 3 patients. This is one of reports. This consumer reported for 14-year-old female patient (reporter's daughter) that, A 14-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date (at the age of 14-years-old) as a dose number unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior Vaccination within four weeks were none. The patient had arm hurt on an unspecified date. Reporter stated that, my girls all their arms hurt (Further clarification wasn't available hence split not made), but none of their neck turn back you got to understand though they are young they are 14 and 16 ok their COVID shot. No Lab Tests were done. Reporter seriousness for the events were Unspecified. The outcome of the event was unknown.  QR comment: This might be a split however it was not made by the call handler as there was no information regarding the details of the other patients.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Chills, aches and pain for 2 days. Swollen and red left arm by around  injection site for three to four days
Subsequent to receiving one dose of varicella virus vaccine live the pt presented to a physician with a rash. The pt was diagnosed with breakthrough varicella that consisted of approximately 30 lesions and the pt was afebrile.
anaphylactic reaction; breastfeeding who had a baby with an anaphylactic reaction; This is a spontaneous report from a contactable pharmacist. This pharmacist reported information for both mother and baby. This is a baby report.   A 12-month-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), transmammary on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's mother received her first Pfizer vaccine and was breastfeeding, the baby (patient) had an anaphylactic reaction. The outcome of the event was unknown. The events were assessed as serious-medically significant.  Information about lot/batch number has been requested.; Sender's Comments: A contributory role of exposure to BNT162B2 via breastfeeding to the development of anaphylactic reaction cannot be excluded based on the product profile.,Linked Report(s) : US-PFIZER INC-2021305689 mother case
Complaints of soreness at site of injection right deltoid. Also, about 6 inch zone of redness.
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with improperly stored oral ROTATEQ (lot# reported as M002254, expiration date 15-NOV-2017; dose and dose number were not reported; temperature/time frame: 49.1 Fahrenheit/4 hours and 30 minutes; therapy type: Digital Data Logger; previous temperature excursion: 65.2 Fahrenheit for 8 hours and 15 minutes) orally. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Arm swelled up and was in severe pain. Went to the ER the next morning the doc told me that a nerve was hit this was about 3 weeks ago and arm still is in some pain.
I did experience arm soreness and nausea within 12 hours of receiving the vaccine, which was expected, although I did not expect my energy to increase since receiving the Moderna Covid-19 vaccine. No other changes in daily habits that can explain increase in energy.
1030: Employee felt nausea, numbness and tingling around her mouth that grew with intensity over an hour. Came back to vaccination site at 1130, where she was put on the monitor and given  water and 4mg sublingual Zofran once by pharmacy director. At 1215, vital signs remained stable and employee felt well enough to go home. employee was instructed to report in Vsafe app.
Patient taken by mother to ER on 6/20/2021 for diarrhea and abdominal pain which had started on 6/14/2021. Received 2nd covid vaccine at 4pm on 6/13/2021. Was well until 6/14/2021. Diarrhea and abdominal pain started evening of 6/14.  Vomited twice on 6/15. Watery loose non bloody diarrhea. RLQ Pain rated as 7/10. No fevers, cough, congestion or rashes.   At ER: US inconclusive, CT showed ascending colitis and possible ileitis. Appendix wnl. Received flagyl, ceftriaxone, toradol and morphine in ER  Transferred to Medical Center on 6/20 for hospitalization for pain control, IVF and GI consult. Received toradol and morphine each x 1.   Started on hyocyamine.  Discharged from Hospital evening of 6/21/2021.    Seen in my office 6/23/2021.  Stool and appetite wnl.  RLQ pain rated as 3/10.
Approximately 6 hours post vaccination, child had episode of prolonged hypotonia, cyanosis (with no respiratory distress) and was hyporesponsive. This lasted approximately 10-15 minutes before he became more alert. He was taken to an emergency department after this and was monitored and released. He did not receive CPR or any other intervention.
Body wide rash with itching. Benadryl 25 mg. Two tablets. po. immediately, then q. 4-6 hrs. prn. 12/08/09 OB Medical records received for DOS 6/03/09-12/08/09 (EDD 01/10/09) Pt telephone call:reported rash, itching on 11/06/09. Advised to take benadryl.  Reported  rash resolved, no further itching on 12/08/09.
High blood pressure; heart rate in the 100's/High heart rate; light headed and dizzy; This is a spontaneous report from a non-contactable nurse(patient). This female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on Dec2020 (reported as on Thursday) for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient received the vaccine on Thursday and within 15 to 20 minutes, she got light headed and dizzy with high blood pressure with a heart rate in the 100's. She went to the ER and was sent home, but her blood pressure continues to be high. Her primary care physician wanted to start her on some blood pressure medication due to continuous high blood pressure. The reporter was asking if high blood pressure and high heart rate had been reported as an adverse event for the Covid vaccine. Outcome of High blood pressure was not resolved. Outcome of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between BNT 162B2 and the events blood pressure increased, dizziness, and heart rate increased cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Hives across the chest, arm, and back.  Patient had itching and redness as well.  Patient took Zyrtec and was feeling better by end of day. Patient said she may follow up with an urgent care visit tomorrow if still having symptoms.
Day 1 to day 4: Left arm pain with ROM on abduction affected. Day 3 to 4: Lip swelling. Juvaderm fillings present. Swelling has occurred in the past with respiratory infections. Prednisone was prescribed, but none taken in this instance. Day 7 to Present: Left axillary, supraclavicular, and pectoral lymph node tenderness and swelling. Red rash at the site of injection, measuring 6 x 2 inches. Hot to the touch, mildly itchy, and swollen.
06/26/2004 at 2200 hours after taking a shower went to bed, developed a fever (not checked with thermometer) Just felt hot. Took tabs Aleve with orange juice 8 oz. Went to sleep. Slept 08:00 over 2 hoursfelt like bugs were crawling on right arm and shoulder. Felt cooler during the night. Woke this AM nauseated.
Woke up at 1:30am on 09/27/14 with hives, chills, diarrhea, and severe abdominal pain. Passed out twice at home, blood pressure performed by EMS at home was 80/52. Treated in ER with IV Benadryl, Demerol, and fluids on 9/27/14 at 3:30am. Discharged on 9/27/14 at 5:00am.
H/A, abd pain, fever, chills, increased BP, pain and swelling at injection site
Approximately 8 minutes post-vaccination patient started to feel dizzy. Patient then got out of his chair to come tell the pharmacist (myself), during which time I witnessed him starting to sway and attempted to approach the patient. Before I could make it to the patient he passed out and fell to the floor, his bottom hit the floor first followed by his torso. I told the intern to call 911 and stayed with the patient. He never stop breathing and a pulse was always present. He attempted to get up moments after falling and I requested he stay on the ground. After a couple minutes he felt slightly better and I assisted him into a chair. At this point the paramedics arrived and took over patient care while I described
12/15- Patient went to her doctor 12/15/06 after developing hives, fever, malaise. 1st shot MMR 10/24/06, 2nd shot 12/1/06. 12/19/06-developed joint pain. 12/31/06 developed fever, chills, hives. - referred to infectious disease specialist. Patient treated with IV fluids, steroids (Prednisone), Hydronyzone HCl.
This spontaneous report as received from a physician refers to a female patient of over 65 years of age. Patient was vaccinated with ZOSTAVAX at some of other facility on November 2013 (reported as "several days ago"). Patient now had redness, pain and swelling at the injection site. Site was unspecified. Physician states that he had not seen the patient in the office yet, so unknown if client has any vesicles or rash. No treatment was taken for the events. The patient sought medical attention by calling the physician. The outcome of the events was reported as not recovered. No PQC was involved. Additional information has been requested.
PROQUAD and MMRII may have been administered after a temperature excursion.; no adverse event; This spontaneous report was received from  a registered nurse (R.N) regarding an unspecified number of patients of unknown ages and genders. Their medical history, historical drugs, known allergies, concurrent conditions, an concomitant therapies were not reported.  On an unknown dates the patients, were vaccinated with doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, both as prophylaxis (strengths, doses, frequencies, lot #'s, expiry dates, and routes of administration were unknown by the reporter) that went through a temperature excursion (Improper storage of product in use). No further adverse events (AE) or information were provided.
slept the whole next day after the vaccine; Her fasting blood sugars were high; Her bilirubin was off, she believes slightly elevated 1.4 or 1.6.; cold like symptoms; cough; headache; stuffiness and running nose; really, really tired; stuffiness and running nose; not feeling like herself; sinus drainage; This is a spontaneous report from a contactable other health care professional (patient herself). A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown), via an unspecified route of administration in arm left on 16Apr2021 as dose 1 single (at the age of 47-year-old) for COVID-19 immunisation. The patient's medical history included Wolfe Parkinson white syndrome, adds this was a problem with electrical current in heart. She has had this a good ten or fifteen years, anxiety, this was occasional, off and on 15 or 20 years, diabetes mellitus, her mom and brother were diabetic from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Ativan, when she flies. On 17Apr2021, slept the whole next day after the vaccine. On an unspecified date in Apr2021, the patient experienced her fasting blood sugars were high, her bilirubin was off and she believed slightly elevated 1.4 or 1.6. On an unspecified date 2021, the patient experienced cold like symptoms, cough, headache, stuffiness and running nose, was really, really tired, not feeling like herself and sinus drainage. It was reported that the cough and the headache began and then more stuffiness and drainage and stuff came a few days later. The cough was better and not as much as in the beginning. The stuffiness, running nose and good old fashion cold symptoms were lingering a little bit. It was reported that she could have slept the whole next day after the vaccine and she was really tired. It had gotten better. She states that since getting the vaccine she has not felt quite normal. It has not stopped her from doing anything, but she just has not felt like herself. That started right after and it was going on. It was reported that she went to the primary care physician visit because she did not feel like herself and for other events. The patient underwent lab tests and procedures on an unspecified date in Apr2021 which included blood bilirubin increased: elevated, her bilirubin was off, she believes slightly elevated 1.4 or 1.6, blood glucose: high, she found out her fasting blood sugars were 120 or 130, A1C, glycosylated haemoglobin: normal, A1C was high end of normal, haemoglobin: normal and on an unknown date rapid and regular SARS-COV-2 test: negative. Therapeutic measures were taken as a result of headache included Motrin, 600 mg, each pill was 200 mg. The outcome of the events was unknown.    Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:27 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 48.36.  Concomitant medication information was not provided by the reporter.  On 15-Apr-2021, At excursion time 09:00 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  Vial was stored on cooler 1, on 15-Apr-2021, Excursion duration At 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 39, 1PM: 43, 2 PM : 44, 3 PM: 44, 4 PM: 42 and 5 PM : 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).