chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial case was retrieved from the scientific literature on 31 May 2010. A 31-year-old female patient, with a medical history of metrorrhagia, received an injection (route and site not provided) of Yellow Fever 17D, (Lot 1873GK) and an injection (route and site not provided) of Smallpox Vaccine in anticipation of travel. "Three days after vaccination, she had sudden onset of fever to 103 degrees Fahrenheit, myalgia, headache, chills, constipation, nausea, and vomiting, and also had swelling, pain, and stiffness at the site of her yellow fever (but not the smallpox) vaccination. On admission to the hospital, she was acutely ill, with temperature of 105 deg F, blood pressure 110/60, pulse 84, and respiration's 20. Her physical exam was unremarkable. The white blood count (WBC) was 8400 cells/mm3 with a striking left shift (91% polymorphonuclear cells, 5% bands, 2% lymphocytes, 2% monocytes) raising the suspicion of bacterial infection. She was anemic (hematocrit 28.4%). Electrolytes were normal, blood urea nitrogen (BUN) was slightly elevated but creatinine was normal (.9 mg/dL). There was 1-2 + protein in urine, mildly elevated amylase, and the asparate aminotransferase (SGOT) was elevated (107 U/L). Her anemia was believed caused by a long history of metrorrhagia. Over the next 7 days in the hospital, the patient continued to run a high fever and required a hypothermia blanket to maintain her temperature between 100 and 102 deg F. She was treated with intravenous hydration and antiemetics. She experienced shaking chills, severe headache, abdominal pain, nausea, and muscle aches, and at times was obtunded. Her liver became palpable and was tender. She was unable to eat until the sixth hospital day. Her liver enzymes rose to a peak SGOT of approximately 800 U/L, SGPT 542 U/L, and LDH 775 U/L. Coagulation tests were normal. She did not become jaundiced, and her maximum total bilirubin was 1.6 mg/dL. Liver scan showed inhomogeneous uptake but was considered "probably normal"; spleen scan and abdominal ultrasound were unremarkable; blood cultures febrile agglutinins, and mono spot test were negative. Blood obtained 6 days after onset was cultured for virus and found negative. A liver biopsy was performed on the fifth hospital day (10 days after vaccination), and was abnormal, showing significant diffuse microvesicular steatosis, liver cell drop-out, Kupffer cell prominence, scattered Councilman bodies, increased intracellular bile staining, without inflammation or midzonal distribution. The liver was sent and immunofluorescent staining performed with yellow fever antibody; results were negative. The patient improved during the second week after admission, liver enzymes normalized and symptoms dissipated. She was discharged 14 days after admission, with a diagnosis of "Viremia non-defined following yellow fever immunization, with hepatocellular inflammation, prolonged high fever. During the course of her hospitalization, consultations were held with hospital specialists (gastroenterology infectious disease) and with outside experts". Documents held by sender: None.
pain, swelling, mild redness of lower lip; pain, swelling, mild redness of lower lip; pain, swelling, mild redness of lower lip; This is a spontaneous report from a non-contactable consumer.  A 54-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3249) via unspecified route of administration on 27Jan2021 as single dose for COVID-19 immunization. The patient Medical history included Hypertension, allergic rhinitis. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient Concomitant medication included fexofenadine hydrochloride (ALLEGRA), famotidine (PEPCID [FAMOTIDINE]), hctz (HCTZ), magnesium oxide (MAG OXIDE), multivitamins within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EK5730) via unspecified route of administration on 06Jan2021 as single dose for COVID-19 immunization. After first dose, the patient experienced brief, intermittent sharp pain on Right side of mouth, lasted 2 days. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced pain, swelling, mild redness of lower lip and lasted 2-3days. The Patient didn't received treatment for the events. The clinical outcome of events was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked with 2018SA335493 (same reporter). This case involves an 8 weeks old male patient who received an expired dose of PENTACEL.(Suspension for injection). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR and HEPATITIS B VACCINE (HEPATITIS B VACCINE) on 03-Dec-2018.for both vaccines. On 03-Dec-2018, the patient received first 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C526AAA (expiry date: 29-Oct-2018) via intramuscular route in the left thigh. It was a case of actual medication error due to expired vaccine used. Patient did not experience any adverse event. 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 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. Documents held by sender: none.
FLU MIST 10-14. 10-19 symptoms of flu, fever, cough. 10-21 (+) flu test influenza A.
Period started 2 weeks early and ever since the vaccine it has been irregular.  Last one was a week late and lasted for 2 weeks.  Prior to vaccine her cycle was regular.
Itching and red, splotchy rash on arms and chest. Began on 3/31/00 through 4/12/00. Didn't seek medical care.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 2:03 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 2:03 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 67.05.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 27-Oct-2021, At excursion time 09:00 AM, temperature was 29, at 10AM temperature was 32, total doses given for the day was 116, condition of vaccine prior to vaccination was not frozen, vaccines were moved to fridge on 29-Sep-2021 and 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 2 and 4 vials were moved to clinic 29-Sep-2021 and 05-Oct-2021 respectively. Vaccine BUD date was 29-Oct-2021 and 04-Nov-2021.  On 27-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM: 46, 3 PM: 46, 4 PM: 46 and 5 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Seen 11/13/17-initially bilat thighs red, raised at injection sites and resolved in 2 days. 11-21-17 2 red, hard lumps upper right thigh. Fever. Worsened 11-22-17 2 red raised lumps, warm to touch. Fever 11-24-17 no fever tiny red dots covering body and face-not itchy. Not warm to touch at injection site. Hydrocortisone cream mixed with baby lotion 1/2 and 1/2.
Parent reported event to Health Center 12/1/2022. Parent reports child had "head to toe" rash with onset approx 3 days post vaccination and resolved 1 week post vaccination. The parent also reports the child was lethargic and spiked high fever 3 days post vaccination and resolved 7 days post vaccination. Client reports she took child to physician and was diagnosed as a viral rash.
Booster dose. Vaccine administered on 11/1/2021. Vial expired 10/11/21. Vial was kept in freezer until 10/30/2021 and removed to fridge on 10/30/2021 for administration on 11/01/2021. Regarding potential for pregnancy, pt answered yes to this question: Are you pregnant or is there a chance you could become pregnant during the next month? Patient answered YES to this question. Given that this vaccine is still recommended during pregnancy, no additional information was gleaned.
A few hours after administration pt became very tired. She then got a headache and her back became sore. ER visit followed.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 19-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 1236 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from an office manager referring to a 12 month old patient of unknown gender. The patients' medical history and concurrent conditions were not reported. On 29-MAR-2018, the patient was vaccinated with an improperly stored M-M-R II lot # N001532, expiration date 13-JAN-2019 (anatomical location and administration route were not reported) for prophylaxis. Concomitant medications included properly stored sterile diluent. No adverse effects were reported. The vaccine was stored at 47 degree Fahrenheit to 77 degree F (61.7 degree F) for 2 hours 30 minutes and 32 degree F to 35 degree F (33F) for 6 hours 51 minutes. The previous temperature excursion was reported as 47 degree F to 77 degree F (52F) for 1 hour 30 minutes. The call was due to digital data logger. This is one of several reports received from same reporter. Sender's Comments: US-009507513-1803USA010116: US-009507513-1808USA007351: US-009507513-1808USA007352: US-009507513-1808USA007354: US-009507513-1808USA007355.
4 YEAR OLD WAS GIVEN BIVALENT BOOSTER INSTEAD OF THIRD DOSE OF MONOVALENT
HEADACHE AND VERY SORE MUSCLES IN NECK AND SHOULDER NOTHING SEEMS TO HELP THE HEADACHE
Shot given in the way back of the arm and not into the deltoid muscle; A spontaneous report was received from a consumer who was also a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and shot was given in the way back of the arm and not into the deltoid muscle.  On 03 or 04 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  As the mRNA-1273 vaccine was being given, the patient noted that the vaccine was not given in the deltoid muscle. It was given way back in the fat part of her arm. She went in the next day for shoulder surgery and the surgeon noted that it was not delivered into the muscle.   Treatment information was not provided.   Action taken with mRNA-1273 was not reported.  The outcome of the event, shot given in the way back of the arm and not into the deltoid muscle, was resolved.; Reporter's Comments: This case concerns a female patient who received the first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection and vaccine was given in the way back of the arm and not into the deltoid muscle. There were no reported adverse events after the vaccine was given in this case of incorrect route of product administration
red bumpy rash around the injection site--hot to touch and itches.  Where the needle went in is white
Very painful arm the next day. Same redness and induration around injection site. 2 days of weakness, chills, nausea. TAC 0.15 cream b.i.d. p.r.n.
Dyspnoea; myalgia; fatigue; Large erythema (3x2') at the site of injection; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (Dyspnoea), INJECTION SITE ERYTHEMA (Large erythema (3x2') at the site of injection), MYALGIA (myalgia) and FATIGUE (fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (gluten), Milk allergy (diary), Allergy to aluminium (alum dyes), Food allergy (eggs) and Autoimmune hypothyroidism since 1995. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyreosis.    On 24-Mar-2021 at 11:10 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE ERYTHEMA (Large erythema (3x2') at the site of injection). On 12-Apr-2021, the patient experienced DYSPNOEA (Dyspnoea), MYALGIA (myalgia) and FATIGUE (fatigue). On 05-Apr-2021, INJECTION SITE ERYTHEMA (Large erythema (3x2') at the site of injection) had resolved with sequelae. On 21-May-2021, DYSPNOEA (Dyspnoea), MYALGIA (myalgia) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: very high (High) Very high.     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.   Patient height was 5' 2". Patient had experienced fatigue in the past at the time of hypothyreosis diagnosis in 1995. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Significant follow up received ,and reporter information, patient information, past medical history, suspect drug information,concomitant information and event information was updated.
chills; shakes; Temps ranging from 98.3-102.9 thru the day and into bedtime.; Sweat profusely during the night waking often; Sweat profusely during the night waking often; Had difficulty breathing somewhat; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration (left arm), on 18Jan2021 09:30, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included rosuvastatin, and metoprolol succinate. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), vaccine location left arm, on 28Dec2020 08:30 AM, for covid-19 immunization at a hospital at 78-years-old. Four days after the second injection, on 22Jan2021 10:00 mid-morning, the patient started with severe chills and shakes, temps ranging from 98.3-102.9 thru the day and into bedtime, sweat profusely during the night waking often, and had difficulty breathing somewhat. By mid-day the next day, the patient was without any more symptoms. The patient did not receive any treatment for these events. The patient recovered from the events on 23Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.
Adverse reaction happened during a covid vaccine clinic. Patient was complaining of having shortness of breath, dizziness after receiving their second dose of covid vaccine. Pharmacy team gave Benadryl 100 mg @ 2:54 pm, and observed patient's blood pressure (108/82 mmHg). Pharmacy team continued observation and notified onsite first aid team, and patient's blood pressure was 102/73 mmHg @ 3:20 pm. Patient was feeling much better and was released.
generalized rash Dx: Delayed Hypersensitivity Reaction Clobetasol 0.05% cream, Benadryl 50 mg PO q6h
Vaccine administered on 01/20/2021 followed by erythema followed by cracking of the skin with bleeding of the palm to the hands and fingers occurring during the next few days following administration of the 2nd dose.  These were improved significantly with prednisone taper of 60-40-20 with 5 day dosing.  Patient was also placed on betamethasone cream. During prednisone treatment patient had resolution of symptoms, but following discontinuation patient's symptoms have returned to a lesser extent.
Patient is a 36-year-old male with past medical history of asthma to ED with SOB/fever  x2 days  He went to urgent care; positive for COVID-19; to ED for low Oxygen sats.   COVID-19 pneumonia.IV steroids, vitamin-C, zinc, follow inflammatory markers, incentive spirometry, self proning; rec'd  IV steroids, montelukast, budesonide treatments. DuoNebs, oxygen; discharge patient on prednisone, zinc, montelukast, vitamin-C, Tessalon Perles,
Severe "Flu Like"  Chills, Sweats, Bilateral Thigh Myalgia, Temporary loss of bladder control during the night x3, Temporary loss of the ability to stand/walk for 36 hours, Orthostatic Vertigo, and generalized weakness. All s/s resolved within 72 hours.
Tingling arms & legs since receiving 2nd dose. Reactivation of shingles rash, which i had in my 30?s.  Excruciatingly heavy painful and period following the vaccine. Shifting pain in arms and legs. Swollen lymphnodes
PT DEVELOPED RASH, MILD SANDPAPER, PAPULAR ERYTHEMATOUS RASH TO B CHEEKS, LOWER NECK, UPPER CHEST, NO RESPIRATORY INVOLVEMENT. PT REMAINED IN CLINIC X1.5 HOURS TO MONITOR, GIVEN BENADRYL, RASH RESOLVED 1.5 HOURS POST FLU VACCINE.
lost taste; achy; soar arm; feels lousy; Headache; felt lethargic; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), LETHARGY (felt lethargic), AGEUSIA (lost taste), PAIN (achy) and PAIN IN EXTREMITY (soar arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rhinitis and Drug allergy (Allergic to anti-inflammatories.).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced HEADACHE (Headache), LETHARGY (felt lethargic), PAIN (achy), PAIN IN EXTREMITY (soar arm) and FEELING ABNORMAL (feels lousy). On 26-Feb-2021, the patient experienced AGEUSIA (lost taste). On 24-Feb-2021, PAIN (achy), PAIN IN EXTREMITY (soar arm) and FEELING ABNORMAL (feels lousy) had resolved. At the time of the report, HEADACHE (Headache) and LETHARGY (felt lethargic) had not resolved and AGEUSIA (lost taste) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Treatment medications was not provided
HYPERSENSTIVITY RASH WITH LARGE UTICARIAL LESIONS OVER TRUNK, FACE, AND EXTREMITIES.  NO EVIDENCE YET OF ERYTHEMA MULTIFORME.
Some of the vaccine leaked out of the syringe while giving the injections in the deltoid. It seemed to leak out of the base of the needle. Couldn't tell how much vaccine leaked out. Patient reported no adverse effect.
On June 3, 2009, client returned to health department for PPD reading.  During visit, she c/o redness and warmth in her left arm.  Visual inspection of her left arm by RN, found the arm to be red and warm around an old BCG scar, measuring 30mm diameter.  This spot was between the two injection sites on that arm.  Client was advised to place cool compress on area and see MD if area worsens (signs of worsening to look for were described as increased puffiness, larger diameter of site, and/or streaks around site).  Call placed to home on June 4 without answer.  Message left for client to return call.  June 5, 2009, no return call from client.  Call again placed to client.  Talked with client, who stated her arm was much improved.  States her arm was "good", that redness is lessing, area is "not hurting as much".  She used ice on area but has stopped, and is no longer needing any treatment of site. Unsure of date and time of unset.  Client also received a two step PPD on April 27 and June 1. Both PPDs were given intradermal in the left forearm, lot number C3062AA. Vaccines were purchased with private and public funds.  Hepatitis B and Varicella were private funds; Td and MMR were public funds.
Coughing for a week; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing for a week) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history not included.  Relevant concomitant products usage were not reported by the reporter.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced COUGH (Coughing for a week). At the time of the report, COUGH (Coughing for a week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.