chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt returned to the office on 2/5/07. Pt's parents stated that 2-3 days after the immunization the patient had an itchy rash develop on his left buttock, which turned in to open lesions (pap/vesicles) filled with clear fluid
chills/ shivering; aches and pains; pain at injection site; headache; feeling feverish; This case was reported by a consumer via call center representative and described the occurrence of chills in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th June 2019, less than a day after receiving Shingrix, the patient experienced chills, pain, injection site pain, headache and fever. On an unknown date, the outcome of the chills, pain, injection site pain, headache and fever were recovered/resolved.   It was unknown if the reporter considered the chills, pain, injection site pain, headache and fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The patient received Shingrix on left arm. On the same day of vaccination, the patient developed aches and pains, shivering, chills, headache, and pain at the injection site. The patient also felt feverish. The reporter did not give consent to follow up.
body aches; sweats; fever; This case was reported by a physician via sales rep and described the occurrence of general body pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 5 hrs after receiving Shingrix, the patient experienced general body pain, sweating and fever. On an unknown date, the outcome of the general body pain, sweating and fever were recovered/resolved.   It was unknown if the reporter considered the general body pain, sweating and fever to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient experienced body aches, sweats and 105 degree fever 5 hours after receiving her 2nd dose of Shingrix.  The symptoms were resolved the following day. The patient would not had been so concerned by the adverse events because and she would had known they were related to the vaccine.      Lab Comments: On unknown date, body temperature was measured.
Rash/redness over most of body(arms, legs, torso). Started saturday on patients stomach by sunday it was on arms/legs/torso. Patient used an oatmeal bath and benadryl . Rash is clearing up 7/22/19. patient went to urgent care physician they said to continue 24 hours of benadryl and gave the patient a prescription for steroids to use if not cleared up tomorrow (7/23)
Pt got Janssen vaccine 1st dose.  Did not eat all day. Immediately after the dose was given, she had symptoms of pain in the arm, didn't feel good, nausea, had to put her head down as she was clearly in discomfort.  We gave her water, cookies, coldpack on the arm and back of neck.  Took blood pressure and it was 122/80.  15 min later, she was feeling better.  Called a code white in the store.  Manager showed up to file a report and interview pt.  Patient was able to leave on her own without medical attention.
Information has been received from a physician referring to unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with improperly stored dose of RECOMBIVAX HB (lot# L038018, expiration date 13-SEP-2017, dose and route unknown), which were under the temperature of 24 Centigrade degree with time frame reported as 838 hours. The temperature was back in range at the time of the report. No previous temperature excursion was reported. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient returned to clinic on 04/20/22 (2 days following Tdap vaccination for a different vaccine that was needed. Patient showed injection site form Tdap and said she started to notice the red welt the day before 04/19/22.  Provider and pharmacist came to assess the site and decided it was a localized reaction.
Appendicitis - started 3 days after vaccine. Resulted in surgery the 4th day after vaccine.
Headache; Chills; I did not feel well; Pain; This is a spontaneous report from a contactable consumer. An 72 year-old male patient received bnt162b2 (BNT162B2), administration date 18Mar2021 at 14:00 (Lot number: EN6207) at the age of 72 years as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 18Mar2021, outcome "recovered" (19Mar2021), described as "Headache"; CHILLS (non-serious) with onset 18Mar2021, outcome "not recovered", described as "Chills"; MALAISE (non-serious) with onset 18Mar2021, outcome "unknown", described as "I did not feel well"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Pain". Therapeutic measures were taken as a result of headache, pain.  Additional information:  "Well, I got the vaccination at hospital yesterday at around 2 O'clock PM. I am calling about the side effects. Last night I had a headache and chills and I didn't feel well. And I took a Motrin (Treatment) for headache for pain and I am laying down and I still have the chills and they told me if I had the side effects just call someone. When asked for the name of the treatment medication; Consumer stated, "It is Ibuprofen, for pain. When probed if the Ibuprofen helped, consumer stated, "No, I do not have the headache because I took it with some water, plenty of water. I set up in my chair. Consumer was informed about the role of Pfizer drug safety. Email address: Consumer stated, "I don't have email address right now. "I don't have primary doctor because Since advisable, everything took down. The only time I can talk to, I want to, I can talk to doctor the doctor calls me."(Further not clarified hence captured as consumer or other non-HCP). Dose: Consumer stated, "I don't know. They did not give me that. "When confirmed the treatment medication as Ibuprofen, consumer stated, "Yes. "When asked for any help, consumer stated, "Well, what do I have to do now for the side effects. What do I have to do?". Consumer was provided with the number of Pfizer Medical Information as # (Option 3, M-S, 8-8 pm as per EST).  No follow-up attempts are possible. No further information is expected.
Injection went into upper shoulder muscle of left arm there was a little blood that came out, which I, the pharmacist attributed to possibly being from the patient being on aspirin, and then the injection site swelled up to about 1/2 inch above arm patient had no other symptoms than the swelling which was brought down with an ice pack applied for 10 minutes. The patient remained in good health throughout and stated he was fine.  He was counseled to use an ice pack again if swelling came back. Patient was called again at 3 pm for a check in by the pharmacist and stated he was fine and feeling completely normal.
Pt recvd 1st dose of vax 20JUL92 & 15AUG92 pt exp severe low back pain that radiated to upper back; required 4 different MD visits;
1055: Patient in 15 minute observation called for medical with c/o dizziness and diaphoretic. Patient taken to first aid station for further assessment by Physician and EMS on Duty.  Patient denies eating an AM meal. Patient given water 8oz able to drink water without issues. VS: 182/90 patient states that his pressure normally runs high.  EMS on duty rechecked b/p-190/102. Patient requested CBG check once EMS on duty went to take CBG patient "I think were making too much of a fuss" Patient refused further treatment and left AMA.
Paresthesia in bilateral legs 3 days after vaccination; This is a spontaneous report from a contactable physician. A 59-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via intramuscular route of administration on 18Mar2021 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history included anemia, seasonal allergy and sulfonamide allergy. Concomitant medications were not provided. The patient previously took macrobid on unknown date for an unspecified indication and experienced drug allergy. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021, 3 days after vaccination, the patient experienced paresthesia in bilateral legs. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. The clinical outcome of the event paresthesia in bilateral legs was recovered with sequelae on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Child given vaccine that may have had temperature excursion (Data logger failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination. Child had no ill effects thus far
Patient reported to Observation nurse that her "throat felt tight" and was coughing lightly.  When patient was speaking, she statrted to sound a bit hoarse.  Patient was wheelchaired to the observation cot after MBC assessed patient, and vital signs were taken and were WNL.  EpiPen (0.3ml) was adminstered to upper L thigh, and oxygen remained at 98%.  911 was called and when paramedicas arrived, a new set of V/S were taken and report of incident was given to paramedic by MBC.  Patient's husband was then contacted and informed of spouse's condition and instructed to come to the Center to pick up his 2 minor children awaiting outside in car.  MBC was then informed by paramedics that patient was being transferred to Hospital.  Patient left site stating she "felt better" upon discharge.
Shoulder very sore - could not sleep on right side. Next day very tired with headache. Saturday am - splotchy rash on upper arm. Rash slowly moved downwards as day progressed - sore to the touch. Rash still apparent on Monday am but much improved in that soreness has almost gone.
Client was waiting in his vehicle after recieving vaccine. Traffic control came in and stated that someone was honking their horn and that they felt unwell. Nurse went outside and assessed Client; whom stated that he thinks he had fainted and was barely coming to. This nurse popped an ammonia inhalant for client to smell, client became more awake, and was given water and snacks. v/s assessed at 14:50 B/P: 110/62, HR: 73, R:16, O2:93%. Client states that he "this always happens after i recieve any shot." Nurse stayed with client for a few minutes until he stated that he felt better, and his wife came outside to sit her 15 min with him.
The patient did not have an adverse reaction, but received the vaccine 8 days early from the 1st dose, which was on 9/29/21, on day 13. The minimum days to receive the vaccine early per guidelines is 4 days, so he received the vaccine  4 days earlier than recommended. This error was not caught until the vaccine was administered.
Information was received on 31-MAY-2017 from a medical assistant who reported that a female patient (age unknown) received an expired dose of PROQUAD (lot# L046507, expiration 17-MAY-2017) (dose and frequency not reported) on 30-MAY-2017 which was reconstituted with sterile diluent that was not expired. No adverse effects reported. No further information was provided. Additional information has been requested.
No additional AE reported; a dose of Gardasil 9 was administered following a temperature excursion; This spontaneous report has been received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided.  On 19-JUL-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe as prophylaxis (vaccine scheme, route of administration, and anatomical site of vaccination were not reported; lot number T030746 has been verified to be a valid lot number, expiration date reported and established as 16-MAR-2023).  The vaccine was improperly stored at 49.69 degrees Fahrenheit for 1 hour, 24 minutes (product storage error), which was detected by a digital data logger; with no previous temperature excursion. No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T030746; expirationdate: 16-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
pt recvd vax;exp bronchospasms,cont coughing;dx w/ asthma;14apr sudden onset of coughing spasms,throat felt as if it had closed up at that point pt could not even cough & tried;lips turned blue;tremors;irritable,palpitat,lightheaded;predni
Asthma symptoms began the evening of the day of the vaccine.  He required 2 rounds of oral Prednisone to get his asthma symptoms under control over the 2 weeks following the vaccine.  He also required daily oral allergy medication and frequent doses of Albuterol.  He also developed hives 1 week following the vaccine.
Patient didn't get the flu until recieved the shot; Patient got very ill after flu shot; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case is linked to cases 2020SA346017, 2020SA346068, 2020SA297294, 2020SA297267 and 2020SA273251 (same reporter).   This case involves patient[ age and gender unspecified] who didn't get the flu until received the shot (Influenza) and got very ill after flu shot (Illness), while patient received vaccines PNEUMOCOCCAL VACCINE [Pneumonia shot] and INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect PNEUMOCOCCAL VACCINE (not produced by Sanofi Pasteur) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) and got very ill after flu shot (unknown latency) following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  No laboratory data reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for events.  There will be no information on the batch number for this case.  Follow up information was received on 10-Nov-2020, from a consumer.    New event (ill), suspect PNEUMOCOCCAL shot was updated in field and narrative.
Rheumatoid Arthritis Flare; Fatigue; Chills; Low grade fever; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4227695-00.  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Apr2021 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single and intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid Arthritis Flare"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "Fatigue"; CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "Chills"; PYREXIA (non-serious) with onset Apr2021, outcome "unknown", described as "Low grade fever". The action taken for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Chills, Fatigue, Rheumatoid arthritis flare up and Low grade fever was not provided. Since no determination has been received, the case is managed based on the company causality assessment.  PFIZER BIONTECH COVID-19 VACCINE: The reporter causality for the event chills, fatigue and low grade fever was reported as possible and for event Rheumatoid arthritis flare up was not reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the events Fatigue, Pyrexia, Chills, Rheumatoid arthritis and the suspect drug BNT162B2. 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
Fully vaccinated patient admitted for COVID.  Provider discharge summary below:  "Presented with 8/30 with worsening shortness of breath and chest discomfort following testing positive for COVID-19 on 8/25. He was vaccinated against COVID-19 with the Pfizer series on 5/3 and 5/28. He was admitted and started on oxygen and completed 5 days of remdesivir and a steroid course. Bilateral PE were found on CTA pulm on 9/5/21 and heparin was started. He continued to worsen despite HiFlo and NIPPV. He required intubation and transfer to CCU on 9/13, and started on pressors for support. CCU course was complicated by ARDS, shock, AKI and anuria requiring CRRT (managed by nephology), metabolic acidosis, liver failure, as well as acute blood loss anemia from a rectus sheath bleed causing an abdominal wall hematoma that required 1U pRBC and an abdominal binder. He was found with Serratia odorifera, Enterobacter cloacae on respiratory cultures suggesting aspiration pneumonia. HSV was detected on skin culture. Staph simulans that grew on one blood culture was deemed a contaminant. He received vancomycin, Zosyn, meropenem, metronidazole, acyclovir with antibiotic management guided by Infectious disease. ENT performed a biopsy of an ulcer of his left nare on 9/25, but pathology was pending at time of discharge. Patient did not improve despite treatment and had persistent respiratory acidosis and required maximum vasopressin and norephinephrine support. Palliative care was consulted and the grim prognosis of the patient communicated to family given his multiple organ failure. Patient was switched to comfort care status per family on 10/3/21. Patient died at 3:45 PM on October, 3, 2021."
The pharmacist, gave patient 0.3mL rather than 0.5mL. He realized his mistake later in the day and called the patient who came back in and patient gave the remaining 0.2mL.
03/08/2012 - Facial swelling one day after vaccine given - seen by dr prescribed ORAPRED 3 ml qd x's 4 days and ZYRTEC 5 mg/5 ml 2.5 ml q-day. 03/09/12 - Facial swelling resolved per dr.
This spontaneous report was received from a nurse who was also the patient's mother and refers to a currently 21 year old patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in 2009, patient's approximate age 12 years, the patient was vaccinated with GARDASIL dose one for and on an unspecified date in 2010, was vaccinated with GARDASIL second dose (strength, route of administration, anatomical location, lot number and expiration date were not reported for any of the administered doses) both for prophylaxis. On an unspecified date in 2018, the patient was vaccinated with GARDASIL 9 dose one (strength, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis as a third dose to finished the series. No adverse effects were reported. As of 23-APR-2018, an unspecified health care professional contacted during telephone follow-up could not supply information regarding this case. Additional information has been requested.
my first shot hurts; had flu like symptoms for a couple of days; low grade fever; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms and fever. On an unknown date, the outcome of the injection site pain and fever were unknown and the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The first short of vaccine hurt's the patient and had flu like symptoms for a couple of days plus a low grade fever. The follow up was not required. This is 1 of the 3 linked cases reported by the same reporter.
Pt recvd MMR vax 8FEB91 & on 25MAR91 recvd measles vax & PPD which was neg; On 9APR91 pt devel itchy rash; following day rash was blotchy & red all over & eyelids were pink & swollen; pt given DPH & Hismanal, & Zantac;
More tired than usual; This is a spontaneous report received from a contactable. This consumer (Patients Mother) reported for a female patient (Reporters Daughter).  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Jun2021 as single dose for covid-19 immunisation Pharmacy. The patient medical history and concomitant medications were not reported. Patient's historical vaccine includes first dose of BNT162B2 via an unspecified route of administration on unspecified date for COVID-19 Immunization and experienced no reaction. Patients Mother states, her daughter got the second one, the Pfizer, her daughter was more tired than usual on unspecified date in 2021, but she okay now, her daughter got the second shot at the same time as the caller got her first one on 15Jun2021. The outcome of the event was reported as resolved on unspecified date in 2021.  Information on batch/lot number has been requested.
States after receiving flu vaccine 10/23/14 developed generalized itching, voice hoarseness and difficulty breathing.
Patient was mistakenly adminstered a Fluad vaccine instead of Fluarix. He is under 65 and the prescription was typed and billed for the correct vaccine but the incorrect one was given.   This error was discovered after the patient left on 9/25/21. I spoke to patient on 9/26/21 and informed him of the error. I described the differences between the two vaccines and that he should not expect any side effects different than that of the standard flu vaccine he was intended to receive. I corrected his prescription records and MCIR to match the immunization he received (Fluad).