chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ear flap was red and inflamed; ear rash; ear is red and tender. It was on the right at first, but she is seeing it on the left today; This is a spontaneous report from a contactable pharmacist. This female pharmacist reported that:  Patient characteristics: Patient sex: Female  Reaction(s)/Event(s): Reaction/event as reported by primary source: ear rash Reaction/event as reported by primary source: ear flap was red and inflamed Reaction/event as reported by primary source: ear is red and tender Reaction/event as reported by primary source: was on the right at first, but she is seeing it on the left today Reaction/event as reported by primary source: I end up going to ER and they think it could be Vertigo  Drug(s) Information: Characterization of drug role: SUSPECT Proprietary medicinal product name: COVID 19 VACCINE Action taken: Unknown Btch/lot number: Not Provided  Narrative case summary and further information:  Case narrative: Submitted by Call Centre 1 Ref: #; ININ: # Selected Report Type: Initial Is the patient also the reporter? Yes Reporter type: Pharmacist   Dates for ear rash: (From: Unspecified To: Unspecified) Dates for ear flap was red and inflamed: (From: Unspecified To: Unspecified) Dates for ear is red and tender: (From: Unspecified To: Unspecified) Dates for was on the right at first, but she is seeing it on the left today: (From: Unspecified To: Unspecified)  Is Covid-19 vaccine a Pfizer product? Unspecified Covid-19 vaccine manufacturer: Unspecified Dates for Covid-19 vaccine: (Start: Unspecified Stop: Unspecified) NDC number of Covid-19 vaccine: Not Provided  Reason for no lot number: of Covid-19 vaccine: Caller unwilling to complete the report Expiry Date of Covid-19 vaccine: Not Provided Other Products: Not Provided Patient History: Not Provided Investigation Assessment: Not Provided  Additional Context: Caller is a pharmacist that was calling about the Covid-19 vaccine and reported that she took the second dose of the vaccine on Saturday 13Feb2021 and after 2 days she noticed a ear rash and her ear flap was red and inflamed. She stated that her ear is red and tender. It was on the right at first, but she is seeing it on the left today.  Caller asked, has this been a side effect that was reported with the vaccine? Caller declined a safety report at this time as she had a meeting in about 5 minutes from the time of the report.   Information for Lot/Batch number is requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
After the second dose I had fatigue and arm pain so bad I could not do anything with that arm for like a week. Then it was gone. 2 weeks after things got really bad in a weird way. I went to a constant period where I only had a couple of days where I was not in my period. In May I ended up getting an infection, which was bacterial vaginosis and I went to the doctor around the 12 or 13, he prescribed me Clindamycin. The infection went away. Last month I got bacterial vaginosis, yeast infection, and constant period. I am not sexually active. I had just been in November to the doctor and been healthy in that area. I made an appt with the OBGYN on the 07/26 so I have not seen the specialist yet. A couple of days after making the appt I went to urgent care, Urgent Care because the pain was so bad, when they looked in there they said it was hard to see because of the blood. They said it looked like bacterial vaginosis and yeast infection and gave me metrogel and it also looked like an abnormality in there. They tested for bacterial vaginosis and yeast infection and said it was negative, and they did not have any idea of what was going on. I took the whole antibiotics and they went away for about a week and now is back again and my period came back again. It was 10 days without having the period. After the second dose when it got worse I am also in a support group for perimenopause women and a woman reported she also had the same symptoms as I did.  They also did blood work at urgent care and it was normal. They were worried about the amount of blood that I lost.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history was not reported. On an unknown date the patient was vaccinated with ROTATEQ that was improperly stored. Concomitant medications were not reported. The nurse reported that an improperly stored ROTATEQ most likely had been administered. The ROTATEQ reached a temperature as low as 30 Fahrenheit (F) for an unspecified amount of hours. The nurse stated that she thought that the proper storage range for the ROTATEQ was 35 F to 46 F because she reports that they have always been considered in range at 35F at her office. No adverse effects were reported. The outcome of improperly stored ROTATEQ have been administered and no adverse effect was unknown. This case is linked to 1406USA009396, 1406USA009397, 1406USA009399 and 1406USA009282. Additional information has been requested.
approx 4yrs p/vax pt exp varicella w/less than 50 lesions. varicella persisted at time of rpt. also rpt vax was not stored at appropriate temp right away. no further info avail
within a few minutes after the vaccination, patient felt her arm go cold and numb.  Patient has never had this happen before.  She denies any other symptoms.  Both hands are cold to touch.  She soon felt better but symptoms did not completely resolve.  Patient is refusing any treatment or transport.
Did not get second dose in the series/ Scared to get the second dose; Fainted / collapsed; Passed out / unconscious; Fell face down; Black and blue bruising; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted / collapsed) and LOSS OF CONSCIOUSNESS (Passed out / unconscious) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Unspecified pan shot).    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PYREXIA (Fever). On 05-May-2021, the patient experienced SYNCOPE (Fainted / collapsed) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Passed out / unconscious) (seriousness criterion medically significant), FALL (Fell face down) and CONTUSION (Black and blue bruising). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get second dose in the series/ Scared to get the second dose). At the time of the report, SYNCOPE (Fainted / collapsed), LOSS OF CONSCIOUSNESS (Passed out / unconscious), FALL (Fell face down), CONTUSION (Black and blue bruising), PRODUCT DOSE OMISSION ISSUE (Did not get second dose in the series/ Scared to get the second dose) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was on no concomitant medications.  Treatment medication was not provided by the reporter.  Patient did not go the emergency room or hospital for evaluation. She decided not to get the second dose in the series at that time. The caller stated his wife was scared to get the second dose.  Company Comment: 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.; 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.
At 3pm, employee reports having redness on both forearms that "comes and goes" since 9pm last night. Also states after redness disappears he has small "bumps" that remain on forearms.  Last "flareup" of redness was approx 12 noon today. On assessment, small reddened, elevated area approx. 12mm x 12mm on R forearm where PPD was placed 10/29/07.  Three pin-head sized elevated "bumps" on L forearm, none on right forearm.
2 weeks after second dose had no ability to taste or smell, lost 5 lbs, loss of energy, and hemoglobin is 9.
Extreme soreness in arm, Fever of 100.2 developed overnight along with sweats.
day of vaccine sore swollen arm. day 2-arm swelling, coughing, short of breath, chills, fever 100.4, severe muscle aches, severe headache. day 3- arm selling, fever 99, less coughing, muscle ache, headache. Day 4- arm very swollen and red with rash, swollen lymph nodes
Child came to our office/clinic 3/15/15. She claims pregnant between 5-6 months. Vaccine was given 11/05/14. Hep A, HPV, IPV, Td, Varicella, FLUMIST.
1.  Pressure in head, constant next day after vaccination for a couple of days.   After the third day and onward, pressure onsets when I stand or while walking.  Pressure increases until dizzyness sets in, hearing diminishes, followed by pain in front of head. 2.  Pain and pressure in neck and down spine. 3.  Occasional sharp pain in head, as if a blood vessel is about to pop. 4.  After two 1/2 weeks, developed constant sensation of having a migraine headache. Visited doctor April 15th.   Prescribed Methylprednisolone, 4 mg.  Pain and pressure down spine reduced, but did not help other symptoms.   Visited doctor again April 27th.  Doctor gave me medication for Migraine headaches.  It is not helping so far. Doctor ordered MRI scan.   Appointment will be April 30, 2021
GAVE MODERNA BOOSTER TO PEDIATRIC PATIENT, OFF LABEL, SHOULD HAVE GIVE PFIZER
CHILLS BODY ACHES CONGESTION  FATIGUE DIZZINESS HEADACHE
This is a spontaneous report from a contactable consumer via Pfizer sales representative. This female consumer reported similar events for herself and her husband. This is 1st of 2 reports concerning the wife. A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced major stinging after vaccination on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2017142847 same reporter/product/event, diff patients.
Very sore at injection site for four days. Lethargy continues at day 6 post injection. Nausea and occasional stomach cramps continue at day 6 post injection.
10/04/2005 Pt given Pneumococcal vaccine right thigh ( vastus lateralis IM) pt is S/P Bil Mastectomy. Increased pain a few hours later. 10/05/2005 non weight bearing. Slight to moderate swelling (lump) no redness.
A couple of days after receiving my second Shingrix vaccine I feel fatigued, dizzy, unsteady on my feet and mildly confused. It's been 5 days since the vaccine and I feel these symptoms more intensely now.
redness and itchiness in bilateral arms and neck. received benadryl iM. improved and dc'd t home with husband.
FATIGUE; OUTER NERVE SENSATION; WARM AND COLDNESS OF ELBOW AND 2 FINGERS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 24-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 24-APR-2021 15:30, the subject experienced outer nerve sensation. On 24-APR-2021 15:30, the subject experienced warm and coldness of elbow and 2 fingers. On 25-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and outer nerve sensation, and the outcome of warm and coldness of elbow and 2 fingers was not reported. This report was non-serious.
parents state pt had inconsolable crying for 3 days p/inject; took pt to MD on 4th day vax given 31JAN93; MD or parents did not notify clinic of react until in for 4mo vax; 223FEB94 ordering no further pertussis vax;
12/20/22 presents to ED for "shortness of breath". PMHx of "T2DM, HTN, oropharyngeal dysphagia, and chronic pain"
This is a 72 y male with PMH significant for multiple medical problems including CAD status post CABG, HTN, and obesity who was admitted on 12/21/2021 because of syncopal episode and was found to be COVID-19 positive .  In regard to COVID-19 infection initially patient was started on Remdesivir. However given the fact that he was not hypoxic Remdesivir was discontinued and patient does not qualify for steroids either.  Patient was treated symptomatically with antitussives.  Patient was a candidate for monoclonal antibody which was ordered for the patient.  However patient declined that.  Patient was found to have UTI and was started on antibiotic therapy initially with IV ceftriaxone but at the time of discharge he was switch to oral Keflex.  Patient was discharged home
Dizziness, Headache, chills, fatigue, sore throat, diaphoresis Narrative:
facial swelling 9OCT97 persisted for several days;limping, inflammation, tenderness, pain in lt foot, ankle, leg & knee 15OCT97 pred started NOV97;to be dec p/2wk;started on Naprosyn NOV97;ibuprofen;seen by DR 3NOV97;
This spontaneous report has been received from a pharmacist referring to unspecified number of patients. On unknown dates the patients were vaccinated with GARDASIL 9 (first dose, dose, frequency, route and lot# not reported). It was reported that the patients received earlier their second or their third dose of GARDASIL 9 late on unspecified dates. This is one of two reports from the same reporter. Additional information has been requested.
COVID arm - large red rash at injection site; COVID arm - large red rash at injection site; Warm to the touch and sore; Warm to the touch and sore; Mild nausea; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 27Dec2021 (Lot number: FJ1611) at the age of 35 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes and "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), all with onset 29Dec2021 at 10:00, outcome "recovering", and all described as "COVID arm - large red rash at injection site"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PAIN (non-serious), all with onset 29Dec2021 at 10:00, outcome "recovering", and all described as "Warm to the touch and sore"; NAUSEA (non-serious) with onset 29Dec2021 at 10:00, outcome "recovering", described as "Mild nausea". Therapeutic measures were taken as a result of vaccination site rash, vaccination site erythema, vaccination site warmth, vaccination site pain and nausea.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included over the counter (OTC) pain relief and antihistamines for vaccination site rash, vaccination site erythema, vaccination site warmth, vaccination site pain and nausea.
diagnosed with COVID; This is a spontaneous report from a contactable consumer (patient) reported for herself via medical information team. A female consumer with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on 23Mar2021, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. The patient stated that she got the first dose of the Pfizer Covid 19 vaccine on 23Mar2021 and was diagnosed with COVID on 02Apr2021. Her second dose is scheduled for tomorrow, 14Apr2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sense of taste of taste buds are off still. I only can taste the food when it hits the back of my throat it?s been like this since days after the vaccine I tried to wait and see if it would go away but it hasn?t.
A report has been received from a Health Professional concerning a 9 year old, female subject, who had been receiving FLUMIST Quadrivalent, 0.2 milliliters. FLUMIST Quadrivalent started on 22-OCT-2015. The patient received a second dose of FLUMIST a week later on 28-OCT-2015. FLUMIST Quadrivalent was continued. The outcome of the event of patient received 2 single doses of FLUMIST also one week apart is unknown. The report was considered to be non-serious by the company physician.
No adverse events were reported or noticed; administered IM instead of SC; This spontaneous report was received from a nurse practitioner concerning a 29-year-old male patient. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 18-MAY-2021, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliter intramuscular route instead of subcutaneous, lot number T012808, has been verified to be a valid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), expiration date reported as 14-AUG-2022, but upon internal validation established as 14-APR-2022 as prophylaxis.  No additional adverse events were reported.
expired dose of Fluzone HD was inadvertently administered to 59 years male patient; expired dose of Fluzone HD was inadvertently administered to 59 years male patient; expired dose of Fluzone HD was inadvertently administered to 59 years male patient; Initial information received on 13-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 59 years old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, concomitant medication and family history were not provided.  On 11-May-2019, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported, expiry date 02-May-2019 via unknown route in unknown administration site.  It was an actual medication error due to expired vaccine used, overdose and inappropriate age at vaccine administration.  It was reported that expired dose of Fluzone HD was inadvertently administered to 59 years male patient.  It was unknown if patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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  List of documents held by sender- none.
Patient noted with redness and swelling to left deltoid. Advised to apply cool pack to area and give Tylenol for discomfort.
flushed, rapid heart rate.   No throat swelling, shortness of breath, vomiting.   NO signs of anaphylaxis
my left hand and my foot swell; my left hand and my foot swell; my entire body hurts; I had the temperature almost like I got the flu; my head is really hurting; I feel disoriented; I am cold but like I am hot really hot. I felt like I am burning up; This is a spontaneous report from a contactable consumer or other non hcp. A 58-year-old female patient received BNT162B2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 (Batch/Lot Number: EW0160; Expiration Date: 31Aug2021) as 2nd, single dose for covid-19 immunization. Medical history included ongoing diabetes mellitus, ongoing thyroid disorder. The patient's concomitant medications were not reported. The patient stated "I take medicine for diabetes. I take thyroid medication. I have been taking the medication for the past, it's been some years now." The patient previously took BNT162B2, dose 1, on an unspecified date. On 07May2021 the patient experienced my left hand and my foot swell, my entire body hurts, i had the temperature almost like i got the flu, my head is really hurting, i feel disoriented, i am cold but like i am hot really hot. i felt like i am burning up. The patient stated that "I take Tylenol, I work for the government. A lot of medical workers do. A nurse said you take Tylenol . So, that's what I have been taking but it is not working."  The outcome of the events were unknown.   No follow-up attempts are possible. No further information is expected.
Reaction to DTAPacel with swelling and redness at site of injection, reaction about 2 1/2" in diameter with no signs of fluctuations. Treated with Motrin prn 190mg q 6, ice to area and monitor for signs of infection.
swelling at the injection site; swelling / face; swelling / other parts of the body; This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number YT5K7, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st December 2020, the patient received Fluarix Tetra 2020-2021 season .5 ml and Fluarix Tetra Pre-Filled Syringe Device. On 1st December 2020, less than a day after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site swelling, facial swelling and swelling. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site swelling, facial swelling and swelling were unknown.   It was unknown if the reporter considered the injection site swelling, facial swelling and swelling to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Fluarix and within 3 hours after administration of the vaccine ended up going to the emergency room with swelling at the injection site as well as his face and other parts of the body. They gave him Benadryl in the emergency room and he responded fine.  The reporter stated that supposedly this patient never had a vaccine reaction in the past.