chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the influenza vaccine 10/23/07 in the afternoon. Had no problems until she woke up the next morning with erythematous rash to her axillae, trunk, abdomen, ears and right foot. Her right foot was swollen to the extent that her shoe had to be removed. She had no breathing difficulties and her vitals were BP 124/86 P 71 respiratory rate 18. Her only c/o was itching. She was sent toDr.'s office for evaluation and treatment. She was given a steroid injction, zyrtec and a medrol dose pack. She called in this morning (10/25/2007)to report that all of her symptoms were resolved except her Right foot which remains swollen and painful. She was instructed to start the medrol dose pack (Dr. told her to begin that today if her symptoms were not resolved.
Severe muscle aches, stiffness for more than three weeks and counting.  Using heat, cold, exercise, stretching to try to alleviate pain.  Taking Advil and Tylenol also.
On the two people who died, one in (State name) and one in (State name); This is a spontaneous report from a contactable other HCP. This other HCP reported similar events for 2 patients. This is 1 of 2 report.   An unknown age male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecific date at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. It was reported that patient was died. Cause of death unknown. Outcome of the event was fatal.  Information on the lot/batch number has been requested.; Sender's Comments: Death with unknown cause is considered related to BNT162B2 for reporting purpose.  Information is very limited.  Case will be reassessed once receiving additional information, including cause of death. 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.,Linked Report(s) : US-PFIZER INC-2021102049 same reporter/drug/event, different patient; Reported Cause(s) of Death: On the two people who died, one in (State name) and one in (State name)
Was exposed to someone positive and then 2 days later tested positive; Was exposed to someone positive and then 2 days later tested positive; Was exposed to someone positive and then 2 days later tested positive; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first COVID-19 vaccine last week in Dec2020, then was exposed to someone positive and then 2 days later, patient tested positive. Reporter inquired whether they can vaccinate patient on schedule 3 weeks after the first dose or if they have to wait 90 days. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: 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.
BODY ACHES; HEADACHE; FEVER; This spontaneous report was received from a consumer, and concerned a female patient of an unspecified age. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. We are unable to perform follow-up to request the batch numbers. On 05-MAR-2021, the patient experienced body aches, headache, and fever.  The husband called to report his wife had fever, body aches, and a headache after administration with the Janssen Covid-19 vaccine. Action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 06-MAR-2021, and had not recovered from body aches, and headache. The reporter considered the causality between the events (body aches, headache, and fever) and Covid-19 vaccine ad26.cov2.s as related. This report was non-serious.
TOOK VIVOTIF ON DAYS 1, 3, AND 4; This spontaneous case report (PVX2019-2565) was received from a nurse on 14-Oct-2019. It described a female consumer who "took Vivotif on days 1, 3, and 4" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer did not take Vivotif according to schedule. She took the third dose on day 4.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took Vivotif on days 1, 3, and 4" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif on days 1, 3, and 4" was considered as not applicable.
One hour post vax, pt complained of flu-like symptoms, nausea, vomiting, body aches and fever lasting for 24 hours.
Patient presented to office with pain, redness and swelling at the injection site. Advised cold/heat compresses, Tylenol, topical hydrocortisone cream and arm elevation.
Injection site indurated, hot, red with redness, swelling and heat 2-3" below injection site (left deltoid). Dx: Reaction to vaccine.
Severe muscle soreness at injection site, applied ice pack for several hours day of shot. Soreness persisted for several days. Severe side effects the night of the injection; woke up around midnight with high fever, violent shivering from chills, put on several layers of flannel night clothes and several blankets and went back to bed. Symptoms subsided by morning. However, ever since getting the shot, I have had a bad ear ache and pain in the neck on the side of the injection, and a mild sore throat. Still have it. May be coincidental?
Patient had 3-4 linear vescicles with red base appear on upper posterior deltoid about 2 days after injection to opposit (left) arm.  Resolved on own; however, slightly reddened area still visible at 2 month revaccination.
Vomiting; GI issues; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number AS5RM, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th August 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 28th August 2022, less than a day after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vomiting and gastrointestinal disorder. On an unknown date, the outcome of the vomiting and gastrointestinal disorder were unknown.   It was unknown if the reporter considered the vomiting and gastrointestinal disorder to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-SEP-2022 Reporter's Comment:  The patient received Fluarix vaccine and had vomiting and gastrointestinal(GI) issues later that evening. It was related to the patient. This was an after hours voicemail left on 24th September 2022 at 13:29 EST, received on 26th September 2022. A call was made one call back attempt to the caller to get more details, and also a voicemail was left that would probably call her for more information since all she left was a phone number. Do not know if the reporter was a healthcare professional or consumer. Follow-up would not possible as no contact details were available.
Child's leg (left anteriolateral thigh) began to swell and was hot to touch the day following vaccination. Child was brought to HD on 11/16/00. The area observed on that date was swollen approx. the diameter of a baseball, hot and tender to touch and covered with a rash. Nurse referred pt to doctor. Doctor advised that the area was infected and prescribed an oral antibiotic and topical cream.
Information has been received from a nurse concerning her daughter who in August 2008, was vaccinated with the first dose of GARDASIL and it was painful. It was unknown if the patient sought medical attention. The patient's outcome was unknown. Additional information has been requested.
were given expired pentacel vaccinations with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional and physician via medical information (Reference number- 00669898) and transmitted to Sanofi on 06-Jul-2021.  This case is linked with 2021SA225602.  This case involves an infant patient (gender not reported) who received expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccinations (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 05-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number: UJ325AA, expiry date not reported] via an intramuscular route at right thigh for prophylactic vaccination (expired product administered) (latency: on the same day).  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  It was reported that "Medical assistant calling to report that (3) patients were given expired PENTACEL vaccinations on 5Jul2021. Caller stated that all the vaccines were given intramuscularly in the right thigh. linked to case : 2021SA225602 and linked to Inquiry Number: 00669898 Case created for 2nd patient It is unknown if the patient experienced any additional symptoms/events."  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.; Sender's Comments:  US-SA-2021SA225602:  00669898:
Initially on waking in the morning, pt was unable to lift arm away from side,  and so could not reach her head to do her hair. Injection location was still visibly swollen and tender to palpation from evening before. Passive range of motion was also limited due to pain. Pt had no issues with range of motion of elbow, and strength in arm and hand was 5/5.   1 hour after waking Pt took 1000mg of acetaminophen for the pain.  1-2 hours after waking, pt began experiencing stiff muscles through out her body, followed by intermittent uncontrollable stretching of arms, legs, and back at various times for different locations. These sensations persisted for 2 hours.   4 hours after waking, pt felt a chill sweep over her body. Pt also had a significant increase in benign essential tremor in her hands. Stiff muscles abated, uncontrolled stretching lessened but did not resolve, chills persisted. Pt took temperature via tympanic membrane: 99.6 F  5-6 hours after waking, pt was still shivering, still had a temperature of 99.6 F. Pt could no longer participate in her daily computer work. She fell asleep for an hour. On waking, her essential tremor had returned to normal and urges to stretch had significantly lessened, but pt had chills and temperature of 99.6 F.   8 hours after waking, pt symptoms returned to her early morning symptoms. Shivering stop, but pt still felt cold and had occasional stretching needs. Arm still unable to be lifted over head, injection site still swollen.
Hospitalization for COVID 19 pneumonia in a patient with 2 COVID vaccines and one booster
His arm was sore at the injection site; This is a Spontaneous report from non-contactable consumer (patient), received via a Pfizer sponsored program t.  A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch No: Unknown), via an unspecified route on 24Jan 2021 fas 1st dose single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had not taken any other vaccination prior to COVID-19 vaccination. On 24Jan2021, the patient experienced (later that night) his arm was sore at the injection site. On the same day after getting the vaccine, the patient did take Tylenol when he got home that evening before bed to ease the pain in his sore arm as he thought while sleep on his arm at night it might hurt. On 25Jan2021 (next day), the sore at the injection site was gone. The soreness at the injection site was completely normal. Then he woke up and felt great and had no issues. His arm did not bother him much at all. He never had problems with shots, he took shot because of his age and stated that he will be having other vaccinations coming up, other than the second dose of the vaccine. The patient queried to double check if it is okay to get other vaccinations after getting the COVID shot. The outcome of the event sore at the injection site was recovered on 25Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
none of them actually prevent getting the disease/ hospitalized after second dose; Suspected vaccination failure/ none of them actually prevent getting the disease/ hospitalized after second dose; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   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 (serious criteria hospitalization). 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 Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that new mRNA jabs had a whole list of adverse side effects. The three people whom reporter knew where hospitalized after receiving their second dose of Shingles jabs. The reporter reported that none of them actually prevent getting the disease. The reporter also mentioned that Flu vaccine was still only 40 to 60 percent effective. This was 1 of 3 linked cases reported by same reporter for different patients. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR156120:Same reporter US-GSK-US2022AMR156126:Same reporter US-GSK-US2022AMR156128:Same reporter (Case deleted, case created in error) US-GSK-US2022AMR156129:Same reporter (Case deleted, case created in error)
Fever; Chills; Tiredness; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Nov2021 18:45 (Lot number: FK5127) at the age of 11 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Influenza vaccine, administration date: 08Oct2021, for Influenza immunisation; Meningococcal vaccine (Meningococcal MCV4P), administration date: 08Oct2021, for Meningococcal Immunisation; Hpv vaccine, administration date: 08Oct2021, for HPV immunisation; Tdap vaccine, administration date: 08Oct2021, for Teatanus . The following information was reported: PYREXIA (non-serious) with onset 09Nov2021 10:00, outcome "recovered" (Nov2021), described as "Fever"; CHILLS (non-serious) with onset 09Nov2021 10:00, outcome "recovered" (Nov2021), described as "Chills"; FATIGUE (non-serious) with onset 09Nov2021 10:00, outcome "recovered" (Nov2021), described as "Tiredness"; VOMITING (non-serious) with onset 09Nov2021 10:00, outcome "recovered" (Nov2021), described as "Vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, fatigue, vomiting.  Additional information: Patient had no known allergies. Patient was not diagnosed with COVID-19, prior to vaccination. On 09Nov2021 (since the vaccination), patient had been tested for COVID-19 via nasal swab (BinaxNow), result was negative.  No follow-up attempts are possible. No further information is expected.
felt like had a bad flu, fever chills, sore, swollen, red arm. body aches.. treatment a few tylenol and went to bed stayed in bed all night and all day
Began getting body aches, and nausea about 10 pm on same evening, then diarrhea  by early morning.  Lasted until late Sunday 2 days later.
Information has been received for diphtheria toxoid (+) hepatitis B vaccine recombinant (+) pertussis vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX) vaccine. On an unspecified date, an infant was vaccinated with a dose of Haemophilus B conjugate vaccine. Concomitant therapy included a dose of diphtheria toxoid (+) hepatitis B vaccine recombinant (+) pertussis vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX) (lot # 21881C9). At an uknown time post-immunization, the patient developed a fever of 102 to 104 degrees F, irritability, and inconsolable crying. The patient was seen by the physician. The patient recovered after an unspecified period of time. This was originally reported by a physician. Additional information has been requested.
This is a spontaneous report from a Pfizer-sponsored program received from a contactable physician reporting for the daughter. A 19-year-old female patient of unspecified race/ethnicity received the 2nd dose of TRUMENBA, via an unspecified route of administration, on 11Sep2017, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. Previously the patient received the 1st dose of TRUMENBA on 06Jan2017 for immunisation and experienced redness, swelling, pain, malaise, headache, nausea, dizziness, fever, muscle and joint ache, diarrhea. The patient experienced redness, malaise, nausea and mild dizziness all on unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017542939 Same reporter/patient/product, different events separated in time.
Pt experienced a fetal demise at 24 weeks 4 days.  Had small abnormalities of placental structure noted on 20 week ultrasound.  Timing of first dose of Moderna was within days of conception and second dose Moderna was 06/11/2021 would have been around 4 weeks pregnancy.  Also received  INFLUENZA PF, QUADRIVALENT while pregnant on 10/14/2021
Patient called complaining of redness from injection site to elbow. She also stated becoming nauseated. It is her right arm affected from PNEUMOVAX.
Rigors with extreme body pain.  Internal organs felt inflamed, left hip, neck and shoulder pain persisted.  Raynaud's flare up.   After April 20th, I had severe leg pain and chest pain, with continues arm and shoulder pain, throbbing in the backs of my thighs and down into my calf - all left side oriented.  I developed numbness and tingling into my left hand and acute pain in my left arm.  My shoulder became frozen after many months of pain.  By May/June, I had developed a indentation in my left thigh muscle that was very painful and warm to the touch.  I still had severe left hip pain and shoulder pain as well.  Blistering started to occur on my skin at the left hip and back of shoulder blade.
Case was reversioned to correct age at time of vaccination. Information regarding PREVNAR was received from a healthcare professional regarding a 25-month-old female patient who experienced streptococcus pneumoniae septicemia, Streptococcus pneumoniae empyema and Streptococcus pneumoniae pneumonia. At 15 months of age, the patient received the fourth dose on 04-Feb-2009. On 29-Nov-2009 the patient experienced streptococcus pneumoniae septicemia, Streptococcus pneumoniae empyema and Streptococcus pneumoniae pneumonia. These events either required or prolonged hospitalization and were reported as immediately life-threatening. The patient was treated with vancomycin, ceftriaxone, chest-tube and lung decortication. It is unknown if serotype testing was performed. Outcome of the events was not reported and no additional information was available at the time of the report.
Right upper arm with swelling, erythema 10x12cm. Pt c/o mild pruritus. Patient treated with Benadryl.
Developed redness, pain and swelling at injection site approx. 48 hrs after receiving VARIVAX. Seen by NP in ED - Red. Abx x 10d.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. The patient's relevant medical history and past drug history were unknown. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported). Other concomitant medications were not reported. The pharmacist reported a patient, while in the pharmacy, mentioned she had been administered a dose of ZOSTAVAX on an unspecified date and was subsequently diagnosed with shingles. The outcome of the event was not reported. Reporter's causality of therapy to adverse event was not provided. Additional information has been requested.
Pain at injection site returned after initially resolving (first noticed on day 6 and ongoing). Soreness when raising arm returned after initially resolving (first noticed on day 6 and ongoing). Hard lump at injection site (day 6, resolved after a day). Swollen axillary lymph node (first noticed around day 4 or 5 and ongoing).  Itchy, spreading, red rash (first noticed on day 9).
Day 2 - January 14 - woke up with a headache at 9am.  Headache went away by 11am but I felt a great deal of fatigue and just wanted to lay down the rest of the day.  Jan 15- woke up and felt better.  By noon I was feeling very fatigued again.  Jan 16 - 20 - fatigued, weak, and brain fogged. Slept a lot.  Jan 14-20 - had spotting which never happens.  I was on day 10 of my cycle on Jan 14.  Today is Jan 21 and I?m feeling better after taking a monolaurin supplement that treats chronic fatigue.