chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Urticarial rash 4/23/03; tx with Benadryl/Pepcid then 50-100 mg qd Atarax/Pepcid 10 mg bid.  Pt did not follow instructions and took 100 mg Atarax q6h x 3 days to improve symptoms; then attempting to "wean" self off meds over weekend.  On 4/27/03 at 9 PM pt reports return of pruritis and took 100mg Atarax.   Pt instructed not to take additional meds - oatmeal bath and ice packs on "achy" feet advised.  4/28/03:  pt seen at emp health for take check - still reports pruritis at site, achy feet, 1 urticarial lesion; called provider line later in day to c/o achy back, arms, joints but reported full motion of joints.  4/29/03: called to report temp 99.7 at 1700, tx with 1000 mg tylenol; at 1845 temp 100.7 and reported painful throat and difficulty breathing.  Sent to local ED where temp 37 noted; nl cbc with wbc of 4.7 noted; nl electrolytes, no urticarial or other rashes, neg rapid strep and neg mono.  Given IV fluids s/p c/o watery diarrhea, antiemetics, and narcotic pain meds; d/c on Tyl #3 elixir with dx viral syndrome.
pt recv 1st vax; in eve exp muscle cramps in both lower extremities;recovered next am;recv 2nd dose,exp leg cramps;pt recovered;recv 3rd dose w/o incident;subsequent booster doses 4 & 5 on 1apr94 & 12may94;titers on may94 anti-HBs neg;
She developed chicken pox w/ fever & cutaneous lesions on 11/15/11.
The vaccine was from Johnson and Johnson. It wasn't listed on your drop-down. He was diagnosed with myocarditis on August 10, 2021.
kicked me like a mule; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 24Sep2021 (Batch/Lot number: unknown) at the age of 73 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: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "kicked me like a mule".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
TOOK ONLY TWO DOSES OF VIVOTIF; This spontaneous case report (PVX2019-1778) was received from a nurse on 10-Jul-2019. It describes a female consumer who "took only two doses of Vivotif", while being on Vivotif for an unknown indication.  Case report: The consumer took only two doses of Vivotif two weeks ago, and then did not take the rest doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took only two doses of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only two doses of Vivotif" was considered as not applicable.
Patient's wife called pharmacy to inquire about adverse reactions from vaccines.  Patient felt dizziness, unsteadiness upon standing, ache and pain, low grade fever, increase in blood pressure (163/91 and 161/90), and fast pulse (107 and 109).  Informed patient to call 911, patient states they will contact their primary care doctor.
PATIENT WAS SCREENED FOR COVID-19 VACCINE DOSE #2. PATIENT WAS ADMINISTERED VACCINE AT 9:03 AM AND ABOUT A MINUTE AFTER RECEIVING VACCINATION THE PATIENT PASSED OUT (BLACKED OUT)  FOR A BRIEF SECOND AND THEN CAME BACK. PATIENT WAS TALKING NORMALLY AND HAD NO SOB. 911 WAS NOT CALLED,  PATIENT THEN STAYED IN OBSERVATION AREA FOR 20 MINTUES AND AT THAT TIME PATIENT STATED THEY WERE FEELING BETTER. BOTH MOTHER AND DAUGTHER LEFT PHARMACY AFTER THAT. I ADVISED TO SEEK MEDICAL ATTENTION IF SYMTPOMS CAME BACK.
headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information not provided   Reporter did not allow further contact
I had running nose and fatigue. I also had diarrhea and coughing. These lasted for about 2 months. On Jan 24th, I tested positive for COVID-19.
pt recvd vax 24MAR93 & 5PM that day parents states pt had fever of 102.8; gave APAP then & through the noc q 4 hrs; pt had malaise, red rash & irritable;
This spontaneous report as received from a physician, via company representative, refers to a 70 year old female report. On approximately 30-AUG-2013 (reported as one week ago), the patient was vaccinated with ZOSTAVAX (dose, route and lot umber were not reported). Concomitant medications were not reported. The physician reported that the patient developed blisters on her feet and lower legs, about one week after being vaccinated with ZOSTAVAX, on approximately 06-SEP-2013. The patient was treated with a cream (unspecified). The outcome of blisters on her feet and lower legs was reported as recovering/resolving. Patient had a office visit on an unknown date. The relationship between ZOSTAVAX and the blisters was not reported. Additional information is not expected.
Lethargic; Cannot eat; I've been laying down all day; Extremely tired/tired/worn out/fatigued; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), DECREASED APPETITE (Cannot eat), SOMNOLENCE (I've been laying down all day) and FATIGUE (Extremely tired/tired/worn out/fatigued) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 023M20A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced LETHARGY (Lethargic), DECREASED APPETITE (Cannot eat), SOMNOLENCE (I've been laying down all day) and FATIGUE (Extremely tired/tired/worn out/fatigued). At the time of the report, LETHARGY (Lethargic), DECREASED APPETITE (Cannot eat), SOMNOLENCE (I've been laying down all day) and FATIGUE (Extremely tired/tired/worn out/fatigued) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported
approx 15 mins post injection client's mother states client is not feeling well. Eval'd client, c/o mild nausea and "throat feels a little scratchy"  denies any other s/s.  v/s remained stable throughout, Administered 5mg of Zyrtec to client, observed for another 30 mins, client states "feeling normal as always now" discharged from site, in stable condition.
Hepatitis B #3 vaccine given on 4-29-09. Pt. c/o swelling and redness of (L) arm where injection given on 4-30-09. Pt. stated on 5-1-09 that redness was better but swelling was worse. No c/o numbness, itching, swelling of face, etc. Advised BENADRYL 50 mg q 4g 16, elevate and call with new Sx PCP notified.
This case was reported by a health professional and described the occurrence of incorrect storage of drug in an 37-year-old female patient who received ENGERIX B (batch number 995J5, expiry date 6th February 2017). On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Patient got ENGERIX B which was not stable. No AE reported.
injection site warm; slightly red; injection site itchiness; swelling arm; my arm hurt; A spontaneous report was received from a 60 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced peripheral swelling (swelling arm), injection site warmth (injection site warm), injection site pruritus (injection site itchiness), injection site pain (my arm hurt), and injection site erythema (slightly red).  The patient's medical history was not provided. The concomitant medications included amlodipine besylate.  On 12-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 13-Jan-2021, a day after receiving the first dose of the vaccine, the patient experienced pain and swelling in the arm. On 18-Jan-2021, the patient had experienced itching. On 19-Jan-2021, it was known that the patient's arm had swelled up again, was red and tender, and hot to touch. On 22-Jan-2021, the redness in arm had decreased although feeling of warmth on touch was persisting. On 26-Jan-2021, slight redness was observed in the arm without any swelling and warmth on touch, though little itchiness was still persisting at the time of the report.  Treatment information included application of ice packs, and hydrocortisone cream.  Action taken with mRNA-1273 was unknown.  The outcome of the events, peripheral swelling (swelling arm), injection site warmth (injection site warm), injection site pain (my arm hurt), was considered as recovered/resolved and for the events injection site pruritus (injection site itchiness), injection site erythema (slightly red), was unknown.
Client developed fever and hives approximately 1 week after immunizations given. Client was seen by private physician and Decadron Elixir and Benadryl was prescribed. Hives lasted approximately 4 days, then faded away.
Patient received Td on 04/04/2008.  Wife called on 04/07/2008 and stated client had fever and chills over the weekend.  Temperature under 101 degrees, B/P 210/98 04/05/2008.  Checked on 04/07/08 120/68.
First attempt of jynneos vaccine given in right foearm with no elevation of the skin or wheal present after administering.  Second dose attempt of jynneos in left forearm with a wheal formed.
I assumed I had bronchitis shortly after getting the first shot. I'd seen my doctor and was given prednisone. I continued to have brochial  symptoms that have not let up for at least 3 months.  I have constant coughing spasms which become constant when in a lying position.   I was also given an antibiotic during the last few months by my PCP.  I kept thinking it was bronchitis, allergies, the pollen.  But this is really getting scary. My friends and family are noticing it now. I can't talk to anyone too long. I've had to take time out of work.  I had a breast reduction scheduled. I mentioned all of this to the surgeon and he didn't seem concerned, but again, I thought it was related to bronchitis.  I had my surgery. My breathing was very poor after the surgery and for at least a week. I couldn't get a breathometer up  even a quarter of the way. I have constant wheezing when I exhale.  I never had a breathing problem like this before. My PCP referred me to a lung specialist, but I haven't an appt until July. I haven't smoked a cigarette in over 40 years.  This is getting very scary and worrisome for me.
30 MINUTES AFTER INJECTION PATIENT NOTED HIVES ALL OVER HER BODY. 15 MINUTES LATER SHE HAD A SORE THROAT AND WAS VERY HOARSE. SHE RETURNED TO PHARMACY AT 3:45PM AND TOOK 25 MG OF BENADRYL AND WENT TO EMERGENCY CARE CLINIC WHERE SHE WAS GIVEN A STEROID SHOT AND A PRESCRIPTION FOR ORAL STEROIDS.
lightheaded, L. arm, tingle, knot in throat w/ swallow only.   pt is in no acute distress.  waited additional 15 mins. w/ improvement.  pt. declined additional medical care and EMS.
Patient called on 11/16/2022 around 12:15 pm saying that he has swollen lower lip which he noticed 11/16/2022 morning and he thinks it is due to getting the pneumonia vaccine (Prevnar 20) on 11/11/2022. Recommended the patient to see the doctor.
08/28/22 presents to EC ED for "Synocope". PMHx of "falls with intracranial hemorrhage, CVA, CAD, and orthostatic hypotension"
This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 50-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number 5R3J5, expiry date 30th June 2019) for prophylaxis.  On 28th August 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular). On 31st August 2018, 3 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site swelling, injection site itching, fever, feeling unwell, injection site discoloration and injection site pain. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the injection site swelling, injection site itching, fever, feeling unwell, injection site discoloration and injection site pain were not recovered/not resolved. The reporter considered the injection site swelling, injection site itching, fever, feeling unwell, injection site discoloration and injection site pain to be possibly related to FLUARIX QUADRIVALENT  2018-2019 season. Additional details were provided as follows: This case was reported by a certified medical assistant (CMA). The patient received a dose of FLUARIX QUADRIVALENT 2018-2019 season vaccine in the left arm. Beginning 3 days after receiving the vaccine, the patient began to experience swelling, pain, itching, and discoloration at the injection site. The patient additionally felt sick and was feverish. As treatment, the patient was prescribed an antibiotic, and the reported events remained ongoing at the time of the report.
This spontaneous report as received from a licensed practical nurse refers to an unspecified amount of patients (demographics unknown). On an unknown date, the patients were vaccinated with GARDASIL (dose, route and lot number were not reported). Concomitant medication was not reported. On unknown dates, the patients received their GARDASIL series off schedule. No adverse effect reported. This is one of two cases from the same reporter (MARRS# 1402USA008471). Additional information has been requested.
HCP called to report that the patient was given PROQUAD instead of MMR II. The PROQUAD also suffered from a non supported temperature excursion. TE cases 02418202, 02418066.  HCP states they do not wish to be contacted about this and declines  any fo; Improper storage of product in use; No Adverse Event; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-JUN-2023, the patient was vaccinated with the dose of improper storage measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin), (PROQUAD) lot #W029552, expiration date: 14-MAR-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (wrong product administered).  Administered dose of vaccine was exposed to the temperature excursion of 8 degrees Celsius for 2160 hours (improper storage of product in use). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).
Fever (101); Extreme lethargy; Entire body ached; Headache (forehead)/Persistent sharp ache back of head; Persistent sharp ache back of neck; This is a spontaneous report received from a non-contactable consumer, the patient. A 55-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in his left arm on 24Mar2021 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroid and obese. Concomitant medications and medications within 2 weeks of vaccination included Multivitamin (MANUFACTURER UNKNOWN), Levothyroxine (MANUFACTURER UNKNOWN), Fish oil (MANUFACTURER UNKNOWN) and Magnesium (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in his left arm on 04Mar2021 at 13:30 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. The patient did not have a history of allergies to medications, food or other products. The patient had not received other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested for COVID-19. The patient had not diagnosed with COVID-19 prior to vaccination. On 25Mar2021 at 09:00, the patient experienced fever (101), extreme lethargy, entire body ached, headache (forehead), persistent sharp ache back of head and neck, no loss of appetite, stayed in bed entire day on 25Mar and woke the following day and felt fine on 26Mar. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. On an unspecified date, the patient underwent body temperature recording and the result was fever 101. The clinical outcomes for the events fever (101), extreme lethargy, entire body ached, headache (forehead), persistent sharp ache back of head and neck was recovered on 26Mar2021.   No follow-up attempts are needed. No further information is expected.
Started as small bumps on hands and then developed into a rash on both hands.  Rash is also located on right upper arms and both thighs with itching.
Initial report received from a consumer on 16 OCTOBER 2012. A 55-year-old female patient had received an intramuscular dose of FLUZONE HD in the right arm region on 12 OCTOBER 2012 (lot no not reported). The patient had no illness at the time of vaccination, however she had medical history of Tetracycline allergies, Valium rash, fast heart rate and history of Mitral Value prolapse. The patient had no reported concomitant medications. It was stated that on 12 OCTOBER 2012 the patient requested for FLUZONE std. vaccine but was administered FLUZONE HD and she immediately had a sore arm and tingling in her legs. She also experienced headache in the evening. On the same day i.e. on 12 OCTOBER 2012 she had body ache and general malaise. Lab details were not reported. As corrective measure she received Ibuprofen. Outcome of the events was reported as not resolved at the time of report. List of documents  held by sender: none.
stroke-like symptoms; her arm went numb/her face went numb; fire burning through her body; her head feels like her brain was laying dead and her brain feels to her like deadweight; This is a spontaneous report from a contactable consumer. A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm (unsure if right or left arm) on 02Aug2021 at 17:00 (Lot Number: FC3180, at the age of 45-year-old) as single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. There were no prior vaccinations (within 4 weeks). Patient took the 1st dose of the vaccine 9 days ago (on 02Aug2021 at 17:00) and 5 minutes after taking the vaccine (on 02Aug2021 at 17:05) her arm went numb and she had been going back and forth to the emergency rooms for the past couple of days; the patient had stroke-like symptoms, her face went numb along with something she described like fire burning through her body and her head felt like her brain was laying dead and her brain felt to her like deadweight. The patient had been going back and forth to different emergency rooms and had several records to show it and her other healthcare professional primary care did all a bunch of blood tests and nothing had come back so far out of the ordinary. The patient kept having the symptoms since she took the Pfizer COVID Vaccine. The patient was in excellent shape and had no health issues in the past before and took the Pfizer COVID vaccine at 5:00pm and by 5:05pm started having the symptoms and by 5:30pm was in the emergency room and it had been that way since then. When she laid down for an extended period of time sometimes it calmed down a little bit regarding her symptoms and then when she got up or started moving or any movement the symptoms kick back in so she had been laying down since then. The patient had been to the emergency room three times in a few days and had hospital visits and then clarified she had not had an overnight stay in the hospital but they pulled her blood and did computerised tomogram (CT) scans and magnetic resonance imaging (MRI) and they were there 6, 7, or 8 hours and then were back home and then went back to the same place but he did not have the additional dates of the emergency room dates to provide. The blood work, CT scans and MRI on Aug2021 that everything came back normal and nothing out of the ordinary and she was in perfect shape before this and takes no medications. The adverse events require a visit to emergency room and physician office. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
?Janssen COVID-19 Vaccine EUA?  Severe shoulder pain at injection site in muscle and joint that has worsened over time. Currently unable to sleep because of pain.
STEEP DECLINE IN EFFICACY, FROM 88% (MARCH 2021) TO 3% (AUGUST 2021); This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced steep decline in efficacy, from 88% (march 2021) to 3% (august 2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of steep decline in efficacy, from 88% (march 2021) to 3% (august 2021) was not reported. This report was non-serious. This report is associated with product quality complaint: 90000199748.
Follow up: Patient received casirivimab instead of intended COVID vaccine.  48-hr follow revealed patient experienced little bit of arm soreness. Patient received COVID vaccine on December 31