chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client received Pneumovax on 10/12/04.  On 10/13/04 the client's husband called and stated the arm was swollen.  I stated that was a normal local reaction.no other symptoms were reported.  I asked the client to use ice packs and Tylenol, if not contraindicated, and was told if no improvement in 48 hrs. to call me. On 10/14/04 the client presented herself to the HD.  Left upper arm from midline to elbow was red,edematous, raised and warm to touch. Client stated it was moving more toward elbow.  The redness wrapped half around arm. The client stated it was painful 10/13/04 but better today. No other symptoms noted or complained. Due to the acute swelling and the client being immuned compromised, I called her walk in clinic she frequents. An appointment was made for today,(10/14/04)
Information has been received from a licensed practical nurse concerning an 8 year old female with convulsion and no allergies who on 30-APR-2002 was vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Merck) (lot # and site of administration not reported).  Concomitant therapy included TRILEPTAL for seizures.  On 22-AUG-2009, the patient was seen in the office with a few raised red spots.  On 24-AUG-2009, in the morning, the patient's mother called the office and stated that more spots had erupted, afebrile.  On 24-AUG-2009 the nurse reported that the patient had chickenpox now.  The patient was treated with calamine lotion and oatmeal baths.  No laboratory diagnostics studies were performed.  At the time of this report, the patient had not recovered.  This is one of several reports from the same source.  Additional information has been requested.
Developed a boil area appx. 3-4inchs diameter, area surrounding boil, hot to touch, tight, raised off arm(right, extremly itchy, 3rd day after vaccine given, developed swollen area which is progrssivly getting larger, constant generalized joint pain.  Difficulty ambulating, getting out of bed, tylenol, motrin, naproxen, no effect.  lymph nodes under arm, up neck under throat, painful not enlarged.  generalized skin itchy all over, all the time. Had difficulty breathing 2-3 days after given shot.  Sometimes feel dizziness, lightheaded, fatigue all the time.  Usual flu like symptoms, chills, sweating, high temp.
Sore arm,  12-18-2020, low grade  fever (99.2),  cough and some chills 12-20-2020  am.
5/29/12 11:17 am - pt had increased itching upper body - rash (R) upper arm- no whelps. DECADRON shot given 11:20AM - Pt. c/o tongue feeling swollen- No swelling on exam - No SOB. BENADRYL given PO and IM - Pt. improved - Monitored > than 30 minutes > left clinic - no distress noted.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 03-AUG-2015 the patient was vaccinated with PROQUAD (Merck) (dose, dosage #, strength and route were not repotted, lot # L007229, expiry date: 03-SEP-2018). The second suspect therapy included KINRIX (administration date: 03-AUG-2015). The patient came back to the office as the patient had developed a rah all over the body on 04-AUG-2015. The outcome of the event was not reported. The reporter also requested a lot check and that lot check request was time sensitive and the reporter wanted a response quickly. This is one of several reports received from the same source. Additional information has been requested.
I'm not sure if it's related to my covid-19 shot. I've been experiencing more dizziness, headaches, some chest tightness, and a little bit of leg pain in my right leg.
Hives on torso moving to legs + arms + neck + swelling lips +swollen face + tingling in mouth. Treated with prednisone by PCP
22FEB93 fever 101; 23FEB93 fever 102-103; 24FEB93 fever 15 seizured (grand mal);
Cutaneous reaction, 3?x1.5?  patch immediately adjacent to injection site.  Initial erythema, edema followed by lichenification.  Resembles atopic dermatitis. No history of eczema.
On 9/25/19 I got a flu shot at my usual pharmacy. The person who was giving me the shot said as she was giving it to me, ?Why is it not goin in??  I had some discomfort after the shot but that is to be expected.  It is a long time ago for me to remember the history of the pain but I do remember that when we were camping a couple of weeks later it was very painful. Since then I have waited for it to go away. I saw my general practitioner about it on 11/22/19. He put down bursitis and suggested icing it. (Dr. is now retired but I am assuming my new GP can access his records.) The pain has since been minimal when my arm is at my side but still hurts when raised to shoulder height or above. I had no previous shoulder problems or pain. I made an appointment with an orthopedic physician 8/18/20. He  sent me to therapy 8/24/20 to 9/15/20. more flexibility but still painful.
Per NP; "Patient  is a 62 y/o female with hx of HTN, DM2, Asthma, severe obesity, being seen in the COVID vaccination clinic for their 1st COVID vaccination. After the vaccination they noted symptoms of tongue tingling and throat tightness approximately 20 minutes after vaccine administration.  Denies facial, tongue or throat tightness, difficulty breathing or shortness of breath.   Patient allergies: PCN and Sulfa   Patient was moved to the aid station and evaluated.    Vaccination provided today was Janssen Hx of reaction to vaccination in the past:denies    Patient was given  Zyrtec 10 mg PO Able to take PO water without difficulty    Plan is to observe, will reevaluate     Patient was advised to take diphenhydramine at home if continued or recurrent symptoms and to follow up with their primary MD. Strict return precautions to ED were discussed in detail.    Diagnosis  VACCINE ADVERSE REACTION, INIT  (primary encounter diagnosis) Plan: CETIRIZINE 10 MG ORAL TAB     Dispo  Home Condition Good"
patient under the age of 18 years old received the product with no reported adverse event; Initial information was received on 22-Nov-2021 regarding an unsolicited valid non-serious case from a pharmacist via Agency (under Inquiry Number: 00868860).  This case involves a patient under the age of 18 years old who received the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] with no reported adverse event (product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported "Caller stated that one of the clinics reported that a patient under the age of 18 years old received the product. Caller wanted to know if there was events that they should look out for. Caller stated that he would be leaving in 20 minutes and would like a back tomorrow."  At the time of reporting, no adverse event was reported.  There will be no information on lot number for this case.  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 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.
feeling very unwell for a short period of time; This case was reported by a nurse via call center representative and described the occurrence of malaise in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient received 1st dose Shingrix and experienced feeling very unwell for a short period of time. As per the reporter, she normally did not experience any untoward event following receipt of vaccines. The reporter declined consent for follow up.
2/25 and 2/26: Joint pain, primarily from jaw to fingers, severe headache, fatigue  2/26 and 2/27: Injection site horribly red, swollen, itchy and painful, fatigue 2/28:  fatigue 3/1: nausea, fatigue
Case received vaccine on 10/12/17 (5:15pm) and stated the administration was very uncomfortable.  Within 24 hours, she was unable to raise her right arm above shoulder level without experiencing  severe, shooting, intermittent pain. Takes Advil twice a day for arthritis in her hands. Encouraged to contact health care provider as symptoms are not decreasing.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose, route not reported). Concomitant medications were not reported. On an unspecified date the patient developed shingles after receiving ZOSTAVAX. Outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Slight soreness and slight enlargement of left axillary  region, suspect lymph node (deep tissue in armpit, firm but not hard, smooth, fixed lump about 2 cm diameter)
Information has been received from a registered nurse concerning a male child who was vaccinated p.o. with a first 2 mL dose of RotaTeq vaccine after 12 weeks of age. No adverse affects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. This is one report of several from the same source.
Initial unsolicited report received from an other health professional on 10-Jul-2018. This case involves a two-month-old male patient who was vaccinated with a dose of 0.5 ml PENTACEL (Batch number, expiration date, dose, route and site of administration was not reported for both vaccines) via subcutaneously instead of intramuscularly in leg on 09-Jul-2018. On 09-Jul-2018, the patient concomitantly received a dose of suspect ROTATEQ not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site and a dose of suspect PREVENAR not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. The patient's medical history were not reported. It was an actual medication error due to Inappropriate route of vaccination. It was reported that parents haven't reported any side effects at this time. 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. List of documents held by sender: none.
vaccination failure; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 at 13:30 as dose 1, single (Lot number: EL3302) intramuscular, in left arm, on 03Feb2021 at 08:00 as dose 2, single (Lot number: EL8482), in left arm and on 24Aug2021 at 12:30 as dose 3 (booster), single (Lot number: FC3183) at the age of 67 years intramuscular, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Apr2022 at 11:00 as dose 4 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Peniciliin" (unspecified if ongoing); "HTN" (unspecified if ongoing); "DM" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN, start date: May2009; PANTOPRAZOLE, start date: May2006; FEXOFENADINE, start date: May1997; FLUTICASONE, start date: May1999; DOXYCYCLINE; ESTRING, start date: May2013. The following information was reported: COVID-19 (medically significant) with onset May2022, outcome "recovered", described as "COVID 19 Treatment"; VACCINATION FAILURE (medically significant) with onset May2022, outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Product investigation report received from product quality group on 25May2022. The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot FC3183 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was  determined to be the reported finished goods lot FC3183, fill lot EY0555, and the bulk formulated drug product lot EP8657. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Nurse stated that she had 3 patients who received 1ml of 1st dose of moderna covid-19 vaccine instead of receiving 0.5ml; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Nurse stated that she had 3 patients who received 1ml of 1st dose of moderna covid-19 vaccine instead of receiving 0.5ml) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Nurse stated that she had 3 patients who received 1ml of 1st dose of moderna covid-19 vaccine instead of receiving 0.5ml). At the time of the report, ACCIDENTAL OVERDOSE (Nurse stated that she had 3 patients who received 1ml of 1st dose of moderna covid-19 vaccine instead of receiving 0.5ml) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.  Nurse stated that she had 3 patients who received 1ml of 1st dose of Moderna COVID-19 vaccine instead of receiving 0.5ml. So, she was looking for the guidance for double dose error and wanted to know about any recommendations on how to proceed with the 2nd dose.   No adverse event occurred post vaccination. VAERS submitted to CDC. All 3 vaccine recipients refused 2nd doses.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: No adverse event occurred post vaccination.
Pt presented 3/8 with c/o tachycardia and palpitations.  REports started on 3/7 at home, off and on throughout day.  Was sent for labs and EKG at clinic which was done on 3/9 am. Started on Metoprolol 12.5mg po qday and follow up scheduled for 3/12.  Pt presented back in office on 3/11 with c/o hive-like rash which started 3/10 evening. Reports it was generalized that evening at bedtime, but improved this am and just remains on right upper arm. Reports taking Benadryl 2 po at bedtime.  Reports tachycardia and palpitation symptoms improved with metoprolol dose but had only taken 1 dose.  Rash symptoms started prior to Metoprolol dose.
Child spiked temperature of 103. The temperature lasted for 3 days off and on, and on the 3rd day she came down with a rash all over her torso and face. She has been extremely fussy and crying a lot.
This spontaneous report as received from a nurse refers to a 10 months 13 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) liquid PEDVAXHIB (injection, lot # K016965, exp date: 20-JUL-201)(dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Measles rash/fever 102 after MMR (erythema spotty sl raised rash over entire body - blanch easily). Started on 2/24/06 per mom - seen in office 2/27/06.
Heartburn; Acid reflux; Belching; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 05Apr2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included helicobacter pylori infection. Concomitant medications were not reported. The patient previously took oxycodone and experienced specific allergy (drug ). 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 did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 10:00, the patient experienced heartburn, acid reflux, belching and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events heartburn, acid reflux, belching and diarrhea were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
hands were swollen/legs swollen/arms swollen; she cannot walk/could not walk; is in bed; super strong muscle pain so strong/muscle pain all over her body; her knee was swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 17 year-old female patient received bnt162b2 (COMIRNATY), administration date 11Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X MANUFACTUERER UNKNOWN (where X=Unknown number)), for COVID-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 13Jan2022, outcome "unknown", described as "hands were swollen/legs swollen/arms swollen"; JOINT SWELLING (non-serious) with onset Jan2022, outcome "unknown", described as "her knee was swollen"; GAIT DISTURBANCE (non-serious) with onset 13Jan2022, outcome "unknown", described as "she cannot walk/could not walk"; BEDRIDDEN (non-serious) with onset 13Jan2022, outcome "unknown", described as "is in bed"; MYALGIA (non-serious) with onset 13Jan2022, outcome "unknown", described as "super strong muscle pain so strong/muscle pain all over her body".  Additional information: It was reported that she received her booster on Tuesday this week. She states that two days ago she felt like her hands were swollen but the next day her knee was swollen, and she has super strong muscle pain so strong she cannot walk and is in bed at a hotel. She was asking what she can do. The report not related to a study or programme. She wanted to know if okay or normal. Stated that it was because of the vaccine. Stated that she was 17.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient states a couple days after her vaccine, she had severe shoulder pain and lost range of motion in arm/shoulder; after visit with MD her diagnosis was shoulder injury related to vaccine administration. She is still experiencing shoulder pain/loss of range of motion 2 weeks after vaccination.
Pt had a large red swollen area that turned into a couple of different blisters. The injection was on the 3rd of August and the reaction occured on 8/04/04 in the evening. This was approximently 24 hours after the injection.Pt's mom was instructed to use warm compresses and watch closely, call our office or go to ER if SOB develops.
erythema & swelling @ site of inj;told to take DPH & warm compresses;
Pt received both doses of the Moderna COVID-19 vaccine, on 3/15/2021 and 4/12/2021.  He developed minor symptoms of COVID-19 and tested positive via PCR test on 7/29/2021.  He did not need to be hospitalized.
Pfizer Bivalent 12yrs+ was administered to a patient as a first dose in the Primary COVDI vaccine series. Per CDC guidance, this will be used as dose 1. Patient will be scheduled Dose 2 monovalent in 3-8 weeks.
Red splotchy rash to forehead, neck and between breasts starting later same day of vaccine or next day.  Denies itching or pain.  Minimal to no relief with OTC Benadryl.  Redness at injection site with approx. half-dollar sized circular erythema and red streak down to axilla.  States site is burning in sensation with mild itching.  Symptoms have not improved or worsened since onset, seen in office 2 days after vaccination.
stayed up all night, slept all day; Hallucinations/ just saw people but never heard voices; stayed up all night, slept all day; This is a spontaneous report from a contactable consumer (patient's daughter). An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EN5318, expiration date unknown) via an unspecified route of administration on the right arm on 01Feb2021 at a single dose as vaccine for COVID-19. The patient had no medical history and no concomitant medications.  On 01Feb2021 23:00, the patient experienced hallucinations. It was reported that patient started hallucinating on 01Feb2021 23:00 and just saw people but never heard voices. The reporter stated that her mom never had hallucinations ever. The patient feared people were in the house and stayed up all night (from 01Feb2021 23:00), slept all day (on 02Feb2021). The reporter wanted to know if they have ever heard of this happening. She has made an appointment with the patient's doctor. The outcome of the events was unknown.