chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my SBP went up to 130''s; I had a sensation of heat in my whole body; received the Pfizer booster dose 3 after 2 Moderna doses; received the Pfizer booster dose 3 after 2 Moderna doses; This is a spontaneous report from a contactable nurse (patient).  A 53-year-old female patient received bnt162b2 (BNT162B2), dose 3 (booster) intramuscular, administered in arm left on 21Sep2021 16:45 (at the age of 53-year-old) (Batch/Lot Number: FE3592) as single dose for COVID-19 immunisation.  Medical history included hypertension HTN but BP was low that morning, prediabetes, sleep apnoea syndrome, allergies to Sulfa. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included amlodipine (AMLODIPINE) 10 mg 1 tablet po daily taken for an unspecified indication, start and stop date were not reported.  The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Moderna COVID 19 vaccine, dose 1 intramuscular, administered in arm left on 04Jan2021 19:00 (at the age of 53-year-old) (Batch/Lot Number: 025L20) as single dose, dose 2 intramuscular, administered in arm left on 29Jan2021 07:15 AM (at the age of 53-year-old) (Batch/Lot Number: 032L20) as single dose for COVID-19 immunisation.  The patient experienced her SBP went up to 130''s (medically significant) on 21Sep2021 17:00 with outcome of recovered in Sep2021, she had a sensation of heat in her whole body (non-serious) on 21Sep2021 17:00 with outcome of recovered in Sep2021, received the Pfizer booster dose 3 after 2 Moderna doses (non-serious) on 21Sep2021 16:45 with outcome of unknown. The clinical course of events was as follows: Immediately after she received the Pfizer as a booster (dose #3), she had a sensation of heat in her whole body and her SBP went up to 130's. As treatment she took Amlodipine; it was a blessing that she did not take it that morning as her BP was low.  The patient underwent lab tests and procedures which included blood pressure measurement: 130 on 21Sep2021 SBP went up to 130's, Sars-cov-2 test: negative (Nasal Swab qualitative RT-PCR). Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Systolic pressure increased due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
injection site with his arm being "a little bit sore"; 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 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) at the age of 69 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site with his arm being "a little bit sore"".  Additional information: It was reported that the event was experienced in the evening of the vaccination day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a 13 year-old boy was administered Flublok instead of Fluzone with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from a other health professional and transmitted to Sanofi on 15-Jan-2021.  The case involved a 13 year old male patient who received a 0.5mL dose of a 13 year-old boy was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: QSAA2050, expiry date: 30-Jun-2021), via intramuscular route in the right arm, for prophylactic vaccination, on 09-Jan-2021, instead of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] (wrong product administered).  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   It was a case of actual medication error due to wrong vaccine administered (latency same day).  At the time of reporting, no adverse event was reported.  The nurse stated that immunization was ordered as part of clinic and administered by certified medical assistants (CMA). The reporter would like to know if any adverse events has been reported.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Disclaimer: Practices. The classification as a medical error was 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 had contributed to or was to be held liable for the occurrence of this medication error.
I got the 2 shots but I still have flare ups/Suspected vaccination failure; I still have flare ups; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 (got shingles in forehead, scalp, nose, all on the left side). Concurrent medical conditions included ophthalmic herpes zoster, scar (lots of scar tissue in left eye, flare ups) and post herpetic neuralgia (aggravates the nerves that were damaged).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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  tried numerous times to get a shingles shot years ago from the date of reporting but even though he/she had insurance it was costing him/her 375.00 of his/her portion, needless to say, patient could not afford that amount. The patient would stop by the pharmacy now and then because was afraid to had get shingles and his/her portion way too high for a long time. Unfortunately, patient got shingles in eye, forehead, scalp and nose, all on the left side and at the time of reporting the patient was living with all the damage to his/her eye and nerves that it did, had lots of scar tissue in his/her left eye and flared ups. The patient had to pull his/her hair off face because it aggravated the nerves that were damaged. The patient had been on an anti-viral pill since he/she got it several years ago and the physician thought that patient might be on them the rest of life. The vaccine came available at prices that were miniscule and patient got the 2 Shingles shots so he/she could not get shingles again but still had flare ups. The patient advised to get the shots and stated that the damage shingles could do was not pleasant. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
This spontaneous report as received from a registered nurse, refers to an unspecified patients of unknown ages and genders. On an unknown date the patient was vaccinated with VARIVAX for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX.; Sender's Comments: US-009507513-1707USA011878:
Patient was having trouble breathing . Patient was brought back to the the observation 1 to be observed. We took the patients vitals at 9:15 am heart rate 76, resp 18, Blood pressure 132/78 o2 100%, again at 9:25 am heart rate 76, resp 18, Blood pressure 119/83, o2 99%. Patient was talking and breathing fine. Patient was released home with others that were driving. Patient was released at 9:27 am.
pt developed sudden onset of tachycardia, SOB, flushing and dizziness about 25 minutes after receiving 1st COVID vaccine today. Pt was sitting in the observation room when symptom started Pt was immediate transferred to bed, vital sign monitor connected, provider on-site.  Pt's BP up to 178/81, HR 141 bpm, sat 98% initially, with shaking, flushing and SOB, symptoms lasted about 5-10 minutes, gradually calmed down, BP slowly down to 169/79 HR 97, sat 98%.  At 3:03, pt feels fully recovered, BP 162/72, HR 92, Sat 97%, able to walk. No med was given during Code Blue except brief O2 supply. Pt was then discharge to home, instructions given for continue monitor symptoms. Appt for 2nd shot scheduled
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 27-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015435, expiration date 17-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Face Swelling; Face hurting on left siide, Face soreness on left side; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Face hurting on left siide, Face soreness on left side), SWELLING FACE (Face Swelling) and ARTHRALGIA (Shoulder pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced ARTHRALGIA (Shoulder pain). On 03-Feb-2021, the patient experienced FACIAL PAIN (Face hurting on left siide, Face soreness on left side). On 06-Feb-2021, the patient experienced SWELLING FACE (Face Swelling). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 13-Feb-2021, SWELLING FACE (Face Swelling) had resolved. At the time of the report, FACIAL PAIN (Face hurting on left siide, Face soreness on left side) was resolving and ARTHRALGIA (Shoulder pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was unknown by the reporter.  Patient took Tylenol and applied ice on her shoulder.
Tested positive for COVID; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was tested with COVID 19 a few days post vaccination. The reporter stated that she was not aware about the concomitant medications taken by the patient. The patient was asymptomatic for the event so the details like when he was infected and when he got COVID shot were unknown. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up document was received on 09 Jul 2021 and contains no new information.
Fever, Insomnia, joint ache, libido loss, joint and muscle pain, strength loss, vision problems, fatigue.
Pt came to office on 6/12/15 for DM follow-up and PA ordered pneumococcal conjugate vaccine 13-valent (Prevnar 13) IM vaccine. Vaccine given at 1110. Within 2 hours after receiving the vaccine, pt started experiencing left arm pain described as throbbing and stated pain 10/10 in intensity.  Pt returned to the office on 6/15/2015.  Pt had c/o left upper arm tenderness and muscle spasm.  On exam, there was no redness, warmth or fevers associated.
8 days after the vaccine developed pain, swelling, erythema/ happened on the arm that the injection was; 8 days after the vaccine developed pain, swelling, erythema/ happened on the arm that the injection was; 8 days after the vaccine developed pain, swelling, erythema/ happened on the arm that the injection was; 8 days after the vaccine developed/ mild blistering in the mouth; This is a spontaneous report from a contactable physician. An elderly female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe), via an unspecified route of administration on unspecified date in 2013 (reported as 8-years-ago) (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunisation. The patient's medical history and concomitant medications were not reported. The physician stated he had a patient who has a reaction to a previous non-covid vaccine. 8 years ago the patient had a Prevnar vaccine which shares components. She did not have an immediate reaction and did not have anaphylaxis. 8 days after the vaccine developed pain, swelling, erythema, and mild blistering in the mouth. He asked what does this mean in terms of getting the Pfizer-BioNTech Covid-19 vaccine. Would it be safe to get. He stated it should be considered that this happened on the arm that the injection was and happened at the same time as the blistering. He stated he knows there was no clear cut answer. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Urinary infection; Spontaneous report received on 09DEC2019 via company which was forwarded to Emergent on 10DEC2019.  A pharmacist reported that a female consumer developed urinary infection (PT: Urinary tract infection), while being on oral Vivotif capsule for typhoid. The consumer took two doses of Vivotif and developed urinary infection. The pharmacist advised the consumer to stop taking Vivotif and reported that consumer must start on 5-day antibiotic dosage quickly. Action taken with Vivotif with respect to the reported event was drug discontinued. Outcome of the reported event was unknown at the time of report.  Company Comment: A consumer who took two doses of Vivotif developed urinary infection. The consumer was advised to stop taking Vivotif and to start on five-day course of antibiotic soon. Further details of the event and information on consumer's medical history was limited. Considering the infectious pathogenesis of urinary infection, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer who took two doses of Vivotif developed urinary infection. The consumer was advised to stop taking Vivotif and to start on five day course of antibiotic soon. Further details of the event and information on consumer's medical history was limited. Considering the infectious pathogenesis of urinary infection, the causality of the event is assessed as not related to Vivotif.
No ADR, timing ERROR, 2nd dose given 44 days after 1st Narrative: No ADR, timing ERROR, 2nd dose given 44 days after 1st.
A report has been received from a Health Professional concerning a 7 month old, subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 10-Oct-2013. The outcome of the event of we inadvertently gave FLUMIST quadrivalent to a 7 month old is unknown. The reporter considered the event to be non-serious.
Red swollen left arm, fever, started iwthin 24 hours.  Seen by own doctor given Keflex 250 mg 4x per day and Motrin 800 mg for pain.  Time off work given.
Day 2-4 sore arm, redness at injection site, arm hot to touch, swelling in upper part of the arm Day 10: redness at injection site reappears, arm hot to touch, swelling in upper part of the arm, headaches, upper back pain, chills
Patient fainted after vaccine given and fell from the exam table onto the floor landing  on her left side bumping the left side of her head and left shoulder. An ambulance was called. She quickly regained consciousness after approximately 10 seconds. She was alert and oriented to place, date and her birthday. She was able to move all extremities with 5/5 strength; no misalignment, asymmetry, or  defects noted in head, neck, spine and major joints. She had full range of motion in all extremities and neck . Pupils equal and react to light.  Left side of head above ear  was slightly tender without any defects. Left shoulder  was slightly tender to palpation anteriorly without difficulty with full range of motion. There were no bruises noted.  She denied any difficulty breathing. BP was 88/60 and HR 125. After evaluation and assessment,  patient was stable and the ambulance was cancelled per father's request. Patient remained in clinic  and drank  approximately 8 oz of water without difficulty. Patient's blood pressure  was checked standing after 45 minutes and patient became slightly light headed again. Patient was instructed to  remain in the clinic for 15 more minutes. Patient's blood pressure was re-evaluated and was 84/60 after standing for 2 minutes; she  was asymptomatic and denies feeling like she would faint. HR 100. Discussed signs and symptoms of a concussion, warning signs to monitor (sleepiness, difficulty moving, headache, or vomiting), and  when to go to ER. Father verbalizes understanding. Patient was able to walk out of the clinic with father and brother in a stable condition. Patient instructed to f/u with doctor in two days or ER sooner if worsening
This spontaneous report as received from a pharmacist refers to a 45 year old female patient with allergy to sulfa. The patient's medical history included Mycobacterium avium complex (MAC) infection. The patient's past drug included SULFA. On 25-AUG-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K004148, expiration date: 10-MAY-2015, 0.5 ml, intramuscular in the right upper arm for vaccination). On 25-AUG-2014, the patient experienced adverse effects. By evening of 25-AUG-2014 the patient had body aches, headache, sweats, chills, shortness of breath, fever, right arm swelling. The patient also vomited once. On 26-AUG-2014, the patient sought medical attention by going to the emergency room of a different hospital. Blood work drawn (unspecified date in August 2014) was normal. The patient was diagnosed as severe allergic reaction to PNEUMOVAX 23. It was specified what type of treatment was given and the patient was not hospitalized. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient has autism and severe apraxia as well as sensory integration disorder. Concern is that the number of vaccines administered over the period of time from 3/13/03 (at 2 months of age) to the time of diagnosis (3/05; at 2 years, 2 months) contributed to or triggered his condition. Symptoms include severe deficits in expressive and receptive language, play skills, socialization, and motor planning. Certain signs presented themselves by the first birthday, including decreased attention, little or no gesturing, and lower arousal. Other signs presented before the second birthday, such as delayed expressive/receptive language, poor play stills, avoidance of sensory experiences and febrile seizures.
Temp 102, vomiting & anorexia; 12APR91 temp 99 vomiting & anorexia;
Patient reports that rash started on her head about four days after vaccine was administered. Rash moved to her ears and legs. Today 7/13/2010 reports a headache and dizzy. Encouraged to go see her doctor.
Nasal ulcer; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of NASAL ULCER (Nasal ulcer) and FATIGUE (Tiredness) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) capsule for Chronic lymphoid leukemia.    Concurrent medical conditions included Chronic lymphoid leukemia and Immunodeficiency.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. In 2021, the patient experienced NASAL ULCER (Nasal ulcer) and FATIGUE (Tiredness). At the time of the report, NASAL ULCER (Nasal ulcer) and FATIGUE (Tiredness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: (Negative) Negative.         No concomitant medication provided. Patient had non serious events of sores in both nostrils, did not believe that developed antibodies  From the covid vaccinations due to low immune system and tired with IMBRUVICA (IBRUTINIB).   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.    The reporter's causality for the event(s) of sores in both nostrils, did not believe that developed antibodies from the covid vaccinations due to low immune system onset in 2021 and did not believe that developed  Antibodies from the covid vaccinations due to low immune system onset in 2021 was not provided. The reporter's causality for the event(s) of tired with IMBRUVICA(IBRUTINIB) was a reasonable possibility. No treatment medication 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   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2022: Significant live follow up reporter's causality updated.
My arm started itching  2 days ago and a hot, inflamed rash has formed around the injection site.