chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling down; HEADACHE; Fever 39°C/ it was very easy to lower; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Feeling down), HEADACHE (HEADACHE) and PYREXIA (Fever 39°C/ it was very easy to lower) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEPRESSED MOOD (Feeling down), HEADACHE (HEADACHE) and PYREXIA (Fever 39°C/ it was very easy to lower). The patient was treated with ACETAMINOPHEN at a dose of 500 milligram every four hours and IBUPROFEN at an unspecified dose and frequency. At the time of the report, DEPRESSED MOOD (Feeling down), HEADACHE (HEADACHE) and PYREXIA (Fever 39°C/ it was very easy to lower) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.  Treatment details include towels with cold water and vinegar to lower the temperature   This case was linked to MOD-2021-118547 (Patient Link).
heart attack from  booster; This spontaneous case was reported by a nurse and describes the occurrence of MYOCARDIAL INFARCTION (heart attack from  booster) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack from  booster) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (heart attack from  booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDIAL INFARCTION (heart attack from  booster) to be related.    Concomitant medication and treatment details were not reported. Reporters daughter does not want get  booster dose because her father-in-law just had a heart attack from  it and she fears that  she may get.  Company comment:  This spontaneous case concerns a male patient with no medical history reported, who experienced serious unexpected AESI of myocardial infarction, that occurred unspecified time after the booster dose of the mRNA-1273. No further details were provided. The rechallenge was not applicable due to occurrence after the booster dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient with no medical history reported, who experienced serious unexpected AESI of myocardial infarction, that occurred unspecified time after the booster dose of the mRNA-1273. No further details were provided. The rechallenge was not applicable due to occurrence after the booster dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
administered an expired dose of Daptacel with no reported adverse event; Initial information received on 20-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old female patient and it was reported that administered an expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine (hepatitis A) for prophylactic vaccination; HIB vaccine (HIB) for prophylactic vaccination; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for prophylactic vaccination.  On 16-Mar-2023, patient was administered an expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] suspension for injection (batch/lot number: C5829BA and expiry date: 01-Mar-2023; strength: standard; dose: 0.5 mL) via intramuscular route in the left deltoid for immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
Fever > 102, irritable. S/S started pm 3/23/09. Redness, warm to touch right thigh edema. Left thigh edema and "knot" present treated with Tylenol.
a patient recently had titers which showed that she is not immune to hepatitis B/Negative hepatitis B titers in a fully vaccinated patient; This spontaneous report has been received from a nurse concerning a 21 years old female patient. The patient's drug reactions or allergies, concomitant therapies, medical history, and concurrent conditions were not provided.   On unknown dates, the patient received three doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) as a child (strength, dose, route, lot#, expire date were not reported) for prophylaxis.  On an unknown date (reported as recently), the patient had Negative hepatitis B titers which showed that she was not immune to hepatitis b (hepatitis B antibody negative). The outcome of the event was not provided.  Causality assessment was not provided.
Patient reports tenderness in her arm and neck x 3 weeks. She states her dr did xrays and believes she has a nerve issue.
Severe flu symptoms.  Vomit, Stomach ache, chills, muscle pain.  Missed  1-1/2 days of work.
Mother noted that she was febrile and moaning 24 hrs after immunizations were given and discovered 3x2 cm red, warm induration inferior to scabbed VZV site.
This patient had a small purple-red rash (vasculitis type) on arms, legs and feet edema.
Itching rash at injection site; Itching rash at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old male patient received the unknown dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 24Mar2021 at 11:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021 at 19:45 (12th day after vaccination), the patient experienced an itching rash at injection site. The clinical outcome of the events itching rash at injection site was unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
~55 yo female had progression of vaccination site thru all stages, but somewhat slow.  Scab did not form until 3 weeks post-vax and persisted until weeks 4-5.  Site healed completely.  At ~ 7 weeks post-vax, she developed 1.5-2 cm area of erythema and induration at vax site.  No fluctuance, no lymphadenopathy, no fever.  Patient with h/o breast CA, not currently on immunosuppressive drugs (only tamoxifen).
This case was reported by a pharmacist via sales rep and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. In seeing reporter during an influenza vaccination event, the patient stated that he had recently received their SHINGRIX vaccine and that one really hurt. The reporter had no additional details available at time of report, but agreed to follow-up by safety department.
Pain and swelling ("knot" at vaccination site in left arm muscle); extreme fatigue; headache; nausea; gastrointestinal issues (upset stomach; diarrhea; loose bowels); and lack of appetite.
Seven days of side effects, including fatigue, body aches, headaches, chills, and body temperature issues.  After one week, still getting severe headaches on the eighth  day which is today 4/15/21. Passed out after vaccine.
Fluzone Quad had given to a patient which was delay in shipping time, no AE; Fluzone Quad had given to a patient which was delay in shipping time, no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case is linked to cases 2019SA320728, 2019SA320727, 2019SA320730, 2019SA320730 and 2019SA320731 (same reporter).  This case involves a 19 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UJ3058A, Exp. Date 20-Jun-2020 via unknown route in unknown administration site on 12-Nov-2019, that was delay in shipping time.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to incorrect product storage and product shipment delay.  It was reported that shipment had been in transit for over 2 days. Customer agent advised the vaccines was not good any longer.  At the time of reporting, no adverse reactions were reported.  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.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 67 years old female patient who experienced bit red at the injection site and pain, FLUZONE HD intramuscular rather than subcutaneously and FLUZONE HIGH-DOSE was administered close to the elbow rather than in the deltoid, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 16-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ030AA via subcutaneous route. On an unknown date, patient developed a non-serious bit red at the injection site and pain following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was also a case of actual medication error due to Inappropriate route of vaccination and vaccine administered at inappropriate site. (Other relevant tests included no lab test.) Final diagnosis was FLUZONE HIGH-DOSE was administered close to the elbow rather than in the deltoid, FLUZONE HD intramuscular rather than subcutaneously and bit red at the injection site. It was not reported if the patient received a corrective treatment. The patient outcome was reported as Unknown for bit red at the injection site and pain. 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.
Patient had some redness and swelling appear on the forward aspect of her upper arm, a little below the deltoid in the evening following vaccination. By the next day, when she reported to me, the "rash" was extending from the armpit to the elbow. The skin was pink-red and swollen. She had been taking acetaminophen to help with pain.
5 months old received Flulaval; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old patient who received Flu Seasonal QIV  (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   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: 25-OCT-2022 Reporter's Comments: The reporter reported that one of his/her nurses accidentally administered Flulaval to a 5 months old patient. The reporter was seeking information on this. The chat dropped before user could provide any information. Additional supportive information: The patient received Flulaval Quadrivalent at 5 month old, which led to inappropriate age at vaccine administration.
Itchy painful rash appeared on torso, buttock area and legs/arms. Appeared 4 days after second dose of vaccine.
Shingles developed on the right side of body wrapping from spine to center of chest. Dr. prescribed Valacyclovir (1,000 mg x3 daily).
Administered Infanrix after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old female patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd February 2022, the patient received the 2nd dose of Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   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: 15-Jun-2022 Reporter's comments: Medical assistant reported that the patient was administered with the Infanrix vaccine after a temperature excursion in left arm. The consent to follow up was given. Additional Supportive Information: The patient was administered with the Infanrix vaccine after a temperature excursion, which led to incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093600:Same reporter. US-GLAXOSMITHKLINE-US2022093640:Same reporter. US-GLAXOSMITHKLINE-US2022093642:Same reporter. US-GLAXOSMITHKLINE-US2022093647:Same reporter. US-GLAXOSMITHKLINE-US2022093602:Same reporter. US-GLAXOSMITHKLINE-US2022093638:Same reporter. US-GLAXOSMITHKLINE-US2022093643:Same reporter. US-GLAXOSMITHKLINE-US2022093637:Same reporter US-GLAXOSMITHKLINE-US2022093597:Same reporter. US-GLAXOSMITHKLINE-US2022093648:Same reporter.
devel 8mm raised, red area 7 days p/vax;20JUN95 starting to resolve;
Information has been received from a consumer concerning her 16 year old daughter who in January 2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) and in June 2007 was vaccinated with the third dose of GARDASIL vaccine (yeast) (time of the second dose was not reported). The patient switched physicians and was told that her pap smear last year came back abnormal. Outcome of the abnormal pap smear was not reported. The patient sought medical attention with a physician office visit. Additional information has been requested.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADVERSE REACTION (adverse reaction 12-14 hours after 2nd dose), FEELING ABNORMAL (woke up feeling miserable), FEELING HOT (hot), HYPERHIDROSIS (sweaty) and FEELING COLD (couldnt get warm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concurrent medical conditions included Hay fever.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced ADVERSE REACTION (adverse reaction 12-14 hours after 2nd dose). 06-Feb-2021, the patient experienced FEELING ABNORMAL (woke up feeling miserable), FEELING HOT (hot), HYPERHIDROSIS (sweaty), FEELING COLD (couldnt get warm), RETCHING (dry heaving), ABDOMINAL PAIN UPPER (stomach ache), ASTHENIA (felt really weak), RASH (5 inch diameter rash), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever between 102 to 103). On an unknown date, the patient experienced ERYTHEMA (erythema), PRURITUS (itching), TENDERNESS (tenderness), SWELLING (Did not lose swelling), FATIGUE (Extreme fatigue/Still fatigue/Slight fatigue) and VOMITING (Threw up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) (oral) at a dose of 29 mg. On 08-Feb-2021, FEELING ABNORMAL (woke up feeling miserable), FEELING HOT (hot), HYPERHIDROSIS (sweaty), FEELING COLD (couldnt get warm), RETCHING (dry heaving), ABDOMINAL PAIN UPPER (stomach ache), ASTHENIA (felt really weak), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever between 102 to 103) had resolved. On 10-Feb-2021, ADVERSE REACTION (adverse reaction 12-14 hours after 2nd dose) and RASH (5 inch diameter rash) had resolved. At the time of the report, ERYTHEMA (erythema), PRURITUS (itching), TENDERNESS (tenderness), SWELLING (Did not lose swelling), FATIGUE (Extreme fatigue/Still fatigue/Slight fatigue) and VOMITING (Threw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Pyrexia: 102-103 (High) 102 to 103 degree F.         No concomitant medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received and does not contain any new information. On 21-Jun-2021: Significant follow-up. Events added and ADR form received.
4-12-12 started with sore arm, 4-13-12 arm swollen to size of "baseball" per mom where varicella vaccine given in right arm. Warm to touch, red, temp of 99.2 degrees, c/o itchiness and pimple-like spot in area of where shot given. Size 8x5 cm by 6 cm.
At around 12 hrs later, developed fever, chills.  12 hrs later, moderate to severe migraine type headache with nausea and vomiting. Unable to perform normal everyday tasks for the following  36 hrs
same day of vax pt had a react, temp, drowsy, dizzy, severe inflammation @ site of inject requiring ATB as Prescribed by pvt MD;
The patient became diaphoretic, pale, and dizzy. Fell on the floor. No injury. BP monitored every 5 minutes,  low BP noted. Sprite offered, cold pack applied to the back of the neck. Laid patient on the couch. The patient rested for about half-hour and felt a little better. Patient BP returned to 121/74 prior to release. Father accompanied the client.
pt states she started having pain in the right arm.  Her arm has limited movement.  Pt has extreme fatigue and has slept the majority of the time after getting home from receiving the vax.  Pt still has these symptoms.
Mild rash night of injection  Moderate to severe arm pain at site of injection Low grade fever Moderate exhaustion  All symptoms were gone in approx 36 hrs except mild arm pain
Client reported feeling like he was going to "pass out" and had blurry vision. Client lost consciousness for approximately 5 seconds and was assisted into gravity chair for observation. Client was provided bottled water and education on vaccine side-effects. Client was advised to seek emergency medical attention, but refused. Client was advised to follow-up with primary care provider. Client left site unassisted with steady gaitafter approximately 40 minutes observation with mother, who advised she will take client to urgent care or emergency room if symptoms persist.
Patient had 1 minute syncope after 5 minutes from administering vaccines. He was pale, not responsive. Heart rate and respirations normal, woke up after gagging w/tongue blade.
Severe inflammation, redness, pain at injection site. Increasing in size over 24 hours after injection. Patient called Doctor's office where injection was given. Primary Care Doctor prescribed prednisone, though the swelling had become severe so patient was advised to go to Urgent care where it was diagnosed that she had cellulitis and given antibiotic. It was verified with patient and staff that injection site was cleaned twice with alcohol wipes.
Headache first 30 min, malaise 6-7 hrs after , joints shoulders and hands/fingers x48 hrs moderate /severe then lessening,  Swollen Armpit lymph node 3 in x 4 in  for  48 hrs then getting smaller . Severe to moderate pain .  Congested all days , needed Inhaler first 24 hrs , benedryl and decongestant , naproxen and Tylenol needed all days