chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chicken pox type reaction/white red blister/red spots; This spontaneous report was received from a 69-year-old patient via Glaxosmithkline GlaxoSmithKline,reporting on herself. Medical history included that she had a total of 4 Shingles outbreaks, starting in the 1970's. Information regarding concurrent conditions and concomitant medication was not provided.  In September 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (dosage information, route, lot number and expiration date were not reported).  On 26-AUG-2021, at at 12:30 PM, the patient was vaccinated with the first dose of varicella zoster vaccine rge (cho) (SHINGRIX) 0.5 (unk) (dosage information, route, lot number and expiration date were not reported).     On 26-AUG-2021, at 11:30 PM that evening, she had 10 or 11 red spots all over her body (one or two spots on each arm, one or two on each leg and one of her chest), then she developed a firm red, whitish raised blister, called the doctor and she said it was a chicken pox type reaction. The patient took diphenhydramine  (BENADRYL) by mouth and used hot and ice compress, all the spots and the blister went away in 6 or 7 days. The outcome of rash vesicular was unknown. The causality assessment was not provided.
Had to call in sick to work; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COVID-19 VACCINE OMI XBB.1.5 - MANUFACTURER UNKNOWN), on 13Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 13Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 14Nov2023, outcome "unknown", described as "Had to call in sick to work". Additional information: reporter got the Covid booster and the Shringrex Vaccine on the same day and the following day had to call in sick to work. Caller does not know whose Covid Booster it is, who manufactured the Covid Booster, but wanted to report details provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tested positive after testing negative with antigen tests.; Tested positive after testing negative with antigen tests.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 15Apr2021 as dose 2, single (Lot number: EW0158), in left arm and on 13Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "high BMI" (unspecified if ongoing); "diabetes" (unspecified if ongoing). The patient's family history included: "family history of high blood pressure" (unspecified if ongoing), notes: family history of high blood pressure. Concomitant medication(s) included: FLUOXETINE, start date: 19May2021; DEXTROAMPHETAMINE [DEXAMFETAMINE], start date: 24Feb2022. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 2022, outcome "unknown" and all described as "Tested positive after testing negative with antigen tests.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive, notes: Tested positive after testing negative. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical Course: Patient received previously Covid Vaccine and patient taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible. No further information is expected.
Pt. receive vaccination on 10/28/15 came back next day, arm where vaccination was given is swollen, red, and inflamed. Pt. also said it's hot and a little painful. Recommended ice pack/BENADRYL after 5 days almost recovered.
Given Flumist influenza vaccine incorrectly in only one nostril - to be revaccinated 11/6/09.
Stomach upset x 3 days, arm pain at site of vaccinations-intense for 3 days, still sore 2 months later.
11-13 head ache, arm ache, and hot/cold, rock hard spot Per FitBit  Breathing  rate 12 & 13 elevated +3 breaths per min Resting Heart rate 13 th +1,  14th +3, 15th +5, 16th +3, 17th +2 11-3 woke up with hives and heat to the injection area.  (Never had hives before in life).  Went to doc office, they suggest warm steamy compress and Benadryl liquid.  On the paper work Elevated heart grate and hives are listed as reasons to call EMS.
Patient had vaccine fully administered and retracted from skin and reported that the vaccine went well.  As I was disposing the needle in the sharps container he passed out while still seated and fell to the floor hitting his head and nose on the floor.  He was unconscious for appr. 10 sec before he came to.  EMS arrived within 5 minutes of adverse reaction.
Pt c/o tachycardia and numbness in hand 10 min after vaccination. VS: 120/72 HR76 O2 Sat 100% EMS called VS stable. Declined transport to hospital ED. Encouraged to follow up with PCP.  Made it home on own uneventfully.
contracted COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID-19) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced COVID-19 (contracted COVID-19). At the time of the report, COVID-19 (contracted COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
09/25/19 The patient is a 67-year-old female with known history of chronic obstructive pulmonary disease, hypertension, hypothyroidism, depression, deep venous thrombosis, who admitted on September 24, 2019, for severe pain and swelling to the left arm extending to the left shoulder following a Pneumovax intramuscular injection to the left shoulder. The patient also started having fever with associated chills, dizziness and generalized weakness. She also had complained of some nausea. She had been unable to move her left shoulder and noted some area of redness on the left upper arm. The patient called the EMS and was brought to ER and was found to be hypotensive and febrile. T-max is at 102.9. Admission white cell count was elevated at 16 and is now down to 11.4. The patient has multiple antibiotic allergies and was started on Rocephin and Zithromax and on some ibuprofen and states that she is now feeling about 50% improved. The patient was wanting to be transferred to another hospital, however, there is no bed available. Nares screen for MRSA has come back negative. Creatinine is at 0.58. Procalcitonin is at 0.22. Troponins were negative. CT angiogram of the chest did not reveal any underlying pulmonary embolus or aortic dissection. An MRI of the left arm and shoulder has been ordered and remains pending. The patient denies any chest pain, palpitations, or shortness of breath. She denies any vomiting, abdominal pain, or diarrhea. The patient could have another severe drug reaction similar to what happened to her in 2008 when she was admitted to Hospital for infected left TKA. She hadanaphylactic shock and generalized pustular rash due to daptomycin. 10/01/2019 Patient received a Pneumovax 23 vaccine on September 23. As the day progressed, she developed severe pain and swelling in her left arm at the injection site extending up to her left shoulder. She also had fever and chills, dizziness and weakness with a MAXIMUM TEMPERATURE of 102.9. She was brought to the emergency room when she was found to be hypotensive as well as febrile. She was treated for cellulitis with azithromycin, Rocephin, and clindamycin given her multiple antibiotic allergies. MRI of the shoulder revealed diffuse myofascial edema and mild Intramuscular edema within the deltoid consistent with nonspecific myositis and fasciitis. Her clinical presentation was therefore felt to be more consistent with an adverse reaction to the vaccine. She was given Solu-Medrol and started on a prednisone taper. She is currently on 40 mg of prednisone daily for 3 days, and will decrease by 10 mg every 3 days, finishing with 5 mg daily for 4 days. She also was given prescriptions for Cefdinir 300 mg b.i.d. for an additional 7 days and clindamycin 300 mg every 6 hours for an additional 7 days. Erythema has essentially resolved. She does note that her tongue is sore now. Her appetite is somewhat low, but food doesn't taste quite right.
1 wk p/vax began low temp; mom thought about 100; inc to 103.8 R evening 21MAY also next morning; mom gave APAP 4 hrs for 2 days; pt devel rash & was fussy; mom felt poss joint pain; pt taken to MD 2x during illness;
Severe nausea, fever 101.5, vomiting after 34 hours, fatigue, severe achiness.
We believe 1 vial of Pfizer vaccine was diluted with less than 1.8 mls, but no less than 1.5ml. Based on this info, I called Pfizer and they said the highest possible dose the patient could have gotten was 34.6 mcg. They also said this should not be harmful to the patient, and it should should not effect the efficacy. I called patient and she said she was feeling fine, just a sore arm, but I reassured her that it was just a slightly higher possible dose, and told her to call the pharmacy if she experiences any other symptoms.
patient recvd vaccination with immediate onset presyncope with diaphoresis with eventual momentary LOC.  recovered within 3 seconds.  monitored in observation for 15 minutes.  patient lucid with nl BP, 100/68.  no dizziness with postural changes after recovery.  patient was with mother who accompanied the patient out
This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (debilitating anxiety), DEPRESSION (depression), IMPAIRED WORK ABILITY (haven't been able to work) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (debilitating anxiety), DEPRESSION (depression), IMPAIRED WORK ABILITY (haven't been able to work) and HEADACHE (headache). At the time of the report, ANXIETY (debilitating anxiety), DEPRESSION (depression), IMPAIRED WORK ABILITY (haven't been able to work) and HEADACHE (headache) outcome was unknown. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.
Two weeks after shot, both armpits turned black and blue with no pain. Shot side was much darker. Also experienced noticeable fatigue that week.  Discoloration cleared within 24 hours
Slight rash upper arms and upper chest and back/ rash on her shoulders, upper chest and upper back/ Rash with little bumps; She had a little bit of a fever.; This is a spontaneous report from a contactable consumer or other non-health care professional(patient). A 52-years-old non pregnant female patient received bnt162b2 second dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER2613, Expiration date: unknown) administered in Arm Right as dose 2, single on 23Mar2021 14:00 (Age at vaccination: 52-Year-old) for covid-19 immunization. The medical history included High blood pressure, Known allergies Penicillin. Concomitant medication included lisinopril. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 (lot number EN6200) dose 1, single, in right arm 02Mar2021, 12:00 PM, for covid-19 immunization. On 24Mar2021 at 02:30PM the patient experienced rash on her shoulders, upper chest and upper back. Stated it was nothing major and she had a little bit of a fever. Adds she had noticed in the past when she gets a fever, she gets a rash with little bumps and that was what she had this time too. Her temperature was 100. The patient underwent lab tests and procedures which included body temperature: 100 on Mar2021. The outcome of event She had a little bit of a fever was unknown whereas another event was recovering.  No follow-up attempts are needed. No further information is expected.
Patient is 11 years old and parents were wanting to get the Pediatric Pfizer vaccine. We were short staff and had 8 other people waiting for flu shots and COVID vaccine at the same time. Somewhere in our paperwork process the patient order was messed up and the wrong patient was called over and received the wrong vaccine. Patient was given Fluzone Quad. Parents requested if he can go ahead and get his Pediatric Pfizer too. I went ahead and administered the correct vaccine in his other arm. Patient should be okay as Fluzone Quad can be given to patient 6 months and older, and we are able to administer his Pfizer vaccine at the same time just in different arms.
Headache, nausea, swollen lymph nodes in neck and under arms, nose bleed
This spontaneous report as received from a pharmacist refers to a 36 years old female patient. The patient had no pertinent medical history. The patient had no known drug allergies. On 17-SEP-2012 the patient was vaccinated by the pharmacist with 0.65 ml ZOSTAVAX (lot # 673029/0616AE, expiration date 28-JUN-2013) subcutaneously in back of left upper arm. Concomitant medications were reported as none. It was reported that the patient experienced injection site reaction of red, itchy, and swelling the size of a silver dollar. The patient sought for medical attention by sending a photo showing the injection site reaction through smart phone to the pharmacist on 18-SEP-2012. No treatment was given. The outcome was reported as not recovered. Additional information has been requested.
LOW BLOOD SUGAR; TIRED; FEVER; HEADACHE; This spontaneous report received from a consumer concerned an 80 year old male. The patient's height, and weight were not reported. The patient's past medical history included pneumonia, and concurrent conditions included low-blood sugar, alcohol user, non smoker, and no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 16:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F.  On 10-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced low blood sugar. On 13-MAR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: ibuprofen, guaifenesin, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 11-MAR-2021, and had not recovered from fever, low blood sugar, and tired. This report was non-serious. This case, involving the same patient is linked to 20210330134.
7 days, post vax, pt had high fever (max 105.2F) with macular rash over the torso. Rash has been present for 7 days. He did have streptococcal pharyngitis and treatment with Amoxicillin 1 month prior to reaction. Still has macular rash.
Fever; Aching; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Aching) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced PYREXIA (Fever), MYALGIA (Aching) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Fever), MYALGIA (Aching) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On 28-OCT-2013 the patient was vaccinated with partial dose of GARDASIL (lot# unspecified), intramuscular. After intramuscular administration, some of the vaccine leaked out of the injection site on the patient's arm. No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.
patient was only given the Hib portion of the Pentacel vaccination that was reconstituted with sterile water; Initial information received on 17-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves female patient of unknown age who received only HIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine that was reconstituted with sterile water (Product preparation error) [lot number and other dosing details were not reported] via unknown route in unknown administration site on an unknown date.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant vaccination included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) [PREVNAR] and RODA vaccine.  It was a case of actual medication error due to product preparation error.  At the time of report no adverse event was 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.  Information on the batch number was requested.
Pt started having swelling in eyes and hives on face around 4:00 pm. No breathing issues. Pt was given a small amount of BENADRYL around 4:00 pm. Swelling has gone down and hives have mostly subsided. Discussed allergic reaction to immunizations, will report, likely PROQUAD. Mom given BENADRYL at home, given dosing chart for weight, given steroids for 5 days and push fluids. Mom did give him a bath and will wash bedding as well. No current airway issues or spreading or urticarial, appears stable. Advised that if SOB or airway issues occur call 911 or to the ER, follow up as needed otherwise.
Patient presented with lump on L clavicle that started on 6/11/06. Received Smallpox vaccination on 6/7/06. Lump tender to touch. 2cm circumcised lesion palpated. ROM within normal limits. Ibuprofen 800mg tid with food, ice to affected area prn.
Jynneos administrated intradermally at a dose of 0.1 ml; A vial was thawed for 10 minutes a 0.1 ml dose was taken from this vial then the vial was placed back in the freezer.; Case reference number US-BN-2022-004435 is a spontaneous case report initially received on 28-Oct-22 from other health care professional (reference number: USBAV22-1806) and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medications details were not provided.  On an unspecified date, as reported four weeks ago, the patient was vaccinated with a dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00016, expiration date: 31-Oct-2024) at a dose of 0.1 ml intradermally, (explicitly coded as 'intradermal injection'), at unknown anatomical location, for monkeypox prophylaxis.  As reported, a vial was thawed for ten minutes, a 0.1 ml dose was taken from this vial then the vial was placed back in the freezer, instead of being refrigerated after being thawed, (explicitly coded as 'product storage error').  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received on 28-Oct-2022 from Bavarian Nordic included local case ID.; Reporter's Comments: A patient of unknown age and gender was vaccinated with Jynneos at a dose of 0.1 ml (at unknown anatomical location), administered intradermally (considered as intradermal injection) for monkeypox prophylaxis. Reportedly, a vial was thawed for ten minutes, a 0.1 ml dose was taken from this vial then the vial was placed back in the freezer, instead of being refrigerated after being thawed, which is considered as product storage error. Injection and product storage error are both considered listed per company conventions. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos vaccination. The patient's relevant medical history and concomitant medications were not reported. Injection and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender was vaccinated with Jynneos at a dose of 0.1 ml (at unknown anatomical location), administered intradermally (considered as intradermal injection) for monkeypox prophylaxis. Reportedly, a vial was thawed for ten minutes, a 0.1 ml dose was taken from this vial then the vial was placed back in the freezer, instead of being refrigerated after being thawed, which is considered as product storage error. Injection and product storage error are both considered listed per company conventions. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos vaccination. The patient's relevant medical history and concomitant medications were not reported. Injection and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious.
pt recv vax 22MAR96 & 1MAR97 pt devel chickenpox;It was reporter that 3 additional pt devel chickenpox p/vax @ same facility (WAES 97030205, 97030210, 97030211);
Information has been received from a nurse practitioner concerning a 6 yr old male who on 27Jul00 was vaccinated with a dose of varicella virus vaccine live. On 19Feb06, the pt developed a moderate case break through chickenpox characterized by approx 100 vesicular lesions. He was noted to be afebrile. Unspecified medical attention was sought and he was treated with diphenhydramine hydrochloride (Benadryl). A product quality complaint was not involved. Breakthrough chickenpox was determined to be an other important medical event (OMIC) by the reporter. Additional information has been requested.